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CIBINQO- abrocitinib tablet, film coated 
Pfizer Laboratories Div Pfizer Inc


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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use CIBINQO safely
and effectively. See full prescribing information for CIBINQO.

CIBINQO™ (abrocitinib) tablets, for oral use
Initial U.S. Approval: 2022


WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR
EVENTS (MACE), AND THROMBOSIS


SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.

 * Increased risk of serious bacterial, fungal, viral and opportunistic
   infections leading to hospitalization or death, including tuberculosis (TB).
   Discontinue treatment with CIBINQO if serious or opportunistic infection
   occurs. Test for latent TB before and during therapy; treat latent TB prior
   to use. Monitor all patients for active TB during treatment, even patients
   with initial negative latent TB test. (5.1)
 * Higher rate of all-cause mortality, including sudden cardiovascular death,
   with another JAK inhibitor vs. TNF blockers in rheumatoid arthritis (RA)
   patients. CIBINQO is not approved for use in RA patients. (5.2)
 * Malignancies have occurred with CIBINQO. Higher rate of lymphomas and lung
   cancers with another JAK inhibitor vs. TNF blockers in RA patients. (5.3)
 * MACE has occurred with CIBINQO. Higher rate of MACE (defined as
   cardiovascular death, myocardial infarction, and stroke) with another JAK
   inhibitor vs. TNF blockers in RA patients. (5.4)
 * Thrombosis has occurred with CIBINQO. Increased incidence of pulmonary
   embolism, venous and arterial thrombosis with another JAK inhibitor vs. TNF
   blockers. (5.5)









INDICATIONS AND USAGE

CIBINQO is a Janus kinase (JAK) inhibitor indicated for the treatment of adults
with refractory, moderate-to-severe atopic dermatitis whose disease is not
adequately controlled with other systemic drug products, including biologics, or
when use of those therapies is inadvisable. (1)

Limitation of Use: CIBINQO is not recommended for use in combination with other
JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.




DOSAGE AND ADMINISTRATION

 * For recommended testing, evaluations and procedures prior to CIBINQO
   initiation, see Full Prescribing Information. (2.1)
 * Recommended dosage is 100 mg orally once daily. (2.2)
 * 200 mg orally once daily is recommended for those patients who are not
   responding to 100 mg once daily. (2.2)
 * Moderate renal impairment: 50 mg once daily or 100 mg once daily for those
   patients who are not responding to 50 mg once daily. (2.3)
 * CYP2C19 poor metabolizer: 50 mg once daily or 100 mg once daily for those
   patients who are not responding to 50 mg once daily. (2.4)
 * For dosage modifications for certain adverse reactions, see Full Prescribing
   Information. (2.6)










DOSAGE FORMS AND STRENGTHS

CIBINQO Tablets: 50 mg, 100 mg, and 200 mg (3)


CONTRAINDICATIONS

Antiplatelet therapies except for low-dose aspirin (≤81 mg daily), during the
first 3 months of treatment. (4)


WARNINGS AND PRECAUTIONS

 * Laboratory Abnormalities: Laboratory monitoring is recommended due to
   potential changes in platelets, lymphocytes, and lipids. (5.6)
 * Immunizations: Avoid use of live vaccines prior to, during, and immediately
   after CIBINQO treatment. (5.7)










ADVERSE REACTIONS

Most common adverse reactions (≥1%) in subjects receiving 100 mg and 200 mg
include: nasopharyngitis, nausea, headache, herpes simplex, increased blood
creatinine phosphokinase, dizziness, urinary tract infection, fatigue, acne,
vomiting, oropharyngeal pain, influenza, gastroenteritis.

Most common adverse reactions (≥1%) in subjects receiving either 100 mg or 200
mg also include: impetigo, hypertension, contact dermatitis, upper abdominal
pain, abdominal discomfort, herpes zoster, and thrombocytopenia. (6.1)


To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or
FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.




DRUG INTERACTIONS

 * Strong inhibitors of CYP2C19: The recommended dose is 50 mg daily or 100 mg
   once daily for those patients who are not responding to 50 mg once daily.
   (2.5, 7.1)
 * Moderate to strong inhibitors of both CYP2C19 and CYP2C9, or strong CYP2C19
   or CYP2C9 inducers: Avoid concomitant use. (7.1)
 * P-gp substrate where small concentration changes may lead to serious or
   life-threatening toxicities: Monitor or titrate dosage of P-gp substrate.
   (7.2)





USE IN SPECIFIC POPULATIONS

 * Lactation: Breastfeeding not recommended. (8.2)
 * Renal Impairment: Avoid use in patients with severe renal impairment or
   end-stage renal disease. (8.6)
 * Hepatic Impairment: Avoid use in patients with severe hepatic impairment.
   (8.7)





















See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 1/2022


FULL PRESCRIBING INFORMATION: CONTENTS*


WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR
EVENTS, AND THROMBOSIS


1 INDICATIONS AND USAGE





2 DOSAGE AND ADMINISTRATION


2.1 RECOMMENDED TESTING, EVALUATIONS, AND PROCEDURES PRIOR TO TREATMENT
INITIATION


2.2 RECOMMENDED DOSAGE


2.3 RECOMMENDED DOSAGE IN PATIENTS WITH RENAL IMPAIRMENT OR HEPATIC IMPAIRMENT


2.4 RECOMMENDED DOSAGE IN CYP2C19 POOR METABOLIZERS


2.5 DOSAGE MODIFICATIONS DUE TO STRONG INHIBITORS


2.6 TREATMENT DISCONTINUATION DUE TO SERIOUS INFECTIONS OR HEMATOLOGIC ADVERSE
REACTIONS


2.7 ADMINISTRATION INSTRUCTIONS


3 DOSAGE FORMS AND STRENGTHS


4 CONTRAINDICATIONS


5 WARNINGS AND PRECAUTIONS


5.1 SERIOUS INFECTIONS


5.2 MORTALITY


5.3 MALIGNANCY AND LYMPHOPROLIFERATIVE DISORDERS


5.4 MAJOR ADVERSE CARDIOVASCULAR EVENTS


5.5 THROMBOSIS


5.6 LABORATORY ABNORMALITIES


5.7 IMMUNIZATIONS


6 ADVERSE REACTIONS


6.1 CLINICAL TRIALS EXPERIENCE


7 DRUG INTERACTIONS


7.1 EFFECTS OF OTHER DRUGS ON CIBINQO


7.2 EFFECTS OF CIBINQO ON OTHER DRUGS


8 USE IN SPECIFIC POPULATIONS


8.1 PREGNANCY


8.2 LACTATION


8.3 FEMALES AND MALES OF REPRODUCTIVE POTENTIAL


8.4 PEDIATRIC USE


8.5 GERIATRIC USE


8.6 RENAL IMPAIRMENT


8.7 HEPATIC IMPAIRMENT


8.8 CYP2C19 POOR METABOLIZERS


10 OVERDOSAGE


11 DESCRIPTION


12 CLINICAL PHARMACOLOGY


12.1 MECHANISM OF ACTION


12.2 PHARMACODYNAMICS


12.3 PHARMACOKINETICS


12.5 PHARMACOGENOMICS


13 NONCLINICAL TOXICOLOGY


13.1 CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY


14 CLINICAL STUDIES


16 HOW SUPPLIED/STORAGE AND HANDLING


17 PATIENT COUNSELING INFORMATION

*Sections or subsections omitted from the full prescribing information are not
listed.


FULL PRESCRIBING INFORMATION




WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR
EVENTS, AND THROMBOSIS

Serious Infections

Patients treated with CIBINQO may be at increased risk for developing serious
infections that may lead to hospitalization or death; The most frequent serious
infections reported with CIBINQO were herpes simplex, herpes zoster, and
pneumonia [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)].

If a serious or opportunistic infection develops, discontinue CIBINQO and
control the infection.

Reported infections from Janus kinase (JAK) inhibitors used to treat
inflammatory conditions:

 * Active tuberculosis, which may present with pulmonary or extrapulmonary
   disease. Test for latent TB before and during therapy; treat latent TB prior
   to use. Monitor all patients for active TB during treatment, even patients
   with initial negative, latent TB test.
 * Invasive fungal infections, including cryptococcosis and pneumocystosis.
   Patients with invasive fungal infections may present with disseminated,
   rather than localized, disease.
 * Bacterial, viral, including herpes zoster, and other infections due to
   opportunistic pathogens.

Avoid use of CIBINQO in patients with an active, serious infection including
localized infections. The risks and benefits of treatment with CIBINQO should be
carefully considered prior to initiating therapy in patients with chronic or
recurrent infections.

Patients should be closely monitored for the development of signs and symptoms
of infection during and after treatment with CIBINQO, including the possible
development of tuberculosis in patients who tested negative for latent
tuberculosis infection prior to initiating therapy [see Warnings and Precautions
(5.1)].

Mortality

In a large, randomized, postmarketing safety study in rheumatoid arthritis (RA)
patients 50 years of age and older with at least one cardiovascular risk factor
comparing another JAK inhibitor to TNF blocker treatment, a higher rate of
all-cause mortality, including sudden cardiovascular death, was observed with
the JAK inhibitor. CIBINQO is not approved for use in RA patients [see Warnings
and Precautions (5.2)].

Malignancies

Malignancies were reported in patients treated with CIBINQO. Lymphoma and other
malignancies have been observed in patients receiving JAK inhibitors used to
treat inflammatory conditions. In RA patients treated with another JAK
inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer
(NMSC)) was observed when compared with TNF blockers. Patients who are current
or past smokers are at additional increased risk [see Warnings and Precautions
(5.3)].

Major Adverse Cardiovascular Events

Major adverse cardiovascular events were reported in patients treated with
CIBINQO. In RA patients 50 years of age and older with at least one
cardiovascular risk factor treated with another JAK inhibitor, a higher rate of
major adverse cardiovascular events (MACE) (defined as cardiovascular death,
myocardial infarction, and stroke), was observed when compared with TNF
blockers. Patients who are current or past smokers are at additional increased
risk. Discontinue CIBINQO in patients that have experienced a myocardial
infarction or stroke [see Warnings and Precautions (5.4)].

Thrombosis

Deep venous thrombosis (DVT) and pulmonary embolism (PE) have been reported in
patients treated with CIBINQO. Thrombosis, including PE, DVT, and arterial
thrombosis have been reported in patients receiving JAK inhibitors used to treat
inflammatory conditions. Many of these adverse reactions were serious and some
resulted in death. In RA patients 50 years of age and older with at least one
cardiovascular risk factor treated with another JAK inhibitor, a higher rate of
thrombosis was observed when compared with TNF blockers. Avoid CIBINQO in
patients at risk. If symptoms of thrombosis occur, discontinue CIBINQO and treat
appropriately [see Warnings and Precautions (5.5)].


1 INDICATIONS AND USAGE

CIBINQO is indicated for the treatment of adults with refractory,
moderate-to-severe atopic dermatitis whose disease is not adequately controlled
with other systemic drug products, including biologics, or when use of those
therapies is inadvisable.

Limitations of Use

CIBINQO is not recommended for use in combination with other JAK inhibitors,
biologic immunomodulators, or with other immunosuppressants.


2 DOSAGE AND ADMINISTRATION


2.1 RECOMMENDED TESTING, EVALUATIONS, AND PROCEDURES PRIOR TO TREATMENT
INITIATION

Perform the following tests and evaluations prior to CIBINQO initiation:

 * Tuberculosis (TB) infection evaluation – CIBINQO initiation is not
   recommended in patients with active TB. For patients with latent TB or those
   with a negative latent TB test who are at high risk for TB, start preventive
   therapy for latent TB prior to initiation of CIBINQO [see Warnings and
   Precautions (5.1)].
 * Viral hepatitis screening in accordance with clinical guidelines – CIBINQO
   initiation is not recommended in patients with active hepatitis B or
   hepatitis C [see Warnings and Precautions (5.1)].
 * A complete blood count (CBC) – CIBINQO initiation is not recommended in
   patients with a platelet count <150,000/mm3, an absolute lymphocyte count
   <500/mm3, an absolute neutrophil count <1,000/mm3, or a hemoglobin value <8
   g/dL [see Warnings and Precautions (5.6)].

Complete any necessary immunizations, including herpes zoster vaccinations, in
agreement with current immunization guidelines prior to CIBINQO initiation [see
Warnings and Precautions (5.7)].


2.2 RECOMMENDED DOSAGE

The recommended dosage of CIBINQO is 100 mg orally once daily.

If an adequate response is not achieved with CIBINQO 100 mg orally daily after
12 weeks, consider increasing dosage to 200 mg orally once daily. Discontinue
therapy if inadequate response is seen after dosage increase to 200 mg once
daily.

CIBINQO can be used with or without topical corticosteroids.

If a dose is missed, administer the dose as soon as possible unless it is less
than 12 hours before the next dose, in which case skip the missed dose.
Thereafter, resume dosing at the regular scheduled time.


2.3 RECOMMENDED DOSAGE IN PATIENTS WITH RENAL IMPAIRMENT OR HEPATIC IMPAIRMENT

Renal Impairment

CIBINQO dosage recommendations for patients with renal impairment are provided
in Table 1 [see Use in Specific Populations (8.6) and Clinical Pharmacology
(12.3)]. In subjects with mild and moderate renal impairment, if an adequate
response is not achieved after 12 weeks, dose of CIBINQO can be doubled [see
Dosage and Administration (2.2)].

Table 1. Dosage Recommendations in Patients with Renal ImpairmentRenal
Impairment StageEstimated Glomerular Filtration (eGFR)*Dosage*Glomerular
filtration rate was estimated by the Modification of Diet in Renal Disease
(MDRD) formula.†Severe Renal Impairment and End-Stage Renal Disease include
patients on renal replacement therapy.Mild60 – 89 mL/minuteCIBINQO 100 mg once
dailyModerate30 – 59 mL/minuteCIBINQO 50 mg once dailySevere†15 – 29
mL/minuteNot recommended for useEnd-Stage Renal Disease† (ESRD)<15 mL/minute

Hepatic Impairment

CIBINQO is not recommended for use in patients with severe hepatic impairment
[see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].


2.4 RECOMMENDED DOSAGE IN CYP2C19 POOR METABOLIZERS

In patients who are known or suspected to be CYP2C19 poor metabolizers, the
recommended dosage of CIBINQO is 50 mg once daily [see Use in Specific
Populations (8.8) and Clinical Pharmacology (12.5)]. If an adequate response is
not achieved with CIBINQO 50 mg orally daily after 12 weeks, consider increasing
dosage to 100 mg orally once daily. Discontinue therapy if inadequate response
is seen after dosage increase to 100 mg once daily.


2.5 DOSAGE MODIFICATIONS DUE TO STRONG INHIBITORS

In patients taking strong inhibitors of cytochrome P450 (CYP) 2C19 reduce the
dosage to 50 mg once daily [see Drug Interactions (7.1) and Clinical
Pharmacology (12.3)]. If an adequate response is not achieved with CIBINQO 50 mg
orally daily after 12 weeks, consider increasing dosage to 100 mg orally once
daily. Discontinue therapy if inadequate response is seen after dosage increase
to 100 mg once daily.


2.6 TREATMENT DISCONTINUATION DUE TO SERIOUS INFECTIONS OR HEMATOLOGIC ADVERSE
REACTIONS

Serious or Opportunistic Infections

If a patient develops a serious or opportunistic infection, discontinue CIBINQO
and control the infection. The risks and benefits of treatment with CIBINQO
should be carefully considered prior to reinitiating therapy with CIBINQO [see
Warnings and Precautions (5.1)].

Hematologic Abnormalities

Recommendations for CIBINQO discontinuation for laboratory abnormalities are
summarized in Table 2.

Table 2. Recommendations for CIBINQO Discontinuation for Hematologic
AbnormalitiesLaboratory MeasureRecommendationAbbreviations: ALC=absolute
lymphocyte count; ANC=absolute neutrophil count; CBC=complete blood count;
Hb=hemoglobinPlatelet Count <50,000/mm3Discontinue CIBINQO and follow with CBC
until >100,000/mm3ALC <500/mm3Treatment should be temporarily discontinued if
ALC is less than 500 cells/mm3 and may be restarted once ALC return above this
valueANC <1,000/mm3Treatment should be temporarily discontinued if ANC is less
than 1,000 cells/mm3 and may be restarted once ANC return above this valueHb
value <8 g/dLTreatment should be temporarily discontinued if Hb is less than 8
g/dL and may be restarted once Hb return above this value

CBC evaluations are recommended at baseline, 4 weeks after treatment initiation
and 4 weeks after dosing increase of CIBINQO. Laboratory evaluations may be
extended for patients on chronic CIBINQO therapy who develop hematologic
abnormalities [see Warnings and Precautions (5.6)].


2.7 ADMINISTRATION INSTRUCTIONS

Administer CIBINQO with or without food at approximately the same time each day.

Swallow CIBINQO tablets whole with water. Do not crush, split, or chew CIBINQO
tablets.


3 DOSAGE FORMS AND STRENGTHS

 * 50 mg: Pink, oval, film-coated tablet debossed with "PFE" on one side and
   "ABR 50" on the other.
 * 100 mg: Pink, round, film-coated tablet debossed with "PFE" on one side and
   "ABR 100" on the other.
 * 200 mg: Pink, oval, film-coated tablet debossed with "PFE" on one side and
   "ABR 200" on the other.


4 CONTRAINDICATIONS

CIBINQO is contraindicated in patients taking antiplatelet therapies, except for
low-dose aspirin (≤81 mg daily), during the first 3 months of treatment [see
Warnings and Precautions (5.6), Drug Interactions (7.2), and Clinical
Pharmacology (12.2)].


5 WARNINGS AND PRECAUTIONS


5.1 SERIOUS INFECTIONS

The most frequent serious infections reported in clinical studies with CIBINQO
for atopic dermatitis were herpes simplex, herpes zoster, and pneumonia [see
Adverse Reactions (6.1)]. Serious infections leading to hospitalization or
death, including tuberculosis and bacterial, invasive fungal, viral, and other
opportunistic infections, have occurred in patients receiving JAK inhibitors
used to treat inflammatory conditions.

Avoid use of CIBINQO in patients with active, serious infection including
localized infections.

Consider the risks and benefits of treatment prior to initiating CIBINQO in
patients:

 * with chronic or recurrent infection
 * who have been exposed to tuberculosis
 * with a history of a serious or an opportunistic infection
 * who have resided or traveled in areas of endemic tuberculosis or endemic
   mycoses
 * with underlying conditions that may predispose them to infection

Closely monitor patients for the development of signs and symptoms of infection
during and after treatment with CIBINQO. If a patient develops a serious or
opportunistic infection, discontinue CIBINQO. Initiate complete diagnostic
testing and appropriate antimicrobial therapy. The risks and benefits of
treatment with CIBINQO should be carefully considered prior to reinitiating
therapy with CIBINQO.

Tuberculosis

Evaluate and test patients for TB before starting CIBINQO therapy and consider
yearly screening for patients in highly endemic areas for TB. CIBINQO is not
recommended for use in patients with active TB. For patients with a new
diagnosis of latent TB or prior untreated latent TB, or for patients with a
negative test for latent TB but who are at high risk for TB infection, start
preventive therapy for latent TB prior to initiation of CIBINQO. Monitor
patients for the development of signs and symptoms of TB, including patients who
were tested negative for latent TB infection prior to initiating therapy.

Viral Reactivation

Viral reactivation, including herpes virus reactivation (e.g., herpes zoster,
herpes simplex), was reported in clinical studies with CIBINQO [see Adverse
Reactions (6.1)]. If a patient develops herpes zoster, consider interrupting
CIBINQO until the episode resolves.

Hepatitis B virus (HBV) reactivation has been reported in patients receiving JAK
inhibitors. Perform viral hepatitis screening and monitoring for reactivation in
accordance with clinical guidelines before starting therapy and during therapy
with CIBINQO. CIBINQO is not recommended for use in patients with active
hepatitis B or hepatitis C [see Clinical Pharmacology (12.3)]. Monitor patients
with inactive HBV for expression of HBV DNA during therapy with CIBINQO. If HBV
DNA is detected during therapy with CIBINQO, consult a liver specialist.


5.2 MORTALITY

In a large, randomized, postmarketing safety study of another JAK inhibitor in
rheumatoid arthritis (RA) patients 50 years of age and older with at least one
cardiovascular risk factor, a higher rate of all-cause mortality, including
sudden cardiovascular death, was observed in patients treated with the JAK
inhibitor compared with TNF blockers. CIBINQO is not approved for use in RA.

Consider the benefits and risks for the individual patient prior to initiating
or continuing therapy with CIBINQO.


5.3 MALIGNANCY AND LYMPHOPROLIFERATIVE DISORDERS

Malignancies, including non-melanoma skin cancer (NMSC), were observed in
clinical studies with CIBINQO for atopic dermatitis [see Adverse Reactions
(6.1)].

Perform periodic skin examination for patients who are at increased risk for
skin cancer. Exposure to sunlight and UV light should be limited by wearing
protective clothing and using broad-spectrum sunscreen.

Malignancies, including lymphomas, have occurred in patients receiving JAK
inhibitors used to treat inflammatory conditions. In a large, randomized,
postmarketing safety study of another JAK inhibitor in RA patients, a higher
rate of malignancies (excluding non-melanoma skin cancer (NMSC)) was observed in
patients treated with the JAK inhibitor compared to those treated with TNF
blockers. CIBINQO is not approved for use in RA. A higher rate of lymphomas was
observed in patients treated with the JAK inhibitor compared to those treated
with TNF blockers. A higher rate of lung cancers was observed in current or past
smokers treated with the JAK inhibitor compared to those treated with TNF
blockers. In this study, current or past smokers had an additional increased
risk of overall malignancies.

Consider the benefits and risks for the individual patient prior to initiating
or continuing therapy with CIBINQO, particularly in patients with a known
malignancy (other than a successfully treated NMSC), patients who develop a
malignancy when on treatment, and patients who are current or past smokers.


5.4 MAJOR ADVERSE CARDIOVASCULAR EVENTS

Major adverse cardiovascular events were reported in clinical studies of CIBINQO
for atopic dermatitis [see Adverse Reactions (6.1)].

In a large, randomized, postmarketing safety study of another JAK inhibitor in
RA patients 50 years of age and older with at least one cardiovascular risk
factor, a higher rate of major adverse cardiovascular events (MACE) defined as
cardiovascular death, non-fatal myocardial infarction (MI), and non-fatal stroke
was observed with the JAK inhibitor compared to those treated with TNF blockers.
CIBINQO is not approved for use in RA. Patients who are current or past smokers
are at additional increased risk.

Consider the benefits and risks for the individual patient prior to initiating
or continuing therapy with CIBINQO, particularly in patients who are current or
past smokers and patients with other cardiovascular risk factors. Patients
should be informed about the symptoms of serious cardiovascular events and the
steps to take if they occur. Discontinue CIBINQO in patients that have
experienced a myocardial infarction or stroke.


5.5 THROMBOSIS

Deep venous thrombosis (DVT) and pulmonary embolism (PE) were observed in
patients receiving CIBINQO in the clinical studies for atopic dermatitis [see
Adverse Reactions (6.1)].

Thrombosis, including DVT, PE, and arterial thrombosis have been reported in
patients receiving JAK inhibitors used to treat inflammatory conditions. Many of
these adverse reactions were serious and some resulted in death.

In a large, randomized, postmarketing safety study of another JAK inhibitor in
RA patients 50 years of age and older with at least one cardiovascular risk
factor, higher rates of overall thrombosis, DVT, and PE were observed compared
to those treated with TNF blockers. CIBINQO is not approved for use in RA.

Avoid CIBINQO in patients that may be at increased risk of thrombosis. If
symptoms of thrombosis occur, discontinue CIBINQO and evaluate and treat
patients appropriately.


5.6 LABORATORY ABNORMALITIES

Hematologic Abnormalities

Treatment with CIBINQO was associated with an increased incidence of
thrombocytopenia and lymphopenia [see Adverse Reactions (6.1)]. Prior to CIBINQO
initiation, perform a CBC [see Dosage and Administration (2.1)]. CBC evaluations
are recommended at 4 weeks after initiation and 4 weeks after dose increase of
CIBINQO. Discontinuation of CIBINQO therapy is required for certain laboratory
abnormalities [see Dosage and Administration (2.6)].

Lipid Elevations

Dose-dependent increase in blood lipid parameters were reported in patients
treated with CIBINQO [see Adverse Reactions (6.1)]. Lipid parameters should be
assessed approximately 4 weeks following initiation of CIBINQO therapy and
thereafter patients should be managed according to clinical guidelines for
hyperlipidemia. The effect of these lipid parameter elevations on cardiovascular
morbidity and mortality has not been determined.


5.7 IMMUNIZATIONS

Prior to initiating CIBINQO, complete all age-appropriate vaccinations as
recommended by current immunization guidelines including prophylactic herpes
zoster vaccinations. Avoid vaccination with live vaccines immediately prior to,
during, and immediately after CIBINQO therapy.


6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere
in the labeling:

 * Serious Infections [see Warnings and Precautions (5.1)]
 * Mortality [see Warnings and Precautions (5.2)]
 * Malignancy and Lymphoproliferative Disorders [see Warnings and Precautions
   (5.3)]
 * Major Adverse Cardiovascular Events [see Warnings and Precautions (5.4)]
 * Thrombosis [see Warnings and Precautions (5.5)]
 * Laboratory Abnormalities [see Warnings and Precautions (5.6)]


6.1 CLINICAL TRIALS EXPERIENCE

Because clinical trials are conducted under widely varying conditions, adverse
reaction rates observed in the clinical trials of a drug cannot be directly
compared to rates in the clinical trials of another drug and may not reflect the
rates observed in practice.

The safety of CIBINQO was evaluated in four randomized, placebo-controlled
clinical trials (2 monotherapy, 1 combination therapy with topical
corticosteroid, and 1 dose-ranging) and one long-term extension trial in
subjects with moderate to severe atopic dermatitis (AD). A total of 1623
subjects with moderate to severe atopic dermatitis were treated with CIBINQO in
these clinical trials representing 1428 patient-years of exposure. There were
634 subjects with at least 1 year of exposure to CIBINQO.

In the placebo-controlled clinical trials, a total of 1198 subjects were exposed
to CIBINQO with 608 subjects receiving CIBINQO 100 mg once daily and 590
subjects receiving CIBINQO 200 mg once daily for up to 16 weeks. The median age
of subjects was 33.0 years, 124 subjects (8.1%) were 12 to less than 18 years
old and 94 subjects (6.1%) were 65 years of age or older. The majority of
subjects were White (68.7%) and male (53.9%). While subjects aged 12 to 17 years
were included in these trials, CIBINQO is not approved for use in pediatric
subjects [see Use in Specific Populations (8.4)].

Adverse reactions occurring at ≥1% in any of the treated groups and at a higher
rate than in the placebo group are presented in Table 3. A total of 61 (5.1%)
subjects treated with CIBINQO were discontinued from the trials due to adverse
reactions. The safety profile of CIBINQO in the monotherapy and the combination
trial(s) were similar.

Table 3. Adverse Reactions from Placebo-Controlled Trials Reported in ≥1% of
CIBINQO Treated Subjects with Moderate to Severe Atopic Dermatitis and at Higher
Rate than Placebo for up to 16 WeeksWeeks 0–16CIBINQO
200 mg
N=590
n (%*)CIBINQO
100 mg
N=608
n (%*)Placebo
N=342
n (%*)*Study size adjusted percentages†Herpes simplex also includes oral herpes,
ophthalmic herpes, herpes dermatitis, genital herpes.Nasopharyngitis51 (8.7)75
(12.4)27 (7.9)Nausea86 (14.5)37 (6.0)7 (2.1)Headache46 (7.8)36 (6.0)12
(3.5)Herpes simplex†25 (4.2)20 (3.3)6 (1.8)Increased blood creatinine
phosphokinase17 (2.9)14 (2.3)5 (1.5)Dizziness17 (2.9)11 (1.8)3 (0.9)Urinary
tract infection13 (2.2)10 (1.7)4 (1.2)Fatigue8 (1.3)10 (1.6)2 (0.5)Acne28
(4.7)10 (1.6)0 (0.0)Vomiting19 (3.2)9 (1.5)3 (0.9)Impetigo3 (0.5)9 (1.5)1
(0.3)Oropharyngeal pain6 (1.0)8 (1.4)2 (0.6)Hypertension5 (0.8)7 (1.2)2
(0.7)Influenza6 (1.1)7 (1.2)0 (0.0)Gastroenteritis8 (1.3)7 (1.1)2
(0.6)Dermatitis contact3 (0.5)6 (1.1)1 (0.3)Abdominal pain upper11 (1.9)4 (0.6)0
(0.0)Abdominal discomfort7 (1.2)3 (0.5)1 (0.3)Herpes zoster7 (1.2)2 (0.3)0
(0.0)Thrombocytopenia9 (1.5)0 (0.0)0 (0.0)

Specific Adverse Reactions

Exposure adjusted incidence rates were adjusted by trial size for all the
adverse reactions reported in this section.

Overall Infections

In the placebo-controlled trials, for up to 16 weeks, overall infections were
reported in 90 subjects (126.8 per 100 patient-years) treated with placebo, 211
subjects (168.8 per 100 patient-years) treated with CIBINQO 100 mg and 204
subjects (159.5 per 100 patient-years) treated with CIBINQO 200 mg. In all 5
clinical trials, including the long-term extension trial, overall infections
were reported in 427 subjects (91.8 per 100 patient-years) treated with CIBINQO
100 mg and 394 subjects (103.2 per 100 patient-years) treated with CIBINQO 200
mg.

Serious Infections

In the placebo-controlled trials, for up to 16 weeks, serious infections were
reported in 2 subjects (2.6 per 100 patient-years) treated with placebo, 6
subjects (3.9 per 100 patient-years) treated with CIBINQO 100 mg, and 2 subjects
(1.3 per 100 patient-years) treated with CIBINQO 200 mg. In all 5 clinical
trials, including the long-term extension trial, serious infections were
reported in 18 subjects (2.3 per 100 patient-years) treated with CIBINQO 100 mg
and 16 subjects (2.3 per 100 patient-years) treated with CIBINQO 200 mg. The
most commonly reported serious infections were herpes simplex, herpes zoster,
and pneumonia.

Herpes Zoster

In the placebo-controlled trials, for up to 16 weeks, opportunistic infections
were generally cases of multidermatomal cutaneous herpes zoster. Herpes zoster
was reported in 0 subjects treated with placebo, 3 subjects (1.9 per 100
patient-years) treated with CIBINQO 100 mg and 8 subjects (5.1 per 100
patient-years) treated with CIBINQO 200 mg. In all 5 clinical trials, including
the long-term extension trial, herpes zoster was reported in 16 subjects (2.0
per 100 patient-years) treated with CIBINQO 100 mg and 35 subjects (5.2 per 100
patient-years) treated with CIBINQO 200 mg.

Malignancy

In the placebo-controlled trials, for up to 16 weeks, no malignancy was reported
in subjects treated with placebo or CIBINQO 100 mg and in 1 patient (0.65 per
100 patient-years) treated with CIBINQO 200 mg. In all 5 clinical trials,
including the long-term extension trial, malignancy was reported in 4 subjects
(0.5 per 100 patient-years) treated with CIBINQO 100 mg and 2 subjects (0.3 per
100 patient-years) treated with CIBINQO 200 mg.

Thrombosis

In all clinical trials, including the long-term extension trial, pulmonary
embolism was reported in 3 subjects (0.4 per 100 patient-years), who were
treated with CIBINQO 200 mg. Deep vein thrombosis was reported in 2 subjects
(0.3 per 100 patient-years) who were treated with CIBINQO 200 mg. No thrombosis
occurred in subjects treated with CIBINQO 100 mg.

Major Adverse Cardiovascular Events

In the placebo-controlled trials, for up to 16 weeks, major adverse
cardiovascular event (MACE) was reported in 1 subject (0.6 per 100
patient-years) treated with CIBINQO 100 mg. In all 5 clinical trials, including
the long-term extension trial, MACE was reported in 1 patient (0.1 per 100
patient-years) treated with CIBINQO 100 mg and 2 subjects (0.3 per 100
patient-years) treated with CIBINQO 200 mg.

Thrombocytopenia

In the placebo-controlled trials, for up to 16 weeks, treatment with CIBINQO was
associated with a dose-related decrease in platelet count. Maximum effects on
platelets were observed within 4 weeks, after which the platelet count returned
towards baseline despite continued therapy. In all 5 clinical trials, including
the long-term extension trial 6 subjects (0.9 per 100 patient-years) treated
with CIBINQO 200 mg had adverse reactions of thrombocytopenia, no subjects
treated with CIBINQO 100 mg had an adverse reaction of thrombocytopenia.

Lymphopenia

In the placebo-controlled trials, for up to 16 weeks, confirmed ALC <500/mm3
occurred in 2 subjects (1.2 per 100 patient-years) treated with CIBINQO 200 mg
and 0 subjects treated with CIBINQO 100 mg or placebo. Both cases occurred in
the first 4 weeks of exposure.

Lipid Elevations

In the placebo-controlled trials, for up to 16 weeks, there was a dose-related
percent increase in low-density lipoprotein cholesterol (LDL-c), total
cholesterol, and high-density lipoprotein cholesterol (HDL-c) relative to
placebo at Week 4 which remained elevated through the final visit in the
treatment period. Adverse reactions related to hyperlipidemia occurred in 1
subject (0.6 per 100 patient-years) exposed to CIBINQO 100 mg, 3 subjects (2.0
per 100 patient-years) exposed to CIBINQO 200 mg.

Retinal Detachment

In the placebo-controlled trials, for up to 16 weeks, retinal detachment
occurred in 1 subject (0.6 per 100 patient-years) treated with CIBINQO 100 mg.
In all 5 clinical trials, including the long-term extension trial, retinal
detachment occurred in 2 subjects (0.3 per 100 patient-years) treated with
CIBINQO 100 mg.

Creatine Phosphokinase Elevations (CPK)

In the placebo-controlled trials, for up to 16 weeks, events of blood CPK
increased were reported in 6 subjects (7.5 per 100 patient-years) treated with
placebo, 11 subjects (6.9 per 100 patient-years) treated with 100 mg of CIBINQO
and 19 subjects (12.3 per 100 patient-years) treated with 200 mg of CIBINQO.
Most elevations were transient, there were no reported adverse reactions of
rhabdomyolysis.


7 DRUG INTERACTIONS


7.1 EFFECTS OF OTHER DRUGS ON CIBINQO

Table 4 includes drugs with clinically significant drug interactions affecting
CIBINQO.

Table 4. Clinically Significant Drug Interactions Affecting CIBINQO Strong
CYP2C19 Inhibitors Clinical ImpactCoadministration of CIBINQO with strong
CYP2C19 inhibitors increases the combined exposure of abrocitinib and its two
active metabolites, M1 and M2 which may increase the adverse reactions of
CIBINQO [see Clinical Pharmacology (12.3)].InterventionDosage reduction of
CIBINQO is recommended when coadministered with strong CYP2C19 inhibitors [see
Dosage and Administration (2.5)].Moderate to Strong Inhibitors of both CYP2C19
and CYP2C9Clinical ImpactCoadministration of CIBINQO with drugs that are
moderate to strong inhibitors of both CYP2C19 and CYP2C9 increases the exposure
of abrocitinib and its two active metabolites, M1 and M2 which may increase the
adverse reactions of CIBINQO [Clinical Pharmacology (12.3)].InterventionAvoid
concomitant use of CIBINQO with drugs that are moderate to strong inhibitors of
both CYP2C19 and CYP2C9.Strong CYP2C19 or CYP2C9 Inducers Clinical
ImpactCoadministration of CIBINQO with strong CYP2C19 or CYP2C9 inducers
decreases the combined exposure of abrocitinib and its two active metabolites,
M1 and M2, which may result in loss of or reduced clinical response [see
Clinical Pharmacology (12.3)].InterventionAvoid concomitant use of CIBINQO with
strong CYP2C19 or CYP2C9 inducers.


7.2 EFFECTS OF CIBINQO ON OTHER DRUGS

Table 5 includes clinically significant drug interactions affecting other drugs.

Table 5. Clinically Significant Interactions Affecting Other Drugs P-gp
Substrate Where Small Concentration Changes May Lead to Serious or
Life-threatening ToxicitiesClinical ImpactCoadministration of CIBINQO with P-gp
substrate increases plasma concentrations of P-gp substrates and may result in
potential adverse reactions of the P-gp substrate where small concentration
changes may lead to serious or life-threatening toxicities (e.g., digoxin) [see
Clinical Pharmacology (12.3)].InterventionMonitor appropriately or dose titrate
P-gp substrate where small concentration changes may lead to serious or
life-threatening toxicities when coadministered with CIBINQO.Antiplatelet
Therapy DrugsClinical ImpactCoadministration of CIBINQO with antiplatelet
therapy drugs may increase the risk of bleeding with thrombocytopenia [see
Warnings and Precautions (5.5) and Clinical Pharmacology
(12.2)].InterventionAntiplatelet drugs, except for low-dose aspirin (≤81 mg
daily), during the first 3 months of treatment are contraindicated with CIBINQO
[see Contraindications (4)].


8 USE IN SPECIFIC POPULATIONS


8.1 PREGNANCY

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women
exposed to CIBINQO during pregnancy. Pregnant women exposed to CIBINQO and
health care providers are encouraged to call 1-877-311-3770.

Risk Summary

Available data from pregnancies reported in clinical trials with CIBINQO are not
sufficient to establish a drug-associated risk for major birth defects,
miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction
studies, oral administration of abrocitinib to pregnant rats and rabbits during
organogenesis at exposure 14 or 5 times the maximum recommended human dose
(MRHD) based on AUC comparison, respectively, resulted in maternal dystocia and
skeletal variations in rats and no adverse effects in rabbits (see Data).

The background risks of major birth defects and miscarriage for the indicated
population are unknown. All pregnancies carry some risk of birth defects, loss,
or other adverse outcomes. The background risks in the U.S. general population
of major birth defects and miscarriages are 2–4% and 15–20% of clinically
recognized pregnancies, respectively.

Data

Animal Data

In an embryofetal development study, abrocitinib was administered orally to
pregnant rats at doses of 10, 30, or 60 mg/kg/day during the period of
organogenesis. No fetal malformations were observed. Abrocitinib increased the
incidence of skeletal variations of short 13th ribs at 30 mg/kg/day (14 times
the MRHD based on AUC comparison). Increased embryofetal lethality and
additional skeletal variations (cervical arches with reduced ventral processes,
thickened ribs, and unossified metatarsals) were noted at 60 mg/kg/day (22 times
the MRHD based on AUC comparison).

In an embryofetal development study, abrocitinib was administered orally to
pregnant rabbits at doses of 10, 30, or 75 mg/kg/day during the period of
organogenesis. No abrocitinib-related maternal or developmental toxicity was
noted at doses up to 75 mg/kg/day (5 times the MRHD based on AUC comparison).

In a prenatal and postnatal development study, abrocitinib was administered
orally to pregnant rats at doses of 10, 30, and 60 mg/kg/day beginning on
gestation day 6 and continuing through lactation day 20. Dystocia with prolonged
parturition and reduced offspring body weights were noted at 30 mg/kg/day (14
times the MRHD based on AUC comparison). Postnatal survival was markedly
decreased at 60 mg/kg/day (22 times the MRHD based on AUC comparison). No
maternal toxicity was observed at 10 mg/kg/day (3 times the MRHD based on AUC
comparison). No abrocitinib-related effects on postnatal developmental,
neurobehavioral, or reproductive performance of offspring was noted at doses up
to 30 mg/kg/day (14 times the MRHD based on AUC comparison).


8.2 LACTATION

Risk Summary

There are no data on the presence of abrocitinib in human milk, the effects on
the breast-fed infant, or the effects on milk production. Abrocitinib was
secreted in milk of lactating rats (see Data). When a drug is present in animal
milk, it is likely that the drug will be present in human milk. Because of the
serious adverse findings in adults, including risks of serious infections,
malignancy, and thrombosis, advise women not to breastfeed during treatment with
CIBINQO and for one day after the last dose (approximately 5–6 elimination
half-lives).

Data

Animal Data

Lactating female rats were orally administered a single dose of 10 mg/kg
abrocitinib on lactation day 12. Abrocitinib AUC was approximately 5 times
greater in milk than in plasma.


8.3 FEMALES AND MALES OF REPRODUCTIVE POTENTIAL

Infertility

Females

Based on the findings in rats, oral administration of CIBINQO may impair female
fertility. Impaired fertility in female rats was reversible 1 month after
cessation of abrocitinib oral administration [see Nonclinical Toxicology
(13.1)].


8.4 PEDIATRIC USE

The safety and effectiveness of CIBINQO have not been established in pediatric
patients.

Juvenile Animal Toxicity Data

In a juvenile animal toxicity study, abrocitinib was administered orally to
juvenile rats at doses of 5, 25, and 75 mg/kg/day beginning on postnatal day 10
(approximately equivalent to a human infant) and continuing through postnatal
day 63 (approximately equivalent to an adolescent). Abrocitinib caused a
reversible, dose-related decrease in the primary spongiosa in the metaphysis of
the proximal tibia and distal femur. Abrocitinib produced adverse effects on
bone development at all dose levels. Abrocitinib caused irreversible
dose-related small or misshapen femoral heads at doses ≥5 mg/kg/day (1.1 times
the MRHD based on AUC comparison). Abrocitinib also irreversibly decreased femur
size and caused paw malrotation and limb impairment at doses ≥25 mg/kg/day (10
times the MRHD based on AUC comparison). At 75 mg/kg/day (36 times the MRHD
based on AUC comparison), paw fractures generally corresponded to limb
impairment, a fractured tibia was noted in a single female, and effects noted at
lower doses were increased in frequency and severity. Irreversible bone findings
have not been observed in older animals.


8.5 GERIATRIC USE

A total of 145 (4.6%) patients 65 years of age and older, while 25 (0.8%) were
75 years of age and older, were enrolled in CIBINQO clinical trials. Clinical
trials of CIBINQO did not include sufficient numbers of patients 65 years of age
and older to determine whether they respond differently from younger adult
patients.

A higher proportion of patients 65 years of age and older discontinued from
clinical trials compared to younger patients. Among all patients exposed to
CIBINQO, including the long-term extension trial, confirmed ALC <500/mm3
occurred only in patients 65 years of age and older. A higher proportion of
patients 65 years of age and older had platelet counts <75,000/mm3. The
incidence rate of herpes zoster in patients 65 years of age and older treated
with CIBINQO (7.40 per 100 patient-years) was higher than that of patients 18 to
less than 65 years of age (3.44 per 100 patient-years).


8.6 RENAL IMPAIRMENT

In patients with severe (eGFR <30 mL/min) and moderate (eGFR 30–59 mL/min) renal
impairment, the combined exposure (AUCinf,u) of abrocitinib and its two active
metabolites, M1 and M2, is increased compared to patients with normal renal
function (eGFR ≥90 mL/min) [see Clinical Pharmacology (12.3)]. This may increase
the risk of adverse reactions such as infections.

CIBINQO is not recommended for use in patients with severe renal impairment and
ESRD including those on renal replacement [see Dosage and Administration (2.3)].

A dosage reduction in patient with moderate renal impairment is recommended. No
dosage adjustment is required in patients with mild renal impairment (eGFR 60–89
mL/min) [see Dosage and Administration (2.3)].

CIBINQO has not been studied in patients on renal replacement therapy. In Phase
3 clinical trials, CIBINQO was not evaluated in patients with atopic dermatitis
with baseline creatinine clearance values less than 40 mL/min.


8.7 HEPATIC IMPAIRMENT

Avoid use of CIBINQO in patients with severe (Child Pugh C) hepatic impairment.

Dosage adjustment is not required in patients with mild (Child Pugh A) or
moderate (Child Pugh B) hepatic impairment based on similar combined exposure
(AUCinf,u) of abrocitinib and its two active metabolites, M1 and M2 compared to
patients with normal hepatic function. In clinical trials, CIBINQO was not
evaluated in patients with severe (Child Pugh C) hepatic impairment [see
Clinical Pharmacology (12.3)].


8.8 CYP2C19 POOR METABOLIZERS

In patients who are CYP2C19 poor metabolizers, the AUC of abrocitinib is
increased compared to CYP2C19 normal metabolizers due to reduced metabolic
clearance. Dosage reduction of CIBINQO is recommended in patients who are known
or suspected to be CYP2C19 poor metabolizers based on genotype or previous
history/experience with other CYP2C19 substrates [see Dosage and Administration
(2.4) and Clinical Pharmacology (12.5)].


10 OVERDOSAGE

There is no experience regarding human overdosage with CIBINQO. There is no
specific antidote for overdose with CIBINQO. In case of an overdose, call Poison
Control Center at 1-800-222-1222 for latest recommendations.


11 DESCRIPTION

CIBINQO (abrocitinib) tablets contain the free base of abrocitinib, a Janus
kinase (JAK) inhibitor, for oral administration.

Abrocitinib is a white to pale colored powder with the following chemical name:
N-((1s,3s)-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)cyclobutyl)propane-1-sulfonamide

The solubility of abrocitinib in water is 0.04 mg/mL at 25ºC.

Abrocitinib has a molecular weight of 323.42 g/mol and a molecular formula of
C14H21N5O2S. The structural formula of abrocitinib is:



Each film-coated tablet contains 50 mg or 100 mg or 200 mg of abrocitinib and
the following inactive ingredients: dibasic calcium phosphate anhydrous,
hypromellose, iron oxide red, lactose monohydrate, Macrogol, magnesium stearate,
microcrystalline cellulose, sodium starch glycolate, titanium dioxide, and
triacetin.


12 CLINICAL PHARMACOLOGY


12.1 MECHANISM OF ACTION

CIBINQO is a Janus kinase (JAK) inhibitor.

Abrocitinib reversibly inhibits JAK1 by blocking the adenosine triphosphate
(ATP) binding site. In a cell-free isolated enzyme assay, abrocitinib was
selective for JAK1 over JAK2 (28-fold), JAK3 (>340-fold), and tyrosine kinase
(TYK) 2 (43-fold), as well as the broader kinome. The relevance of inhibition of
specific JAK enzymes to therapeutic effectiveness is not currently known. Both
the parent compound and the active metabolites inhibit JAK1 activity in vitro
with similar levels of selectivity.


12.2 PHARMACODYNAMICS

Treatment with CIBINQO was associated with dose-dependent reduction in serum
markers of inflammation, including high sensitivity C-reactive protein (hsCRP),
interleukin-31 (IL-31) and thymus and activation regulated chemokine (TARC).
These changes returned to near baseline within 4 weeks of drug discontinuation.

Effect on Platelet Count

Treatment with CIBINQO was also associated with a transient, dose-dependent
decrease in platelet count with the nadir occurring at a median of 24 days after
continuous administration of abrocitinib 200 mg once daily. The percent change
from baseline of the nadir increases with decreasing baseline platelet counts
(-41.2%, -33.4%, and -26.5% for baseline platelet counts of 170, 220, and 270×
103/mm3, respectively). Recovery of platelet count (~40% recovery by 12 weeks)
occurred without discontinuation of the treatment.

Cardiac Electrophysiology

At a dose 3 times the maximum approved recommended dose, abrocitinib does not
prolong the QT interval to any clinically relevant extent.


12.3 PHARMACOKINETICS

Abrocitinib plasma Cmax and AUC increased dose proportionally up to 200 mg.
Steady-state plasma concentrations of abrocitinib are achieved within 48 hours
after once daily administration.

Absorption

Abrocitinib is absorbed with over 91% extent of oral absorption and absolute
oral bioavailability of approximately 60%. The peak plasma concentrations of
abrocitinib are reached within 1 hour.

Effect of Food

Coadministration of CIBINQO with a high-fat, high-calorie meal (total 916
calories, with approximate distribution of 55% fat, 29% carbohydrates, and 16%
protein) had no clinically relevant effect on abrocitinib exposures (AUC and
Cmax of abrocitinib increased by approximately 26% and 29%, respectively, and
Tmax was prolonged by 2 hours) [see Dosage and Administration (2.7)].

Distribution

After intravenous administration, the volume of distribution of abrocitinib is
approximately 100 L. Approximately 64%, 37% and 29% of circulating abrocitinib
and its active metabolites M1 and M2, respectively, are bound to plasma
proteins. Abrocitinib and its active metabolites M1 and M2 bind predominantly to
albumin and distribute equally between red blood cells and plasma.

Elimination

Abrocitinib is eliminated primarily by metabolic clearance mechanisms. The mean
elimination half-lives of abrocitinib and its two active metabolites, M1 and M2,
range 3 to 5 hours.

Metabolism

The metabolism of abrocitinib is mediated by multiple CYP enzymes, CYP2C19
(~53%), CYP2C9 (~30%), CYP3A4 (~11%) and CYP2B6 (~6%). In a human radiolabeled
study, abrocitinib was the most prevalent circulating species, with two active
polar mono-hydroxylated metabolites identified as M1 (3-hydroxypropyl), and M2
(2-hydroxypropyl). Metabolite M1 is less active than abrocitinib while
metabolite M2 is as active as the parent. The pharmacologic activity of
abrocitinib is attributable to the unbound exposure of parent molecule (~60%) as
well as M1 (~10%) and M2 (~30%) in systemic circulation. The sum of unbound
exposures of abrocitinib, M1 and M2, each expressed in molar units and adjusted
for relative potencies, is referred to as the combined exposure of abrocitinib
and its two active metabolites, M1 and M2.

Excretion

After a single radiolabeled abrocitinib dose, less than 1% of the dose was
excreted in urine as unchanged drug. The metabolites of abrocitinib, M1 and M2
are excreted predominantly in urine, and are substrates of OAT3 transporter.

Specific Populations

Body weight, sex, race, and age did not have a clinically meaningful effect on
CIBINQO exposure.

Patients with Renal Impairment

In a renal impairment study, subjects with severe (eGFR <30 mL/min as estimated
by MDRD equation) and moderate (eGFR 30–59 mL/min, MDRD) renal impairment had
approximately 191% and 110% increase in the combined exposure (AUCinf,u) of
abrocitinib and its active metabolites, M1 and M2, respectively, compared to
subjects with normal renal function (eGFR ≥90 mL/min, MDRD). Based on these
results, a clinically significant increase in the combined exposure of
abrocitinib and its active metabolites, M1 and M2, is not expected in subjects
with mild renal impairment (eGFR 60 –89 mL/min, MDRD) [see Dosage and
Administration (2.3) and Use in Specific Population (8.6)].

CIBINQO has not been studied in subjects on renal replacement therapy [see
Dosage and Administration (2.3) and Use in Specific Population (8.6)]. In Phase
3 clinical studies, CIBINQO was not evaluated in subjects with atopic dermatitis
with baseline creatinine clearance values less than 40 mL/min.

Patients with Hepatic Impairment

Subjects with mild hepatic impairment (Child Pugh A) had approximately 4%
decrease in the combined exposure (AUCinf,u) of abrocitinib and its two active
metabolites, M1 and M2, compared to subjects with normal hepatic function.
Subjects with moderate hepatic impairment (Child Pugh B) had approximately 15%
increase in the combined exposure (AUCinf,u) of abrocitinib and its two active
metabolites, M1 and M2, compared to subjects with normal hepatic function. These
changes are not clinically significant. In clinical studies, CIBINQO has not
been studied in subjects with severe (Child Pugh C) hepatic impairment, or in
subjects screened positive for active hepatitis B or hepatitis C [see Use in
Specific Populations (8.7) and Warnings and Precautions (5.1)].

Drug Interaction Studies

Clinical Studies

The effect of coadministered drugs on the pharmacokinetics of abrocitinib is
presented in Table 6.

Table 6. Change in Pharmacokinetics of the Combined Exposure of Abrocitinib and
its Two Active Metabolites (M1 and M2) in the Presence of Coadministered
DrugsCoadministered DrugsRegimen of Coadministered DrugDose of AbrocitinibRatio*
(90% Confidence Interval)Cmax,uAUCinf,u*Ratios for Cmax,u and AUCinf,u compare
coadministration of the drug with abrocitinib versus administration of
abrocitinib alone.†When coadministered with Fluconazole, the systemic exposure
of abrocitinib was approximately 4.8-fold higher compared to when abrocitinib is
administered alone.‡Drug interaction with OAT3 inhibitor is not clinically
significant.Strong CYP2C19 and moderate CYP3A inhibitor:
Fluvoxamine [see Drug Interactions (7.1)]50 mg once daily × 9 days100 mg1.33
(1.00–1.78)1.91 (1.74–2.10)Strong CYP2C19, moderate CYP2C9 and CYP3A inhibitor:
Fluconazole [see Drug Interactions (7.1)]400 mg on Day 1 and 200 mg on Days
2–7100 mg1.23 (1.08–1.42)2.55† (2.42–2.69)Strong CYP Enzymes Inducers:
Rifampin [see Drug Interactions (7.1)]600 mg once daily × 8 days200 mg0.69
(0.50–0.94)0.44 (0.41–0.47)OAT3 inhibitor:
Probenecid‡1,000 mg twice daily × 3 days200 mg1.30 (1.04–1.63)1.66 (1.52–1.80)

The effect of abrocitinib on the pharmacokinetics of coadministered drugs is
presented in Table 7.

Table 7. Change in Pharmacokinetics of Coadministered Drugs in the Presence of
AbrocitinibCoadministered Drugs or In Vivo Markers of CYP ActivityDose Regimen
of AbrocitinibRatio* (90% Confidence Interval)CmaxAUCinf*Ratios for Cmax and
AUCinf compare coadministration of abrocitinib with the drug versus
administration of the drug alone.†AUClast of levonorgestrel was reported in lieu
of AUCinf because the terminal phase of levonorgestrel was not well
characterized.Oral contraceptive:
Ethinyl estradiol (EE) and levonorgestrel (LN)200 mg once daily × 9 daysEE: 1.07
(0.99, 1.15)
LN: 0.86 (0.75, 0.97)EE: 1.19 (1.12, 1.26)
LN†: 0.98 (0.87, 1.10)Sensitive CYP3A Substrate:
Midazolam200 mg once daily × 7 days0.93 (0.84, 1.04)0.92 (0.86, 0.99)Sensitive
P-gp substrate:
Dabigatran200 mg single dose1.40 (0.92, 2.13)1.53 (1.09, 2.15)Sensitive BCRP and
OAT3 substrate:
Rosuvastatin200 mg once daily × 3 days0.99 (0.86, 1.14)1.02 (0.93,
1.12)Sensitive MATE1/2K substrate:
Metformin200 mg once daily × 2 days0.88 (0.81, 0.96)0.93 (0.85, 1.03)

Coadministration of dabigatran etexilate (a P-gp substrate), with a single dose
of CIBINQO 200 mg increased dabigatran AUCinf and Cmax by approximately 53% and
40%, respectively, compared with administration alone. These increases in
dabigatran exposure are not considered clinically significant change. However,
appropriate dose titration of P-gp substrate where small concentration changes
may lead to serious or life-threatening toxicities (e.g., digoxin) when
coadministered with the CIBINQO would be needed.

In Vitro Studies

Cytochrome P450 (CYP) Enzymes: Abrocitinib and its metabolites M1 and M2 are not
inhibitors or inducers of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or
CYP3A4.

Uridine diphosphate (UDP)-glucuronosyl transferase (UGT) Enzymes: Abrocitinib
and its metabolites M1 and M2 are not inhibitors or inducers of UGT1A1, UGT1A4,
UGT1A6, UGT1A9, or UGT2B7.

Transporter Systems: Abrocitinib is an inhibitor of organic cation transporter
(OCT)1 but is not an inhibitor of organic anion transporting polypeptide
(OATP)1B1/1B3, bile salt export pump (BSEP), OAT1 or OCT2.


12.5 PHARMACOGENOMICS

Patients who are CYP2C19 poor metabolizers have little to no CYP2C19 enzyme
function compared to CYP2C19 normal metabolizers that have fully functional
CYP2C19 enzymes.

After single doses of abrocitinib, CYP2C19 poor metabolizers demonstrated
dose-normalized AUC of abrocitinib values that were 2.3-fold higher when
compared to CYP2C19 normal metabolizers. Approximately 3–5% of Caucasians and
Blacks and 15 to 20% of Asians are CYP2C19 poor metabolizers [see Dosage and
Administration (2.4) and Use in Specific Populations (8.8)].


13 NONCLINICAL TOXICOLOGY


13.1 CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

In a 2-year oral carcinogenicity study in rats, abrocitinib increased the
incidence of benign thymomas in female rats at doses of 10 and 30 mg/kg/day (4
and 19 times the MRHD, respectively, based on AUC comparison). Abrocitinib was
not carcinogenic in female rats at 3 mg/kg/day (0.8 times the MRHD based on AUC
comparison) or male rats at doses up to 30 mg/kg/day (19 times the MRHD based on
AUC comparison). Abrocitinib was not carcinogenic in Tg.rasH2 mice at oral doses
up to 60 mg/kg/day in males and 75 mg/kg/day in females.

Abrocitinib was not mutagenic in the bacterial mutagenicity assay (Ames assay).
Although abrocitinib was aneugenic in the in vitro TK6 micronucleus assay,
abrocitinib was not aneugenic or clastogenic in an in vivo rat bone marrow
micronucleus assay.

Abrocitinib did not impair male fertility at doses up to 70 mg/kg/day (35 times
the MRHD based on AUC comparison) or female fertility at 10 mg/kg/day (3 times
the MRHD based on AUC comparison). Abrocitinib impaired female fertility
(reducing fertility index, corpora lutea, and implantation sites) at 70
mg/kg/day (39 times the MRHD based on AUC comparison). Impaired fertility in
female rats reversed 1 month after cessation of abrocitinib administration.


14 CLINICAL STUDIES

The efficacy of CIBINQO as monotherapy and in combination with background
topical corticosteroids were evaluated in 3 randomized, double-blind,
placebo-controlled trials [Trial-AD-1 (NCT03349060), Trial-AD-2 (NCT03575871),
and Trial-AD-3 (NCT03720470)] in 1615 subjects 12 years of age and older
(CIBINQO is not approved for use in pediatric patients) with moderate-to-severe
atopic dermatitis as defined by Investigator's Global Assessment (IGA) score ≥3,
Eczema Area and Severity Index (EASI) score ≥16, body surface area (BSA)
involvement ≥10%, and Peak Pruritus Numerical Rating Scale (PP-NRS) ≥4 at the
baseline visit prior to randomization.

Overall, 53% of subjects were male, 69% of subjects were white, 64% of subjects
had a baseline IGA score of 3 (moderate AD), and 36% of subjects had a baseline
IGA score of 4 (severe AD). The baseline mean EASI score was 30. The baseline
mean age was 36 years old with 8% of subjects 12 to less than 18 years old and
92% of subjects 18 years of age or older. Subjects in these trials were those
who had inadequate response to previous topical therapy, or were subjects for
whom topical treatments were medically inadvisable, or who had received systemic
therapies including dupilumab. In each of the trials, over 40% of subjects had
prior exposure to systemic therapy. In Trial-AD-1 and Trial-AD-2, 6% of the
subjects had received dupilumab, whereas prior use of dupilumab was not allowed
in Trial-AD-3.

Trial-AD-1, Trial-AD-2, and Trial-AD-3 assessed the co-primary endpoints of IGA
and EASI-75 responses at Week 12. The designs of the trials are summarized in
Table 8.

Table 8. Summary of Clinical Study DesignsStudy Name
(regimen type)
Treatment DurationPopulation
(number of randomized and dosed subjects)Treatment ArmsCo-Primary
EndpointsAbbreviations: EASI=Eczema Area and Severity Index; IGA=Investigator's
Global Assessment; QD=once daily; Q2W=once every 2 weeks. *Pediatric subjects 12
years of age and older were included in the trial population; however, CIBINQO
is not approved for use in pediatric patients.†IGA response was based on IGA
score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from
baseline of ≥2 points.‡EASI-75 was based on ≥75% improvement in EASI from
baseline.§Dupilumab treatment in Trial-AD-3: An initial dose of 600 mg on day 1,
followed by 300 mg Q2W.Trial-AD-1
(monotherapy)
12 weeks*Subjects 12 years of age or older (387)Oral administration of:
 * CIBINQO 200 mg QD
 * CIBINQO 100 mg QD
 * Placebo

 * IGA response† at Week 12
 * EASI-75‡ at Week 12

Trial-AD-2
(monotherapy)
12 weeks*Subjects 12 years of age or older (391)Oral administration of:
 * CIBINQO 200 mg QD
 * CIBINQO 100 mg QD
 * Placebo

Trial-AD-3
(combination therapy)
16 weeksSubjects 18 years of age or older (837)Oral administration of:
 * CIBINQO 200 mg QD
 * CIBINQO 100 mg QD
 * Placebo

Subcutaneous administration of:
 * Dupilumab 300 mg Q2W SC§

All subjects received background topical corticosteroids

Clinical Response

Monotherapy Trials

The results of the CIBINQO monotherapy trials (Trial-AD-1 and Trial-AD-2) are
presented in Table 9.

Table 9. Efficacy Results of CIBINQO Monotherapy at Week 12 in Subjects with
Moderate-to-Severe AD (Trial-AD-1 and
Trial-AD-2)Trial-AD-1Trial-AD-2CIBINQOPlacebo
N=77CIBINQOPlacebo
N=78200 mg QD
N=154100 mg QD
N=156200 mg QD
N=155100 mg QD
N=158Abbreviations: CI=confidence interval; EASI=Eczema Area and Severity Index;
IGA=Investigator Global Assessment; QD=once daily.*IGA responders were subjects
with IGA score of clear (0) or almost clear (1) (on a 5-point scale) and a
reduction from baseline of ≥2 points.†EASI -75 responders were patients with
≥75% improvement in EASI from baseline.IGA 0 or 1*44%24%8%
38%
28%9%  Difference from Placebo
(95% CI)36%
(26%, 46%)16%
(7%, 25%)-29%
(19%, 39%)19%
(9%, 29%)-EASI-75†62%
40%
12%
61%44%10%
  Difference from Placebo
(95% CI)51%
(40%, 61%)28%
(18%, 39%)-50%
(40%, 61%)33%
(23%, 44%)-

The proportion of subjects achieving PP-NRS4 at Week 2 (defined as an
improvement of ≥4 points from baseline in PP-NRS) was higher in subjects treated
with CIBINQO monotherapy 200 mg once daily (28% in Trial-AD-1 and 24% in
Trial-AD-2) and 100 mg once daily (11% in both trials) compared to placebo (2%
in both trials).

A higher proportion of subjects in the CIBINQO monotherapy 100 mg or 200 mg once
daily arm compared to placebo achieved improvement in itching at Week 12.

Combination Therapy Trial

The results of CIBINQO in combination with background topical corticosteroids
(Trial-AD-3) are presented in Table 10.

Table 10. Efficacy Results of CIBINQO with Concomitant Topical Corticosteroids
at Week 12 in Subjects with Moderate-to-Severe AD (Trial-AD-3)%
RespondersCIBINQOPlacebo
N=131200 mg QD
N=226100 mg QD
N=238Abbreviations: CI=confidence interval; EASI=Eczema Area and Severity Index;
IGA=Investigator Global Assessment; QD=once daily.*IGA responders were subjects
with IGA score of clear (0) or almost clear (1) (on a 5-point scale) and a
reduction from baseline of ≥2 points.†EASI-75 responders were subjects with ≥75%
improvement in EASI, from baseline.IGA 0 or 1*at Week 1247%36%14%  Difference
from Placebo
(95% CI)34%
(25%, 42%)23%
(15%, 31%)-EASI-75† at Week 1268%58%27%  Difference from Placebo
(95% CI)41%
(32%, 51%)32%
(22%, 41%)-

The proportions of subjects achieving PP-NRS4 at Week 2 was higher in subjects
treated with CIBINQO 200 mg once daily (30%) and 100 mg once daily (14%) in
combination with background medicated topical therapies compared to placebo
(8%).

Examination of age, gender, race, weight and previous systemic AD therapy
treatment did not identify differences in response to CIBINQO 100 mg or 200 mg
once daily among these subgroups in Trial-AD-1, Trial-AD-2, and Trial-AD-3.


16 HOW SUPPLIED/STORAGE AND HANDLING

CIBINQO is supplied as:

Dosage FormStrengthDescriptionBottle Size
(number of tablets)NDC NumberTablets50 mgPink, oval tablet debossed with "PFE"
on one side and "ABR 50" on the other.30 count bottle0069-0235-30Tablets100
mgPink, round tablet debossed with "PFE" on one side and "ABR 100" on the
other.30 count bottle0069-0335-30Tablets200 mgPink, oval tablet debossed with
"PFE" on one side and "ABR 200" on the other.30 count bottle0069-0435-30

Store CIBINQO at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C
to 30°C (59°F to 86°F). Keep in original package. The container closure system
is child resistant.


17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Pregnancy Registry

Advise patients to report their pregnancy to 1-877-311-3770 [see Use in Specific
Populations (8.1)].

Serious Infections

Inform patients that they may develop infections when taking CIBINQO. Instruct
patients to tell their healthcare provider if they develop any signs or symptoms
of an infection [see Warnings and Precautions (5.1)].

Advise patients that the risk of herpes zoster is increased in patients treated
with CIBINQO and some cases can be serious [see Warnings and Precautions (5.1)].

Malignancies

Inform patients that CIBINQO may increase their risk of certain cancers,
including skin cancers. Periodic skin examinations are recommended while using
CIBINQO. Advise patients that exposure to sunlight and UV light should be
limited by wearing protective clothing and using a broad-spectrum sunscreen [see
Warnings and Precautions (5.3)].

Major Adverse Cardiovascular Events

Inform patients that CIBINQO may increase their risk of major adverse
cardiovascular events (MACE) including myocardial infarction, stroke, and
cardiovascular death. Instruct all patients, especially current or past smokers
or patients with other cardiovascular risk factors, to be alert for the
development of signs and symptoms of cardiovascular events [see Warnings and
Precautions (5.4)].

Thrombosis

Advise patients that events of DVT and PE have been reported in clinical trials
with CIBINQO. Instruct patients to seek immediate medical attention if they
develop any signs or symptoms of a DVT or PE [see Warnings and Precautions
(5.5)].

Laboratory Abnormalities

Inform patients that CIBINQO may affect certain lab tests, and that blood tests
are required before and during CIBINQO treatment [see Dosage and Administration
(2.1) and Warnings and Precautions (5.6)].

Immunizations

Advise patients that vaccination with live vaccines is not recommended during
CIBINQO treatment and immediately prior to or after CIBINQO treatment. Instruct
patients to inform the healthcare practitioner that they are taking CIBINQO
prior to a potential vaccination [see Warnings and Precautions (5.7)].

Retinal Detachment

Inform patients that retinal detachment has been reported in clinical trials for
atopic dermatitis in patients who received CIBINQO. Advise patients to
immediately inform their healthcare provider if they develop any sudden changes
in vision while receiving CIBINQO [see Adverse Reactions (6.1)].

Infertility

Advise females of reproductive potential that CIBINQO may impair fertility [see
Use in Specific Populations (8.3)].

Lactation

Advise a woman not to breastfeed during treatment with CIBINQO [see Use in
Specific Populations (8.2)].

Administration

Advise patients not to chew, crush, or split CIBINQO tablets [see Dosage and
Administration (2.7)].

This product's labeling may have been updated. For the most recent prescribing
information, please visit www.pfizer.com.

For Medical Information about CIBINQO, please visit www.pfizermedinfo.com or
call 1-800-438-1985.



LAB-1423-1.0

Medication Guide
CIBINQO (Si BINK oh)
(abrocitinib)
tablets, for oral useThis Medication Guide has been approved by the U.S. Food
and Drug Administration.Issued: 1/2022What is the most important information I
should know about CIBINQO?
CIBINQO may cause serious side effects, including:
1. Serious infections
CIBINQO is a medicine that affects your immune system. CIBINQO can lower the
ability of your immune system to fight infections. Some people have had serious
infections while taking CIBINQO or other similar medicines, including
tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can
spread throughout the body. Some people have died from these infections.
 * Your healthcare provider should test you for TB before starting treatment
   with CIBINQO.
 * Your healthcare provider should watch you closely for signs and symptoms of
   TB during treatment with CIBINQO.

You should not start taking CIBINQO if you have any kind of infection unless
your healthcare provider tells you it is okay.
You may be at a higher risk of developing shingles (herpes zoster).
Before starting CIBINQO, tell your healthcare provider if you:
 * are being treated for an infection.
 * have had an infection that does not go away or that keeps coming back.
 * have diabetes, chronic lung disease, HIV, or a weak immune system.
 * have TB or have been in close contact with someone with TB.
 * have had shingles (herpes zoster).
 * have had hepatitis B or hepatitis C.
 * live or have lived or have traveled to certain parts of the country (such as
   the Ohio and Mississippi River valleys and the Southwest) where there is an
   increased chance for getting certain kinds of fungal infections. These
   infections may happen or become more severe if you use CIBINQO. Ask your
   healthcare provider if you do not know if you have lived in an area where
   these infections are common.
 * think you have an infection or have symptoms of an infection such as:

 * fever, sweating, or chills
 * muscle aches
 * cough or shortness of breath

 * blood in your phlegm
 * weight loss
 * warm, red, or painful skin or sores on your body

 * diarrhea or stomach pain
 * burning when you urinate or urinating more often than usual
 * feeling very tired

After starting CIBINQO, call your healthcare provider right away if you have any
symptoms of an infection. CIBINQO can make you more likely to get infections or
make any infections that you have worse.
2. Increased risk of death in people 50 years of age and older who have at least
1 heart disease (cardiovascular) risk factor and are taking a medicine in the
class of medicines called Janus kinase (JAK) inhibitors. CIBINQO is a JAK
inhibitor medicine.
3. Cancer and immune system problems
CIBINQO may increase your risk of certain cancers by changing the way your
immune system works.
 * Lymphoma and other cancers, including skin cancers, can happen in people
   taking CIBINQO.
 * People taking a medicine in the class of medicines called Janus kinase (JAK)
   inhibitors have a higher risk of certain cancers including lymphoma and lung
   cancer, especially if you are a current or past smoker.
 * Follow your healthcare provider's advice about having your skin checked for
   skin cancer during treatment with CIBINQO. Limit the amount of time you spend
   in sunlight. Avoid using tanning beds or sunlamps. Wear protective clothing
   when you are in the sun and use a sunscreen with a high protection factor
   (SPF 30 and above). This is especially important if your skin is very fair or
   of you have a family history of skin cancer.

Tell your healthcare provider if you have ever had any type of cancer.
4. Increased risk of major cardiovascular events such as heart attack, stroke or
death in people 50 years of age and older who have at least 1 heart disease
(cardiovascular) risk factor and taking a medicine in the class of medicines
called JAK inhibitors, especially if you are a current or past smoker.
Some people taking CIBINQO have had major cardiovascular events.
Get emergency help right away if you develop any symptoms of a heart attack or
stroke during treatment with CIBINQO, including:
 * discomfort in the center of your chest that lasts for more than a few
   minutes, or that goes away and comes back
 * severe tightness, pain, pressure, or heaviness in your chest, throat, neck,
   or jaw
 * pain or discomfort in your arms, back, neck, jaw, or stomach
 * weakness in one part or on one side of your body
 * slurred speech
 * shortness of breath with or without chest discomfort
 * breaking out in a cold sweat
 * nausea or vomiting
 * feeling lightheaded

5. Blood clots
Blood clots in the veins of your legs (deep vein thrombosis, DVT) or lungs
(pulmonary embolism, PE) can happen in some people taking CIBINQO. This may be
life-threatening. Blood clots in the veins of the legs (deep vein thrombosis,
DVT) and lungs (pulmonary embolism, PE) have happened more often in people who
are 50 years of age and older and with at least 1 heart disease (cardiovascular)
risk factor taking a medicine in the class of medicines called Janus kinase
(JAK) inhibitors.
 * Tell your healthcare provider if you have had blood clots in the veins of
   your legs or lungs in the past.
 * Get medical help right away if you have any signs and symptoms of blood clots
   during treatment with CIBINQO, including:
   * swelling, pain or tenderness in one or both legs
   * sudden, unexplained chest or upper back pain
   * shortness of breath or difficulty breathing

6. Changes in certain laboratory test results
Your healthcare provider should do blood tests before you start taking CIBINQO
and during treatment with CIBINQO to check for the following:
 * low lymphocyte count. Lymphocytes are white blood cells that help the body
   fight off infections.
 * low neutrophil count. Neutrophils are white blood cells that help the body
   fight off infections.
 * low red blood cell count. This may mean that you have anemia, which may make
   you feel weak and tired.
 * low platelet count. Platelets help form clots and stop or prevent bleeding.

You should not take CIBINQO if your lymphocyte counts, neutrophil counts, red
blood cell counts, or platelet counts are too low. Your healthcare provider may
stop your CIBINQO treatment for a period of time if needed because of changes in
these blood test results. You may also have changes in other laboratory tests,
such as your blood cholesterol levels.
Your healthcare provider should do blood tests about 4 weeks after you start
taking CIBINQO, and 4 weeks after any increase in your dose of CIBINQO to check
your blood cell counts, and as often as needed for your other laboratory tests.
See "What are the possible side effects of CIBINQO?" for more information about
side effects.What is CIBINQO?
CIBINQO is a prescription medicine that is a Janus Kinase (JAK) inhibitor.
CIBINQO is used to treat adults with moderate-to-severe atopic dermatitis
(eczema) that did not respond to other treatment and is not well controlled with
prescription therapies, including biologic medicines or in adults who cannot
tolerate these therapies.
It is not known if CIBINQO is safe and effective in children.During the first 3
months of treatment with CIBINQO, do not take CIBINQO with other medicines that
prevent blood clots. You can take low-dose aspirin up to a dose of 81 mg each
day during this time if prescribed by your healthcare provider.Before taking
CIBINQO, tell your healthcare provider about all of your medical conditions,
including if you:
 * See "What is the most important information I should know about CIBINQO?"
 * have an infection.
 * are a current or past smoker
 * have had a heart attack, other heart problems, or stroke
 * have kidney problems or liver problems.
 * have low platelet counts or white blood cell counts.
 * have any eye problems, including cataracts or retinal detachment.
 * have recently received or are scheduled to receive an immunization (vaccine).
   People who take CIBINQO should not receive live vaccines.
 * are pregnant or plan to become pregnant. It is not known if CIBINQO will harm
   your unborn baby.
   * Pregnancy Exposure Registry. Pfizer has a registry for women who take
     CIBINQO during pregnancy. The purpose of this registry is to check the
     health of you and your baby. If you are pregnant or become pregnant during
     treatment with CIBINQO, talk to your healthcare provider about how you can
     join this pregnancy registry, or you may contact the registry at
     1-877-311-3770 or www.cibinqopregnancyregistry.com.
 * are breastfeeding or plan to breastfeed. It is not known if CIBINQO passes
   into your breast milk. You and your healthcare provider should decide if you
   will take CIBINQO or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including
prescription and over-the-counter medicines, vitamins, and herbal supplements.
CIBINQO and other medicines may affect each other causing side effects.
Especially tell your healthcare provider if you take aspirin or any antiplatelet
therapies. See "Do not take CIBINQO if you." Ask your healthcare provider if you
are unsure.
Know the medicines you take. Keep a list of them to show your healthcare
provider and pharmacist whenever you get a new medicine.How should I take
CIBINQO?
 * Take CIBINQO exactly as your healthcare provider tells you to take it.
 * Take CIBINQO 1 time each day, at about the same time each day.
 * Swallow CIBINQO tablets whole with water. Do not split, crush, or chew the
   tablets.
 * You can take CIBINQO with or without food.
 * CIBINQO can be used with or without prescribed topical medicines for atopic
   dermatitis. Prescribed topical medicine are lotions, creams, or ointments
   applied to your skin.
 * If you miss a dose, take the dose as soon as possible. If it is less than 12
   hours before the next dose, skip the dose. Take the next dose at your usually
   scheduled time.
 * If you take too much CIBINQO, call the Poison Control Center at
   1-800-222-1222 right away.

What are the possible side effects of CIBINQO?
CIBINQO may cause serious side effects, including:
 * See "What is the most important information I should know about CIBINQO?"

The most common side effects of CIBINQO include:
See "What is the most important information I should know about CIBINQO.
 * common cold
 * nausea
 * headache
 * herpes simplex including cold sores
 * increased blood level of creatinine phosphokinase
 * dizziness
 * urinary tract infection
 * tiredness
 * acne
 * vomiting

 * mouth and throat pain
 * flu
 * stomach flu
 * bacterial skin infection (impetigo)
 * high blood pressure
 * allergic skin rash to something you came into contact with
 * stomach-area pain
 * shingles
 * low platelet count

CIBINQO may cause fertility problems in females, which may affect your ability
to get pregnant. Talk to your healthcare provider if you have concerns about
fertility.
Separation or tear to the lining of the back part of the eye (retinal
detachment) has happened in people with atopic dermatitis treated with CIBINQO.
Call your healthcare provider right away if you have any sudden changes in your
vision during treatment with CIBINQO.
These are not all the possible side effects of CIBINQO.
Call your doctor for medical advice about side effects. You may report side
effects to FDA at 1-800-FDA-1088.
You may also report side effects to Pfizer at 1-800-438-1985.How should I store
CIBINQO?
 * Store CIBINQO at room temperature between 68°F to 77°F (20°C to 25°C).
 * Store CIBINQO in the original package.
 * The container has a child resistant closure.

Keep CIBINQO and all medicines out of the reach of children.General information
about the safe and effective use of CIBINQO.
Medicines are sometimes prescribed for purposes other than those listed in a
Medication Guide. Do not use CIBINQO for a condition for which it was not
prescribed. Do not give CIBINQO to other people, even if they have the same
symptoms you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about CIBINQO
that is written for health professionals.What are the ingredients in CIBINQO?
Active ingredient: abrocitinib
Inactive ingredients: dibasic calcium phosphate anhydrous, hypromellose, iron
oxide red, lactose monohydrate, Macrogol, magnesium stearate, microcrystalline
cellulose, sodium starch glycolate, titanium dioxide, and triacetin.



LAB-1424-1.0



Revised: 1/2021
Document Id: bc07eed4-995a-4420-8518-8512a1f1fd38
34391-3
Set id: 3f6d6fcd-e9f9-42c8-bfa2-bb2cfc9ed258
Version: 1
Effective Time: 20210122
 
Pfizer Laboratories Div Pfizer Inc