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Important Safety Information  |   FULL PRESCRIBING INFORMATION

[DoctorOrFirstname] [Lastname],

How would you treat the following patient with locally advanced BCC?

LIBTAYO is the FIRST AND ONLY treatment indicated for patients with locally
advanced basal cell carcinoma (laBCC) previously treated with a hedgehog pathway
inhibitor (HHI) or for whom an HHI is not appropriate.1

While most instances of early-stage BCC are curable with surgery and/or
radiation, many patients with advanced disease have a poor prognosis.2-4

The following patient case study of an laBCC clinical trial patient treated with
LIBTAYO (cemiplimab-rwlc) may be of interest.5

LIBTAYO is the #1 most-prescribed

immunotherapy by oncologists in laBCC5*

*Based on IQVIA medical claims data from October 2018 to December 2021. Claims
calibrated with actual vials sold.5

BCC=basal cell carcinoma.

 

Important Safety Information

Warnings and Precautions

Severe and Fatal Immune‑Mediated Adverse Reactions

Immune‑mediated adverse reactions, which may be severe or fatal, can occur in
any organ system or tissue at any time after starting treatment. While
immune‑mediated adverse reactions usually occur during treatment, they can also
occur after discontinuation. Immune‑mediated adverse reactions affecting more
than one body system can occur simultaneously. Early identification and
management are essential to ensuring safe use of PD‑1/PD‑L1–blocking antibodies.
The definition of immune‑mediated adverse reactions included the required use of
systemic corticosteroids or other immunosuppressants and the absence of a clear
alternate etiology. Monitor closely for symptoms and signs that may be clinical
manifestations of underlying immune‑mediated adverse reactions. Evaluate liver
enzymes, creatinine, and thyroid function at baseline and periodically during
treatment. In cases of suspected immune‑mediated adverse reactions, initiate
appropriate workup to exclude alternative etiologies, including infection.
Institute medical management promptly, including specialty consultation as
appropriate.

No dose reduction for LIBTAYO is recommended. In general, withhold LIBTAYO for
severe (Grade 3) immune-mediated adverse reactions. Permanently discontinue
LIBTAYO for life-threatening (Grade 4) immune-mediated adverse reactions,
recurrent severe (Grade 3) immune-mediated adverse reactions that require
systemic immunosuppressive treatment, or an inability to reduce corticosteroid
dose to 10 mg or less of prednisone equivalent per day within 12 weeks of
initiating steroids.

Withhold or permanently discontinue LIBTAYO depending on severity. In general,
if LIBTAYO requires interruption or discontinuation, administer systemic
corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until
improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate
corticosteroid taper and continue to taper over at least 1 month. Consider
administration of other systemic immunosuppressants in patients whose
immune‑mediated adverse reactions are not controlled with corticosteroids.

Immune‑mediated pneumonitis: LIBTAYO can cause immune‑mediated pneumonitis. In
patients treated with other PD-1/PD-L1–blocking antibodies, the incidence of
pneumonitis is higher in patients who have received prior thoracic radiation.
Immune‑mediated pneumonitis occurred in 3.2% (26/810) of patients receiving
LIBTAYO, including Grade 4 (0.5%), Grade 3 (0.5%), and Grade 2 (2.1%).
Pneumonitis led to permanent discontinuation in 1.4% of patients and withholding
of LIBTAYO in 2.1% of patients. Systemic corticosteroids were required in all
patients with pneumonitis. Pneumonitis resolved in 58% of the 26 patients. Of
the 17 patients in whom LIBTAYO was withheld, 9 reinitiated after symptom
improvement; of these, 3/9 (33%) had recurrence of pneumonitis. Withhold LIBTAYO
for Grade 2, and permanently discontinue for Grade 3 or 4. Resume in patients
with complete or partial resolution (Grade 0 to 1) after corticosteroid taper.
Permanently discontinue if no complete or partial resolution within 12 weeks of
initiating steroids or inability to reduce prednisone to less than 10 mg per day
(or equivalent) within 12 weeks of initiating steroids.

Immune‑mediated colitis: LIBTAYO can cause immune‑mediated colitis. The primary
component of immune‑mediated colitis was diarrhea. Cytomegalovirus (CMV)
infection/reactivation has been reported in patients with
corticosteroid-refractory immune‑mediated colitis treated with
PD-1/PD-L1–blocking antibodies. In cases of corticosteroid-refractory
immune‑mediated colitis, consider repeating infectious workup to exclude
alternative etiologies. Immune‑mediated colitis occurred in 2.2% (18/810) of
patients receiving LIBTAYO, including Grade 3 (0.9%) and Grade 2 (1.1%). Colitis
led to permanent discontinuation in 0.4% of patients and withholding of LIBTAYO
in 1.5% of patients. Systemic corticosteroids were required in all patients with
colitis. Colitis resolved in 39% of the 18 patients. Of the 12 patients in whom
LIBTAYO was withheld, 4 reinitiated LIBTAYO after symptom improvement; of these,
3/4 (75%) had recurrence. Withhold LIBTAYO for Grade 2 or 3, and permanently
discontinue for Grade 4. Resume in patients with complete or partial resolution
(Grade 0 to 1) after corticosteroid taper. Permanently discontinue if no
complete or partial resolution within 12 weeks of initiating steroids or
inability to reduce prednisone to less than 10 mg per day (or equivalent) within
12 weeks of initiating steroids.

Immune‑mediated hepatitis: LIBTAYO can cause immune‑mediated hepatitis.
Immune‑mediated hepatitis occurred in 2% (16/810) of patients receiving LIBTAYO,
including fatal (0.1%), Grade 4 (0.1%), Grade 3 (1.4%), and Grade 2 (0.2%).
Hepatitis led to permanent discontinuation of LIBTAYO in 1.2% of patients and
withholding of LIBTAYO in 0.5% of patients. Systemic corticosteroids were
required in all patients with hepatitis. Additional immunosuppression with
mycophenolate was required in 19% (3/16) of these patients. Hepatitis resolved
in 50% of the 16 patients. Of the 5 patients in whom LIBTAYO was withheld, 3
reinitiated LIBTAYO after symptom improvement; of these, none had recurrence.

For hepatitis with no tumor involvement of the liver: Withhold LIBTAYO if AST or
ALT increases to more than 3 and up to 8 times the upper limit of normal (ULN)
or if total bilirubin increases to more than 1.5 and up to 3 times the ULN.
Permanently discontinue LIBTAYO if AST or ALT increases to more than 8 times the
ULN or total bilirubin increases to more than 3 times the ULN.

For hepatitis with tumor involvement of the liver: Withhold LIBTAYO if baseline
AST or ALT is more than 1 and up to 3 times ULN and increases to more than 5 and
up to 10 times ULN. Also, withhold LIBTAYO if baseline AST or ALT is more than 3
and up to 5 times ULN and increases to more than 8 and up to 10 times ULN.
Permanently discontinue LIBTAYO if AST or ALT increases to more than 10 times
ULN or if total bilirubin increases to more than 3 times ULN. If AST and ALT are
less than or equal to ULN at baseline, withhold or permanently discontinue
LIBTAYO based on recommendations for hepatitis with no liver involvement.

Resume in patients with complete or partial resolution (Grade 0 to 1) after
corticosteroid taper. Permanently discontinue if no complete or partial
resolution within 12 weeks of initiating steroids or inability to reduce
prednisone to less than 10 mg per day (or equivalent) within 12 weeks of
initiating steroids.

Immune‑mediated endocrinopathies: For Grade 3 or 4 endocrinopathies, withhold
until clinically stable or permanently discontinue depending on severity.

• Adrenal insufficiency: LIBTAYO can cause primary or secondary adrenal
insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic
treatment, including hormone replacement as clinically indicated. Withhold
LIBTAYO depending on severity. Adrenal insufficiency occurred in 0.4% (3/810) of
patients receiving LIBTAYO, including Grade 3 (0.4%). Adrenal insufficiency led
to permanent discontinuation of LIBTAYO in 1 (0.1%) patient. LIBTAYO was not
withheld in any patient due to adrenal insufficiency. Systemic corticosteroids
were required in all patients with adrenal insufficiency; of these, 67% (2/3)
remained on systemic corticosteroids. Adrenal insufficiency had not resolved in
any patient at the time of data cutoff

• Hypophysitis: LIBTAYO can cause immune‑mediated hypophysitis. Hypophysitis
can present with acute symptoms associated with mass effect such as headache,
photophobia, or visual field defects. Hypophysitis can cause hypopituitarism.
Initiate hormone replacement as clinically indicated. Withhold or permanently
discontinue depending on severity. Hypophysitis occurred in 0.4% (3/810) of
patients receiving LIBTAYO, including Grade 3 (0.2%) and Grade 2 (0.1%) adverse
reactions. Hypophysitis led to permanent discontinuation of LIBTAYO in 1 (0.1%)
patient and withholding of LIBTAYO in 1 (0.1%) patient. Systemic corticosteroids
were required in 67% (2/3) of patients with hypophysitis. Hypophysitis had not
resolved in any patient at the time of data cutoff

• Thyroid disorders: LIBTAYO can cause immune‑mediated thyroid disorders.
Thyroiditis can present with or without endocrinopathy. Hypothyroidism can
follow hyperthyroidism. Initiate hormone replacement or medical management of
hyperthyroidism as clinically indicated. Withhold or permanently discontinue
LIBTAYO depending on severity • Thyroiditis: Thyroiditis occurred in 0.6%
(5/810) of patients receiving LIBTAYO, including Grade 2 (0.2%) adverse
reactions. No patient discontinued LIBTAYO due to thyroiditis. Thyroiditis led
to withholding of LIBTAYO in 1 patient. Systemic corticosteroids were not
required in any patient with thyroiditis. Thyroiditis had not resolved in any
patient at the time of data cutoff. Blood thyroid stimulating hormone increased
and blood thyroid stimulating hormone decreased have also been reported

• Hyperthyroidism: Hyperthyroidism occurred in 3.2% (26/810) of patients
receiving LIBTAYO, including Grade 2 (0.9%). No patient discontinued treatment
and LIBTAYO was withheld in 0.5% of patients due to hyperthyroidism. Systemic
corticosteroids were required in 3.8% (1/26) of patients. Hyperthyroidism
resolved in 50% of 26 patients. Of the 4 patients in whom LIBTAYO was withheld
for hyperthyroidism, 2 patients reinitiated LIBTAYO after symptom improvement;
of these, none had recurrence of hyperthyroidism

• Hypothyroidism: Hypothyroidism occurred in 7% (60/810) of patients receiving
LIBTAYO, including Grade 2 (6%). Hypothyroidism led to permanent discontinuation
of LIBTAYO in 1 (0.1%) patient. Hypothyroidism led to withholding of LIBTAYO in
1.1% of patients. Systemic corticosteroids were not required in any patient with
hypothyroidism. Hypothyroidism resolved in 8.3% of the 60 patients. Majority of
the patients with hypothyroidism required long-term thyroid hormone replacement.
Of the 9 patients in whom LIBTAYO was withheld for hypothyroidism, 1 reinitiated
LIBTAYO after symptom improvement; 1 required ongoing hormone replacement
therapy

• Type 1 diabetes mellitus, which can present with diabetic ketoacidosis:
Monitor for hyperglycemia or other signs and symptoms of diabetes. Initiate
treatment with insulin as clinically indicated. Withhold LIBTAYO depending on
severity. Type 1 diabetes mellitus occurred in 0.1% (1/810) of patients,
including Grade 4 (0.1%). No patient discontinued treatment due to type 1
diabetes mellitus. Type 1 diabetes mellitus led to withholding of LIBTAYO in
0.1% of patients

Immune‑mediated nephritis with renal dysfunction: LIBTAYO can cause
immune‑mediated nephritis. Immune‑mediated nephritis occurred in 0.6% (5/810) of
patients receiving LIBTAYO, including fatal (0.1%), Grade 3 (0.1%), and Grade 2
(0.4%). Nephritis led to permanent discontinuation in 0.1% of patients and
withholding of LIBTAYO in 0.4% of patients. Systemic corticosteroids were
required in all patients with nephritis. Nephritis resolved in 80% of the 5
patients. Of the 3 patients in whom LIBTAYO was withheld, 2 reinitiated LIBTAYO
after symptom improvement; of these, none had recurrence. Withhold LIBTAYO for
Grade 2 or 3 increased blood creatinine, and permanently discontinue for Grade 4
increased blood creatinine. Resume in patients with complete or partial
resolution (Grade 0 to 1) after corticosteroid taper. Permanently discontinue if
no complete or partial resolution within 12 weeks of initiating steroids or
inability to reduce prednisone to less than 10 mg per day (or equivalent) within
12 weeks of initiating steroids.

Immune‑mediated dermatologic adverse reactions: LIBTAYO can cause
immune‑mediated rash or dermatitis. Exfoliative dermatitis, including
Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash
with eosinophilia and systemic symptoms (DRESS) has occurred with
PD-1/PD-L1–blocking antibodies. Immune‑mediated dermatologic adverse reactions
occurred in 1.6% (13/810) of patients receiving LIBTAYO, including Grade 3
(0.9%) and Grade 2 (0.6%). Immune‑mediated dermatologic adverse reactions led to
permanent discontinuation in 0.1% of patients and withholding of LIBTAYO in 1.4%
of patients. Systemic corticosteroids were required in all patients with
immune‑mediated dermatologic adverse reactions. Immune‑mediated dermatologic
adverse reactions resolved in 69% of the 13 patients. Of the 11 patients in whom
LIBTAYO was withheld for dermatologic adverse reactions, 7 reinitiated LIBTAYO
after symptom improvement; of these, 43% (3/7) had recurrence of the
dermatologic adverse reaction. Topical emollients and/or topical corticosteroids
may be adequate to treat mild to moderate non-exfoliative rashes. Withhold
LIBTAYO for suspected SJS, TEN, or DRESS. Permanently discontinue LIBTAYO for
confirmed SJS, TEN, or DRESS. Resume in patients with complete or partial
resolution (Grade 0 to 1) after corticosteroid taper. Permanently discontinue if
no complete or partial resolution within 12 weeks of initiating steroids or
inability to reduce prednisone to less than 10 mg per day (or equivalent) within
12 weeks of initiating steroids.

Other immune‑mediated adverse reactions: The following clinically significant
immune‑mediated adverse reactions occurred at an incidence of <1% in 810
patients who received LIBTAYO or were reported with the use of other
PD-1/PD-L1–blocking antibodies. Severe or fatal cases have been reported for
some of these adverse reactions.

• Cardiac/vascular: Myocarditis, pericarditis, and vasculitis. Permanently
discontinue for Grades 2, 3, or 4 myocarditis

• Nervous system: Meningitis, encephalitis, myelitis and demyelination,
myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré
syndrome, nerve paresis, and autoimmune neuropathy. Withhold for Grade 2
neurological toxicities and permanently discontinue for Grades 3 or 4
neurological toxicities. Resume in patients with complete or partial resolution
(Grade 0 to 1) after corticosteroid taper. Permanently discontinue if no
complete or partial resolution within 12 weeks of initiating steroids or
inability to reduce prednisone to less than 10 mg per day (or equivalent) within
12 weeks of initiating steroids

• Ocular: Uveitis, iritis, and other ocular inflammatory toxicities. Some cases
can be associated with retinal detachment. Various grades of visual impairment
to include blindness can occur. If uveitis occurs in combination with other
immune‑mediated adverse reactions, consider a Vogt-Koyanagi-Harada–like
syndrome, as this may require treatment with systemic steroids to reduce the
risk of permanent vision loss • Gastrointestinal: Pancreatitis to include
increases in serum amylase and lipase levels, gastritis, duodenitis, stomatitis

• Musculoskeletal and connective tissue: Myositis/polymyositis, rhabdomyolysis,
and associated sequelae including renal failure, arthritis, polymyalgia
rheumatica

• Endocrine: Hypoparathyroidism • Other (hematologic/immune): Hemolytic anemia,
aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory
response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi
lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ
transplant rejection

Infusion-related reactions

Severe infusion-related reactions (Grade 3) occurred in 0.1% of patients
receiving LIBTAYO as a single agent. Monitor patients for signs and symptoms of
infusion-related reactions. The most common symptoms of infusion-related
reaction were nausea, pyrexia, rash, and dyspnea. Interrupt or slow the rate of
infusion for Grade 1 or 2, and permanently discontinue for Grade 3 or 4.

Complications of allogeneic HSCT

Fatal and other serious complications can occur in patients who receive
allogeneic hematopoietic stem cell transplantation (HSCT) before or after being
treated with a PD-1/PD-L1–blocking antibody. Transplant-related complications
include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD,
hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and
steroid-requiring febrile syndrome (without an identified infectious cause).
These complications may occur despite intervening therapy between PD-1/PD-L1
blockade and allogeneic HSCT. Follow patients closely for evidence of
transplant-related complications and intervene promptly. Consider the benefit
versus risks of treatment with a PD-1/PD-L1–blocking antibody prior to or after
an allogeneic HSCT.

Embryo-fetal toxicity

LIBTAYO can cause fetal harm when administered to a pregnant woman due to an
increased risk of immune‑mediated rejection of the developing fetus resulting in
fetal death. Advise women of the potential risk to a fetus. Advise females of
reproductive potential to use effective contraception during treatment with
LIBTAYO and for at least 4 months after the last dose.

Adverse Reactions

• In the pooled safety analysis of 810 patients, the most common adverse
reactions (≥15%) with LIBTAYO were musculoskeletal pain, fatigue, rash, and
diarrhea

• In the pooled safety analysis of 810 patients, the most common Grade 3-4
laboratory abnormalities (≥2%) with LIBTAYO were lymphopenia, hyponatremia,
hypophosphatemia, increased aspartate aminotransferase, anemia, and hyperkalemia

Use in Specific Populations

• Lactation: Because of the potential for serious adverse reactions in breastfed
children, advise women not to breastfeed during treatment and for at least 4
months after the last dose of LIBTAYO

• Females and males of reproductive potential: Verify pregnancy status in
females of reproductive potential prior to initiating LIBTAYO

LIB.21.02.0051

Please click here for full Prescribing Information.

For more information, visit LIBTAYOhcp.com

For prescribers in Colorado, please click here for pricing information.

References: 1. LIBTAYO (cemiplimab-rwlc) injection full U.S. prescribing
information. Regeneron Pharmaceuticals, Inc. 2. Puig S, Berrocal A. Management
of high-risk and advanced basal cell carcinoma.Clin Transl Oncol. 2015;17(7):
497-503. 3. Migden MR, Chang ALS, Dirix L, Stratigos AJ, Lear JT. Emerging
trends in the treatment of advanced basal cell carcinoma. Cancer Treat Rev.
2018;64:1-10. 4. Cameron MC, Lee E, Hibler BP, et al. Basal cell carcinoma:
epidemiology; pathophysiology; clinical and histological subtypes; and disease
associations. J Am Acad Dermatol. 2019;80(2):303-317. 5. Data on file. Regeneron
Pharmaceuticals, Inc.

Let’s connect soon. Click below to be contacted by a Regeneron Oncology Account
Specialist to discuss LIBTAYO® (cemiplimab-rwlc)



© 2023 Regeneron Pharmaceuticals, Inc.     All rights reserved.
LIB.22.12.0055    01/23

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