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Prescribing Info
 * About
 * Dosing & Administration
 * Efficacy
 * Safety Profile

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INDICATED FOR

TSC-SEGA

AFINITOR® (everolimus) Tablets and AFINITOR DISPERZ® (everolimus tablets for
oral suspension) are indicated in adult and pediatric patients 1 year and older
with tuberous sclerosis complex (TSC) for the treatment of subependymal giant
cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be
curatively resected.

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TSC-Seizure TSC-Renal Angiomyolipoma Advanced HR+, HER2-Negative Breast Cancer
Advanced Renal Cell Carcinoma Advanced Pancreatic Neuroendocrine Tumor (NET)
Progressive, Nonfunctional GI and Lung Neuroendocrine Tumors (NET)




TREATING WITH AFINITOR AND AFINITOR DISPERZ

AFINITOR® (everolimus) Tablets is the only FDA-approved mTOR inhibitor that is
proven to reduce tumor volume in patients who have SEGA with TSC.

FDA, US Food and Drug Administration; mTOR, mammalian target of rapamycin; SEGA,
subependymal giant cell astrocytoma; TSC, tuberous sclerosis complex.

Dosing & Administration

Discover dosing, administration, and dosing modifications for AFINITOR and
AFINITOR DISPERZ.

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Efficacy

More information on study designs and results.

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Safety Profile

Learn more about adverse reactions profile and laboratory abnormalities.

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ACCESS


ACCESS



Novartis offers a variety of patient-support opportunities—including financial
assistance, counseling, a co-pay program, and more.

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PATIENT RESOURCES


PATIENT RESOURCES



The following resources are intended to help patients navigate their TSC-SEGA
experience. We encourage you to share these resources with your patients.


PATIENT BROCHURE

This comprehensive brochure about AFINITOR and AFINITOR DISPERZ can be shared
with patients and their families.


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HOW AFINITOR DISPERZ WORKS

Patients can learn about AFINITOR DISPERZ and find additional resources.



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PREPARING AFINITOR DISPERZ

Patients should prepare and take AFINITOR DISPERZ as their doctor advises and
can find supporting information in this video.



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Dosing & Administration


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IMPORTANT SAFETY INFORMATION

AFINITOR® (everolimus) Tablets and AFINITOR DISPERZ® (everolimus tablets for
oral suspension) are contraindicated in patients with hypersensitivity to
everolimus, to other rapamycin derivatives, or to any of the excipients.

Noninfectious Pneumonitis

Noninfectious pneumonitis is a class effect of rapamycin derivatives.
Noninfectious pneumonitis was reported in up to 19% of patients treated with
AFINITOR in clinical trials, some cases reported with pulmonary hypertension
(including pulmonary arterial hypertension) as a secondary event.

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IMPORTANT SAFETY INFORMATION AND INDICATIONS

Indication

AFINITOR and AFINITOR DISPERZ are indicated in adult and pediatric patients 1
year and older with tuberous sclerosis complex (TSC) for the treatment of
subependymal giant cell astrocytoma (SEGA) that requires therapeutic
intervention but cannot be curatively resected.

IMPORTANT SAFETY INFORMATION

AFINITOR® (everolimus) Tablets and AFINITOR DISPERZ® (everolimus tablets for
oral suspension) are contraindicated in patients with hypersensitivity to
everolimus, to other rapamycin derivatives, or to any of the excipients.

 

Noninfectious Pneumonitis

Noninfectious pneumonitis was reported in up to 19% of patients treated with
AFINITOR; some cases were reported with pulmonary hypertension (including
pulmonary arterial hypertension) as a secondary event. The incidence of grade 3
and 4 noninfectious pneumonitis was up to 4% and up to 0.2%, respectively. Fatal
outcomes have been observed. Monitor for clinical symptoms or radiological
changes. Consider opportunistic infections such as Pneumocystis jiroveci
pneumonia (PJP) in the differential diagnosis. For grade 2 to 4 noninfectious
pneumonitis, withhold or permanently discontinue based on severity.
Corticosteroids may be indicated until clinical symptoms resolve. Administer
prophylaxis for PJP when concomitant use of corticosteroids or other
immunosuppressive agents are required. The development of pneumonitis has been
reported even at a reduced dose.

 

Infections

AFINITOR/AFINITOR DISPERZ has immunosuppressive properties and may predispose
patients to bacterial, fungal, viral, or protozoal infections, including those
with opportunistic pathogens. Localized and systemic infections, including
pneumonia, mycobacterial infections, other bacterial infections; invasive fungal
infections, such as aspergillosis, candidiasis, or PJP; and viral infections,
including reactivation of hepatitis B virus, have occurred. Some of these
infections have been severe (eg, sepsis, septic shock, or resulting in
multisystem organ failure) or fatal. The incidence of grade 3 and 4 infections
was up to 10% and up to 3%, respectively. The incidence of serious infections
was reported at a higher frequency in patients <6 years of age. Complete
treatment of preexisting invasive fungal infections prior to starting treatment.
Monitor for signs and symptoms of infection. Withhold or permanently discontinue
AFINITOR/AFINITOR DISPERZ based on severity of infection. Administer prophylaxis
for PJP when concomitant use of corticosteroids or other immunosuppressive
agents are required.

 

Severe Hypersensitivity Reactions

Hypersensitivity reactions to AFINITOR/AFINITOR DISPERZ have been observed and
include anaphylaxis, dyspnea, flushing, chest pain, and angioedema (eg, swelling
of the airways or tongue, with or without respiratory impairment). The incidence
of grade 3 hypersensitivity reactions was up to 1%. Permanently discontinue
AFINITOR/AFINITOR DISPERZ for the development of clinically significant
hypersensitivity.

 

Angioedema With Concomitant Use of Angiotensin-Converting Enzyme (ACE)
Inhibitors

Patients taking concomitant ACE inhibitors with AFINITOR/AFINITOR DISPERZ may be
at increased risk for angioedema (eg, swelling of the airways or tongue, with or
without respiratory impairment). In a pooled analysis of randomized,
double-blind, oncology clinical trials, the incidence of angioedema in patients
taking AFINITOR/AFINITOR DISPERZ with an ACE inhibitor was 6.8% compared to 1.3%
in the control arm with an ACE inhibitor. Permanently discontinue AFINITOR for
angioedema.

 

Stomatitis

Stomatitis, including mouth ulcers and oral mucositis, has occurred in patients
treated with AFINITOR/AFINITOR DISPERZ at an incidence ranging from 44% to 78%
across the clinical trial experience. Grade 3/4 stomatitis was reported in 4% to
9% of patients. Stomatitis most often occurs within the first 8 weeks of
treatment. When starting AFINITOR/AFINITOR DISPERZ, initiating dexamethasone
alcohol-free oral solution as a swish-and-spit mouthwash reduces the incidence
and severity of stomatitis. If stomatitis does occur, mouthwashes and/or other
topical treatments are recommended, but alcohol-, hydrogen peroxide-, iodine-,
or thyme-containing products should be avoided. Antifungal agents should not be
used unless fungal infection has been diagnosed.

 

Renal Failure

Cases of renal failure (including acute renal failure), some with a fatal
outcome, have occurred in patients taking AFINITOR. Elevations of serum
creatinine and proteinuria have been reported in patients taking
AFINITOR/AFINITOR DISPERZ. The incidence of grade 3 and 4 elevations of serum
creatinine was up to 2% and up to 1%, respectively. The incidence of grade 3 and
4 proteinuria was up to 1% and up to 0.5%, respectively. Monitor renal function
prior to starting AFINITOR/AFINITOR DISPERZ and annually thereafter. Monitor
renal function at least every 6 months in patients who have additional risk
factors for renal failure.

 

Risk of Impaired Wound Healing

Impaired wound healing can occur in patients who receive drugs that inhibit the
vascular endothelial growth factor (VEGF) signaling pathway. Therefore, AFINITOR
DISPERZ has the potential to adversely affect wound healing. Withhold AFINITOR
DISPERZ for at least 1 week prior to elective surgery. Do not administer for at
least 2 weeks following major surgery and until adequate wound healing occurs.
The safety of resuming treatment upon resolution of wound healing complications
has not been established.

 

Metabolic Disorders

Hyperglycemia, hypercholesterolemia, and hypertriglyceridemia have been reported
in patients taking AFINITOR/AFINITOR DISPERZ at an incidence up to 75%, 86%, and
73%, respectively. The incidence of these grade 3 and 4 laboratory abnormalities
was up to 15% and up to 0.4%, respectively. In nondiabetic patients, monitor
fasting serum glucose prior to starting AFINITOR/AFINITOR DISPERZ and annually
thereafter. In diabetic patients, monitor fasting serum glucose more frequently
as clinically indicated. Monitor lipid profile prior to starting
AFINITOR/AFINITOR DISPERZ and once yearly thereafter. When possible, achieve
optimal glucose and lipid control prior to starting AFINITOR/AFINITOR DISPERZ.
For grade 3 to 4 metabolic events, withhold or permanently discontinue
AFINITOR/AFINITOR DISPERZ based on severity.

 

Myelosuppression

Anemia, lymphopenia, neutropenia, and thrombocytopenia have been reported in
patients taking AFINITOR/AFINITOR DISPERZ. The incidence of these grade 3 and 4
laboratory abnormalities was up to 16% and up to 2%, respectively. Monitor
complete blood count prior to starting AFINITOR/AFINITOR DISPERZ, every 6 months
for the first year of treatment, and annually thereafter. Withhold or
permanently discontinue AFINITOR/AFINITOR DISPERZ based on severity.

 

Risk of Infection or Reduced Immune Response With Vaccinations

The safety of immunization with live vaccines during AFINITOR/AFINITOR DISPERZ
therapy has not been studied. Due to the potential increased risk of infection
and/or reduced immune response to the vaccine, avoid the use of live vaccines
and close contact with individuals who have received live vaccines during
treatment with AFINITOR/AFINITOR DISPERZ. Due to the potential increased risk of
infection or reduced immune response with vaccination, complete the recommended
childhood series of live vaccinations according to American Council on
Immunization Practices (ACIP) guidelines prior to the start of therapy. An
accelerated vaccination schedule may be appropriate.

 

Radiation Sensitization and Radiation Recall

Radiation sensitization and recall, in some cases severe, involving cutaneous
and visceral organs (including radiation esophagitis and pneumonitis) have been
reported in patients treated with radiation before, during, or after
AFINITOR/AFINITOR DISPERZ treatment. Monitor patients closely when administering
AFINITOR/AFINITOR DISPERZ during, or sequentially with, radiation treatment.

 

Embryo-Fetal Toxicity

Based on animal studies and the mechanism of action, AFINITOR/AFINITOR DISPERZ
can cause fetal harm when administered to a pregnant woman. In animal studies,
everolimus caused embryo-fetal toxicities in rats when administered during the
period of organogenesis at maternal exposures that were lower than human
exposures at the clinical dose of 10 mg once daily. Advise pregnant women of the
potential risk to a fetus. Advise female patients of reproductive potential to
avoid becoming pregnant and to use effective contraception during treatment with
AFINITOR/AFINITOR DISPERZ and for 8 weeks after the last dose. Advise male
patients with female partners of reproductive potential to use effective
contraception during treatment with AFINITOR/AFINITOR DISPERZ and for 4 weeks
after the last dose.

 

Adverse Reactions

The most common adverse reactions (incidence ≥30%, all grades) were stomatitis
(62%) and respiratory tract infection (31%). The most common grade 3/4 adverse
reactions (incidence ≥2%) were stomatitis, pyrexia, pneumonia, gastroenteritis,
aggression, agitation, and amenorrhea. Updated safety information from 111
patients treated with AFINITOR for a median duration of 47 months identified the
following additional notable adverse reactions: decreased appetite (14%),
hypertension (11%), urinary tract infection (9%), cellulitis (6%), abdominal
pain (5%), and decreased weight (5%).

 

Laboratory Abnormalities

The most common key laboratory abnormalities (incidence ≥50%, all grades) were
hypercholesterolemia (81%) and elevated partial thromboplastin time (72%). The
most common grade 3/4 laboratory abnormality (incidence ≥3%) was neutropenia
(9%). Updated safety information from 111 patients treated with AFINITOR for a
median duration of 47 months identified the following additional key laboratory
abnormalities: hyperglycemia (13%), decreased fibrinogen (8%), elevated
creatinine (5%), and azoospermia (1%).

 

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