Drug Safety-related Labeling Changes (SrLC)

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AFINITOR (NDA-022334)

(EVEROLIMUS)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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04/10/2018 (SUPPL-40)

Approved Drug Label (PDF)

4 Contraindications

Additions and/or revisions underlined:

AFINITOR/AFINITOR DISPERZ is contraindicated in patients with clinically significant hypersensitivity to everolimus or to other rapamycin derivatives.

5 Warnings and Precautions

Additions and/or revisions underlined:

5.1 Non-infectious Pneumonitis

Addition of /AFINITOR DISPERZ to wherever the word AFINITOR is throughout the W&P section.

Continue AFINITOR/AFINITOR DISPERZ without dose alteration in patients who develop radiological changes …

For Grade 2 to 4 non-infectious pneumonitis, withhold or permanently discontinue AFINITOR/AFINITOR DISPERZ 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.

5.2 Infections

… Some of these infections have been severe (e.g., 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 less than 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 …

5.3 Severe Hypersensitivity Reactions

Newly added subsection:

Hypersensitivity reactions to AFINITOR/AFINITOR DISPERZ have been observed and include anaphylaxis, dyspnea, flushing, chest pain, and angioedema (e.g., 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.

Additions and/or revisions underlined:

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

Patients taking concomitant ACE inhibitors with AFINITOR/AFINITOR DISPERZ … was 6.8% compared to 1.3% in the control arm with an ACE inhibitor. Permanently discontinue AFINITOR/AFINITOR DISPERZ for angioedema.

5.5 Stomatitis

… as they may exacerbate the condition. Do not administer antifungal agents, unless fungal infection has been diagnosed.

5.6 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.

5.9 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 non- diabetic 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 annually 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.

5.10 Myelosuppression

Newly added subsection:

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.

Additions and/or revisions underlined:

5.11 Risk of Infection or Reduced Immune Response with Vaccination

The safety of immunization with live vaccines during AFINITOR/AFINITOR DISPERZ therapy has not been studied. Due to the potential increased risk of infection, 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 vaccinations …

6 Adverse Reactions

  • Severe Hypersenstivity Reactions

  • Metabolic Disorders

  • Myelopsuppression

6.1 Clinical Trials Experience

This section has undergone numerous revisions in text and tables; please refer to label for complete information.

6.2 Postmarketing Experience

Additions and/or revisions underlined:

  • Gastrointestinal: Acute pancreatitis

  • Hepatobiliary: Cholecystitis and cholelithiasis

  • Vascular: Arterial thrombotic events

  • Nervous System: Reflex sympathetic dystrophy

  • Cardiac: Cardiac failure …

  • Infections: Sepsis and septic shock

7 Drug Interactions

Additions and/or revisions underlined:

7.1 Effect of Other Drugs on AFINITOR/AFINITOR DISPERZ

Inhibitors

Avoid the concomitant use of P-gp and strong CYP3A4 inhibitors.

Reduce the dose for patients taking AFINITOR/AFINITOR DISPERZ with a P-gp and moderate CYP3A4 inhibitor as recommended.

Inducers

Increase the dose for patients taking AFINITOR/AFINITOR DISPERZ with a P-gp and strong CYP3A4 inducer as recommended.

7.2 Effects of Combination Use of Angiotensin Converting Enzyme (ACE) Inhibitors

Patients taking concomitant ACE inhibitors with AFINITOR/AFINITOR DISPERZ may be at increased risk for angioedema. Avoid the concomitant use of ACE inhibitors with AFINITOR/AFINITOR DISPERZ.

 

8 Use in Specific Populations

8.1 Pregnancy

Additions and/or revisions underlined:

… . 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 recommended dose of AFINITOR 10 mg orally once daily …

Data

Animal Data

… Embryo-fetal toxicities in rats occurred at doses greater than or equal to 0.1 mg/kg (0.6 mg/m2) with resulting exposures of approximately 4% of the human exposure at the recommended dose of AFINITOR 10 mg orally once daily based on area under the curve (AUC). In rabbits, embryo-toxicity evident as an increase in resorptions occurred at an oral dose of 0.8 mg/kg (9.6 mg/m2), approximately 1.6 times the recommended dose of AFINITOR 10 mg orally once daily or the median dose administered to patients with tuberous sclerosis complex (TSC)-associated subependymal giant cell astrocytoma (SEGA), and 1.3 times the median dose administered to patients with TSC-associated partial-onset seizures based on body surface area. The effect in rabbits occurred …

8.2 Lactation

Additions and/or revisions underlined:

Risk Summary

There are no data on the presence of everolimus or its metabolites in human milk …

8.3 Females and Males of Reproductive Potential

Additions and/or revisions underlined:

Pregnancy Testing

Verify the pregnancy status of females of reproductive potential prior to starting AFINITOR/AFINITOR DISPERZ.

Contraception

AFINITOR/AFINITOR DISPERZ can cause fetal harm when administered to pregnant women. Females: Advise female patients of reproductive potential to use effective contraception during treatment with AFINITOR/AFINITOR DISPERZ and for 8 weeks after the last dose.

8.4 Pediatric Use

Additions and/or revisions underlined:

TSC-Associated SEGA

The safety and effectiveness of AFINITOR/AFINITOR DISPERZ have been established in pediatric patients age 1 year and older with TSC-associated SEGA that requires therapeutic intervention but cannot be curatively resected. Use of AFINITOR/AFINITOR DISPERZ for this indication is supported by evidence from a randomized, double-blind, placebo- controlled trial in adult and pediatric patients (EXIST-1); an open-label, single-arm trial in adult and pediatric patients (Study 2485); and additional pharmacokinetic data in pediatric patients. The safety and effectiveness of AFINITOR/AFINITOR DISPERZ have not been established in pediatric patients less than 1 year of age with TSC-associated SEGA.

In EXIST-1, the incidence of infections and serious infections were reported at a higher frequency in patients less than 6 years of age. Ninety-six percent of 23 AFINITOR-treated patients less than 6 years had at least one infection compared to 67% of 55 AFINITOR-treated patients greater than or equal to 6 years. Thirty-five percent of 23 AFINITOR-treated patients less than 6 years of age had at least 1 serious infection compared to 7% of 55 AFINITOR-treated patients greater than or equal to 6 years.

TSC-Associated Partial-Onset Seizures

The safety and effectiveness of AFINITOR DISPERZ has been established for the adjunctive treatment of pediatric patients aged 2 years and older with TSC-associated partial-onset seizures. Use of AFINITOR DISPERZ for this indication is supported by evidence from a randomized, double-blind, placebo-controlled trial in adult and pediatric patients (EXIST-3) with additional pharmacokinetic data in pediatric patients. The safety and effectiveness of AFINITOR DISPERZ and AFINITOR have not been established for the adjunctive treatment of pediatric patients less than 2 years of age with TSC-associated partial-onset seizures.

The incidence of infections and serious infections were reported at a higher frequency in patients less than 6 years of age compared to patients greater than or equal to 6 years old. Seventy-seven percent of 70 AFINITOR DISPERZ-treated patients less than 6 years had at least one infection, compared to 53% of 177 AFINITOR DISPERZ-treated patients greater than or equal to 6 years. Sixteen percent of 70 AFINITOR DISPERZ-treated patients less than 6 years of age had at least 1 serious infection, compared to 4% of 177 AFINITOR DISPERZ-treated patients greater than or equal to 6 years of age. Two fatal cases due to infections were reported in pediatric patients.

Other Indications

The safety and effectiveness of AFINITOR/AFINITOR DISPERZ in pediatric patients have not been established in:

  • Hormone receptor-positive, HER2-negative breast cancer

  • Neuroendocrine tumors (NET)

  • Renal cell carcinoma (RCC)

  • TSC-associated renal angiomyolipoma

8.6 Hepatic Impairment

Additions and/or revisions underlined:

AFINITOR/AFINITOR DISPERZ exposure may increase in patients with hepatic impairment.

For patients with breast cancer, NET, RCC, and TSC-associated renal angiomyolipoma who have hepatic impairment, reduce the AFINITOR dose as recommended.

For patients with TSC-associated SEGA and TSC-associated partial-onset seizures who have severe hepatic impairment (Child-Pugh C), reduce the starting dose of AFINITOR/AFINITOR DISPERZ as recommended and adjust the dose based on everolimus trough concentrations.

 

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Non-infectious Pneumonitis

Advise patients of the risk of developing non-infectious pneumonitis and to immediately report any new or worsening respiratory symptoms to their healthcare provider.

Infections

Advise patients that they are more susceptible to infections and that they should immediately report any signs or symptoms of infections to their healthcare provider.

Hypersensitivity Reactions

Advise patients of the risk of clinically significant hypersensitivity reactions and to promptly contact their healthcare provider or seek emergency care for signs of hypersensitivity reaction including rash, itching, hives, difficulty breathing or swallowing, flushing, chest pain, or dizziness.

Geriatric Patients

 

Inform patients that in a study conducted in patients with breast cancer, the incidence of deaths and adverse reactions leading to permanent discontinuation was higher in patients greater than or equal to 65 years compared to patients less than 65 years.

Metabolic Disorders

Advise patients of the risk of metabolic disorders and the need to monitor glucose and lipids periodically during therapy

Myelosuppression

Advise patients of the risk of myelosuppression and the need to monitor complete blood counts periodically during therapy.

Risk of Infection or Reduced Immune Response with Vaccination

Advise patients to avoid the use of live vaccines …

PATIENT INFORMATION

Section revised; please see label for complete information.

09/26/2017 (SUPPL-39)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.12 Embryo-Fetal Toxicity

(additions underlined)

Based on animal studies and the mechanism of action, AFINITOR 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 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 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 and for 4 weeks after the last dose.

5.4 Stomatitis

(subsection revised, additions underlined)

Stomatitis, including mouth ulcers and oral mucositis, has occurred in patients treated with AFINITOR at an incidence ranging from 44%-78% across the clinical trial experience. Grade 3 or 4 stomatitis was reported in 4%-9% of patients. Stomatitis most often occurs within the first 8 weeks of treatment. When starting AFINITOR, 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 as they may exacerbate the condition.

6 Adverse Reactions

6.1 Clinical Study Experience in Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer

(additions underlined)

Topical Prophylaxis for Stomatitis

In a single arm study (SWISH; N=92) in postmenopausal women with hormone receptor-positive, HER2-negative breast cancer beginning AFINITOR (10 mg/day) plus exemestane (25 mg/day), patients started dexamethasone 0.5mg/5mL alcohol-free mouthwash (10 mL swished for 2 minutes and spat, 4 times daily for 8 weeks) concurrently with AFINITOR and exemestane. No food or drink was to be consumed for at least 1 hour after swishing and spitting the dexamethasone mouthwash. The primary objective of this study was to assess the incidence of Grade greater than or equal to 2 stomatitis within 8 weeks. The incidence of Grade greater than or equal to 2 stomatitis within 8 weeks was 2%, which was lower than the 33% reported in the BOLERO-2 trial. The incidence of Grade 1 stomatitis was 19%. No cases of Grade 3 or 4 stomatitis were reported. Oral candidiasis was reported in 2% of patients in this study compared to 0.2% in the BOLERO-2 trial.

6.2 Clinical Study Experience in Advanced Neuroendocrine Tumors

(additions underlined)

Advanced Pancreatic Neuroendocrine Tumors (PNET)

In a randomized, controlled trial (RADIANT-3) of AFINITOR (n=204) versus placebo (n=203) in patients with advanced PNET the median age of patients was 58 years (range 20-87), 79% were White, and 55% were male. Patients on the placebo arm could cross over to open-label AFINITOR upon disease progression.

In a randomized, controlled trial (RADIANT-4) of AFINITOR (n=202 treated) versus placebo (n=98 treated) in patients with advanced non-functional NET of GI or lung origin, the median age of patients was 63 years (range 22-86), 76% were White, and 53% were female. The median duration of exposure to AFINITOR was 9.3 months; 64% of patients were treated for greater than or equal to 6 months and 39% were treated for greater than or equal to 12 months. AFINITOR was discontinued for adverse reactions in 29% of patients, dose reduction or delay was required in 70% of AFINITOR-treated patients.

6.3 Clinical Study Experience in Advanced Renal Cell Carcinoma

(additions underlined)

The data described below reflect exposure to AFINITOR (n=274) and placebo (n=137) in a randomized, controlled trial (RECORD-1) in patients with metastatic renal cell carcinoma who received prior treatment with sunitinib and/or sorafenib. The median age of patients was 61 years (range 27-85), 88% were Caucasian, and 78% were male. The median duration of blinded study treatment was 141 days (range 19-451 days) for patients receiving AFINITOR and 60 days (range 21-295 days) for those receiving placebo.

6.4 Clinical Study Experience in Renal Angiomyolipoma with Tuberous Sclerosis Complex

(additions underlined)

The data described below are based on a randomized (2:1), double-blind, placebo-controlled trial (EXIST-2) of AFINITOR in 118 patients with renal angiomyolipoma as a feature of TSC (n=113) or sporadic lymphangioleiomyomatosis (n=5). The median age of patients was 31 years (range 18 to 61 years), 89% were Caucasian, and 34% were male. The median duration of blinded study treatment was 48 weeks (range 2 to 115 weeks) for patients receiving AFINITOR and 45 weeks (range 9 to 115 weeks) for those receiving placebo.

6.5 Clinical Study Experience in Subependymal Giant Cell Astrocytoma with Tuberous Sclerosis Complex

(additions underlined)

The data described below are based on a randomized (2:1), double-blind, placebo-controlled trial (EXIST-1) of AFINITOR in 117 patients with subependymal giant cell astrocytoma (SEGA) and tuberous sclerosis complex (TSC). The median   age of patients was 9.5 years (range 0.8 to 26 years), 93% were Caucasian, and 57% were male. The median duration of blinded study treatment was 52 weeks (range 24 to 89 weeks) for patients receiving AFINITOR and 47 weeks (range   14 to 88 weeks) for those receiving placebo.

8 Use in Specific Populations

8.3 Females and Males of Reproductive Potential

(additions underlined)

AFINITOR can cause fetal harm when administered to pregnant women. Advise females of reproductive potential to seek counseling on fertility and family planning options prior to starting treatment with AFINITOR.

Contraception

Females

Advise female patients of reproductive potential to use effective contraception during treatment and for 8 weeks after last dose of AFINITOR.

Males

Based on findings in animal reproduction studies, advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 4 weeks after the last dose of AFINITOR.

Infertility

Females

Menstrual irregularities, secondary amenorrhea, and increases in luteinizing hormone (LH) and follicle stimulating hormone (FSH) occurred in female patients taking AFINITOR. Based on these clinical findings and findings in animals, female fertility may be compromised by treatment with AFINITOR.

Males

Based on the clinical findings and findings in animals, AFINITOR treatment may impair fertility in male patients. Cases of reversible azoospermia have been reported in male patients taking AFINITOR. In male rats, sperm motility, sperm count, plasma testosterone levels and fertility were diminished at exposures (AUC) similar to those in patients receiving a dose of 10 mg daily. The fertility index in rats increased when everolimus administration was stopped for a 10-13 week recovery period.

8.4 Pediatric Use

(additions underlined)

StudyEXIST-1 was a randomized, double-blind, multicenter trial comparing AFINITOR (n=78) to placebo (n=39) in pediatric and adult patients. The median age was 9.5 years (range 0.8 to 26 years). At the time of randomization, a total of 20 patients were < 3 years of age, 54 patients were 3 to < 12 years of age, 27 patients were 12 to < 18 years of age, and 16 patients were ? 18 years of age. The overall nature, type, and frequency of adverse reactions across the age groups evaluated were similar, with the exception of a higher per patient incidence of infectious serious adverse events in patients < 3 years of age. A total of 6 of 13 patients (46%) < 3 years of age had at least 1 serious adverse event due to infection, compared to 2 of 7 patients (29%) treated with placebo. No patient in any age group discontinued AFINITOR due to infection.Subgroup analyses showed reduction in SEGA volume with AFINITOR treatment in all pediatric age subgroups.

Study 2485 was an open-label, single-arm, single-center trial of AFINITOR (N=28) in patients aged greater than or equal to 3 years; median age was 11 years (range 3 to 34 years). A total of 16 patients were 3 to < 12 years, 6 patients were 12 to < 18 years, and 6 patients were greater than or equal to 18 years. The frequency of adverse reactions across the age groups was generally similar. Subgroup analyses showed reductions in SEGA volume with AFINITOR treatment in all pediatric age subgroups.

Although a conclusive determination cannot be made due to the limited number of patients and lack of a comparator arm in the open label follow-up periods of EXIST-1 and Study 2485, AFINITOR did not appear to adversely impact growth and pubertal development in the 115 pediatric patients treated with AFINITOR for a median duration of 4.1 years.

Everolimus clearance normalized to body surface area was higher in pediatric patients than in adults with SEGA. The recommended starting dose and subsequent requirement for therapeutic drug monitoring to achieve and maintain trough concentrations of 5 to 15 ng/mL are the same for adult and pediatric patients with SEGA.

Co-administration of AFINITOR and dexamethasone alcohol-free oral solution has not been studied in pediatric patients.

8.5 Geriatric Use

In the randomized advanced hormone receptor positive, HER2-negative breast cancer study (BOLERO-2), 40% of AFINITOR-treated patients were greater than or equal to 65 years of age, while 15% were 75 years and over. No overall differences in effectiveness were observed between elderly and younger patients. The incidence of deaths due to any cause within 28 days of the last AFINITOR dose was 6% in patients greater than or equal to 65 years of age compared to 2% in patients < 65 years of age. Adverse reactions leading to permanent treatment discontinuation occurred in 33% of patients greater than or equal to 65 years of age compared to 17% in patients < 65 years of age.

In two other randomized trials (advanced renal cell carcinoma and advanced neuroendocrine tumors of pancreatic origin), no overall differences in safety or effectiveness were observed between elderly and younger patients. In the randomized advanced RCC study (RECORD-1), 41% of AFINITOR treated patients were greater than or equal to 65 years of age, while 7% were 75 years and over. In the randomized advanced PNET study (RADIANT-3), 30% of AFINITOR-treated patients were greater than or equal to 65 years of age, while 7% were 75 years and over.

Other reported clinical experience has not identified differences in response between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

No dosage adjustment in initial dosing is required in elderly patients, but close monitoring and appropriate dose adjustments for adverse reactions is recommended.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

(additions underlined)

Stomatitis

Inform patients of the possibility of developing stomatitis. In such cases, mouthwashes and/or other topical treatments are recommended, but these should not contain alcohol, peroxide, iodine, or thyme.

Embryo-Fetal Toxicity

AFINITOR can cause fetal harm if taken during pregnancy. Advise a pregnant woman of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 8 weeks after the last dose of AFINITOR. Advise patients to inform their healthcare provider of a known or suspected pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 4 weeks after the last dose of AFINITOR.

PATIENT INFORMATION

(additions underlined)

What should I tell my healthcare provider before taking AFINITOR or AFINITOR DISPERZ?

Before taking AFINITOR or AFINITOR DISPERZ,

  • Are pregnant, could become pregnant, or have a partner who could become pregnant. AFINITOR or AFINITOR DISPERZ can cause harm to your unborn baby. If you are a woman who is able to become pregnant you should use effective birth control during treatment and for 8 weeks after your last dose of AFINITOR or AFINITOR DISPERZ. If you are a man with a woman partner, you should use effective birth control during treatment and for 4 weeks after your last dose of AFINITOR or AFINITOR DISPERZ. Talk to your healthcare provider about birth control methods that may be right for you during this time. If you become pregnant or think you are pregnant, tell your healthcare provider right away.

  • Are breastfeeding or plan to breastfeed. It is not known if AFINITOR or AFINITOR DISPERZ passes into your breast milk. Do not breastfeed during treatment and for 2 weeks after your last dose of AFINITOR or AFINITOR DISPERZ.

  • Are about to have surgery, if you have had a recent surgery, or if you have an unhealed wound

06/14/2016 (SUPPL-38)

Approved Drug Label (PDF)

5 Warnings and Precautions

Non-infectious Pneumonitis

  • (Update of the following sentence in paragraph 1) Non-infectious 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.

6 Adverse Reactions

Postmarketing Experience

  • (addition to paragraph) and cardiac failure with some cases reported with pulmonary hypertension (including pulmonary arterial hypertension) as a secondary event.

Questions related to the drug data in these files should be directed to the Center for Drug Evaluation and Research, Division of Drug Information
druginfo@fda.hhs.gov.

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