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Label Changes for:

Afinitor (everolimus)

June 2016

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)  

June 2016

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.
 

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.

 

July 2014

WARNINGS AND PRECAUTIONS

Non-infectious Pneumonitis
  • … Opportunistic infections such as pneumocystis jiroveci pneumonia (PJP) should be considered in the differential diagnosis. For patients who require use of corticosteroids for treatment of non-infectious pneumonitis, prophylaxis for PJP may be considered...
Infections
  • ...Localized and systemic infections, including… or pneumocystis jiroveci pneumonia (PJP)…
  • Pneumocystis jiroveci pneumonia, some with a fatal outcome, has been reported in patients who received everolimus. This may be associated with concomitant use of corticosteroids or other immunosuppressive agents. Prophylaxis for PJP should be considered when concomitant use of corticosteroids or other immunosuppressive agents are required.

ADVERSE REACTIONS

Postmarketing Experience
  • The following adverse reactions … cholecystitis, cholelithiasis, arterial thrombotic events and reflex sympathetic dystrophy

 

February 2014

5 WARNINGS AND PRECAUTIONS

5.5 Impaired Wound Healing
  • Everolimus delays wound healing and increases the occurrence of wound-related complications like wound dehiscence, wound infection, incisional hernia, lymphocele, and seroma. These wound-related complications may require surgical intervention. Exercise caution with the use of AFINITOR in the peri-surgical period.
5.11 Embryo-fetal Toxicity
  • Based on the mechanism of action, AFINITOR can cause fetal harm. Everolimus caused embryo-fetal toxicities in animals at maternal exposures that were lower than human exposures. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see Use in Specific Populations (8.1)]. Advise female patients of reproductive potential to avoid becoming pregnant and to use highly effective contraception while using AFINITOR and for up to 8 weeks after ending treatment [see Use in Specific Populations (8.6)].

6 ADVERSE REACTIONS

6.2 Clinical Study Experience in Advanced Pancreatic Neuroendocrine Tumors
  • irregular menstruation…percentage increased … occurred in 5 of 46 (11%)

 

 

May 2011

WARNINGS AND PRECAUTIONS

Renal Failure Events
  • Cases of renal failure (including acute renal failure), some with a fatal outcome, have been observed in patients treated with Afinitor

 

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