Label Changes for:
Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
5 WARNINGS AND PRECAUTIONS
5.6 Other Immune-mediated Adverse Reactions, Including Ocular Manifestations
- include autoimmune central neuropathy (encephalitis), neurosensory hypoacusis, myositis, polymyositis, ocular myositis and sarcoidosis
USE IN SPECIFIC POPULATIONS
- In a combined study of embryo-fetal and peri-postnatal development, pregnant cynomolgus monkeys received ipilimumab every 3 weeks from the onset of organogenesis in the first trimester through parturition, at exposure levels either 2.6 or 7.2 times higher by AUC than the exposures at the clinical dose of 3 mg/kg of ipilimumab. No treatment-related adverse effects on reproduction were detected during the first two trimesters of pregnancy. Beginning in the third trimester, the ipilimumab treated groups experienced higher incidences of severe toxicities including abortion, stillbirth, premature delivery (with corresponding lower birth weight), and higher incidences of infant mortality in a dose-related manner compared to controls.
- In monkeys treated at dose levels resulting in exposures 2.6 and 7.2 times higher than those in humans at the recommended dose, ipilimumab was present in milk at concentrations of 0.1 and 0.4 mcg/mL, representing a ratio of up to 0.3% of the serum concentration of the drug. Because many drugs are secreted in human milk and because of the potential for serious adverse reactions in nursing infants from Yervoy, a decision should be made whether to discontinue nursing or to discontinue Yervoy, taking into account the importance of Yervoy to the mother.
- No dose adjustment is needed for patients with renal impairment.
- No dose adjustment is needed for patients with mild hepatic impairment (total bilirubin [TB] >1.0 x to 1.5 x the upper limit of normal [ULN] or AST >ULN). Yervoy has not been studied in patients with moderate (TB >1.5 x to 3.0 x ULN and any AST) or severe (TB >3 x ULN and any AST) hepatic impairment.