FDA 블랙박스 경고: POMALIDOMIDE

블랙박스 경고

Pomalidomide (POMALIDOMIDE) — Apotex Corp.

WARNING: EMBRYO-FETAL TOXICITY and VENOUS AND ARTERIAL THROMBOEMBOLISM Embryo-Fetal Toxicity Pomalidomide is contraindicated in pregnancy. Pomalidomide is a thalidomide analogue. Thalidomide is a known human teratogen that causes severe birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting pomalidomide treatment. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after stopping pomalidomide treatment [ see Contraindications ( 4 ), Warnings and Precautions ( 5.1 ), and Use in Specific Populations ( 8.1, 8.3 ) ]. Pomalidomide is only available through a restricted distribution program called Pomalidomide REMS [ see Warnings and Precautions ( 5.2 ) ]. Venous and Arterial Thromboembolism Deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke occur in patients with multiple myeloma treated with pomalidomide . Prophylactic antithrombotic measures were employed in clinical trials. Thromboprophylaxis is recommended, and the choice of regimen should be based on assessment of the patient's underlying risk factors [ see Warnings and Precautions ( 5.3 ) ]. WARNING: EMBRYO-FETAL TOXICITY and VENOUS AND ARTERIAL THROMBOEMBOLISM See full prescribing information for complete boxed warning EMBRYO-FETAL TOXICITY Pomalidomide is contraindicated in pregnancy. Pomalidomide is a thalidomide analogue. Thalidomide is a known human teratogen that causes severe life-threatening birth defects ( 4 , 5.1 , 8.1 ). For females of reproductive potential: Exclude pregnancy before start of treatment. Prevent pregnancy during treatment by the use of 2 reliable methods of contraception ( 5.1, 8.3 ) . Pomalidomide is available only through a restricted program called Pomalidomide REMS program ( 5.2 ). VENOUS AND ARTERIAL THROMBOEMBOLISM Deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, a

약물 상호작용

7 DRUG INTERACTIONS Strong CYP1A2 Inhibitors: Avoid concomitant use of strong CYP1A2 inhibitors. If concomitant use of a strong CYP1A2 inhibitor is unavoidable, reduce pomalidomide dose to 2 mg ( 2.6 , 7.1 , 12.3 ). 7.1 Drugs That Affect Pomalidomide Plasma Concentrations CYP1A2 inhibitors : In healthy subjects, co-administration of fluvoxamine, a strong CYP1A2 inhibitor, increased C max and AUC of pomalidomide by 24% and 125% respectively [ see Clinical Pharmacology ( 12.3 ) ]. Increased pomali

주의사항

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