(tisotumab vedotin-tftv)
HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use TIVDAK safely and effectively. See full prescribing information for TIVDAK. TIVDAK® (tisotumab vedotin-tftv) for injection, for intravenous use Initial U.S. Approval: 2021 WARNING: OCULAR TOXICITYSee full prescribing information for complete boxed warning.
RECENT MAJOR CHANGESINDICATIONS AND USAGETIVDAK is a tissue factor-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. (1) DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHSFor Injection: 40 mg as a lyophilized cake or powder in a single-dose vial for reconstitution. (3) CONTRAINDICATIONSNone. (4) WARNINGS AND PRECAUTIONS
ADVERSE REACTIONSThe most common (≥25%) adverse reactions, including laboratory abnormalities, were hemoglobin decreased, peripheral neuropathy, conjunctival adverse reactions, nausea, fatigue, aspartate aminotransferase increased, epistaxis, alopecia, alanine aminotransferase increased, and hemorrhage. (6.1) DRUG INTERACTIONSStrong CYP3A4 Inhibitors: Closely monitor for TIVDAK adverse reactions. (7.1) USE IN SPECIFIC POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: 4/2024 |
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