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 TOXICITY
See full prescribing information for complete boxed warning.- TIVDAK can cause severe ocular toxicities resulting in changes in vision, including severe vision loss and corneal ulceration. (5.1)
- Conduct an ophthalmic exam, including an assessment of ocular symptoms, visual acuity, and slit lamp exam of the anterior segment of the eye prior to initiation of TIVDAK, prior to every cycle for the first nine cycles, and as clinically indicated. (2.2, 5.1)
- Adhere to the required premedication and eye care before, during, and after infusion. (2.2)
- Withhold TIVDAK until improvement and resume, reduce the dose, or permanently discontinue, based on severity (2.3, 5.1)
RECENT MAJOR CHANGES| Boxed Warning, Ocular Toxicity | 04/2024 | | Indications and Usage (1) | 04/2024 | | Dosage and Administration (2.2), (2.3) | 04/2024 | | Warnings and Precautions (5.1), (5.2), (5.3), (5.4), (5.5) | 04/2024 |
INDICATIONS 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- For intravenous infusion only. Do not administer TIVDAK as an intravenous push or bolus. Do not mix with, or administer as an infusion with, other medicinal products. (2.4)
- The recommended dose of TIVDAK is 2 mg/kg (up to a maximum of 200 mg) given as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity. (2.1)
DOSAGE FORMS AND STRENGTHSFor Injection: 40 mg as a lyophilized cake or powder in a single-dose vial for reconstitution. (3) WARNINGS AND PRECAUTIONS- Peripheral neuropathy: Monitor patients for new or worsening peripheral neuropathy. Withhold, reduce the dose, or permanently discontinue TIVDAK based on severity. (2.3, 5.2)
- Hemorrhage: Monitor patients for signs and symptoms of hemorrhage. Withhold, reduce the dose, or permanently discontinue TIVDAK based on severity. (2.3, 5.3)
- Pneumonitis: Severe, life-threatening, or fatal pneumonitis may occur. Withhold TIVDAK for persistent or recurrent Grade 2 pneumonitis and consider dose reduction. Permanently discontinue TIVDAK for Grade 3 or 4 pneumonitis. (2.3, 5.4)
- Severe Cutaneous Adverse Reactions: Severe cutaneous adverse reactions, including events of fatal or life-threatening Stevens-Johnson syndrome (SJS), can occur in patients treated with TIVDAK. Immediately withhold TIVDAK for suspected severe cutaneous adverse reactions, including SJS. Permanently discontinue TIVDAK for confirmed Grade 3 or 4 severe cutaneous adverse reactions, including SJS. (2.3, 5.5)
- Embryo-fetal toxicity: TIVDAK can cause fetal harm. Advise of the potential risk to a fetus and to use effective contraception. (5.6, 8.1, 8.3)
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)
To report SUSPECTED ADVERSE REACTIONS, contact Seagen Inc. at 1-855-4SEAGEN or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONSStrong CYP3A4 Inhibitors: Closely monitor for TIVDAK adverse reactions. (7.1) USE IN SPECIFIC POPULATIONS- Moderate or severe hepatic impairment: Exposure to MMAE and adverse reactions are increased. Avoid use. (8.6)
- Lactation: Advise women not to breastfeed. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: 4/2024 |