Tisotumab Vedotin-tftv
Class: Antineoplastic Agents
Brands: Tivdak
Warning
Warning: Ocular Toxicity
See full prescribing information for complete boxed warning.
Tisotumab vedotin-tftv caused changes in the corneal epithelium and conjunctiva resulting in changes in vision, including severe vision loss, and corneal ulceration.
Conduct an ophthalmic exam at baseline, prior to each dose, and as clinically indicated.
Adhere to premedication and required eye care before, during, and after infusion.
Withhold tisotumab vedotin-tftv until improvement and resume, reduce the dose, or permanently discontinue, based on severity.
Introduction
Tisotumab vedotin-tftv, a tissue factor-directed antibody and microtubule inhibitor conjugate, is an antineoplastic agent.
Uses for Tisotumab Vedotin-tftv
Tisotumab vedotin-tftv has the following uses:
Tisotumab vedotin-tftv is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Tisotumab Vedotin-tftv Dosage and Administration
General
Tisotumab vedotin-tftv is available in the following dosage form(s) and strength(s):
For Injection: 40 mg as a lyophilized cake or powder in a single-dose vial for reconstitution.
Dosage
It isessentialthat the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:
Adults
Dosage and Administration
For intravenous infusion only. Do not administer tisotumab vedotin-tftv as an intravenous push or bolus. Do not mix with, or administer as an infusion with, other medicinal products.
The recommended dose of tisotumab vedotin-tftv is 2 mg/kg (up to a maximum of 200 mg for patients weighing ≥100 kg) given as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity.
Cautions for Tisotumab Vedotin-tftv
Contraindications
None.
Warnings/Precautions
Ocular Adverse Reactions
Ocular adverse reactions occurred in 60% of patients with cervical cancer treated with tisotumab vedotin-tftv across ...
