Tivdak Generic Name & Formulations
Tisotumab vedotin-tftv 40mg; per vial; lyophilized cake or pwd for IV infusion after reconstitution and dilution; preservative-free.
Tissue factor (TF)-directed antibody drug conjugate (ADC).
In adults with recurrent or metastatic cervical cancer who had disease progression on or after chemotherapy.
Tivdak Dosage and Administration
Premedicate with steroid and vasoconstrictor eye drops. Apply cold packs over eyes during each infusion. Give as IV infusion over 30mins. 2mg/kg every 3 weeks until disease progression or unacceptable toxicity. Patients ≥100kg: max 200mg. Dose modifications for adverse reactions: see full labeling.
Tivdak Boxed Warnings
Risk of ocular toxicity. Conduct eye exam at baseline, prior to each dose, and as indicated. Adhere to premedication and required eye care (eg, lubricating eye drops, contact lenses) before, during, and after infusion; see full labeling. Monitor for new or worsening ocular symptoms (eg, keratitis, conjunctival ulceration, conjunctival/corneal scarring, symblepharon, conjunctivitis, others), peripheral neuropathy. Withhold therapy until improvement and resume, reduce the dose, or permanently discontinue based on the severity of the adverse reaction. Monitor for hemorrhage; withhold dose if Grade ≥2 severity in any other location; permanently discontinue if pulmonary or CNS hemorrhage, or Grade 4 in any other location. Monitor for pneumonitis; withhold if persistent/recurrent Grade 2 severity and consider dose reduction; permanently discontinue if Grade 3 or 4. Hepatic impairment (moderate or severe): avoid; (mild): monitor closely. Embryo-fetal toxicity. Advise to use effective contraception during and for 2 months (females of reproductive potential) and for 4 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 3 weeks after the last dose).
Concomitant strong CYP3A4 inhibitors may increase unconjugated MMAE exposure; monitor for increased adverse reactions.
Tivdak Adverse Reactions
Fatigue, nausea, peripheral neuropathy, alopecia, epistaxis, conjunctival adverse reactions, hemorrhage, dry eye, diarrhea, rash, lab abnormalities (decreased hemoglobin, decreased lymphocytes, decreased leukocytes, increased creatinine, increased PT INR, prolonged aPTT); visual acuity changes, ileus, pneumonia, sepsis, possible male infertility.
Tivdak Clinical Trials
Tivdak Patient Counseling