Tisotumab vedotin is a prescription medicine indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. It is available as powder for injection for intravenous use. MedsAcross supplies Tisotumab vedotin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
TIVDAK ® is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. TIVDAK 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.
Source: US FDA prescribing information
Tisotumab vedotin-tftv is a tissue factor (TF)-directed antibody drug conjugate (ADC). The antibody is a human IgG1 directed against cell surface TF. TF is the primary initiator of the extrinsic blood coagulation cascade. The small molecule, MMAE, is a microtubule-disrupting agent, attached to the antibody via a protease-cleavable linker. Nonclinical data suggests that the anticancer activity of tisotumab vedotin-tftv is due to the binding of the ADC to TF expressing cancer cells, followed by internalization of the ADC-TF complex, and release of MMAE via proteolytic cleavage. MMAE disrupts the microtubule network of actively dividing cells, leading to cell cycle arrest and apoptotic cell death. In vitro, tisotumab vedotin-tftv also mediates antibody-dependent cellular phagocytosis and antibody-dependent cellular cytotoxicity.
Source: US FDA prescribing information
• 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. • 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.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
Boxed warning (ocular toxicity • tivdak): can cause severe ocular toxicities resulting in changes in vision, including severe vision loss, and corneal ulceration. • 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. • Peripheral neuropathy: Monitor patients for new or worsening peripheral neuropathy. Withhold, reduce the dose, or permanently discontinue TIVDAK based on severity. • Hemorrhage: Monitor patients for signs and symptoms of hemorrhage. Withhold, reduce the dose, or permanently discontinue TIVDAK based on severity. • Pneumonitis: Severe, life-threatening, or fatal pneumonitis may occur. Withhold TIVDAK for persistent or recurrent Grade 2 pneumonitis and consider dose reduction.
Source: US FDA prescribing information
The following serious adverse reactions are described elsewhere in the labeling: • Ocular Adverse Reactions • Peripheral Neuropathy • Hemorrhage • Pneumonitis • Severe Cutaneous Adverse Reactions The 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.
Source: US FDA prescribing information
Strong CYP3A4 Inhibitors: Closely monitor for TIVDAK adverse reactions. Effects of Other Drugs on TIVDAK Strong CYP3A4 Inhibitors MMAE is a CYP3A4 substrate. Concomitant use of TIVDAK with strong CYP3A4 inhibitors may increase unconjugated MMAE exposure, which may increase the risk of TIVDAK adverse reactions. Closely monitor patients for adverse reactions of TIVDAK when used concomitantly with strong CYP3A4 inhibitors.
Source: US FDA prescribing information
Storage Store TIVDAK vials refrigerated at 2ºC to 8ºC (36ºF to 46ºF) in the original carton to protect from light. Do not freeze. Do not shake.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Tisotumab vedotin, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Tivdak 40 mg/4 mL powder for injectionIntravenous Cold chain | Seagen | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 1 presentations of Tisotumab vedotin and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Tisotumab vedotin, including Tivdak.
Yes. The US FDA first approved Tisotumab vedotin on 20 September 2021, according to Drugs@FDA.
Yes. Tisotumab vedotin has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Tisotumab vedotin must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Tisotumab vedotin is classified under ATC code L01FX23 (Tisotumab vedotin).
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