Tisotumab vedotin

What is Tisotumab vedotin?[edit | edit source]

Tisotumab vedotin (Tivdak) is a tissue factor-directed antibody and microtubule inhibitor conjugate used to treat recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

It is an antibody-drug conjugate (ADC) comprised of a monoclonal antibody against human tissue factor (TF) covalently coupled, via a protease-cleavable peptide linker, to monomethyl auristatin E (MMAE), an auristatin derivative and potent microtubule disrupting agent, with potential antiangiogenic, anticoagulant and antineoplastic activities.

Tisotumab vedotin (Tivdak) is a prescription medicine used to treat adults with cervical cancer:

Upon administration, tisotumab vedotin binds to cell surface TF and is internalized.
The antibody moiety prevents binding of TF to factor VIIa (FVIIa) and interferes with the activation of factor X (FX) into FXa. This may prevent thrombin formation and cancer-associated venous thromboembolism, and may inhibit angiogenesis and tumor cell proliferation.
After internalization of the agent, the MMAE moiety is released by proteolytic cleavage.
It then binds to tubulin and inhibits its polymerization, which results in G2/M phase arrest and apoptosis.
TF, a transmembrane protein and initiator of the coagulation cascade, is overexpressed in many tumor cells and tumor-resident endothelial cells.
Expression of TF is correlated with metastasis, angiogenesis, tumor cell growth and tumor-associated thrombosis.

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.

Tisotumab vedotin was approved for medical use in the United States in September 2021.

Recommended dosage:

The recommended dose of TIVDAK is 2 mg/kg (up to a maximum of 200 mg for patients ≥100 kg) administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity.

Administration:

TIVDAK will be given to you by intravenous (IV) infusion into your vein over 30 minutes.
TIVDAK is usually given every 3 weeks.
Your healthcare provider will decide how many infusions you need
Your healthcare provider will put cold packs on your eyes during each infusion.
Your healthcare provider may decrease your dose, temporarily stop, or completely stop treatment with TIVDAK if you have side effects.

This medicine is available in fallowing doasage form:

As Injection: 40 mg as a lyophilized cake or powder in a single-dose vial for reconstitution.

This medicine is available in fallowing brand namesː

The most common side effects of this medicine include:

TIVDAK can cause serious side effects, including:

Peripheral neuropathy occurred in patients with cervical cancer treated with TIVDAK. Monitor patients for new or worsening peripheral neuropathy. Withhold, reduce the dose, or permanently discontinue TIVDAK based on severity.
Hemorrhage occurred in patients with cervical cancer treated with TIVDAK. Monitor patients for signs and symptoms of hemorrhage. Withhold, reduce the dose, or permanently discontinue TIVDAK based on severity.
Severe, life-threatening, or fatal pneumonitis can occur in patients treated with antibody drug conjugates containing vedotin including TIVDAK. Withhold TIVDAK for persistent or recurrent Grade 2 pneumonitis and consider dose reduction. Permanently discontinue TIVDAK for Grade 3 or 4 pneumonitis.
Based on the mechanism of action and findings in animals, TIVDAK can cause fetal harm when administered to a pregnant woman. Advise of the potential risk to a fetus and to use effective contraception.
Ocular adverse reactions occurred in patients with cervical cancer treated with TIVDAK. Withhold, reduce the dose, or permanently discontinue TIVDAK based on the severity of the adverse reaction.

In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

Overdose related information is also available online at poisonhelp.org/help.
In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Based on the mechanism of action and findings in animals, TIVDAK can cause fetal harm when administered to a pregnant woman.
There are no available human data on TIVDAK use in pregnant women to inform a drug-associated risk.

Safety and effectiveness of TIVDAK in pediatric patients have not been established.

Active ingredient: tisotumab vedotin-tftv
Inactive ingredients: d-mannitol, l-histidine, l-histidine monohydrochloride, and sucrose.

Manufactured by: Seagen Inc., Bothell, WA 98021, 1-855-4SEAGEN
Marketed by: Seagen Inc., Bothell, WA 98021 and Genmab US, Inc., Plainsboro, NJ

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.

Special Handling:

Tisotumab vedotin Resources
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