Pronunciation: TIFF-dack
Generic name: tisotumab
Dosage form: injection for intravenous use
Drug class: Miscellaneous antineoplastics

Medically reviewed by Carmen Pope, BPharm. Last updated on May 2, 2024.

What is Tivdak?

Tivdak (tisotumab vedotin-tftv) is an injectable tissue factor-directed antibody and microtubule inhibitor conjugate that may be used to treat adults with cervical cancer:

• that has returned or has spread to other parts of the body, and
• who have received chemotherapy that did not work or is no longer working.

Tivdak is a first in its class antibody-drug conjugate (ADC). The antibody part is a human IgG1 that targets tissue factor (TF) on the cell surface. Tissue factor is a protein expressed on cervical cancer cells that can promote tumor growth, angiogenesis, and metastases. TF is the primary initiator of the extrinsic blood coagulation cascade. The small molecule drug, MMAE, is attached to the antibody by a link that is easily broken by protease enzymes. The ADC binds to TF-expressing cancer cells which then take up Tivdak and release the active MMAE which disrupts the microtubule network of actively dividing cells, stopping replication and leading to cell death. Because TF is also present in some normal cells, Tivdak can still harm normal cells.

Tivdak gained full FDA approval on April 29, 2024. Before that, it was approved on September 20, 2021 under the accelerated approval designation and was contingent upon continued favorable results in clinical trials.

Tivdak side effects

Tivdak can cause serious side effects, including eye problems, peripheral neuropathy, serious skin reactions, and bleeding, see warnings below. 

The most common side effects of Tivdak affecting 25% or more people who take it include:

• decreased red blood cell counts
• nausea
• nosebleeds
• numbness or tingling in your hands or feet
• tiredness
• hair loss (alopecia)
• eye problems (conjunctival disorders)
• changes in liver function
• bleeding (hemorrhage).

These are not all of the possible side effects of Tivdak. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

Keytruda, carboplatin, pembrolizumab, fluorouracil, Avastin, cisplatin

Warnings

Tivdak can cause serious side effects, including:

Eye problems. These can be common and/or severe. Tivdak can cause changes to the surface of your eye that can lead to dry eyes, eye redness, eye irritation, corneal ulcers, blurred vision, and severe vision loss. Tell your healthcare provider if you develop new or worsening vision changes or eye problems during treatment.

• Your healthcare provider will send you to an eye specialist to check your eyes before you start treatment with Tivdak, before each infusion for your first 9 infusions of TIVDAK, and as needed for any new or worsening signs or symptoms of eye problems.
• Your healthcare provider will ask if you have any signs or symptoms of eye problems before each infusion. You will be referred to an eye specialist for any new or worsening signs or symptoms of eye problems.
• Your healthcare provider will prescribe 3 different types of eye drops before you start treatment with Tivdak. Bring the eye drops with you to each infusion and use them as directed by your healthcare provider to reduce your risk of eye problems:
• Use 1 drop of steroid eye drops in each eye before each infusion and continue to use your eye drops 3 times a day for 3 days after each infusion.
• Use vasoconstrictor eye drops right before each infusion.
• Use lubricating eye drops throughout treatment and for 30 days after your last dose of Tivdak.
• Do not wear contact lenses throughout your treatment with Tivdak unless you are told to use them by your eye specialist.

Peripheral neuropathy (nerve problems in the hands or feet). These are common with Tivdak, and can also be serious. Tell your healthcare provider right away if you get numbness or tingling in your hands or feet or muscle weakness.

Bleeding (hemorrhage) is common with Tivdak and can also be serious. Tell your healthcare provider or get medical help right away if you get signs or symptoms of bleeding during treatment such as:

• blood in your stools or black stools (looks like tar)
• unusual vaginal bleeding
• blood in your urine
• any unusual or heavy bleeding
• cough up or vomit blood.

Severe or life-threatening inflammation of the lungs that can lead to death. Tell your healthcare provider right away if you get new or worsening symptoms, including trouble breathing, shortness of breath, or cough.

Severe skin reactions. Tivdak may cause severe or life-threatening skin reactions that can lead to death. Tell your healthcare provider or get medical help right away if you get signs or symptoms of a severe skin reaction during treatment, including:

• skin reactions that look like rings (target lesions)
• fever or flu-like symptoms
• rash or itching that continues to get worse
• swollen lymph nodes
• blistering or peeling of the skin
• painful sores or ulcers in your mouth, nose, throat, or genital area

It is not known if Tivdak is safe and effective in children.

Before taking

Before receiving Tivdak, tell your healthcare provider about all of your medical conditions, including if you:

• have a history of vision or eye problems
• have numbness or tingling in your hands or feet
• have bleeding problems
• have liver problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

Tivdak can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Tivdak.

If you are a female who can become pregnant your healthcare provider should do a pregnancy test before you start treatment with Tivdak and you should use an effective birth control during treatment and for 2 months after your last dose.

Males with female partners who can become pregnant should use effective birth control during treatment and for 4 months after their last dose of Tivdak.

Fertility

Tivdak may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.

Breastfeeding

It is not known if Tivdak passes into your breast milk. Do not breastfeed during treatment and for 3 weeks after your last dose.

How is Tivdak administered?

Tivdak is administered by a healthcare professional through an 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
• put cold packs on your eyes during each infusion
• may decrease your dose, temporarily stop, or completely stop treatment if you have side effects.

What other drugs will affect Tivdak?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking Tivdak with certain other medicines may cause side effects. 

MMAE is a substrate of CYP3A4 liver enzymes. Using Tivdak with strong CYP3A4 inhibitors, such as clarithromycin, erythromycin, and isoniazid, may increase blood levels of MMAE increasing the risk of Tivdak side effects.

This is not a complete list of interactions. Tell your healthcare provider about all the medicines you take.

Storage

Tivdak is a hazardous substance. Healthcare providers should follow special handling and disposal procedures.

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.

If not used immediately, reconstituted vials may be stored for up to 24 hours in refrigeration at 2°C to 8°C (36 °F to 46 °F) or at room temperature up to 25°C (77°F) for up to a maximum of 8 hours before dilution.

Do not freeze. Do not be exposed to direct sunlight. Discard unused vials with a reconstituted solution beyond the recommended storage time.

Ingredients

Active ingredient: tisotumab vedotin-tftv

Inactive ingredients: d-mannitol, l-histidine, l-histidine monohydrochloride, and sucrose.

Manufacturer

Seagen Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer