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

Medically reviewed by Carmen Pope, BPharm. Last updated on Aug 26, 2024.

What is Tivdak?

Tivdak (tisotumab vedotin-tftv) is an injectable prescription medicine that may be used to treat adults with cervical cancer that has returned or spread and who have received chemotherapy that has not worked or is no longer working.

• Tivdak is usually given by a healthcare provider once every 3 weeks as an intravenous (into a vein) infusion.

Tivdak is a new type of cancer medicine called an antibody-drug conjugate (ADC). Tivdek has two main parts that work together to target and kill cancer cells. The first part is a human immunoglobulin G antibody that finds and sticks to a protein called tissue factor (TF), located on cervical cancer cells. The second part is a drug called MMAE, which is attached to the antibody. The mechanism of action of Tivdak is as follows:

1. The antibody part finds cancer cells with TF on them.
2. The whole medicine enters these cells.
3. Inside the cell, the drug part breaks off.
4. The drug then stops the cancer cell from dividing and causes it to die.

While Tivdak is designed to target cancer cells, some normal cells also have TF. This means Tivdak might affect some healthy cells too, which can cause side effects.

In clinical trials, Tivdak showed better results than standard chemotherapy. With Tivdak, 2.4% of people had a complete response and 15.4% had a partial response. With standard chemotherapy, no one had a complete response, while 5.2% had a partial response. This means more patients experienced tumor shrinkage or disappearance with Tivdak compared to standard chemotherapy.

Tivdak gained full FDA approval on April 29, 2024, after continued success was reported in clinical trials. Tivdak initially was approved under the accelerated approval designation on September 20, 2021

Tivdak side effects

The most common side effects of Tivdak are:

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

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.

Serious side effects and warnings

Tivdak carries a Boxed Warning for severe eye toxicity.

Severe eye toxicity including vision loss and other eye problems. 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.

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

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.

Tivdak dosage

The dosage of Tivdak depends on weight.

• The recommended dose of Tivdak for cervical cancer is 2 mg/kg (maximum dosage 200 mg).
• This is given as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity occurs.

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.

Tivdak is available in a 40 mg single-dose vial that requires reconstitution before use.

Who makes Tivdak?

Seagen Inc. makes Tivdak.

Tivdak Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Tivdak.

Further information

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

Medical Disclaimer