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Tivdak is used to treat cervical cancer. It stops cancer cells from growing and helps destroy cancer cells. The most common side effects are numbness or tingling in your hands or feet, pink eye, nausea, tiredness, nosebleeds, and hair loss. Tell your health care provider right away if you have eye pain or vision trouble, swollen or itchy eyelids, painful skin rash, fever, trouble breathing, fainting, or chest pain. Tivdak is given by a health care provider in a hospital or clinic.

Uses

What is Tivdak used for?

Tivdak (tisotumab-vedotin) is commonly used for cancer of the cervix, which is where the uterus connects to the vagina.

Tivdak may also be used for other conditions as determined by your health care provider.

How does Tivdak work (mechanism of action)?

Tivdak works by targeting a protein called tissue factor (TF), which is found on the surface of certain cancer cells. Tivdak is made of two parts: an antibody attached to a medicine. Once the antibody part attaches to TF on the cancer cell, Tivdak is taken into the cell and releases the medicine part. This disrupts the cell’s structure, causing it to stop growing and die. Tivdak may also attract certain immune system cells to help destroy the cancer cells.

How is Tivdak supplied (dosage forms)?

Brands and other names

  • Tivdak

Dosage forms and strengths

Tivdak is available in an injectable form that is given by a health care provider.

How should I store Tivdak?

Tivdak is given by a health care provider in a hospital or clinic. You will not store it at home.

Side Effects

What are the most common side effects of Tivdak?

The most common side effects of Tivdak are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Low levels of hemoglobin, which is a protein that carries oxygen in your blood
  • Nerve problems (see below)
  • Pink eye
  • Nausea
  • Tiredness
  • Changes in liver test results
  • Nosebleeds
  • Hair loss
  • Bleeding (see below)

There may be other side effects of Tivdak that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Tivdak?

While less common, the most serious side effects of Tivdak are described below, along with what to do if they happen.

Severe Allergic Reactions. Tivdak may cause allergic reactions, which can be serious. Get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Severe Eye Problems. Tivdak may cause eye problems, such as pink eye (conjunctivitis), inflammation of the cornea (keratitis), or an open sore on the cornea (corneal ulcer). These problems may lead to vision loss. Keep all eye exam appointments while using Tivdak. Contact your health care provider right away if you have any of the following symptoms.

  • Eye redness, itchiness, or pain
  • Swollen or itchy eyelids
  • Feeling like you have something in your eye
  • Eye dryness, watering, or discharge
  • Vision changes, such as blurry vision or sensitivity to light

Serious Lung Problems. Tivdak can cause inflammation in your lungs, also called interstitial lung disease or pneumonitis. These lung problems can be serious or even life-threatening. Get emergency help if you have trouble breathing. Contact your health care provider right away if you have new symptoms, such as a cough or chest pain.

Nerve Problems. Nerves are the fibers that carry sensations from your body to the brain. Damage to these nerves, called peripheral neuropathy, can happen in people using Tivdak. Tell your health care provider if you develop the following symptoms in your arms, hands, legs, or feet. 

  • Pain
  • Tingling, prickling, or burning sensation
  • Numbness
  • Weakness 

Severe Bleeding. Tivdak can increase your risk of severe bleeding that can lead to death. Some people with serious bleeding may need a blood transfusion or surgery. Call your health care provider right away if you have any of the following signs of severe bleeding while using Tivdak.

  • Pink, red, or brown urine (pee)
  • Vomit with blood that looks like coffee grounds
  • Red or black stools (looks like tar)
  • Coughing up blood or blood clots
  • Fainting

Severe Skin Reactions. Tivdak can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), which can lead to death if not treated. If you develop a rash, call your health care provider right away. Get emergency help if you have any of the following symptoms of SJS.

  • Painful red or purple skin that looks burned and peels off
  • Flat red rash or blisters on your skin, mouth, nose, and genitals
  • Red, painful, watery eyes
  • Flu-like symptoms, including fever, chills, and muscle aches
  • Painful sores in the mouth, throat, nose, or genital area

Warnings & Precautions

Who should not use Tivdak?

Allergies to Ingredients. People who are allergic to any of the following should not use Tivdak.

  • Tisotumab-vedotin
  • Tivdak
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Tivdak.

What should I know about Tivdak before using it?

Tivdak is usually given by a health care provider in a hospital or clinic.

Tivdak may make it difficult for you to get pregnant or get your partner pregnant. If you have concerns, talk to your health care provider.

Keep all appointments with your health care provider, including appointments for blood tests. 

Keep all eye exam appointments while using Tivdak and follow the recommended eye care. Your health care provider will recommend some eye drops to help prevent and manage side effects of Tivdak. Bring all of your eye drops to each appointment for your infusion of Tivdak. Do not wear contact lenses unless your health care provider tells you it is OK. 

What should I tell my health care provider before using Tivdak?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Tivdak is right for you.

In particular, make sure that you discuss any of the following.

Other Medicines and Supplements. Tivdak may interact with other medicines and supplements. Before using Tivdak, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Liver problems
  • Lung problems
  • Eye or vision problems
  • Nerve problems, such as tingling or numbness in your hands or feet
  • Bleeding problems

Pregnancy. Tivdak may cause harm to a fetus. If you are able to become pregnant, your health care provider will confirm that you are not pregnant before you start Tivdak treatment. Tell your health care provider if you or your partner is pregnant or planning to become pregnant. If you can become pregnant, it is recommended to use birth control during Tivdak treatment and for two months after your last dose. If your partner can become pregnant, use birth control (such as condoms) during Tivdak treatment and for four months after your last dose. 

Breastfeeding. Do not breastfeed while using Tivdak and for three weeks after your last dose. It is not known if Tivdak passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. 

How can I get more information about Tivdak?

For more information about Tivdak, you can visit the drugmaker’s website at www.tivdak.com or call them at 855-473-2436.

Interactions

Does Tivdak interact with foods or drinks?

Your health care provider may suggest limiting or avoiding grapefruit while using Tivdak. Grapefruit and grapefruit juice may increase the levels of Tivdak in your blood, raising the risk of side effects.

It is unknown if drinking alcohol will affect Tivdak, but heavy drinking can slow your immune response and make it harder for your body to fight cancer. Alcohol can also increase your risk of bleeding. It is best to limit the amount of alcohol you drink.

Does Tivdak interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before using Tivdak.

  • Ketoconazole, which is a medicine used for fungal infections
  • Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis

Some other medicines may alter the blood levels of Tivdak. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Tivdak. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Tivdak?

If you or someone else has used too much Tivdak, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Tivdak?

Tivdak is given by a health care provider in a hospital or clinic. If you miss an appointment to get your Tivdak dose, call to make another appointment as soon as possible.