Tivdak (Tisotumab Vedotin) – Side Effects, Interactions, Uses, Dosage, Warnings

Tisotumab vedotin is used to treat cervical cancer that has spread to other parts of the body (metastatic) after other treatments did not work or stopped working.

Tisotumab vedotin may also be used for purposes not listed in this medication guide.


What is Tivdak (Tisotumab Vedotin) used for?

  • Cervical Cancer


What is the most important information I should know about Tivdak (Tisotumab Vedotin)?

Tell your doctor if you have ever had:

  • vision or eye problems;
  • bleeding problems;
  • liver disease; or
  • numbness or tingling (neuropathy) in your hands and feet.

Tisotumab vedotin can harm an unborn baby if the mother or the father is using this medicine.

  • If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use birth control while using this medicine and for at least 2 months after your last dose.
  • If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 4 months after your last dose.
  • Tell your doctor right away if a pregnancy occurs.

This medicine may affect fertility (ability to have children) in men. However, it is important to use birth control to prevent pregnancy because tisotumab vedotin can harm an unborn baby.

Do not breastfeed while using this medicine, and for at least 3 weeks after your last dose.

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Side Effects

What are the side effects of Tivdak (Tisotumab Vedotin)?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • new or worsening vision changes;
  • eye redness, dryness, or irritation;
  • white or red patches on the surface of your eye;
  • new or worsening cough, trouble breathing;
  • stomach cramps, bloating, nausea, vomiting, severe constipation;
  • nosebleeds, blood in your urine, abnormal vaginal bleeding, any bleeding that will not stop;
  • nerve problems–numbness, tingling, pain, burning sensation in your hands or feet, weakness;
  • low hemoglobin (red blood cells)–pale skin, weakness, feeling tired or short of breath, fast heartbeats; or
  • low white blood cell counts–fever, mouth sores, skin sores, sore throat, cough.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

  • dry eyes;
  • fever, low red or white blood cells;
  • nausea, diarrhea;
  • feeling tired;
  • nosebleeds;
  • numbness or tingling;
  • hair loss;
  • rash; or
  • abnormal kidney function or blood-clotting tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Pregnancy & Breastfeeding

Can I take Tivdak (Tisotumab Vedotin) if I’m pregnant or breastfeeding?

Do not breastfeed while using this medicine, and for at least 3 weeks after your last dose.


What drugs and food should I avoid while taking Tivdak (Tisotumab Vedotin)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Dosage Guidelines & Tips

How to take Tivdak (Tisotumab Vedotin)?

Use Tivdak (Tisotumab Vedotin) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Tisotumab vedotin is injected into a vein by a healthcare provider.

This medicine must be given slowly over 30 minutes.

Tisotumab vedotin is usually given once every 3 weeks until your body no longer responds to the medication or you have certain side effects.

Using tisotumab vedotin can cause changes to the surface of your eye and in some cases may cause serious eye problems including vision loss. An eye doctor will need to check your eyes before and during treatment with tisotumab vedotin.

You will be given 3 different eye medications to use: steroid eyedrops, vasoconstrictor eyedrops, and lubricating eyedrops. You will need to have all eye medications with you each time you receive a tisotumab vedotin infusion.

  • The steroid eye medication is used before each infusion and continued for 72 hours.
  • The vasoconstrictor eye medication is given just before the infusion.
  • Lubricating eye drops should be used the entire time you are receiving tisotumab vedotin and for 30 days after your last dose.

Do not wear contact lenses while receiving tisotumab vedotin, unless your eye doctor tells you to.

What should I do if I missed a dose of Tivdak (Tisotumab Vedotin)?

Call your doctor for instructions if you miss an appointment for your tisotumab vedotin injection.

Overdose Signs

What happens if I overdose on Tivdak (Tisotumab Vedotin)?

In a medical setting an overdose would be treated quickly.

If you think you or someone else may have overdosed on: Tivdak (Tisotumab Vedotin),  call your doctor or the Poison Control center

(800) 222-1222

If someone collapses or isn't breathing after taking Tivdak (Tisotumab Vedotin), call 911


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