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.

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.

Use Tisotumab Vedotin (Intravenous) 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.

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.

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