Tisotumab vedotin-tftv can cause changes to the cornea (clear tissue that covers the front of the eye) and conjunctiva (a membrane that lines the inside of eyes) that can lead to vision loss. Tell your doctor if you have or have ever had vision or eye problems. If you experience any of the following symptoms, call your doctor immediately: blurred vision, loss of vision, eye pain or redness, or other visual changes.

Your doctor will order an eye exam before starting your treatment and before receiving each dose of tisotumab vedotin-tftv. Keep all appointments with your doctor and your eye doctor.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with tisotumab vedotin-tftvand each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer’s website to obtain the Medication Guide.

Talk to your doctor about the risks of receiving tisotumab vedotin-tftv injection.

Tisotumab vedotin-tftv injection is used to treat cervical cancer (cancer that begins in the opening of the uterus [womb]) that has not improved or has come back after treatment with other medications or has spread to other parts of the body. Tisotumab vedotin-tftv is in a class of medications called antibody-drug conjugates. It works by killing cancer cells.

Tisotumab vedotin-tftv injection comes as a powder to be mixed with liquid and injected intravenously (into a vein) over 30 minutes by a doctor or nurse in a hospital or medical facility. It is usually injected on day 1 of a 21-day cycle. The length of your treatment depends on how well your body responds to the medication and the side effects that you experience.

Your doctor will prescribe 3 different eye drops for you to use during your treatment with tisotumab vedotin-tftv injection to reduce the risk of eye problems. You should bring the eye drops with you to your appointments for each treatment. Your doctor will tell you how and when to use the eye drops. Use these eye drops exactly as directed. While you are receiving tisotumab vedotin-tftv injection, your doctor or nurse will place a cold pack over your eyes.

Your doctor may delay or stop your treatment with tisotumab vedotin-ejfv injection, or treat you with additional medications, depending on your response to the medication and any side effects that you experience. Talk to your doctor about how you are feeling during your treatment.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving tisotumab vedotin-tftv injection,

• tell your doctor and pharmacist if you are allergic to tisotumab vedotin-tftv, any other medications, or any of the ingredients in tisotumab vedotin-tftv injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while receiving tisotumab vedotin-tftv injection. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had peripheral neuropathy (numbness, tingling, burning, or pain sensation in your hands or feet, or decreased ability to feel temperature or touch in your hands or feet), bleeding problems, or kidney or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or if you plan to father a child. You or your partner should not become pregnant while you are receiving tisotumab vedotin-ejfv injection. Your doctor may perform a pregnancy test to be sure that you are not pregnant before you receive tisotumab vedotin-ejfv injection. If you are female, you should use birth control during your treatment and for 2 months after your final dose. If you are male, you and your female partner should use birth control during your treatment and for 4 months after your final dose. Talk to your doctor about birth control methods that will work for you. If you or your partner become pregnant while receiving tisotumab vedotin-ejfv injection, call your doctor. Tisotumab vedotin-ejfv injection may harm the fetus.
• tell your doctor if you are breastfeeding. You should not breastfeed while you are receiving tisotumab vedotin-tftv injection and for 3 weeks after the final dose.
• you should know that this medication may decrease fertility in men. Talk to your doctor about the risks of receiving tisotumab vedotin-tftv injection.
• tell your doctor if you wear contact lenses. You should not wear contact lenses during your treatment with tisotumab vedotin-tftv.

Unless your doctor tells you otherwise, continue your normal diet.

Tisotumab vedotin-tftv may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• diarrhea
• constipation
• decreased appetite
• weight loss
• stomach pain
• tiredness
• hair loss
• pain in the joints, arms, legs, back, or neck
• fever
• rash
• itching
• frequent, painful, or difficult urination

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• unusual or heavy bleeding or bruising
• bloody, black, or tarry stools
• vomiting blood or material that looks like coffee grounds
• blood in urine
• unusual vaginal bleeding
• nosebleed
• trouble breathing, shortness of breath, or cough
• numbness or tingling of the hands or feet; or muscle weakness, pain, or burning

Tisotumab vedotin-tftv may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Tivdak^®