Tisotumab Vedotin Injection

What is this medication?

TISOTUMAB VEDOTIN (tye SOT ue mab ve DOE tin) is a chemotherapy medicine and monoclonal antibody. It treats cervical cancer.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Tivdak

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• bleeding disorder
• eye disease
• liver disease
• lung disease
• tingling of the fingers or toes or other nerve disorder
• vision problems
• an unusual or allergic reaction to tisotumab vedotin, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is injected into a vein. It is given by a health care provider in a hospital or clinic setting.

A special MedGuide will be given to you before each treatment. Be sure to read this information carefully each time.

Talk to your health care provider about the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up doses. It is important not to miss your dose. Call your health care provider if you are unable to keep an appointment.

What may interact with this medication?

• certain antibiotics like clarithromycin or telithromycin
• certain antivirals for HIV or hepatitis
• certain medicines for fungal infections like itraconazole, ketoconazole, posaconazole, or voriconazole
• grapefruit juice

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

This medicine may make you feel generally unwell. This is not uncommon as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your health care provider tells you to stop.

This medicine can cause serious eye damage. Tell your health care provider right away if you have changes in your eyesight. Your vision will be tested before and during use of this medicine.

Your health care provider will prescribe 3 different types of eye drops before you start treatment. Bring the eye drops with you to each infusion and use them as directed by your health care provider.

Do not wear contact lenses during treatment unless you are told to use them by your eye doctor.

Do not become pregnant while taking this medicine or for 2 months after stopping it. Women should inform their health care provider if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine and for 4 months after stopping it. There is potential for serious harm to an unborn child. Talk to your health care provider for more information. Do not breast-feed an infant while taking this medicine or for 3 weeks after stopping it.

This medicine may make it more difficult to father a child. Talk to your health care provider if you are concerned about your fertility.

This medicine may increase your risk of getting an infection. Call your health care provider for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Avoid taking medicines that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your health care provider. These medicines may hide a fever.

This medicine may increase your risk to bruise or bleed. Call your health care provider if you notice any unusual bleeding.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)
• bleeding (bloody or black, tarry stools; red or dark brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eyes, gums, or nose)
• blood clot (chest pain; shortness of breath; pain, swelling, or warmth in the leg)
• blurred vision OR changes in vision
• cough
• dry eyes
• eye pain
• infection (fever, chills, cough, sore throat, pain or trouble passing urine)
• kidney injury (trouble passing urine or change in the amount of urine)
• liver injury (dark yellow or brown urine; general ill feeling or flu-like symptoms; right upper belly pain; yellowing of the skin or eyes)
• low red blood cell counts (feeling faint; lightheaded, falls)
• pain, tingling, numbness in the hands or feet
• trouble breathing
• weakness

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• diarrhea
• hair loss
• lack or loss of appetite
• nausea
• stomach pain
• unusually weak or tired

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This medicine is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.