Tivdak - Tisotumab Vedotin Injection

What is this medication?

TISOTUMAB VEDOTIN (tye SOT ue mab ve DOE tin) treats cervical cancer. It works by blocking a protein that causes cancer cells to grow and multiply. This helps to slow or stop the spread of cancer cells.

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 medications, foods, dyes, or preservatives
• If you or your partner are pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is injected into a vein. It is given by your care team 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 care team about the use of this medication 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 care team if you are unable to keep an appointment.

What may interact with this medication?

• Certain antibiotics, such as clarithromycin, telithromycin
• Certain antivirals for HIV or hepatitis
• Certain medications for fungal infections, such as itraconazole, ketoconazole, posaconazole, 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?

Your condition will be monitored carefully while you are receiving this medication.

This medication 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 care team tells you to stop.

This medication can cause serious eye damage. Tell your care team right away if you have any change in your eyesight. Your vision will be tested before and during use of this medication.

Your care team 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 care team.

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

This medication may increase your risk of getting an infection. Call your care team 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 medications that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your care team. These medications may hide a fever.

This medication may increase your risk to bruise or bleed. Call your care team if you notice any unusual bleeding.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. You may also notice a red rash with swelling of the face, lips, or lymph nodes in your neck or under your arms.

Talk to your care team if you or your partner may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 2 months after the last dose. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for 2 months after the last dose. Your care team can help you find the option that works for you.

If your partner can get pregnant, use a condom during sex while taking this medication and for 4 months after the last dose.

Do not breastfeed while taking this medication and for 3 weeks after the last dose.

This medication may cause infertility. Talk to your care team if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• Dry cough, shortness of breath or trouble breathing
• Eye pain, redness, irritation, or discharge with blurry or decreased vision
• Frequent or severe nosebleeds
• Heavy vaginal bleeding
• Pain, tingling, or numbness in the hands or feet
• Rash, fever, and swollen lymph nodes
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth

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

• Diarrhea
• Dry eyes
• Fatigue
• Hair loss
• Nausea

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 medication 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.