Tisotumab Vedotin-tftv (tye-SOT-ue-mab ve-DOE-tin - tftv)

Treats cervical cancer.

Brand Name(s):

Tivdak

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV placed in a vein. It must be given slowly, so the IV will have to remain in place for at least 30 minutes.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• Your doctor will also give you 3 different types of eye drops (including steroid, vasoconstrictor, and lubricating eye drops) before and after treatment with this medicine. Do not wear contact lenses during treatment with this medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how tisotumab vedotin-tftv works. Tell your doctor if you are using ketoconazole or rifampin.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control to prevent pregnancy while you are receiving this medicine and for at least 2 months after the last dose. Males with female partners who can become pregnant must use an effective birth control during treatment and for at least 4 months after the last dose.
• Do not breastfeed during treatment and for at least 3 weeks after the last dose.
• Tell your doctor if you have kidney disease, liver disease, bleeding problems, nerve problems, or history of eye or vision problems.
• This medicine may cause the following problems:
  • Eye or vision problems, including conjunctivitis, dry eye, blepharitis, keratopathy
  • Peripheral neuropathy (nerve problem)
  • Bleeding problems
  • Serious skin reaction, including Stevens-Johnson syndrome
  • Lung problem, including pneumonitis
• This medicine could cause infertility (unable to have children) in some men. Talk with your doctor before using this medicine if you plan to have children.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bleeding gums, coughing up blood, nosebleeds
• Blistering, peeling, red skin rash
• Blurred vision, dry eyes, eye pain or redness
• Chest pain, cough, trouble breathing
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Diarrhea
• Hair loss

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088