Tisotumab vedotin

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.

Tisotumab vedotin is injected into a vein by a healthcare provider.

This medicine must be given slowly over 30 minutes.

Tisotumab vedotin is usually given once every 3 weeks until your body no longer responds to the medication or you have certain side effects.

Using tisotumab vedotin can cause changes to the surface of your eye and in some cases may cause serious eye problems including vision loss. An eye doctor will need to check your eyes before and during treatment with tisotumab vedotin.

You will be given 3 different eye medications to use: steroid eyedrops, vasoconstrictor eyedrops, and lubricating eyedrops. You will need to have all eye medications with you each time you receive a tisotumab vedotin infusion.

• The steroid eye medication is used before each infusion and continued for 72 hours.
• The vasoconstrictor eye medication is given just before the infusion.
• Lubricating eye drops should be used the entire time you are receiving tisotumab vedotin and for 30 days after your last dose.

Do not wear contact lenses while receiving tisotumab vedotin, unless your eye doctor tells you to.

Using tisotumab vedotin can cause changes to your eye surface and may lead to serious eye problems, including vision loss. Inform your doctor if you experience eye redness, dryness, or irritation, or if you notice any changes in your vision or white patches on your eyes.

An eye doctor will need to examine your eyes before and during your treatment with tisotumab vedotin. You will also need to use prescription eye medications each time you receive a tisotumab vedotin infusion. Make sure to bring all your eye medications with you to each infusion appointment.

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 tisotumab vedotin.

• 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 can become 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.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tisotumab vedotin may cause serious side effects. Call your doctor immediately 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 stopped permanently if you have certain side effects.

Common side effects of tisotumab vedotin 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.

Usual Adult Dose for Cervical Cancer:

2 mg/kg (up to a maximum of 200 mg for patients 100 kg or greater) IV over 30 minutes every 3 weeks until disease progression or unacceptable toxicityPremedication and Eye Care:-Conduct an ophthalmic exam including visual acuity and slit lamp exam at baseline, prior to each dose, and as indicated.-The initial prescription and all renewals of any corticosteroid medications should be made only after examination with a slit lamp. -Administer the first drop in each eye prior to each infusion; continue to administer the drops in each eye 72 hours after each infusion.-Administer topical ocular vasoconstrictor drops in each eye immediately prior to each infusion.-Use cooling eye pads during the infusion.-Administer topical lubricating eye drops for the duration of therapy and for 30 days after the last dose.-Advise patients to avoid wearing contact lenses unless advised by their eye care provider for the entire duration of therapy.Use: For the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy

Call your doctor for instructions if you miss an appointment for your Tisotumab vedotin injection.

In a medical setting, an overdose would be treated quickly.

Follow your doctor's instructions about any limits on food, drinks, or activities.

Other drugs may affect tisotumab vedotin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.