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tisotumab vedotin

Pronunciation: tye SOT ue mab ve DOE tin

Brand: Tivdak

What is the most important information I should know about tisotumab vedotin?

Using tisotumab vedotin can cause changes to the surface of your eye and in some cases may cause serious eye problems including vision loss. Tell your doctor if you have eye redness, dryness, or irritation, or if you notice vision changes or white patches on your eyes.

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

What is 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.

What should I discuss with my healthcare provider before receiving tisotumab vedotin?

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 this medicine.

  • 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 is able to get 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.

How is tisotumab vedotin given?

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.

What happens if I miss a dose?

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

What happens if I overdose?

In a medical setting an overdose would be treated quickly.

What should I avoid while receiving tisotumab vedotin?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of tisotumab vedotin?

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

Call your doctor at once 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 permanently discontinued if you have certain side effects.

Common side effects 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.

What other drugs will affect tisotumab vedotin?

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.

Where can I get more information?

Your doctor or pharmacist can provide more information about tisotumab vedotin.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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