Tisotumab vedotin

Generic name: Tisotumab Vedotin
Brand names: Tivdak
Dosage form: intravenous powder for injection (tftv 40 mg)
Drug class: Miscellaneous antineoplastics

Usage of 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 side effects

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

Tisotumab vedotin may cause serious side effects. 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 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.

Before taking 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 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 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.

Relate drugs

How to use Tisotumab vedotin

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

Warnings

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 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.

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com'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. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com 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.