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Tisotumab vedotin-tftv (Intravenous)

Generic name: tisotumab vedotin-tftv [ tye-SOT-ue-mab-ve-DOE-tin-- tftv ]
Brand name: Tivdak
Drug class: Miscellaneous antineoplastics

Medically reviewed by Drugs.com. Last updated on Jun 26, 2024.

Intravenous route(Powder for Solution)

WARNING: OCULAR TOXICITYTisotumab vedotin-tftv caused changes in the corneal epithelium and conjunctiva resulting in changes in vision, including severe vision loss, and corneal ulceration.

Conduct an ophthalmic exam at baseline, prior to each dose, and as clinically indicated.

Adhere to premedication and required eye care before, during, and after infusion.

Withhold tisotumab vedotin-tftv until improvement and resume, reduce the dose, or permanently discontinue, based on severity .

Uses for tisotumab vedotin-tftv

Tisotumab vedotin-tftv injection is used to treat cervical cancer that has returned or has spread to other parts of the body and in patients who have received other cancer medicines that did not work well.

This medicine is to be given only by or under the immediate supervision of your doctor.

Before using tisotumab vedotin-tftv

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of tisotumab vedotin-tftv injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tisotumab vedotin-tftv injection in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Proper use of tisotumab vedotin-tftv

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.

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. It must be given slowly, so the needle will need to stay in place for at least 30 minutes every 3 weeks.

Your doctor will also give you 3 different types of eye drops (eg, 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 comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Keytruda, pembrolizumab, fluorouracil, cisplatin, carboplatin, Avastin

Precautions while using tisotumab vedotin-tftv

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause eye or vision problems (eg, dry eye, blepharitis, ulcerative keratitis). Check with your doctor right away if you have dry eyes, eye redness, irritation, or pain, or redness, swelling, and/or itching of the eyelid. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Receiving this medicine while you are pregnant can harm your unborn baby. 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. If a pregnancy occurs while you are using this medicine, tell your doctor right away.

Check with your doctor right away if you are having burning, numbness, tingling, or painful sensations, weakness in the arms, hands, legs, or feet, or unsteadiness. These could be symptoms of a condition called peripheral neuropathy.

This medicine may cause bleeding problems (eg, epistaxis, hematuria, and vaginal hemorrhage). Check with your doctor right away if you have blood in the urine, bloody nose, or heavy nonmenstrual vaginal bleeding.

This medicine may cause pneumonitis (swelling of the lungs). Check with your doctor right away if you have chest pain, chills, cough, fever, general feeling of discomfort or illness, thickening of bronchial secretions, or trouble breathing

This medicine may cause serious skin reaction, including Stevens-Johnson syndrome. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness.

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.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of tisotumab vedotin-tftv

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Less common

Incidence not known

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Commonly used brand name(s)

In the U.S.

Available Dosage Forms:

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Tisotumab Vedotin

Biological Products Related to tisotumab vedotin

Find detailed information on biosimilars for this medication.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.