Pronunciation:

tye-SOT-ue-mab ve-DOE-tin - tftv

Brand Names:

• Tivdak

Dosage Forms:

• Powder for Solution

Warnings:

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 .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Tisotumab Vedotin

Uses of This Medicine:

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 This Medicine:

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.

Children—

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.

Older adults—

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.

Other 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.

Other interactions—

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:

• Bleeding problems or
• Eye or vision problems, history of or
• Liver disease, mild or
• Peripheral neuropathy (nerve problem)—Use with caution. May make these conditions worse.

• Liver disease, moderate or severe—Use is not recommended in patients with this condition.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

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 This Medicine:

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

Bladder pain

bleeding from the rectum

bleeding gums

bloody eye

bloody nose

bloody or cloudy urine

blurred vision or any other change in vision

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

burning, dry or itching eyes

burning, numbness, tingling, or painful sensations

coughing or spitting up blood

difficult, burning, or painful urination

difficulty breathing or swallowing

discharge, excessive tearing

dizziness

dry eyes

eye redness, irritation, or pain

frequent urge to urinate

headache

increased menstrual flow or vaginal bleeding

increased sensitivity to pain

increased sensitivity to touch

lower back or side pain

nerve pain

nosebleeds

painful irritation of the clear front part of the eye

paralysis

prolonged bleeding from cuts

red or black, tarry stools

red or dark brown urine

redness, pain, swelling of eye, eyelid, or inner lining of the eyelid

redness of the white part of eyes or inside of the eyelids

tingling in the hands and feet

trouble breathing

unsteadiness or awkwardness

walking in unusual manner

weakness in the arms, hands, legs, or feet

Less common

Anxiety

chest pain

chills

dizziness or lightheadedness

fainting

fast heartbeat

general feeling of discomfort or illness

tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area

thickening of bronchial secretions

Incidence not known

Blistering, peeling, or loosening of the skin

diarrhea

joint or muscle pain

red irritated eyes

red skin lesions, often with a purple center

sore throat

sores, ulcers, white spots in the mouth or on the lips

unusual tiredness or weakness

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

Arm or leg pain

constipation

decreased appetite

decreased weight

difficulty in moving

lack or loss of strength

loss or thinning of the hair

muscle or bone pain

stomach pain or cramps

vomiting

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.