Tisotumab vedotin-tftv (Intravenous)

Tisotumab vedotin-tftv injection is used to treat cervical cancer that has come back or has spread to other areas of the body, and in patients who have already tried other cancer treatments that were not effective.

This medicine is to be given only by your doctor or under their direct supervision.

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 (e.g., 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 (e.g., epistaxis, hematuria, and vaginal hemorrhage). Check with your doctor right away if you have blood in the urine, a 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, a general feeling of discomfort or illness, thickening of bronchial secretions, or trouble breathing.

This medicine may cause serious skin reactions, 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, a 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.

In deciding to use a medicine, you and your doctor need to think about the risks of taking it compared to the benefits it may provide. For this medicine, consider the following:

Allergies

Let your doctor know if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also inform your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been enough studies on how age affects the use of tisotumab vedotin-tftv injection in children. Its safety and effectiveness have not been proven.

Geriatric

Studies so far have not found any specific problems in older adults that would limit the usefulness of tisotumab vedotin-tftv injection.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines might be used together, even if an interaction could happen. In these situations, your doctor may need to adjust the dose or take other precautions. Inform 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 taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how you can use this medicine. Be sure to 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. This may worsen these conditions.

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

Along with its needed effects, Tisotumab vedotin-tftv (Intravenous) may cause some unwanted effects. Not all of these side effects may occur, but if they do, 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 Tisotumab vedotin-tftv. 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.

In the U.S.

• Tivdak

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Tisotumab Vedotin

Find detailed information on biosimilars for this medication.

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.