Description
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.
This product is available in the following dosage forms:
- Powder for Solution
Before Using
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.
Breastfeeding
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.
Drug Interactions
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
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 an IV catheter that is placed into one of your veins. It must be given slowly, so the IV 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
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, conjunctivitis, dry eye, blepharitis, keratopathy). Check with your provider right away if you have dry eyes, eye redness, irritation, or pain, or redness, swelling, and/or itching of the eyelid. Your provider may want you to have your eyes checked by an ophthalmologist (eye specialist).
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 provider right away if you have 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 provider right away if you have blood in the urine, a bloody nose, or heavy vaginal bleeding that is not related to your menstrual cycle.
This medicine may cause pneumonitis (swelling of the lungs). Check with your provider 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 a serious skin reaction, including Stevens-Johnson syndrome. Check with your provider 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
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.
CON-XXXXXXXX
