Description
Telisotuzumab vedotin-tllv injection is used to treat non-squamous non-small cell lung cancer (NSCLC) that has spread to areas near the lung (locally advanced) or throughout the body (metastatic) in patients whose tumors have high c-Met protein overexpression and who have received other cancer medicines. Your doctor will test for the presence of the high c-Met protein overexpression.
Telisotuzumab vedotin-tllv injection is a monoclonal antibody that changes the immune system to help control the growth of cancer cells.
This medicine is to be given only by or under the direct 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 telisotuzumab vedotin-tllv 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 telisotuzumab vedotin-tllv 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:
- Eye or vision problems (eg, keratitis, dry eye) or
- Lung or breathing problems or
- Peripheral neuropathy (nerve problem), history of—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 doctor 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. The medicine must be given slowly, so the IV will have to stay in place for at least 30 minutes. This medicine is given once every 2 weeks.
This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
You may also receive other medicines (eg, allergy medicine, fever medicine, steroids) 30 to 60 minutes before receiving this medicine to help prevent unwanted side effects from the injection.
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.
Receiving this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is receiving it when his sexual partner becomes pregnant. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before starting the treatment. Female patients should use effective birth control during treatment with this medicine and for at least 2 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 4 months after the last dose. If you think you have become pregnant while receiving the medicine, tell your doctor right away.
This medicine may cause peripheral neuropathy (nerve problem). 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.
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. These maybe symptoms of serious lung problems (eg, interstitial lung disease, pneumonitis).
This medicine may cause eye or vision problems. Check with your doctor right away if you have blurred vision, dry eye, or eye redness, irritation, or pain. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
This medicine may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have back pain, chest tightness, chills, fever, flushing, headache, nausea and vomiting, trouble breathing, or weakness.
Some men and women who use this medicine have become infertile (unable to have children). 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
- Blindness
- bloating or swelling of face, arms, hands, lower legs, or feet
- blurred vision
- burning, numbness, tingling, or painful sensations
- chest pain or tightness
- cough
- decreased vision
- dry eye
- eye redness, irritation, or pain
- fever or chills
- general feeling of discomfort or illness
- painful irritation of the clear front part of the eye
- rapid weight gain
- sore throat
- swelling of the eye
- thickening of bronchial secretions
- tingling of the hands or feet
- trouble breathing
- unsteadiness or awkwardness
- unusual weight gain or loss
- weakness in the arms, hands, legs, or feet
Incidence not known
- Back pain
- flushing
- headache
- nausea and vomiting
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
- Constipation
- decreased appetite
- unusual tiredness or weakness
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.
DRG-80007466
