Telisotuzumab vedotin

Telisotuzumab vedotin is used in adults to treat non-squamous non-small cell lung cancer that has spread to other areas of the body (metastatic), or when other treatments did not work or stopped working.

Your doctor will confirm that you have the right type of tumor to be treated with telisotuzumab vedotin.

Telisotuzumab vedotin may also be used for reasons not mentioned in this medication guide.

Your doctor will do tests to ensure that telisotuzumab vedotin is the right treatment for you.

Telisotuzumab vedotin is injected into a vein by a healthcare provider once every 2 weeks. Your doctor will decide the best treatment schedule for you.

You may need regular medical tests, including vision exams, and your cancer treatments may be adjusted or postponed based on the results.

You will be monitored for a short time to ensure you do not have an allergic reaction.

You may receive other medications to help prevent serious side effects or an allergic reaction. Continue using these medicines for as long as your doctor has prescribed.

Doses are based on weight. Your dose may change if you gain or lose weight.

Telisotuzumab vedotin can lead to serious and potentially life-threatening side effects after the injection. Contact your doctor immediately if you experience numbness, tingling, or burning pain in your hands or feet, blurred vision, eye pain or redness, fever, cough, difficulty breathing, or if you feel dizzy, nauseous, light-headed, itchy, sweaty, or have a headache.

Tell your doctor if you have or have ever had:

• nerve problems;
• other lung or breathing problems besides lung cancer;
• eye problems; or
• liver disease.

Telisotuzumab vedotin can harm an unborn baby if the mother or the father is using telisotuzumab vedotin.

• If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use birth control while using this medicine and for at least 2 months after your last dose.
• If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 4 months after your last dose.
• Tell your doctor right away if a pregnancy occurs.

Do not breastfeed while using this medicine, and for at least 1 month after your last dose.

Telisotuzumab vedotin may affect fertility in men or women. Pregnancy could be harder to achieve while either parent is using this medicine.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Telisotuzumab vedotin can cause severe and life-threatening side effects. Call your doctor right away if you have numbness, tingling, muscle weakness, or burning pain in your hands or feet, blurred vision, eye pain, swelling, or redness, increased sensitivity to light, fever, cough, wheezing, or feeling short of breath.

Some side effects may occur during the injection. Tell your medical caregiver if you feel dizzy, nauseous, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Your cancer treatments may be delayed or permanently stopped if you have certain side effects.

Common side effects of telisotuzumab vedotin may include:

• loss of appetite;
• abnormal blood tests;
• nerve problems, swelling in the feet, ankles, legs or hands; or
• feeling tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Non-Small Cell Lung Cancer:

1.9 mg/kg IV every 2 weeksMaximum dose: 190 mg/doseDuration of therapy: Until disease progression or unacceptable toxicityComments:-Infuse over at least 30 minutes.-Select patients for treatment based on the presence of high c-Met protein overexpression using an approved US FDA test.---Information on US FDA-approved tests is available at: http://www.fda.gov/CompanionDiagnostics.Use: For the treatment of locally advanced or metastatic, nonsquamous non-small cell lung cancer with high c-Met protein overexpression (50% or more of tumor cells with strong [3+] staining) in patients who have received 1 prior systemic therapy

Call your doctor for guidance if you miss an appointment for your telisotuzumab vedotin injection.

In a medical setting, an overdose would be treated quickly.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Sometimes, it is not safe to use certain medicines together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medicines less effective.

Other drugs may affect telisotuzumab vedotin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you are using.