Telisotuzumab vedotin
Generic name: telisotuzumab vedotin [ tel-EYE-soe-TOOZ-ue-mab-ve-DOE-tin ]
Brand name: Emrelis
Dosage form: intravenous powder for injection (tllv 100 mg; tllv 20 mg)
Drug class: Miscellaneous antineoplastics
What is telisotuzumab vedotin?
Telisotuzumab vedotin is used in adults to treat non-squamous non-small cell lung cancer that has spread to other parts of the body (metastatic), or after other treatments did not work or stopped working.
Your doctor will make sure you have the correct tumor type to be treated with telisotuzumab vedotin.
Telisotuzumab vedotin may also be used for purposes not listed in this medication guide.
Telisotuzumab vedotin side effects
Get emergency medical help if you have signs of an allergic reaction: hives, difficult 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, nauseated, 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 discontinued if you have certain side effects.
Common side effects of telisotuzumab vedotin may include:
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loss of appetite;
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abnormal blood tests;
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nerve problems, swelling in the feet, ankles, legs or hands; or
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tired feeling.
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.
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Warnings
Telisotuzumab vedotin can cause severe and life-threatening side effects after the injection. Call your doctor right away if you have numbness, tingling, or burning pain in your hands or feet, blurred vision, eye pain or redness, fever, cough, feeling short of breath, or you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache.
Before taking this medicine
Tell your doctor if you have or have ever had:
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nerve problems;
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other lung or breathing problems besides lung cancer;
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eye problems; or
Telisotuzumab vedotin can harm an unborn baby if the mother or the father is using telisotuzumab vedotin.
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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.
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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.
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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.
How is telisotuzumab vedotin given?
Your doctor will perform tests to make sure 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 determine the right treatment schedule for you.
You may need frequent medical tests including vision exams, and your cancer treatments may be changed or delayed based on the results.
You will be watched for a short time to make sure you do not have an allergic reaction.
You may be given other medications to help prevent serious side effects or an allergic reaction. Keep 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 dosing information
Usual Adult Dose for Non-Small Cell Lung Cancer:
1.9 mg/kg IV every 2 weeks
Maximum dose: 190 mg/dose
Duration of therapy: Until disease progression or unacceptable toxicity
Comments:
-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
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your telisotuzumab vedotin injection.
What happens if I overdose?
In a medical setting an overdose would be treated quickly.
What should I avoid while receiving telisotuzumab vedotin?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What other drugs will affect telisotuzumab vedotin?
Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, 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 use.
Telisotuzumab vedotin Biosimilars
Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.
Reference products
These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for telisotuzumab vedotin.
Emrelis (telisotuzumab vedotin-tllv) - AbbVie Inc.
Formulation type | Strength |
---|---|
Single-Dose Vial | 100 mg |
Single-Dose Vial | 20 mg |
View Emrelis information in detail.
More about telisotuzumab vedotin
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Further information
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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