Tepotinib

What is Tepotinib?

• Tepotinib (TEPMETKO) is a kinase inhibitor used to treat adults with non-small cell lung cancer (NSCLC).

What are the uses of this medicine?

This medicine is used to treat adults with non-small cell lung cancer (NSCLC) that:

• has spread to other parts of the body (metastatic), and
• whose tumors have an abnormal mesenchymal epithelial transition (MET) gene. Your healthcare provider will perform a test to make sure that TEPMETKO is right for you.

How does this medicine work?

• An inhibitor of MET tyrosine kinase with potential antineoplastic activity.
• Tepotinib selectively binds to MET tyrosine kinase and disrupts MET signal transduction pathways, which may induce apoptosis in tumor cells overexpressing this kinase.
• The receptor tyrosine kinase MET (also known as hepatocyte growth factor receptor or HGFR), is the product of the proto-oncogene c-Met and is overexpressed or mutated in many tumor cell types; this protein plays key roles in tumor cell proliferation, survival, invasion, and metastasis, and tumor angiogenesis.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Avoid concomitant use of TEPMETKO with dual strong CYP3A inhibitors and P-gp inhibitors.
• Avoid concomitant use of TEPMETKO with strong CYP3A inducers.

Is this medicine FDA approved?

• It was approved for use in the United States in 2021.

How should this medicine be used?

• Select patients for treatment with TEPMETKO on the presence of METex14 skipping.

Recommended Dosage

• The recommended dosage of TEPMETKO is 450 mg orally once daily with food until disease progression or unacceptable toxicity.

Dose Modifications for Adverse Reactions

• The recommended dose reduction of TEPMETKO for the management of adverse reactions is 225 mg orally once daily.

Administration

• Take TEPMETKO exactly as your healthcare provider tells you to.
• Take TEPMETKO 1 time a day with food.
• Swallow TEPMETKO tablets. Do not chew, crush or split tablets.
• Take your dose of TEPMETKO at about the same time each day.
• Do not change your dose or stop taking TEPMETKO unless your healthcare provider tells you to.
• If you miss a dose of TEPMETKO, take it as soon as you remember. If your next dose is due within 8 hours, skip the missed dose and take your next dose at your regular scheduled time.
• If you vomit after taking a dose of TEPMETKO, take your next dose at your regular scheduled time.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Tablets: 225 mg

This medicine is available in fallowing brand namesː

• TEPMETKO

What side effects can this medication cause?

The most common side effects of this medicine include:

• swelling in your face or other parts of your body
• tiredness
• nausea
• diarrhea
• muscle and joint pain
• shortness of breath

TEPMETKO may cause serious side effects, including: Liver problems:

• your skin or the white part of your eyes turns yellow
• dark or "tea colored" urine
• light-colored stools (bowel movements)
• confusion
• tiredness
• loss of appetite for several days or longer
• nausea and vomiting
• pain, aching, or tenderness on the right side of your stomach-area (abdomen)
• weakness
• swelling in your stomach-area

What special precautions should I follow?

• Immediately withhold TEPMETKO in patients with suspected ILD/pneumonitis. Permanently discontinue TEPMETKO in patients diagnosed with ILD/pneumonitis of any severity.
• This medicine may cause hepatotoxicity. Monitor liver function tests. Withhold, dose reduce, or permanently discontinue TEPMETKO based on severity.
• TEPMETKO can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• TEPMETKO can cause fetal harm when administered to a pregnant woman.
• There are no available data on the use of TEPMETKO in pregnant women.

Can this medicine be used in children?

• The safety and efficacy of TEPMETKO in pediatric patients have not been established.

What should I know about storage and disposal of this medication?

• Store TEPMETKO at room temperature between 68°F to 77°F (20°C to 25°C).
• TEPMETKO tablets come in blister cards with child-resistant blister foil.
• Store TEPMETKO in original package.

• Dailymed label info on Tepotinib
• FDA Tepotinib

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