Tepotinib

Tepotinib is a prescription medication used for the treatment of non-small cell lung cancer. 

• Tepotinib is available under the following different brand names: Tepmetko.

Common side effects of Tepotinib include:

• Swelling in the face or other parts of the body
• Tiredness
• Nausea
• Diarrhea
• Muscle and joint pain
• Shortness of breath

Serious side effects of Tepotinib include:

• Liver problems, which may include:
• Yellowing of the sclera.
• 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 the stomach-area

Rare side effects of Tepotinib include:

• None 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Tablet

• 225 mg

Non–Small Cell Lung Cancer

Adult dosage

• 450 mg orally once a day
• Continue until disease progression or unacceptable toxicity.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Tepotinib has severe interactions with no other drugs.
• Tepotinib has serious interactions with at least 120 other drugs.
• Tepotinib has moderate interactions with no other drugs.
• Tepotinib has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Tepotinib?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Tepotinib?”

Cautions

• ILD/pneumonitis, which can be fatal, occurred; monitor for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (. g, dyspnea, cough, fever)
• Fetal harm may occur when administered to pregnant females.
• Hepatoxicity
  • Hepatoxicity reported.
  • Median time to onset of Grade above 3 was 30 days.
  • Monitor liver function tests (. g, AST, ALT, total bilirubin) before initiation, every 2 weeks during the first 3 months, then monthly or as clinically indicated.
  • More frequent testing if increased AST/ALT or bilirubin develops.
• Drug interaction overview
  • Inhibits P-gp
  • Certain P-gp substrates
  • Avoid coadministration with P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicities.
  • Tepotinib may increase concentration levels and risk of toxicities of P-gp substrates.

Pregnancy and Lactation

• Based on animal studies and mechanism of action, fetal harm may occur when administered to pregnant females
• Data are unavailable for use in pregnant females.
• Verify pregnancy status in females of reproductive potential before initiation.
• Contraception
  • Females of reproductive potential: Use effective contraception during treatment and for 1 week after the final dose.
  • Male partners with female partners of reproductive potential: Use effective contraception during treatment and for 1 week after the final dose.
• Lactation
  • There are no data regarding tepotinib or its metabolites in human milk, its effects on breastfed infants, or milk production.
  • Advise females not to breastfeed during treatment and for 1 week after the final dose