Frequently Asked Questions About Tepmetko® (tepotinib)
Generic Name: tepotinib
Trade Name: Tepmetko®
For which conditions is TEPMETKO approved for? TEPMETKO is indicated for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping alterations. It is estimated that ~4% of NSCLC patients have MET exon 14 skipping alterations which is associated with a poorer prognosis.
TEPMETKO was approved under accelerated approved based on overall response rate and duration of response; continued approval may be contingent on additional efficacy data in ongoing clinical trials.
What is the mechanism of action? TEPMETKO is a targeted kinase inhibitor. In NSCLC with MET exon skipping alterations, the MET gene does not function correctly and sends instructions to cells that worsen cancer. TEPMETKO works by limiting the instructions that the MET gene can send to cells thus impacting cancer growth.
How is TEPMETKO typically given (administered)? TEPMETKO tablets are taken once a day with food. The tablet must be swallowed whole with food and never opened, broken, or chewed. Talk to you doctor for instructions if you vomit or miss a dose of TEPMETKO.
How are patients typically monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with TEPMETKO. Blood may be drawn to check for side effects and to monitor functions of some organ systems. Patients may also undergo physical examinations or other measures to assess side effects and response to therapy.
What are the most common side effects of treatment with TEPMETKO?
- Swelling in extremities (edema)
- Bone or muscle pain
- Shortness of breath
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?
Take TEPMETKO exactly as your healthcare provider tells you to take it. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Avoid CYP3A and P-gp inhibitors during treatment with TEPMETKO.
Are there any special precautions patients should be aware of before starting treatment?
- Talk to your healthcare provider about any medicines (prescription and over-the-counter), vitamins or herbal supplements that you are taking.
- Tell your healthcare provider about all your medical conditions prior to starting treatment with TEPMETKO including if you have infection, liver problems or if you have abdominal or intestinal problems.
- Talk to your doctor if you or your partner are pregnant or planning to become pregnant. TEPMETKO can cause fetal harm. If a man’s sexual partner is not pregnant but could become pregnant, effective birth control should be used during treatment and for one week after treatment ends. Females should use an effective method of birth control during treatment and for one week after the last dose of TEPMETKO.
- Do not breastfeed during treatment or for 1 week after the last dose of TEPMETKO.
When should patients notify their physician?
Tell your doctor if you experience any side effects that bother you or don’t go away. Tell your healthcare provider right away if you experience:
- Symptoms of interstitial lung disease or pneumonitis (new or worsening respiratory symptoms).
- Symptoms of liver dysfunction.
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
Important Limitations of Use
The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.
As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment kin selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.
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The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.