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Dosing

For all eligible METex14+ NSCLC patients, consider

TEPMETKO® (tepotinib)—The only approved once-daily oral MET inhibitor1


Dosing & administration

Patient selection1

Select patients for treatment with TEPMETKO based on the presence of METex14 skipping alterations in plasma or tumor specimens. Testing for the presence of METex14 skipping alterations in plasma specimens is recommended only in patients for whom a tumor biopsy cannot be obtained. If an alteration is not detected in a plasma specimen, reevaluate the feasibility of biopsy for tumor tissue testing. An FDA-approved test for detection of METex14 skipping alterations in NSCLC for selecting patients for treatment with TEPMETKO is not available.

Once-daily dosing1

The recommended dosage of TEPMETKO is 450 mg (two 225 mg tablets) orally once daily with food until disease progression or unacceptable toxicity.

 

Take TEPMETKO with food1

Instruct patients to take their dose at approximately the same time every day and to swallow tablets whole. Do not chew, crush, or split tablets. Advise patients not to make up a missed dose within 8 hours of the next scheduled dose. If vomiting occurs after taking a dose, advise patients to take the next dose at the scheduled time.

 

Dose reductions

Testing for the presence of METex14 skipping alterations in plasma specimens is recommended only in patients for whom a tumor biopsy cannot be obtained.If an alteration is not detected in a plasma specimen, reevaluate the feasibility of biopsy for tumor tissue testing. An FDA-approved test for detection of METex14 skipping alterations in NSCLC for selecting patients for treatment with TEPMETKO is not available.

Dose reductions

Dose modifications for adverse reactions1

The recommended dose reduction is from two 225 mg tablets to one 225 mg tablet orally once daily. Permanently discontinue in patients who are unable to tolerate the 225 mg dose.

Management of some ARs may require temporary interruption or permanent discontinuation. See the full Prescribing Information for recommended dosage modifications of TEPMETKO.

dose-reductions
Chart showing TEPMETKO® (tepotinib) dose modifications for adverse reactions dose-reductions
dose-reductions
dose-reductions


mNSCLC=metastatic non-small cell lung cancer.
 

Dose modifications for adverse reactions1

Chart showing TEPMETKO® (tepotinib) dose modifications for adverse reactions
Chart showing TEPMETKO® (tepotinib) dose modifications for adverse reactions

IMPORTANT SAFETY INFORMATION AND INDICATION

TEPMETKO can cause interstitial lung disease (ILD)/pneumonitis, which can be fatal. Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (eg, dyspnea, cough, fever). Immediately withhold TEPMETKO in patients with suspected ILD/pneumonitis and permanently discontinue if no other potential causes of ILD/pneumonitis are identified. ILD/pneumonitis occurred in 2.2% of patients treated with TEPMETKO, with one patient experiencing a Grade 3 or higher event; this event resulted in death.

TEPMETKO can cause hepatotoxicity, which can be fatal. Monitor liver function tests (including ALT, AST, and total bilirubin) prior to the start of TEPMETKO, every 2 weeks during the first 3 months of treatment, then once a month or as clinically indicated, with more frequent testing in patients who develop increased transaminases or total bilirubin. Based on the severity of the adverse reaction, withhold, dose reduce, or permanently discontinue TEPMETKO. Increased alanine aminotransferase (ALT)/increased aspartate aminotransferase (AST) occurred in 13% of patients treated with TEPMETKO. Grade 3 or 4 increased ALT/AST occurred in 4.2% of patients. A fatal adverse reaction of hepatic failure occurred in one patient (0.2%). The median time-to-onset of Grade 3 or higher increased ALT/AST was 30 days (range 1 to 178).

TEPMETKO can cause embryo-fetal toxicity. Based on findings in animal studies and its mechanism of action, TEPMETKO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential or males with female partners of reproductive potential to use effective contraception during treatment with TEPMETKO and for one week after the final dose.

Avoid concomitant use of TEPMETKO with dual strong CYP3A inhibitors and P-gp inhibitors and strong CYP3A inducers. Avoid concomitant use of TEPMETKO with certain P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicities. If concomitant use is unavoidable, reduce the P-gp substrate dosage if recommended in its approved product labeling.

Fatal adverse reactions occurred in one patient (0.4%) due to pneumonitis, one patient (0.4%) due to hepatic failure, and one patient (0.4%) due to dyspnea from fluid overload.

Serious adverse reactions occurred in 45% of patients who received TEPMETKO. Serious adverse reactions in >2% of patients included pleural effusion (7%), pneumonia (5%), edema (3.9%), dyspnea (3.9%), general health deterioration (3.5%), pulmonary embolism (2%), and musculoskeletal pain (2%).

The most common adverse reactions (≥20%) in patients who received TEPMETKO were edema, fatigue, nausea, diarrhea, musculoskeletal pain, and dyspnea.

Clinically relevant adverse reactions in <10% of patients who received TEPMETKO included ILD/pneumonitis, rash, fever, dizziness, pruritus, and headache.

Selected laboratory abnormalities (≥20%) from baseline in patients receiving TEPMETKO in descending order were: decreased albumin (76%), increased creatinine (55%), increased alkaline phosphatase (ALP) (50%), decreased lymphocytes (48%), increased ALT (44%), increased AST (35%), decreased sodium (31%), decreased hemoglobin (27%), increased potassium (25%), increased gamma-glutamyltransferase (GGT) (24%), increased amylase (23%), and decreased leukocytes (23%).

The most common Grade 3-4 laboratory abnormalities (≥2%) in descending order were: decreased lymphocytes (11%), decreased albumin (9%), decreased sodium (8%), increased GGT (5%), increased amylase (4.6%), increased ALT (4.1%), increased AST (2.5%), and decreased hemoglobin (2%).

A clinically relevant laboratory abnormality in <20% of patients who received TEPMETKO was increased lipase in 18% of patients, including 3.7% Grades 3 to 4.

INDICATION

TEPMETKO is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.

This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Please see the full Prescribing Information and Medication Guide for additional Important Safety Information for TEPMETKO.

Reference: 1. TEPMETKO® (tepotinib) [prescribing information]. EMD Serono, Inc., Rockland, MA; 2021.