Tepotinib Dosage

Usual Adult Dose for Non-Small Cell Lung Cancer

450 mg orally once a day

Comments:
-Patients should be selected for treatment based on the presence of MET exon 14 skipping alterations in plasma or tumor specimens.
-In patients for whom a tumor biopsy cannot be obtained, it is recommended to test for the presence of MET exon 14 skipping alterations in plasma specimens.
-Re-evaluate the feasibility of biopsy for tumor tissue testing if an alteration is not detected in a plasma specimen.
-An FDA-approved test for detection of MET exon 14 skipping alterations in NSCLC for selecting patients for treatment with this drug is not available.
-Treatment should be continued until disease progression or unacceptable toxicity.

Use: For the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymalepithelial transition (MET) exon 14 skipping alterations

Renal Dose Adjustments

Mild or moderate renal dysfunction (CrCl 30 to 89 mL/min): No adjustment recommended.
Severe renal dysfunction (CrCl less than 30 mL/min): Recommended dosage has not been established.

Liver Dose Adjustments

Mild or moderate liver dysfunction (Child-Pugh A or B): No adjustment recommended.
Severe liver dysfunction (Child-Pugh C): Data not available

Dose Adjustments

-The recommended dose reduction for the management of adverse reactions is 225 mg orally once a day.
-It is recommended to permanently discontinue treatment in patients unable to tolerate the dose of 225 mg once a day.

DOSE MODIFICATIONS FOR ADVERSE REACTIONS
Any Grade of interstitial lung disease (ILD)/pneumonitis:
-Withhold treatment if ILD is suspected.
-If ILD is confirmed, permanently discontinue treatment.

Grade 3 increased ALT and/or AST without increased in total bilirubin:
-Withhold treatment until recovery to baseline ALT/AST.
-Resume treatment at the same dose if recovered to baseline within 7 days; otherwise resume treatment at a reduced dose.
Grade 4 increased ALT and/or AST without increased in total bilirubin: Permanently discontinue treatment.
ALT and/or AST greater than 3 times ULN with total bilirubin greater than 2 times ULN in the absence of cholestasis or hemolysis: Permanently discontinue treatment.

Grade 3 increased total bilirubin without concurrent increased ALT and/or AST:
-Withhold treatment until recovery to baseline bilirubin.
-Resume treatment at a reduced dose if recovered to baseline within 7 days; otherwise Permanently discontinue treatment.
Grade 4 increased total bilirubin without concurrent increased ALT and/or AST: Permanently discontinue treatment.
Grade 2 adverse reactions: Maintain dose level. If intolerable, consider withholding treatment until resolved, then resume at a reduced dose.
Grade 3 adverse reactions: Withhold treatment until resolved, then resume at a reduced dose.
Grade 4 adverse reactions: Permanently discontinue treatment.

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration Advice:
-This drug should be taken with food at the same approximate time each day.
-Swallow tablets whole; do not chew, crush or split tablets
-If you missed a dose, take the dose as soon as possible. If your next dose is due within 8 hours, skip the missed dose and resume with the next scheduled dose.
-If vomit occurs, take the next dose at the next scheduled time.

Storage Requirements:
-Store at 20C to 25C (68F to 77F)
-Excursion permitted to 15 to 30C (59F to 86F)

Monitoring:
-Hepatic: Monitor for liver function tests (including ALT, AST, and total bilirubin) prior to, every 2 weeks during the first 3 months of treatment, and then once a month or as appropriate.
-Pulmonary: Monitor for new or worsening pulmonary symptoms indicative of interstitial lung disease/pneumonitis.

Patient Advice:
-Read the US FDA-approved patient labeling (Patient Information).
-Take this drug once a day with food.
-Advise males and females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for one week after the last dose.
-Advise female patients not to breastfeed during and for one week after the last dose.
-Advise patients to immediately report any symptoms suggestive of liver dysfunction.
-Advise patients to report any new or worsening symptoms suggestive of respiratory dysfunction.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer