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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.

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