Tepmetko (Tepotinib Hydrochloride)

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Dosage & administration

* Select patients for treatment with TEPMETKO on the presence of

MET

ex14 skipping. (

2.1 Patient Selection for METex14 Skipping Alterations

Select patients for treatment with TEPMETKO based on the presence of

MET

exon 14 skipping alterations in plasma or tumor specimens. Testing for the presence of

MET

exon 14 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, re-evaluate the feasibility of biopsy for tumor tissue testing. An FDA-approved test for detection of

MET

exon 14 skipping alterations in NSCLC for selecting patients for treatment with TEPMETKO is not available.

14 CLINICAL STUDIES

The efficacy of TEPMETKO was evaluated in a single-arm, open-label, multicenter, non-randomized, multicohort study (VISION, NCT02864992). Eligible patients were required to have advanced or metastatic NSCLC harboring

MET

ex14 skipping alterations, epidermal growth factor receptor (EGFR) wild-type and anaplastic lymphoma kinase (ALK) negative status, at least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, and Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1. Patients with symptomatic CNS metastases, clinically significant uncontrolled cardiac disease, or who received treatment with any MET or hepatocyte growth factor (HGF) inhibitor were not eligible for the study.

Identification of

MET

ex14 skipping alterations was prospectively determined using central laboratories employing either a PCR-based or next-generation sequencing-based clinical trial assay using tissue (66%) and/or plasma (57%) samples.

Patients received TEPMETKO 450 mg once daily until disease progression or unacceptable toxicity. The major efficacy outcome measure was confirmed overall response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) as evaluated by a Blinded Independent Review Committee (BIRC). An additional efficacy outcome measure was duration of response (DOR) by BIRC.

The efficacy population included 164 treatment naïve patients and 149 previously treated patients. The median age was 72 years (range 41 to 94 years); 51% female; 62% White, 34% Asian; 26% had Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 and 74% had ECOG PS 1; 49% never smoked; 81% had adenocarcinoma; 94% had metastatic disease; and 13% had CNS metastases. Amongst previously treated patients, 84% received prior platinum-based chemotherapy.

Efficacy results are presented in Table 4.

Table 4: Efficacy Results in the VISION study
Efficacy parameter	Treatment-Naïve (N=164)	Previously Treated (N=149)
CI: Confidence interval, + denotes ongoing response.
Overall response rate (95% CI)Blinded Independent Review Committee (BIRC) review.^,Confirmed responses.	57% (49, 65)	45% (37, 53)
Duration of Response
Range in monthsBased on observed duration of response.	1.3+, 56.6+	1.4+, 67.6+
Patients with DOR ≥ 6 months	66%	66%
Patients with DOR ≥ 12 months	40%	36%

)
*

Recommended dosage

: 450 mg orally once daily with food until disease progression or unacceptable toxicity. (

2.2 Recommended Dosage

The recommended dosage of TEPMETKO is 450 mg orally once daily with food

[see Clinical Pharmacology (12.3)]

until disease progression or unacceptable toxicity.

Instruct patients to take their dose of TEPMETKO at approximately the same time every day and to swallow tablets whole. Do not chew, crush or split tablets. Patients who have difficulty swallowing solids can disperse tablets in water

[see Dosage and Administration (2.3)].

Advise patients not to make up a missed dose within 8 hours of the next scheduled dose.

If vomiting occurs after taking a dose of TEPMETKO, advise patients to take the next dose at the scheduled time.

)

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Tepmetko prescribing information

Indication and Usage (

1 INDICATIONS AND USAGE

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.

TEPMETKO is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (

MET

) exon 14 skipping alterations.

)

02/2024

Dosage and Administration (

2.3 Administration to Patients Who Have Difficulty Swallowing Solids

Place TEPMETKO tablet(s) in a glass containing 30 mL (1 ounce) of non-carbonated water. No other liquids should be used or added. Stir, without crushing, until the tablet(s) is dispersed into small pieces (tablets will not completely dissolve) and drink immediately or within 1 hour. Swallow the tablet dispersion. Do not chew pieces of the tablet. Rinse the glass with an additional 30 mL and drink immediately ensuring no residue remains in the glass and the full dose is administered.

If an administration via a naso-gastric tube (with at least 8 French gauge) is required, disperse the tablet(s) in 30 mL of non-carbonated water as described above. Administer the 30 mL of liquid immediately or within 1 hour as per naso-gastric tube manufacturer's instructions. Immediately rinse twice with 30 mL each time to ensure that no residue remains in the glass or syringe and the full dose is administered.

2.4 Dose Modifications for Adverse Reactions

The recommended dose reduction of TEPMETKO for the management of adverse reactions is 225 mg orally once daily.

Permanently discontinue TEPMETKO in patients who are unable to tolerate 225 mg orally once daily.

The recommended dosage modifications of TEPMETKO for adverse reactions are provided in Table 1.

Table 1: Recommended TEPMETKO Dosage Modifications for Adverse Reactions
Adverse Reaction	SeveritySeverity as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.	Dose Modification
Interstitial Lung Disease (ILD)/Pneumonitis [see Warnings and Precautions (5.1)]	Any Grade	Withhold TEPMETKO if ILD is suspected. Permanently discontinue TEPMETKO if ILD is confirmed.
Increased ALT and/or AST without increased total bilirubin [see Warnings and Precautions (5.2)]	Grade 3	Withhold TEPMETKO until recovery to baseline ALT/AST. If recovered to baseline within 7 days, then resume TEPMETKO at the same dose; otherwise resume TEPMETKO at a reduced dose.
	Grade 4	Permanently discontinue TEPMETKO.
Increased ALT and/or AST with increased total bilirubin in the absence of cholestasis or hemolysis [see Warnings and Precautions (5.2)]	ALT and/or AST greater than 3 times ULN with total bilirubin greater than 2 times ULN	Permanently discontinue TEPMETKO.
Increased total bilirubin without concurrent increased ALT and/or AST [see Warnings and Precautions (5.2)]	Grade 3	Withhold TEPMETKO until recovery to baseline bilirubin. If recovered to baseline within 7 days, then resume TEPMETKO at a reduced dose; otherwise permanently discontinue.
	Grade 4	Permanently discontinue TEPMETKO.
Increased lipase or amylase [see Warnings and Precautions (5.3)]	Grade 3	Withhold TEPMETKO until ≤ Grade 2 or baseline. If recovered to baseline or ≤ Grade 2 within 14 days, resume TEPMETKO at a reduced dose; otherwise permanently discontinue TEPMETKO.
	Grade 4	Permanently discontinue TEPMETKO.
Pancreatitis [see Warnings and Precautions (5.3)]	Grade 3 or 4	Permanently discontinue TEPMETKO.
Other adverse reactions [see Adverse Reactions (6.1)]	Grade 2	Maintain dose level. If intolerable, consider withholding TEPMETKO until resolved, then resume TEPMETKO at a reduced dose.
	Grade 3	Withhold TEPMETKO until resolved, then resume TEPMETKO at a reduced dose.
	Grade 4	Permanently discontinue TEPMETKO.

)

02/2024

Warnings and Precautions (

5.3 Pancreatic Toxicity

Elevations in amylase and lipase levels occurred in patients treated with TEPMETKO

[see Adverse Reactions (6.1)].

Increased amylase and/or lipase occurred in 13% of patients treated with TEPMETKO. Grade 3 and 4 increased amylase and/or lipase occurred in 5% and 1.2% of patients, respectively. Monitor amylase and lipase at baseline and regularly during treatment with TEPMETKO. Based on the severity of the adverse drug reaction, temporarily withhold, dose reduce, or permanently discontinue TEPMETKO

[see Dosage and Administration (2.4)].

)

02/2024

Select patients for treatment with TEPMETKO on the presence of

MET

ex14 skipping. (

2.1 Patient Selection for METex14 Skipping Alterations

Select patients for treatment with TEPMETKO based on the presence of

MET

exon 14 skipping alterations in plasma or tumor specimens. Testing for the presence of

MET

exon 14 skipping alterations in NSCLC for selecting patients for treatment with TEPMETKO is not available.

14 CLINICAL STUDIES

MET

Identification of

MET

Efficacy results are presented in Table 4.

Table 4: Efficacy Results in the VISION study
Efficacy parameter	Treatment-Naïve (N=164)	Previously Treated (N=149)
CI: Confidence interval, + denotes ongoing response.
Overall response rate (95% CI)Blinded Independent Review Committee (BIRC) review.^,Confirmed responses.	57% (49, 65)	45% (37, 53)
Duration of Response
Range in monthsBased on observed duration of response.	1.3+, 56.6+	1.4+, 67.6+
Patients with DOR ≥ 6 months	66%	66%
Patients with DOR ≥ 12 months	40%	36%

)

Recommended dosage
: 450 mg orally once daily with food until disease progression or unacceptable toxicity. (
2.2 Recommended Dosage
The recommended dosage of TEPMETKO is 450 mg orally once daily with food
[see Clinical Pharmacology (12.3)]
until disease progression or unacceptable toxicity.
Instruct patients to take their dose of TEPMETKO at approximately the same time every day and to swallow tablets whole. Do not chew, crush or split tablets. Patients who have difficulty swallowing solids can disperse tablets in water
[see Dosage and Administration (2.3)].
Advise patients not to make up a missed dose within 8 hours of the next scheduled dose.
If vomiting occurs after taking a dose of TEPMETKO, advise patients to take the next dose at the scheduled time.
)

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