TABRECTA Film-coated tablet (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Novartis Pharmaceuticals Corporation

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1. Indications and Usage

TABRECTA is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping ...

2. Dosage and Administration

2.1 Patient Selection Select patients for treatment with TABRECTA based on the presence of a mutation that leads to MET exon 14 skipping in tumor specimens [see Clinical Studies (14)]. 2.2 Recommended ...

3. Dosage Forms and Strengths

Tablets: 150 mg: pale orange brown, ovaloid, curved film-coated with beveled edges, unscored, debossed with DU on one side and NVR on the other side 200 mg: yellow, ovaloid, curved film-coated with beveled ...

4. Contraindications

None.

5. Warnings and Precautions

5.1 Interstitial Lung Disease (ILD)/Pneumonitis ILD/pneumonitis, which can be fatal, occurred in patients treated with TABRECTA [see Adverse Reactions (6.1)]. ILD/pneumonitis occurred in 4.5% ...

6. Adverse Reactions

The following clinically significant adverse reactions are described elsewhere in the labeling: ILD/Pneumonitis [see Warnings and Precautions (5.1)] Hepatotoxicity [see Warnings and Precautions ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

7. Drug Interactions

7.1 Effect of Other Drugs on TABRECTA Strong CYP3A Inhibitors Coadministration of TABRECTA with a strong CYP3A inhibitor increased capmatinib exposure, which may increase the incidence and severity of ...

8.1. Pregnancy

Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology (12.1)], TABRECTA can cause fetal harm when administered to a pregnant woman. There are ...

8.2. Lactation

Risk Summary There are no data on the presence of capmatinib or its metabolites in either human or animal milk or its effects on the breastfed child or on milk production. Because of the potential for ...

8.3. Females and Males of Reproductive Potential

Based on animal data, TABRECTA can cause malformations at doses less than the human exposure based on AUC at the 400 mg twice daily clinical dose [see Use in Specific Populations (8.1)]. Pregnancy ...

8.4. Pediatric Use

Safety and effectiveness of TABRECTA in pediatric patients have not been established.

8.5. Geriatric Use

In GEOMETRY mono-1, 57% of the 334 patients were 65 years or older and 16% were 75 years or older. No overall differences in the safety or effectiveness were observed between these patients and younger ...

8.6. Renal Impairment

No dosage adjustment is recommended in patients with mild (baseline creatinine clearance [CLcr] 60 to 89 mL/min by Cockcroft-Gault) or moderate renal impairment (CLcr 30 to 59 mL/min) [see Clinical ...

11. Description

Capmatinib is a kinase inhibitor. The chemical name is 2-Fluoro-N-methyl-4-[7-(quinolin-6-ylmethyl)imidazo[1,2-b][1,2,4]triazin-2-yl]benzamide-hydrogen chloride-water (1/2/1). The molecular formula ...

12.1. Mechanism of Action

Capmatinib is a kinase inhibitor that targets MET, including the mutant variant produced by exon 14 skipping. MET exon 14 skipping results in a protein with a missing regulatory domain that reduces its ...

12.2. Pharmacodynamics

Exposure-Response Capmatinib exposure-response relationships and the time course of pharmacodynamics response are unknown. Cardiac Electrophysiology No large mean increase in QTc (i.e. >20 ms) was detected ...

12.3. Pharmacokinetics

Capmatinib exposure (AUC0-12h and Cmax) increased approximately proportionally over a dose range of 200 mg (0.5 times the recommended dosage) to 400 mg. Capmatinib reached steady-state ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies were not conducted with capmatinib. Capmatinib was not mutagenic in an in vitro bacterial reverse mutation assay and did not cause chromosomal aberrations in an in vitro chromosome ...

13.2. Animal Toxicology and/or Pharmacology

In rats, capmatinib administration resulted in vacuolation of white matter of the brain in both 4- and 13-week studies at doses ≥2.2 times the human exposure (AUC) at the 400 mg twice daily clinical dose. ...

14. Clinical Studies

Metastatic NSCLC with a Mutation that Leads to MET Exon 14 Skipping The efficacy of TABRECTA was evaluated in GEOMETRY mono-1, a multicenter, non-randomized, open-label, multi-cohort study (NCT02414139). ...

16.1. How Supplied

TABRECTA (capmatinib) 150 mg and 200 mg tablets: Strength Description Tablets per Bottle NDC Number 150 mg Pale orange brown, ovaloid, curved film-coated tablet with beveled edges, unscored, debossed ...

16.2. Storage and Handling

Dispense in the original package with the desiccant cartridge. Store at 20˚C to 25˚C (68˚F to 77˚F), excursions permitted between 15˚C and 30˚C (59˚F and 86˚F) [see USP Controlled Room Temperature] ...

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information). Interstitial Lung Disease (ILD)/Pneumonitis Inform patients of the risks of severe or fatal ILD/pneumonitis. Advise patients ...