Active Ingredient and Strength	CAPMATINIB DIHYDROCHLORIDE MONOHYDRATE EQV CAPMATINIB - 200 MG
Dosage Form	TABLET, FILM COATED
Manufacturer and Country	LEK D.D. (PRIMARY AND SECONDARY PACKAGER) - SLOVENIA NOVARTIS PHARMA PRODUKTIONS GMBH - GERMANY
Registration Number	SIN16351P
Licence Holder	NOVARTIS (SINGAPORE) PTE LTD
Forensic Classification	PRESCRIPTION ONLY MEDICINES
Anatomical Therapeutic Chemical (ATC) code	L01EX17

3 Indications

Tabrecta is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a MET exon 14 skipping mutation.

4 Dosage regimen and administration

Patient selection

Patients should be selected for treatment with Tabrecta based on the presence of a MET exon 14 skipping mutation in tumor or plasma specimens using a validated test. If a MET exon 14 skipping mutation is not detected in a plasma specimen, tumor tissue should be tested if feasible.

Dosage regimen

General target population

The recommended dose of Tabrecta is 400 mg orally twice daily with or without food (see section 11 Clinical pharmacology – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Treatment duration

Treatment should be continued based on individual safety and tolerability and as long as the patient is deriving clinical benefit from therapy.

Dose modifications for adverse drug reactions

The recommended dose reduction schedule for the management of adverse drug reactions (ADRs) based on individual safety and tolerability is listed in Table 4-1.

Tabrecta should be permanently discontinued in patients unable to tolerate 200 mg orally twice daily.

Recommendations for dose modifications of Tabrecta for ADRs are provided in Table 4-2.

Special populations

Renal impairment

No dose adjustment is necessary in patients with mild or moderate renal impairment based on population pharmacokinetic evaluations; Tabrecta has not been studied in patients with severe renal impairment (see section 11 Clinical pharmacology – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment

No dose adjustment is necessary in patients with mild, moderate, or severe hepatic impairment (see section 11 Clinical pharmacology – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Pediatric patients (below 18 years of age)

The safety and efficacy of Tabrecta in pediatric patients have not been established.

Geriatric patients (65 years of age or older)

No dose adjustment is necessary in patients 65 years of age or older.

Method of administration

Tabrecta should be taken orally twice daily with or without food. The tablets should be swallowed whole and should not be broken, chewed, or crushed.

If a dose of Tabrecta is missed or vomiting occurs, the patient should not make up the dose, but take the next dose at the scheduled time.

5 Contraindications

None.