TABRECTA 150 MG

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

CAPMATINIB AS DIHYDROCHLORIDE MONOHYDRATE

Tilgjengelig fra:

NOVARTIS ISRAEL LTD

ATC-kode:

L01EX17

Legemiddelform:

FILM COATED TABLETS

Sammensetning:

CAPMATINIB AS DIHYDROCHLORIDE MONOHYDRATE 150 MG

Administreringsrute:

PER OS

Resept typen:

Required

Produsert av:

NOVARTIS PHARMA PRODUKTIONS GMBH

Terapeutisk område:

CAPMATINIB

Indikasjoner:

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 as detected by an approved test.

Autorisasjon dato:

2022-02-09

Informasjon til brukeren

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Preparatomtale

TAB SPI 27APR23 V3
USPI 03.23
TABRECTA 150 MG, TABRECTA 200 MG
Film coated tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
TABRECTA 150 MG: Each film-coated tablet contains 150 mg capmatinib
(as capmatinib dihydrochloride
monohydrate).
TABRECTA 200 MG: Each film-coated tablet contains 200 mg capmatinib
(as capmatinib dihydrochloride
monohydrate).
For the full list of excipients, see section 16.
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 as detected by an
approved test.
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 Dosage
The recommended dosage of TABRECTA is 400 mg orally twice daily with
or without food,
adequate hydration is recommended. Swallow TABRECTA tablets whole. Do
not break,
crush or chew the tablets.
If a patient misses or vomits a dose, instruct the patient not to make
up the dose, but to take the next dose at its scheduled
time.
2.3
Dosage Modifications for Adverse Reactions
The recommended dose reductions for the management of adverse
reactions are listed in Table 1.
Table 1: Recommended TABRECTA Dose Reductions for Adverse Reactions
Dose reduction
Dose and schedule
First
300 mg orally twice daily
Second
200 mg orally twice daily
Permanently discontinue TABRECTA in patients who are unable to
tolerate 200 mg orally twice daily.
The recommended dosage modifications of TABRECTA for adverse reactions
are provided in Table 2.
TAB SPI 27APR23 V3
USPI 03.23
Table 2: Recommended TABRECTA Dosage Modifications for Adverse
Reactions
Adverse reaction
Severity
Dosage modification
Interstitial Lung Disease
(ILD)/Pneumonitis
_[see Warnings and Precautions (5.1)]_
Any grade
Permanently discontinue
TABRECTA.
Increased ALT and/or AST without
incre