TARCEVA- erlotinib hydrochloride tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

ERLOTINIB HYDROCHLORIDE (UNII: DA87705X9K) (ERLOTINIB - UNII:J4T82NDH7E)

Disponível em:

Genentech, Inc.

DCI (Denominação Comum Internacional):

ERLOTINIB HYDROCHLORIDE

Composição:

ERLOTINIB 25 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

TARCEVA® is indicated for:     •    The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen [see Clinical Studies (14.1, 14.3)]. Limitations of use:     •    Safety and efficacy of TARCEVA have not been established in patients with NSCLC whose tumors have other EGFR mutations [see Clinical Studies (14.1, 14.2)].     •    TARCEVA is not recommended for use in combination with platinum-based chemotherapy [see Clinical Studies (14.4)] . TARCEVA in combination with gemcitabine is indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer [see Clinical Studies (14.5)] . None. Risk Summary Based on animal data and its mechanism of action, TARC

Resumo do produto:

25 mg Tablets: round, biconvex face and straight sides, white film-coated, printed in orange with a “T” and “25” on one side and plain on the other side; supplied in: Bottles of 30: NDC 50242-062-01 100 mg Tablets: round, biconvex face and straight sides, white film-coated, printed in gray with “T” and “100” on one side and plain on the other side; supplied in: Bottles of 30: NDC 50242-063-01 150 mg Tablets: round, biconvex face and straight sides, white film-coated, printed in maroon with “T” and “150” on one side and plain on the other side; supplied in: Bottles of 30: NDC 50242-064-01 Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59°F - 86°F). See USP Controlled Room Temperature.

Status de autorização:

New Drug Application

Características técnicas

TARCEVA- ERLOTINIB HYDROCHLORIDE TABLET
GENENTECH, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TARCEVA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR TARCEVA.
TARCEVA (ERLOTINIB) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2004
RECENT MAJOR CHANGES
Indications and Usage, Non-Small Cell Lung Cancer (NSCLC) (1.1)
10/2016
Dosage and Administration (2.1) 06/2016
Dosage and Administration, Dose Modifications (2.4) 05/2016
Warnings and Precautions, Cerebrovascular Accident (5.6) 10/2016
Warnings and Precautions, Embryo-fetal Toxicity (5.10) 10/2016
INDICATIONS AND USAGE
TARCEVA is a kinase inhibitor indicated for:
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Limitations of Use:
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DOSAGE AND ADMINISTRATION
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•
DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg, 100 mg, and 150 mg (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
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®
The treatment of patients with metastatic non-small cell lung cancer
(NSCLC) whose tumors have epidermal growth
factor receptor (EGFR) exon 19 deletions or exon 21 (L858R)
substitution mutations as detected by an FDA-
approved test receiving first-line, maintenance, or second or greater
line treatment after progression following at
least one prior chemotherapy regimen. (1.1)
First-line treatment of patients with locally advanced, unresectable
or metastatic pancreatic cancer, in combination
with gemcitabine. (1.2)
Safety and efficacy of TARCEVA have not been established in patients
with NSCLC whose tumors have other EGFR
mutations. (1.1)
TARCEVA is not recommended for use in combination with platinum-based
chemotherapy. (1.1)
NSCLC: 150 mg orally, on an empty stomach, once daily. (2.2)
Pancreatic cancer: 100 mg orally, on an empty stomach, once daily.
(2.3)
Interstitial lung disease (ILD): Occurs in 1.1% of patients. Withhold
TARCEVA for acute onset of new or progressive
unexplained pulmonary symptoms, such as dyspnea, cough and fever.
Discontinue TARCEVA if ILD is diagnosed.
(5.1)
Renal failu