ERLOTINIB- erlotinib hydrochloride tablet, film coated

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

Erlotinib Hydrochloride (UNII: DA87705X9K) (Erlotinib - UNII:J4T82NDH7E)

Disponible desde:

Breckenridge Pharmaceutical, Inc.

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Erlotinib tablets are 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 erlotinib tablets have not been established in patients with NSCLC whose tumors have other EGFR mutations [see Clinical Studies (14.1, 14.2)] . - Erlotinib tablets are not recommended for use in combination with platinum-based chemotherapy [see Clinical Studies (14.4)] . Erlotinib tablets in combination with gemcitabine are 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 mechanis

Resumen del producto:

25 mg Tablets: Round, biconvex, white film-coated tablets debossed with "N 25" on one side and plain on the other side; supplied in: Bottles of 30: NDC 51991-890-33 100 mg Tablets: Round, biconvex, white film-coated tablets debossed with "N 100" on one side and plain on the other side; supplied in: Bottles of 30: NDC 51991-891-33 150 mg Tablets: Round, biconvex, white film-coated tablets debossed with "N 150" on one side and plain on the other side; supplied in: Bottles of 30: NDC 51991-892-33 Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

ERLOTINIB- ERLOTINIB HYDROCHLORIDE TABLET, FILM COATED
BRECKENRIDGE PHARMACEUTICAL, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ERLOTINIB TABLETS SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ERLOTINIB
TABLETS.
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
Erlotinib tablets are a kinase inhibitor 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. (1.1)
First-line treatment of patients with locally advanced, unresectable
or metastatic pancreatic cancer, in
combination with gemcitabine. (1.2)
Limitations of Use:
Safety and efficacy of erlotinib tablets have not been established in
patients with NSCLC whose tumors
have other EGFR mutations. (1.1)
Erlotinib tablets are not recommended for use in combination with
platinum-based chemotherapy. (1.1)
DOSAGE AND ADMINISTRATION
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)
DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg, 100 mg, and 150 mg. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Interstitial lung disease (ILD): Occurs in 1.1% of patients. Withhold
erlotinib tablets for acute onset of
new or progressive unexplained pulmonary symptoms, such as dyspnea,
cough and fever. Discontinue
erlotinib tablets if ILD is di