ERLOTINIB HYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Alembic Pharmaceuticals Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 tablet 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

Product summary:

Erlotinib tablets 25 mg are round, biconvex, white film-coated tablet debossed with “L55” on one side and plain on other side. Bottle of 30 tablets with child resistant closure, NDC 62332-565-30 Bottle of 90 tablets with child resistant closure, NDC 62332-565-90 Erlotinib tablets 100 mg are round, biconvex, white film-coated tablet debossed with “L630” on one side and plain on other side. Bottle of 30 tablets with child resistant closure, NDC 62332-566-30 Bottle of 90 tablets with child resistant closure, NDC 62332-566-90 Erlotinib tablets 150 mg are round, biconvex, white film-coated tablet debossed with “L631” on one side and plain on other side. Bottle of 30 tablets with child resistant closure, NDC 62332-567-30 Bottle of 90 tablets with child resistant closure, NDC 62332-567-90 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). See USP Controlled Room Temperature.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ERLOTINIB HYDROCHLORIDE - ERLOTINIB HYDROCHLORIDE TABLET, FILM COATED
ALEMBIC PHARMACEUTICALS 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
INDICATIONS AND USAGE
Erlotinib tablets are a kinase inhibitor indicated for: (1)
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: (1)
Safety and efficacy of erlotinib tablets has 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) (3)
CONTRAINDICATIONS
None. (4) (4)
WARNINGS AND PRECAUTIONS
Interstitial lung disease (ILD): Occurs in 1.1% of patients. Withhold
erlotinib for acute onset of new or
progressive unexplained pulmonary symptoms, such as dyspnea, cough and
fever. Discontinue
erlotinib if ILD is diagnosed. (5.1)
Renal failure: Monitor renal function and electrolytes, particularly
in patients at risk of dehydration.
Withhold erlotinib for severe renal toxicity. (5.2)
Hepatotoxicity: Occurs with or without hepatic impairment, including
hepatic failure and hepatorenal
syndrome: Monitor periodic liver test