ERLOTINIB- 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:

Armas Pharmaceuticals Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Erlotinib Tablets was 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 have not been established in patients with NSCLC whose tumors have other EGFR mutations [see Clinical Studies(14.1,14.2)]. - Erlotinib tablet is 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 Based on animal data and its mechanism of action, erlotinib tablets

Product summary:

25 mg Tablets: White to off white round, biconvex film-coated tablets, debossed with “S13” on one side and plain on other side. Supplied in: Bottles of 30: NDC 72485-217-30 100 mg Tablets: White to off white round, biconvex film-coated tablets, debossed with “S12” on one side and plain on other side. Supplied in: Bottles of 30: NDC 72485-218-30 150 mg Tablets: White to off white round, biconvex film-coated tablets, debossed with “S11” on one side and plain on other side. Supplied in: Bottles of 30: NDC 72485-219-30 Store at 25°C (77°F); excursions permitted to 15°C -30°C (59°F -86°F). [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ERLOTINIB- ERLOTINIB HYDROCHLORIDE TABLET, FILM COATED
ARMAS 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 tablet is 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 rst-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, unrespectable
or metastatic pancreatic cancer, in combination with
gemcitabine. (1.2)
Limitations of Use:
Safety and efcacy 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: 150mg 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: 25mg, 100mg and 150mg (3) (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 if ILD is
diagnosed. (5.1)
Renal failure: Monitor renal function and electrolytes, particularly
in patients at risk of dehydration. Withhold erlotinib
tablets for severe renal toxicity. (5.2)
Hepatotoxicity: Occurs with or without hepatic impairment, including
hepatic failure and hepatorenal syndrome: Monitor
periodic liver testing. Withhold or dis