TARCEVA erlotinib hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Avera McKennan Hospital

INN (International Name):

ERLOTINIB HYDROCHLORIDE

Composition:

ERLOTINIB 100 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

TARCEVA- ERLOTINIB HYDROCHLORIDE TABLET
AVERA MCKENNAN HOSPITAL
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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
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
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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First-line 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. (1.1)
Maintenance treatment of patients with locally advanced or metastatic
NSCLC whose disease has not progressed
after four cycles of platinum-based first-line chemotherapy. (1.1)
Treatment of locally advanced or metastatic NSCLC after failure of 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)
TARCEVA is not recommended for use in combination with platinum-based
chemotherapy.
Safety and efficacy of TARCEVA have not been evaluated as first-line
treatment in patients with metastatic NSCLC
whose tumors have EGFR mutations other than exon 19 deletions or exon
21 (L858R) substitution.
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)
Tablets: 25 mg, 100 mg, and 150 mg. (3)
None. (4)
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 Failure: Monitor renal function and electrolytes, particularly
in