ERLOTINIB tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Zydus Pharmaceuticals USA Inc.

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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 i

Ringkasan produk:

Erlotinib Tablets equivalent to 25 mg of erlotinib are white to off-white, round, film-coated tablets, debossed with '913' on one side and plain on other side and are supplied as follows: NDC 68382-913-06 in bottles of 30 tablets with child-resistant closure NDC 68382-913-16 in bottles of 90 tablets with child-resistant closure NDC 68382-913-84 in unit-dose blister cartons of 30 tablets (3 x 10 unit-dose) Erlotinib Tablets equivalent to 100 mg of erlotinib are white to off-white, round, film-coated tablets, debossed with '914' on one side and plain on other side and are supplied as follows: NDC 68382-914-06 in bottles of 30 tablets with child-resistant closure NDC 68382-914-16 in bottles of 90 tablets with child-resistant closure NDC 68382-914-84 in unit-dose blister cartons of 30 tablets (3 x 10 unit-dose) Erlotinib Tablets equivalent to 150 mg of erlotinib are white to off-white, round, film-coated tablets, debossed with '915' on one side and plain on other side and are supplied as follows: NDC 68382-915-06 in bottles of 30 tablets with child-resistant closure NDC 68382-915-16 in bottles of 90 tablets with child-resistant closure NDC 68382-915-84 in unit-dose blister cartons of 30 tablets (3 x 10 unit-dose) Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

ERLOTINIB- ERLOTINIB TABLET
ZYDUS PHARMACEUTICALS USA 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:
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 have not been established in patients
with NSCLC whose tumors have
other EGFR mutations. (1.1)
Erlotinib is 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 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 testing. Withhold or discontinue
erlotinib for severe or worsening liver
test