ERLOTINIB HYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ERLOTINIB (UNII: J4T82NDH7E) (ERLOTINIB - UNII:J4T82NDH7E)

Available from:

Mylan Pharmaceuticals Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Erlotinib tablets are indicated for: Erlotinib tablets 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 can cause fetal harm when administered to a pregnant woman. Limited available data on use of erlotinib in pregnant women are not sufficient to inform a risk of major birth defects or miscarriage. When given during organogenesis, erlotinib administration resulted in embryo-fetal lethality and abortion in rabbits at exposures approximately 3 times the exposure at the recommended human daily dose of 150 mg. Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Erlotinib has been shown to cause maternal toxicity resulting in embryo-fetal let

Product summary:

Erlotinib Tablets are available containing 27.3 mg, 109.3 mg or 163.9 mg of erlotinib hydrochloride equivalent to 25 mg, 100 mg or 150 mg of erlotinib (as the free base), respectively. The 25 mg tablets are white to off-white, film-coated, round, unscored tablets debossed with M on one side of the tablet and E over 31 on the other side. They are available as follows: NDC 0378-7131-93 bottles of 30 tablets NDC 0378-7131-05 bottles of 500 tablets The 100 mg tablets are white to off-white, film-coated, round, unscored tablets debossed with M on one side of the tablet and E over 32 on the other side. They are available as follows: NDC 0378-7132-93 bottles of 30 tablets NDC 0378-7132-05 bottles of 500 tablets The 150 mg tablets are white to off-white, film-coated, round, unscored tablets debossed with M on one side of the tablet and E over 33 on the other side. They are available as follows: NDC 0378-7133-93 bottles of 30 tablets NDC 0378-7133-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ERLOTINIB HYDROCHLORIDE- ERLOTINIB HYDROCHLORIDE TABLET, FILM COATED
MYLAN PHARMACEUTICALS INC.
----------
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:
•
•
Limitations of Use:
•
•
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg, 100 mg, and 150 mg. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
•
•
•
ADVERSE REACTIONS
The most common adverse reactions (≥ 20%) with erlotinib from a
pooled analysis in patients with NSCLC across all
approved lines of therapy, with and without EGFR mutations, and in
patients with pancreatic cancer were rash, diarrhea,
anorexia, fatigue, dyspnea, cough, nausea, and vomiting. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN AT 1-877-446-3679
(1-877-4-INFO-RX) OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
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)
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)
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)
Interstitial lung disease