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:

Physicians Total Care, Inc.

INN (International Name):

ERLOTINIB HYDROCHLORIDE

Composition:

ERLOTINIB 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Enter section text here TARCEVA monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen [see Clinical Studies (14.1)]. Results from two, multicenter, placebo-controlled, randomized, Phase 3 trials conducted in first-line patients with locally advanced or metastatic NSCLC showed no clinical benefit with the concurrent administration of TARCEVA with platinum-based chemotherapy [carboplatin and paclitaxel or gemcitabine and cisplatin] and its use is not recommended in that setting [see Clinical Studies (14.3)]. TARCEVA in combination with gemcitabine is indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer [see Clinical Studies (14.3)]. None. Pregnancy Category D [See Warnings and Precautions (5.8) ] Erlotinib has been shown to cause maternal toxicity with associated embryo/fetal lethality and abortion in rabbits when given at dose

Product summary:

25 mg Tablets Round, biconvex face and straight sides, white film-coated, printed in orange with a “T” and “25” on one side and plain on the other side; supplied in:   100 mg Tablets Round, biconvex face and straight sides, white film-coated, printed in gray with “T” and “100” on one side and plain on the other side; supplied in:   150 mg Tablets Round, biconvex face and straight sides, white film-coated, printed in maroon with “T” and “150” on one side and plain on the other side; supplied in:   Store at 25°C (77°F); excursions permitted to 15° – 30°C (59° – 86°F). See USP Controlled Room Temperature.

Authorization status:

New Drug Application

Summary of Product characteristics

TARCEVA - ERLOTINIB HYDROCHLORIDE TABLET
PHYSICIANS TOTAL CARE, INC.
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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 HYDROCHLORIDE)
TABLET FOR ORAL USE INITIAL U.S.
APPROVAL: 2004
RECENT MAJOR CHANGES
Warnings and Precautions, Hepatic Impairment (5.2) 09/2008
Warnings and Precautions, Hepatotoxicity (5.3) 09/2008
Warning and Precautions, Renal Failure (5.4) 09/2008
INDICATIONS AND USAGE
TARCEVA is a tyrosine kinase inhibitor indicated for the treatment of:
Locally advanced or metastatic non-small cell lung cancer (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)
DOSAGE AND ADMINISTRATION
The dose for NSCLC is 150 mg/day. (2.1)
The dose for pancreatic cancer is 100 mg/day. (2.2)
All doses of TARCEVA should be taken at least one hour before or two
hours after food. (2.1, 2.2)
Reduce in 50 mg decrements, when necessary. (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)-like events, including fatalities have
been infrequently reported. Interrupt TARCEVA if
acute onset of new or progressive unexplained pulmonary symptoms, such
as dyspnea, cough and fever occur.
Discontinue TARCEVA if ILD is diagnosed. (5.1)
Monitor patients with hepatic impairment closely. Interrupt or
discontinue TARCEVA if changes in liver function are
severe (5.2)
Cases of hepatic failure and hepatorenal syndrome (including
fatalities) have been reported. Monitor periodic liver
function testing. Interrupt or discontinue TARCEVA if liver function
changes are severe. (5.3)
Cases of acute renal failure (including fatalities), and renal
insufficiency have been reported. Interrupt TARCEVA in the
event of dehydration. Monitor ren