Buy Erlotinib (Tarceva) online

Buy Tarceva (Erlotinib HCl) anticancer medication
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HOW AND WHERE TO BUY ERLOTINIB HCL (TARCEVA) 150 MG TABLETS ONLINE:

TARCEVA (ERLOTINIB): PRESCRIBING INFORMATION

DESCRIPTION

Erlotinib Hydrochloride (Tarceva), a kinase inhibitor, is a quinazolinamine with the chemical name N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine. Tarceva contains erlotinib as the hydrochloride salt.

Erlotinib Hydrochloride has the molecular formula C22H23N3O4.HCl and a molecular weight of 429.90. The molecule has a pKa of 5.42 at 25oC. Erlotinib Hydrochloride is very slightly soluble in water, slightly soluble in methanol and practically insoluble in acetonitrile, acetone, ethyl acetate and hexane.

Aqueous solubility of Erlotinib Hydrochloride is dependent on pH with increased solubility at a pH of less than 5 due to protonation of the secondary amine. Over the pH range of 1.4 to 9.6, maximal solubility of approximately 0.4 mg/mL occurs at a pH of approximately 2.

Tarceva (Erlotinib HCl) tablets for oral administration are available in three dosage strengths containing erlotinib hydrochloride (27.3 mg, 109.3 mg and 163.9 mg) equivalent to 25 mg, 100 mg and 150 mg erlotinib and the following inactive ingredients: hypromellose, lactose monohydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, sodium starch glycolate, sodium lauryl sulfate and titanium dioxide. The tablets also contain trace amounts of color additives, including FD&C Yellow #6 (25 mg only) for product identification.


INDICATIONS AND USAGE

Non-Small Cell Lung Cancer (NSCLC)

Tarceva monotherapy is indicated for the maintenance treatment of patients with locally advanced or metastatic non-small cell lung cancer whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.

Erlotinib 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.

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 (Erlotinib) with platinum-based chemotherapy [carboplatin and paclitaxel or gemcitabine and cisplatin] and its use is not recommended in that setting.

Pancreatic Cancer

Erlotinib (Tarceva) in combination with gemcitabine is indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.


DOSAGE AND ADMINISTRATION

Tarceva dosage and administration


DOSAGE FORMS AND STRENGTHS

25 mg tablets White film-coated tablets for daily oral administration. 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.

100 mg tablets White film-coated tablets for daily oral administration. 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.

150 mg tablets White film-coated tablets for daily oral administration. 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.


CONTRAINDICATIONS

None.


WARNINGS AND PRECAUTIONS

Tarceva warnings and precautions


ADVERSE REACTIONS

Tarceva adverse reactions


DRUG INTERACTIONS

Tarceva drug interactions


USE IN SPECIFIC POPULATIONS

Tarceva use in specific populations


OVERDOSAGE

Single oral doses of Tarceva (Erlotinib) up to 1,000 mg in healthy subjects and weekly doses up to 1,600 mg in cancer patients have been tolerated. Repeated twice-daily doses of 200 mg single-agent Erlotinib (Tarceva) in healthy subjects were poorly tolerated after only a few days of dosing. Based on the data from these studies, an unacceptable incidence of severe adverse reactions, such as diarrhea, rash, and liver transaminase elevation, may occur above the recommended dose. In case of suspected overdose, Tarceva (Erlotinib Hydrochloride) should be withheld and symptomatic treatment instituted.


CLINICAL PHARMACOLOGY

Tarceva clinical pharmacology


NONCLINICAL TOXICOLOGY

Carcinogenesis, Mutagenesis, Impairment of Fertility

Tarceva (Erlotinib) has not been tested for carcinogenicity.

Erlotinib has been tested for genotoxicity in a series of in vitro assays (bacterial mutation, human lymphocyte chromosome aberration, and mammalian cell mutation) and an in vivo mouse bone marrow micronucleus test and did not cause genetic damage.

Erlotinib (Tarceva) did not impair fertility in either male or female rats.


CLINICAL STUDIES

Tarceva clinical studies


HOW SUPPLIED / STORAGE AND HANDLING

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 bottles of 30

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 bottles of 30

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 bottles of 30

Store Tarceva (Erlotinib) at 25°C (77°F); excursions permitted to 15° - 30°C (59° - 86°F). See USP Controlled Room Temperature.

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