Tarceva (Erlotinib) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 21, 2012

Tarceva

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Cancer of the lung, like all cancers, results from an abnormality in the body's basic unit of life, the cell. Normally, the body maintains a system of checks and balances on cell growth so that cells divide to produce new cells only when new cells are needed. Disruption of this system of checks and balances on cell growth results in an uncontrolled division and proliferation of cells that eventually forms a mass known as a tumor.

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TARCEVA®
(erlotinib) Tablets, Oral

DRUG DESCRIPTION

TARCEVA (erlotinib), 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 that has the following structural formula:

TARCEVA® (erlotinib) Structural Formula Illustration

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) 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: lactose monohydrate, hypromellose, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, 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.

What are the possible side effects of erlotinib (Tarceva)?

If you experience any of the following serious side effects from erlotinib, contact your doctor immediately:

an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
lung problems (difficulty breathing, shortness of breath, increased coughing, fever, or chest pain);
severe or persistent nausea, vomiting, loss of appetite, or diarrhea; or
eye pain or irritation.

Other, less serious side effects may be more likely to...

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What are the precautions when taking erlotinib (Tarceva)?

Before taking erlotinib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney problems, stomach/intestinal disease (such as ulcers, diverticulosis).

Use caution with sharp objects like safety razors or nail cutters and avoid activities such as contact sports to lower the chance of getting cut, bruised or injured.

This medicine may increase your risk of stomach bleeding. Limit alcoholic beverages.

Sunlight may worsen any skin reactions that may occur while you...

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Last reviewed on RxList: 5/7/2010
This monograph has been modified to include the generic and brand name in many instances.