Tarceva

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...

Read All Potential Side Effects and See Pictures of Tarceva »

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...

Read All Potential Precautions of Tarceva »


Tarceva Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, loss of appetite, mouth sores, dry skin, or eye irritation may occur. Changes in diet such as eating several small meals or limiting activity may help lessen the chance of nausea. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Diarrhea is a common side effect. Drink plenty of fluids as directed by your doctor to reduce your risk of losing too much body water. Your doctor may prescribe anti-diarrhea medication (e.g., loperamide) to control your symptoms. Tell your doctor immediately if you develop: severe or persistent diarrhea, signs of dehydration (e.g., dizziness, decreased amount of urine).

Tell your doctor immediately if any of these rare but very serious side effects occur: black stools, vomit that looks like coffee grounds, easy bleeding/bruising, stomach/abdominal pain, yellowing eyes or skin, dark urine, unusual fatigue, signs of infection (e.g., fever, chills, persistent sore throat), eye pain, vision changes.

Seek immediate medical attention if you develop any of these rare but very serious side effects: new or worsening shortness of breath or cough.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Erlotinib can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, seek immediate medical attention if you develop any rash.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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 are taking this drug. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

This drug is not recommended for use during pregnancy. It may cause harm to an unborn baby or miscarriage. Women of childbearing age should use reliable form(s) of birth control during treatment and for at least 2 weeks following the end of treatment with this drug. Consult your doctor for more details.

It is not known whether this drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Tarceva Patient Information Including Side Effects

Brand Names: Tarceva

Generic Name: erlotinib (Pronunciation: er LOE ti nib)

  • What is erlotinib (Tarceva)?
  • What are the possible side effects of erlotinib (Tarceva)?
  • What is the most important information I should know about erlotinib (Tarceva)?
  • What should I discuss with my healthcare provider before taking erlotinib (Tarceva)?
  • How should I use erlotinib (Tarceva)?
  • What happens if I miss a dose (Tarceva)?
  • What happens if I overdose (Tarceva)?
  • What should I avoid while using erlotinib (Tarceva)?
  • What other drugs will affect erlotinib (Tarceva)?
  • Where can I get more information?

What is erlotinib (Tarceva)?

Erlotinib is a cancer chemotherapy medication. Erlotinib interferes with the growth of cancer cells and slows their growth and spread in the body.

Erlotinib is used in the treatment of non-small cell lung cancer.

Erlotinib may also be used for purposes other than those listed in this medication guide.

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 occur. Continue taking erlotinib and talk to your doctor if you experience:

  • mild to moderate nausea, vomiting, loss of appetite, or diarrhea;
  • skin rash, dryness, itching, or acne; or
  • weakness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about 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 (especially new or worsening 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.
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