Tarceva

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|Tarceva

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ERLOTINIB (Systemic)

Some commonly used brand names are:

In the U.S.—

  • Tarceva

In Canada—

  • Tarceva

Category

  • Antineoplastic

Description

Erlotinib ((er-LOE-tye-nib)) belongs to the group of medicines called antineoplastics. It is used to treat non-small cell lung cancer after the failure of other chemotherapy treatment. It is also used together with another medicine called gemcitabine (e.g., Gemzar) to treat cancer of the pancreas.

This medicine is available only with your doctor"s prescription, in the following dosage forms:

  • Oral
  • Tablets (U.S. and Canada))

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For erlotinib, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to erlotinib. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Erlotinib has been shown to cause miscarriages and death of the fetus in animals. However, this medicine may be needed in serious diseases or other situations that threaten the mother"s life. Be sure you have discussed this with your doctor.

It is best to use some kind of birth control while you are receiving erlotinib. Tell your doctor right away if you think you have become pregnant while receiving erlotinib.

Breast-feeding—It is not known whether erlotinib passes into the breast milk. However, erlotinib is not recommended during breast-feeding, because it may cause unwanted effects in nursing babies.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of erlotinib in children with use in other age groups.

Older adults—This medicine has been tested in elderly patients and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking erlotinib, it is especially important that your doctor and pharmacist know if you are taking any of the following:

  • CYP3A4 inducers such as
  • Carbamazepine (e.g., Tegretol) or
  • Phenobarbital (e.g., Barbiturates) or
  • Phenytoin (e.g., Dilantin, Phenytek), or
  • Rifabutin (e.g., Mycobutin) or
  • Rifampin (e.g., Rifadin, Rimactane) or
  • Rifapentin (e.g., Priftin) or
  • St. John"s Wort—May decrease the effectiveness of erlotinib
  • CYP3A4 inhibitors such as
  • Ketoconazole (e.g., Nizoral) or
  • Atazanavir (e.g., Reyataz) or
  • Clarithromycin (e.g., Biaxin) or
  • Indinavir (e.g., (Crixivan) or
  • Itraconazole (e.g., Sporanox) or
  • Nefazodone (e.g., Serzone) or
  • Nelfinavir (e.g., Viracept) or
  • Ritonavir (e.g., Norvir) or
  • Saquinavir (e.g., Fortovase, Invirase) or
  • Telithromycin (e.g., Ketek) or
  • Troleandomycin (e.g., TAO) or
  • Voriconazole (e.g., Vfend)—May increase the amount or erlotinib in you blood and your doctor may lower your dose of erlotinib
  • Warfarin (e.g., Coumadin) or
  • Other anticoagulants (blood thinners)—Bleeding may occur.

Other medical problems—The presence of other medical problems may affect the use of erlotinib. Make sure you tell your doctor if you have any other medical problems, especially:

  • Liver disease—The chance of serious side effects is greatly increased.

Proper Use of This Medicine

It is important that you take erlotinib one hour before or at least two hours after the ingestion of food

Dosing—The dose of erlotinib will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of erlotinib. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets that you take depends on the strength of the medicine.

  • For oral dosage form (tablets):
    • For lung cancer, non-small cell:
      • Adults—150 milligrams (mg) daily.
      • Children—Use and dose must be determined by your doctor.
    • For cancer of the pancreas:
      • Adults—100 mg daily.
      • Children—Use and dose must be determined by your doctor.

Missed dose—If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

  • Keep out of the reach of children.
  • Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
  • Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is very important that your doctor check you at regular visits.

It is important that you seek prompt medical attention should severe or persistent diarrhea, nausea, anorexia, or vomiting occur.

You should seek prompt medical attention if onset or worsening of unexplained shortness of breath or cough occur.

Contact your doctor if you develop eye irritation.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Burning, tingling, numbness or pain in the hands, arms, feet, or legs; cough; diarrhea, severe; difficult or labored breathing; fever; rash, severe; sensation of pins and needles; shortness of breath; stabbing pain; tightness in chest; wheezing

Rare

Bloody or black, tarry stool; blurred vision; chest pain or discomfort; constipation; eye irritation or redness; inability to speak; pain or discomfort in arms, jaw, back, or neck; seizures; severe stomach pain; shortness of breath; slurred speech; sudden and severe headache; sudden and severe weakness in arm and/or leg on one side of the body; sudden weakness in arms or legs; sudden, severe chest pain; sweating; temporary blindness; vomiting of blood or material that looks like coffee grounds

Symptoms of Overdose

Get emergency help immediately if any of the following symptoms of overdose occur

Diarrhea; rash

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

More common

Acid or sour stomach; belching; bloated full feeling; bone pain; burning, dry or itching eyes; diarrhea, mild; difficulty in moving; discharge; discouragement; dizziness; dryness of the eye; dry skin; excess air or gas in stomach or intestines; excessive tearing; fear; feeling sad or empty; feeling unusually cold; fever or chills; hair loss; headache; heartburn; hoarseness; indigestion; irritability; itching skin; joint pain; lack or loss of appetite; loss of interest or pleasure; lower back or side pain; muscle aching or cramping; muscle pains or stiffness; nausea; nervousness; painful or difficult urination; passing gas; rash, mild; redness, pain, swelling of eye, eyelid, or inner lining of eyelid; shivering; sleeplessness; stomach discomfort, upset, or pain; swelling; swelling or inflammation of the mouth; swollen joints; thinning of hair; tiredness; trouble concentrating; trouble or inability to sleep; unusual tiredness or weakness; vomiting; weight loss

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 02/17/2005
Revised: 11/14/2005

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