MedlinePlus Drug Information: Erlotinib

Skip navigation


Other drug names:	A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 0-9

Erlotinib

(er loe' ti nib)

Contents of this page:
Why is this medication prescribed? How should this medicine be used? Other uses for this medicine What special precautions should I follow? What special dietary instructions should I follow? What should I do if I forget a dose?	What side effects can this medication cause? What storage conditions are needed for this medicine? In case of emergency/overdose What other information should I know? Brand names

IMPORTANT WARNING: Return to top

[Posted 05/08/2009] OSI, Genentech and FDA notified healthcare professionals of new safety information added to the WARNINGS AND PRECAUTIONS sections of the prescribing information for erlotinib hydrochloride (Tarceva). Gastrointestinal perforation (including fatalities), bullous, blistering and exfoliative skin conditions including cases suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, in some cases fatal, and ocular disorders, including corneal perforation or ulceration have been reported during use of erlotinib. The new safety information comes from routine pharmacovigilance activities of clinical study and postmarketing reports. 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. In combination with gemcitabine, erlotinib is also indicated for the first-line treatment of patients with locally advanced, unresectable, or metastatic pancreatic cancer. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#Tarceva, and http://www.fda.gov/medwatch/safety/2009/Tarceva_DHCP_Letter_April09.pdf.

Why is this medication prescribed? Return to top

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Erlotinib is used to treat non-small cell lung cancer in patients who have already been treated with at least one other chemotherapy medication and have not gotten better. Erlotinib is also used in combination with another medication (gemcitabine [Gemzar]) to treat pancreatic cancer. Erlotinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells.

How should this medicine be used? Return to top

Erlotinib comes as a tablet to take by mouth. It is usually taken on an empty stomach once a day, at least 1 hour before or 2 hours after you eat a meal or snack. Take erlotinib at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take erlotinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may decrease your dose of erlotinib during your treatment. This depends on how well the medication works for you and the side effects you experience. Talk to your doctor about how you are feeling during your treatment. Continue to take erlotinib even if you feel well. Do not stop taking erlotinib without talking to your doctor.

Other uses for this medicine Return to top

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow? Return to top

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Before taking erlotinib,

tell your doctor and pharmacist if you are allergic to erlotinib or any other medications.
tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin); antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral); carbamazepine (Tegretol); ciprofloxacin (Cipro); clarithromycin (Biaxin); HIV protease inhibitors such as atazanavir (Reyataz), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Fortovase, Invirase); H2 blockers such as cimetidine (Tagamet), famotidine (Pepcid), nizatidine (Axid), and ranitidine (Zantac); nefazodone; nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); phenobarbital (Luminal, Solfoton); phenytoin (Dilantin); proton pump inhibitors such as esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), and rabeprazole (AcipHex); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane); rifapentine; telithromycin (Ketek); troleandomycin (TAO); and voriconazole (Vfend). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with erlotinib, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
if you are taking antacids, take them several hours before or several hours after erlotinib.
tell your doctor what herbal products you are taking, especially St. John's wort.
tell your doctor if you are or have recently been treated with chemotherapy or radiation therapy (treatment for cancer that uses waves of high energy particles to kill cancer cells). Also tell your doctor if you have or have ever had lung, liver, or kidney disease.
tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are taking erlotinib and for at least 2 weeks after treatment. Talk to your doctor about birth control methods that you can use during your treatment. If you become pregnant while taking erlotinib, call your doctor immediately. Erlotinib may harm the fetus.
tell your doctor if you are breast-feeding.
if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking erlotinib.
tell your doctor if you use tobacco products. Cigarette smoking may decrease the effectiveness of this medication.

What special dietary instructions should I follow? Return to top

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine.

What should I do if I forget a dose? Return to top

Take the missed dose on an empty stomach (at least 1 hour before or 2 hours after you eat a meal or snack) as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause? Return to top

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Erlotinib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

diarrhea
loss of appetite
nausea
vomiting
stomach pain
mouth sores
extreme tiredness
itching
dry skin

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

rash
shortness of breath
cough
fever
headache
dry, red, or irritated eyes
blurred vision
chest pain or pressure
pain in the arms, neck, or upper back
rapid, irregular, or pounding heartbeat
slow or difficult speech
dizziness or faintness
weakness or numbness of an arm or leg
unusual bruising or bleeding
black and tarry stools
red blood in stools
bloody vomit
vomit that looks like coffee grounds
sunken eyes
dry mouth
decreased urination

Erlotinib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine? Return to top

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose Return to top

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

diarrhea
rash

What other information should I know? Return to top

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to erlotinib.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand names Return to top

Tarceva®

Last Revised - 12/01/2008

American Society of Health-System Pharmacists, Inc. Disclaimer

AHFS^® Consumer Medication Information. © Copyright, 2009. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.