Erlotinib

Erlotinib is a prescription medication used to treat non-small cell lung cancer that has spread to nearby tissues or to other parts of the body in patients. It is used when other treatments have not succeeded. Erlotinib is also used to treat pancreatic cancer that has spread to nearby tissues or to other parts of the body. Erlotinib belongs to a group of drugs called kinase inhibitors. These work by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells.

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 eating a meal or snack. Take erlotinib at around the same time every day.

Common side effects include rash, diarrhea, and tiredness. Do not drive or operate heavy machinery until you know how erlotinib will affect you.

Erlotinib is a prescription medication used to treat non-small cell lung cancer (NSCLC) that has spread to nearby tissues or to other parts of the body in patients. It is used when other treatments have not succeeded. This medication is approved to treat patients whose tumors have specific epidermal growth factor receptor (EGFR) mutations.

Erlotinib is also used to treat pancreatic cancer that has spread to nearby tissues or to other parts of the body.

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

Erlotinib may be found in some form under the following brand names:

• Tarceva

Common side effects of erlotinib include the following:

• rash
• diarrhea
• loss of appetite
• fatigue
• difficulty breathing
• cough
• nausea
• vomiting

This is not a complete list of this medication’s side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• angiogenesis inhibitors such as bevacizumab (Avastin)
• anticoagulants ('blood thinners') such as warfarin (Coumadin)
• certain antifungals such as itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend)
• carbamazepine (Tegretol)
• ciprofloxacin (Cipro, Proquin XR)
• 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)
• medications for acne such as benzoyl peroxide (in Epiduo, in BenzaClin, in Benzamycin, others)
• midazolam (Versed)
• nefazodone
• nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn)
• oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone)
• 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
• taxane medications for cancer such as docetaxel (Taxotere) and paclitaxel (Abraxane, Taxol
• telithromycin (Ketek)
• cigarette smoke
• St. John's wort

This is not a complete list of all drug interactions. Ask your doctor or pharmacist for more information.

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

• rash (may look like acne and may affect the skin on the face, upper chest, or back)
• blistering, peeling, dry, or cracked skin
• itching, tenderness, or burning of the skin
• shortness of breath
• cough
• fever or chills
• growth of eyelashes on the inside of the eyelid
• dry, red, painful, 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 or bloody stools
• vomit that is bloody or looks like coffee grounds
• sunken eyes
• dry mouth
• decreased urination
• dark urine
• pale or yellow skin
• redness, warmth, pain, tenderness, or swelling in one leg

Do not take erlotinib if you are allergic to erlotinib or to any of its inactive ingredients.

Erlotinib may cause fatigue. Do not drive or operate heavy machinery until you know how erlotinib will affect you.

Grapefruit and grapefruit juice may interact with this medication and can lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before taking erlotinib,

• tell your doctor and pharmacist if you are allergic to erlotinib, any other medications, or any of the ingredients in erlotinib tablets
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take
• if you are taking antacids, take them several hours before or several hours after you take erlotinib
• tell your doctor what herbal products you are taking, especially St. John's wort
• tell your doctor if you are being treated 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 disease or infection, stomach ulcers, diverticular disease (condition in which abnormal pouches form in the large intestine and may become inflamed), or 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 your 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 (unborn baby).
• tell your doctor if you are breastfeeding
• 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.
• plan to avoid unnecessary or prolonged exposure to sunlight and to wear a hat, other protective clothing, sunglasses, and sunscreen. Choose a sunscreen that has a sun protection factor (SPF) of at least 15 and contains zinc oxide or titanium dioxide. Exposure to sunlight increases the risk that you will develop a rash during your treatment with erlotinib.
• you should know that erlotinib may cause rashes and other skin problems. To protect your skin, use a mild alcohol-free moisturizer, wash your skin with mild soap, and remove cosmetics with a mild cleanser.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category D.  You should not become pregnant while you are taking erlotinib and for at least 2 weeks after your 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 (unborn baby).

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if erlotinib crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using this medication.

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 eating a meal or snack. Take erlotinib at around the same time every day.

To prevent diarrhea that may be caused by erlotinib:

• drink small sips of a liquid such as a sugar-free sports drink often throughout the day
• eat mild foods such as crackers and toast
• avoid spicy foods

It is recommended that you should stop smoking if prescribed erlotinib. The dose may need to be adjusted if you smoke while taking erlotinib.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended daily dose of erlotinib for non-small cell lung cancer is 150 mg taken on an empty stomach (or at least one 1 before or 2 hours after the ingestion of food).

The recommended daily dose of erlotinib for pancreatic cancer is 100 mg taken on an empty stomach (or at least one 1 before or 2 hours after the ingestion of food).

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.
 

• Store at room temperature.
• Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to erlotinib.
• Keep this and all other medications out of the reach of children.