Erlotinib, Oral

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KEY POINTS

• This medicine is taken by mouth to treat non-small cell lung cancer or pancreatic cancer. Take it exactly as directed.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antineoplastic (anticancer); kinase inhibitor

Generic and brand names: erlotinib, oral; Tarceva

What is this medicine used for?

This medicine is taken by mouth to treat non-small cell lung cancer or pancreatic cancer. It is used when other cancer medicines have not worked.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A stroke or transient ischemic attack (TIA)
• Any other lung disease (such as pulmonary fibrosis)
• Chemotherapy or radiation therapy
• Heart disease or a heart attack
• Liver or kidney disease

Tell your healthcare provider if you smoke. Smoking affects the way this medicine works.

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Use an effective method of birth control while taking this medicine and for at least 2 weeks after you complete treatment. Do not become pregnant during treatment with this medicine. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while you are taking this medicine.

How do I use it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more of it or for longer than prescribed. Taking too much increases the risk of serious side effects.

Check with your healthcare provider before using this medicine in children under age 18.

Take this medicine on an empty stomach, at least 1 hour before or 2 hours after food.

What if I miss a dose?

If you miss a daily dose and do not remember until the next day, skip that dose and take the regular daily dose. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: stomach pain, severe diarrhea, rash.

What should I watch out for?

This medicine may cause serious or life-threatening lung, liver, kidney, heart, eye, or intestinal problems. It may also cause severe bleeding problems. Talk with your healthcare provider about this.

You need to have blood tests regularly to see how this medicine affects you. Keep all appointments.

This medicine is may cause nausea, vomiting, or diarrhea. Contact your healthcare provider if these symptoms are severe or do not go away.

This medicine may make your skin more sensitive to the sun, which may lead to painful sunburns. While you are taking this medicine, avoid long exposure to the sun. Wear protective clothing, a hat, and sunscreen lotion when you need to be outdoors. Do not use a sunlamp. If you get a severe sunburn, contact your healthcare provider right away.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Shortness of breath; chest pain; unexplained cough, sore throat, or fever; eye pain or irritation; unusual bruising or bleeding; blood in bowel movement, urine or vomit; severe stomach pain, diarrhea, nausea, or vomiting; ongoing loss of appetite; yellowing of the skin or eyes; dark urine; light-colored bowel movements; numbness or tingling; trouble urinating; severe skin redness, peeling, or blisters; unusual tiredness or weakness.

Other: Mild rash, mild nausea or vomiting, dry skin, diarrhea, decreased appetite, tiredness, trouble sleeping, mouth sores, muscle or joint pain, headache, nail changes, hair loss, acne.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antacids that contain aluminum, calcium, or magnesium, such as Gaviscon, Maalox, Mylanta, Phillips' Chewable Tablets, Rolaids, or TUMS (Take antacids at least 2 hours before or 4 hours after you take this medicine.)
• Antibiotics such as ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), telithromycin (Ketek), and tetracycline
• Antidepressants such as desipramine (Norpramin), fluvoxamine (Luvox), and nefazodone
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Aprepitant (Emend)
• Bosentan (Tracleer)
• Cancer medicines such as abiraterone (Zytiga), ceritinib (Zykadia), crizotinib (Xalkori), dabrafenib (Tafinlar), enzalutamide (Xtandi), idelalisib (Zydelig), imatinib (Gleevec), and mitotane (Lysodren)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), fluvastatin (Lescol), lomitapide (Juxtapid), lovastatin (Altoprev), pravastatin (Pravachol), and simvastatin (Zocor)
• Conivaptan (Vaprisol)
• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Cyclosporine (Gengraf, Neoral, Sandimmune)
• Heart medicines such as amiodarone (Cordarone, Pacerone), diltiazem (Cardizem, Cartia, Tiazac), dronedarone (Multaq), quinidine, and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), cobicistat (Tybost), darunavir (Prezista), delavirdine (Rescriptor), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• Medicines to block or prevent stomach acid such as cimetidine (Tagamet), dexlansoprazole (Dexilant), esomeprazole (Nexium), famotidine (Pepcid), lansoprazole (Prevacid), nizatidine (Axid), omeprazole (Prilosec), pantoprazole (Protonix), and ranitidine (Zantac) (Ask your healthcare provider. Some medicines to block or prevent stomach acid need to be taken several hours before or after this medicine.)
• Mifepristone (Korlym, Mifeprex)
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• St. John's wort
• Warfarin (Coumadin)

Do NOT eat or drink products that contain grapefruit, Seville oranges, and tangelos at any time while you are taking this medicine. These fruits and juices affect the way this medicine works and increase your risk of serious side effects. Talk with your healthcare provider or pharmacist about this.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.