Erlotinib Oral tablet

What is this medicine?

ERLOTINIB (er LOE ti nib) is a medicine that targets proteins in cancer cells and stops the cancer cells from growing. It is used to treat non-small cell lung cancer and pancreatic cancer.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• liver disease

• lung fibrosis

• previous or ongoing radiation therapy

• an unusual or allergic reaction to erlotinib, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take erlotinib tablets by mouth. Follow the directions on the prescription label. Take this medicine on an empty stomach, at least 1 hour before or 2 hours after food. Do not take with food. Taking this drug with food may increase your chance of developing side effects. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Take your missed dose as soon as you remember. If it is almost time for your next dose, take only that one, and skip your missed dose. Do not take extra or double doses.

What may interact with this medicine?

• amiodarone

• carbamazepine

• ciprofloxacin

• antiviral medicines for HIV or AIDS

• bosentan

• certain medicines for blood pressure

• certain medicines for cholesterol like atorvastatin, lovastatin, and simvastatin

• clarithromycin

• erythromycin

• grapefruit juice

• medicines for depression

• medicines for fungal infections like fluconazole, itraconazole, ketoconazole, or voriconazole

• non-steroidal anti-inflammatory drugs (NSAIDs such as ibuprofen or naproxen)

• omeprazole

• phenobarbital

• phenytoin

• rifabutin

• rifampin

• rifapentine

• St. John's wort

• warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor for regular check ups. Report any side effects. Continue your course of treatment unless your doctor tells you to stop. You will need blood work done while you are taking this medicine.

If you experience any of the following, contact your health care provider: eye irritation; severe or continuing diarrhea, nausea, decreased appetite, or vomiting; or if your breathing gets worse or you develop shortness of breath or cough.

If you smoke cigarettes, you should stop smoking. The effectiveness of this drug is reduced by cigarette smoking. If you stop smoking during treatment, be sure to inform your doctor of this change.

Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• eye irritation

• eye pain

• fever

• mouth sores

• severe or persistent diarrhea, nausea, vomiting, or loss of appetite

• signs and symptoms of bleeding such as bloody or black, tarry stools; red or dark-brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eye, gums, or nose

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• acne

• diarrhea

• dry skin

• itching

• loss of appetite

• nausea

• weak or tired

• weight loss

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.