Erlotinib tablets

What is this medication?

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.

COMMON BRAND NAME(S): Tarceva

What should I tell my care team before I take this medication?

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

• dehydration
• eye disease, vision problems
• kidney disease
• liver disease
• lung or breathing disease, like asthma
• stomach or intestine problems
• 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 medication?

Take erlotinib tablets by mouth with a glass of water. 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. Do not take with grapefruit juice. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

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?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take extra or double doses.

What may interact with this medication?

This medicine may interact with the following medications:

• antiviral medicines for HIV or AIDS
• boceprevir
• certain antibiotics like ciprofloxacin, clarithromycin, erythromycin, telithromycin
• certain medicines for fungal infections like itraconazole, ketoconazole, posaconazole, or voriconazole
• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin
• certain medicines for stomach problems like cimetidine, famotidine, omeprazole, lansoprazole
• certain medicines for tuberculosis like rifabutin, rifampin, rifapentine
• certain medicines that treat or prevent blood clots like warfarin
• conivaptan
• grapefruit juice
• nefazodone
• St. John's Wort
• teriflunomide

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 medication?

Tell your doctor or healthcare provider if your symptoms do not start to get better or if they get worse.

This medicine may cause serious skin reactions. They can happen weeks to months after starting the medicine. Contact your healthcare provider right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips, or lymph nodes in your neck or under your arms.

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.

Tell your doctor or healthcare provider right away if you have any change in your eyesight.

Check with your doctor or healthcare provider if you get an attack of severe diarrhea, nausea and vomiting, or if you sweat a lot. The loss of too much body fluid can make it dangerous for you to take this medicine.

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 or for 1 month after stopping it. 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 healthcare provider or pharmacist for more information. Do not breast-feed an infant while taking this medicine or for 2 weeks after stopping it.

What side effects may I notice from receiving this medication?

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
• cough
• eye irritation
• eye pain
• fever
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• 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
• signs and symptoms of kidney injury like trouble passing urine or change in the amount of urine
• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin
• signs and symptoms of a stroke like changes in vision; confusion; trouble speaking or understanding; severe headaches; sudden numbness or weakness of the face, arm or leg; trouble walking; dizziness; loss of balance or coordination

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
• mouth sores
• nausea, vomiting
• 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 medication?

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.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.