When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to erlotinib or if you are pregnant.

How to Use This Medicine:
Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• It is best to take this medicine on an empty stomach. Take the medicine at least 1 hour before or 2 hours after you eat.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how erlotinib works. Tell your doctor if you are using any of the following:
  
  • Nefazodone, St John's wort
  • Blood thinner (such as warfarin)
  • Medicine to treat seizures (such as carbamazepine, phenobarbital, phenytoin)
  • Medicine to treat an infection (such as ciprofloxacin, clarithromycin, itraconazole, ketoconazole, rifabutin, rifampin, rifapentine, telithromycin, troleandomycin, voriconazole)
  • Medicine to treat HIV (such as atazanavir, indinavir, nelfinavir, ritonavir, saquinavir)
  • Steroid medicine (such as hydrocortisone, methylprednisolone, prednisolone, prednisone)
  • NSAID pain or arthritis medicine (such as aspirin, diclofenac, ibuprofen, naproxen)
• Tell your doctor if you take any stomach medicine, such as omeprazole, ranitidine, or an antacid. Some stomach medicines need to be taken several hours before or after you take erlotinib.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.
• Tell your doctor if you change how much or how often you smoke, or if you quit smoking. Your treatment might need to be changed.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. You should continue to use birth control for at least 14 days after you have stopped taking this medicine.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, liver disease, bleeding problems, eye or vision problems, stomach problems (such as ulcers or diverticulosis), or a history of other lung disease, heart attack, or stroke.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• This medicine may cause the following problems:
  
  • Lung problems
  • Bleeding in your digestive system
  • Liver problems
  • Kidney problems
  • Eye problems
• Cancer medicines can cause severe diarrhea, nausea, or vomiting. Ask your doctor about ways to control these side effects.
• This medicine may cause a rash or other skin problems. You may use alcohol-free emollient creams or sunscreen to help prevent this. Stay out of the sun when possible.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Bloody or black, tarry stools, vomiting material that looks like coffee grounds
• Chest pain that may spread, unusual sweating, faintness
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Decrease in how much or how often you urinate
• Eye redness, irritation, or pain
• Fever, chills, cough, sore throat, and body aches
• Numbness or weakness on one side of your body, sudden or severe headache, problems with vision, speech, or walking
• Severe diarrhea, nausea, or vomiting
• Tiny red dots on the skin, especially on the lower legs
• Unusual bleeding, bruising, or weakness
• Unusual trouble breathing, fever, cough

If you notice these less serious side effects, talk with your doctor:

• Mild diarrhea or stomach pain
• Mild skin rash, itching, tenderness, or burning, darker skin, dry skin
• Sores or white patches on your lips, mouth, or throat
• Tiredness
• Weight loss, loss of appetite

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088