Tarceva is a cancer medicine that interferes with the growth of cancer cells and slows their spread in the body.

Tarceva is used to treat non-small cell lung cancer or pancreatic cancer that has spread to other parts of the body (metastatic).

Tarceva is usually given after other cancer medicines have been tried without success.

Do not take Tarceva if you are pregnant. It could harm the unborn baby. Use effective birth control while you are taking this medication and for at least 1 month after your last dose.

Before taking Tarceva, tell your doctor if you have lung problems (other than lung cancer), kidney or liver disease, if you are dehydrated, or if you smoke.

To be sure Tarceva is helping your condition and not causing harmful effects, your blood will need to be tested often. This will help your doctor determine how long to treat you with this medicine. Visit your doctor regularly.

Avoid exposure to sunlight or tanning beds. Erlotinib can cause skin rash, dryness, or other irritation. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Avoid using skin products that can cause dryness or irritation.

Stop taking Tarceva and call your doctor at once if you have new or worsening lung problems (chest pain, dry cough with fever, wheezing, feeling short of breath), chest pain spreading to the arm or shoulder, sudden numbness or weakness, eye pain or irritation, rapid weight gain, urinating less than usual or not at all, severe or ongoing diarrhea or vomiting, coughing up blood, black or bloody stools, pale skin, easy bruising or bleeding, mouth sores, or a severe skin rash.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Take Tarceva exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Take Tarceva on an empty stomach, at least 1 hour before or 2 hours after eating.

If you have diarrhea while taking Tarceva: start taking anti-diarrhea medicine such as loperamide (Imodium) to quickly treat diarrhea. Drink extra fluids and call your doctor if you have severe diarrhea.

You may need frequent medical tests to be sure this medicine is not causing harmful effects. Your cancer treatments may be delayed based on the results.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Non-Small Cell Lung Cancer:

150 mg orally once a day on an empty stomach (at least 1 hour before or 2 hours after food)
-Duration of therapy: Until disease progression or unacceptable toxicity

Use: For patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen

Usual Adult Dose for Pancreatic Cancer:

100 mg orally once a day on an empty stomach (at least 1 hour before or 2 hours after food)
-Duration of therapy: Until disease progression or unacceptable toxicity

Use: For first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine

You should not take Tarceva if you are allergic to erlotinib.

To make sure Tarceva is safe for you, tell your doctor if you have ever had:

• lung or breathing problems (other than lung cancer);

• kidney disease;

• liver disease;

• stomach bleeding;

• eye problems;

• if you are dehydrated;

• if you smoke; or

• if you also take warfarin (Coumadin, Jantoven).

Do not take Tarceva if you are pregnant. Erlotinib could harm the unborn baby. Use effective birth control while you are taking this medication and for at least 1 month after your last dose.

Do not breastfeed while using this medicine, and for at least 2 weeks after your last dose.

Take the medicine (on an empty stomach) as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe diarrhea or severe skin rash.

Avoid smoking. It can make Tarceva less effective.

Grapefruit may interact with erlotinib and lead to unwanted side effects. Avoid the use of grapefruit products.

Avoid taking an antacid within several hours before or after you take Tarceva. Ask a doctor or pharmacist before taking any medicine to reduce stomach acid, such as cimetidine (Tagamet).

Avoid taking an herbal supplement containing St. John's wort.

Avoid exposure to sunlight or tanning beds. Erlotinib can cause skin rash, dryness, or other irritation. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Avoid using skin products that can cause dryness or irritation, such as acne medications, harsh soaps or skin cleansers, or skin products that contain alcohol.

Get emergency medical help if you have signs of an allergic reaction to Tarceva (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop using Tarceva and call your doctor at once if you have:

• sudden chest pain or discomfort, wheezing, dry cough, feeling short of breath;

• severe stomach pain, fever, chills, coughing up blood;

• severe ongoing nausea, vomiting, or diarrhea;

• eye pain or irritation, vision problems;

• heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance; or

• kidney or liver problems - little or no urinating; swelling, rapid weight gain (especially in your face and midsection); nausea, vomiting; dark urine, or jaundice (yellowing of the skin or eyes).

Erlotinib may cause increased growth of body hair, or loose, brittle nails on your fingers or toes.

Common Tarceva side effects may include:

• nausea, vomiting, diarrhea, loss of appetite;

• cough, trouble breathing;

• rash; or

• feeling weak or tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Many drugs can interact with erlotinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.