Generic Name: erlotinib (er LOE ti nib)
Brand Names: Tarceva

What is Tarceva?

Tarceva (erlotinib) 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.

Important information

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 2 weeks after your treatment ends.

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 Tarceva. Visit your doctor regularly.

Slideshow: Flashback: FDA Drug Approvals 2013

Avoid exposure to sunlight or tanning beds. Tarceva 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.

Before taking this medicine

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:

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

  • kidney disease;

  • liver disease;

  • a history of 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. It could harm the unborn baby. Use effective birth control while you are taking this medication and for at least 2 weeks after your treatment ends.

It is not known whether erlotinib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while taking Tarceva.

How should I take Tarceva?

Take Tarceva exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

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

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 of these tests.

Store at room temperature away from moisture and heat.

Tarceva dosing information

Usual Adult Dose for Non-Small Cell Lung Cancer:

150 mg orally once a day

Duration of therapy: Until disease progression or unacceptable toxicity

Comments:
-There is no evidence that treatment beyond disease progression is beneficial.

Uses:
-First-line treatment of 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.
-Maintenance treatment of patients with locally advanced or metastatic NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
-Treatment of locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen.

Usual Adult Dose for Pancreatic Cancer:

100 mg orally once a day

Duration of therapy: Until disease progression or unacceptable toxicity

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

What happens if I miss a dose?

Take the missed dose as soon as you remember (take only on an empty stomach). Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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.

What should I avoid while using Tarceva?

Avoid taking an antacid within several hours before or after you take Tarceva. Ask a doctor or pharmacist before taking other stomach medicines such as cimetidine (Tagamet) or ranitidine (Zantac).

Avoid exposure to sunlight or tanning beds. Tarceva 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.

Avoid smoking. It can make Tarceva less effective.

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

Avoid taking an herbal supplement containing St. John's wort at the same time you are taking Tarceva.

Erlotinib can pass into body fluids (including urine, feces, vomit, semen, vaginal fluid). Patients and caregivers should wear rubber gloves while cleaning up body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Body fluids should not be handled by a woman who is pregnant or who may become pregnant. Use condoms during sexual activity to avoid exposure to body fluids.

Tarceva side effects

Get emergency medical help if you have any signs of an allergic reaction to Tarceva: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

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;

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

  • severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common Tarceva side effects may include:

  • nausea, vomiting, diarrhea, loss of appetite;

  • dry eyes;

  • cough, trouble breathing;

  • rash; or

  • weakness, tired feeling.

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.

See also: Side effects (in more detail)

What other drugs will affect Tarceva?

Many drugs can interact with erlotinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Tarceva. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

  • Your pharmacist can provide more information about Tarceva.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2015 Cerner Multum, Inc. Version: 6.02. Revision Date: 2014-12-30, 2:31:22 PM.

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