Medication Guide App

erlotinib

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

What is erlotinib?

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

Erlotinib is used to treat non-small cell lung cancer. Erlotinib is also used in combination with other cancer medicine to treat pancreatic cancer.

Erlotinib may also be used for purposes not listed in this medication guide.

What is the most important information I should know about erlotinib?

Do not take erlotinib 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 erlotinib, 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 this medication 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 erlotinib. Visit your doctor regularly.

Slideshow: Flashback: FDA Drug Approvals 2013

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 erlotinib 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.

There are many other drugs that can interact with erlotinib. Tell your doctor about all medications you use. Keep a list of all your medicines and show it to any healthcare provider who treats you.

What should I discuss with my healthcare provider before taking erlotinib?

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

If you have any of these other conditions, you may need a dose adjustment or special tests:

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

  • kidney disease;

  • liver disease;

  • if you are dehydrated; or

  • if you smoke.

FDA pregnancy category D. Do not take erlotinib 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 erlotinib.

How should I take erlotinib?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

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

Do not crush an erlotinib tablet. The medicine from a crushed or broken pill can be dangerous if it gets on your skin. If this occurs, wash your skin with soap and water and rinse thoroughly.

To be sure this medication 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 erlotinib. Visit your doctor regularly.

Store at room temperature away from moisture and heat.

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 erlotinib?

Avoid taking an antacid within several hours before or after you take erlotinib.

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.

Avoid smoking. It can make erlotinib less effective.

Grapefruit and grapefruit juice may interact with erlotinib and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

Erlotinib side effects

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

Stop taking erlotinib and call your doctor at once if you have a serious side effect such as:

  • new or worsening lung problems such as chest pain, dry cough with fever, wheezing, rapid breathing, feeling short of breath;

  • chest pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

  • sudden numbness or weakness, sudden severe headache, or problems with vision, speech, or balance;

  • eye pain, redness, or irritation;

  • confusion, mood changes, increased thirst, urinating less than usual or not at all;

  • swelling, rapid weight gain;

  • severe or ongoing diarrhea, vomiting, or loss of appetite;

  • black, bloody, or tarry stools;

  • coughing up blood or vomit that looks like coffee grounds;

  • pale or yellowed skin, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

  • white patches or sores inside your mouth or on your lips;

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

  • the first sign of any type of skin rash, no matter how mild; or

  • nausea, upper stomach pain, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • mild stomach upset, nausea, or diarrhea;

  • weight loss;

  • acne, dry skin; or

  • 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)

Erlotinib dosing information

Usual Adult Dose for Non-Small Cell Lung Cancer:

150 mg orally once a day

Duration of therapy: Treatment should continue until disease progression or unacceptable toxicity occurs.

Comments:
-Erlotinib should be taken at least one hour before or two hours after ingestion of food.
-Erlotinib is not recommended for use in combination with platinum-based chemotherapy
-Safety and efficacy of erlotinib have not been evaluated as first-line treatment in patients with metastatic NSCLC whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution.

Usual Adult Dose for Pancreatic Cancer:

100 mg orally once a day

Duration of therapy: Treatment should continue until disease progression or unacceptable toxicity occurs.

Comments: Erlotinib should be taken at least one hour before or two hours after ingestion of food.

What other drugs will affect erlotinib?

Many drugs can interact with erlotinib. Below is just a partial list. Tell your doctor if you are using:

  • bosentan (Tracleer);

  • conivaptan (Vaprisol);

  • dexamethasone (Decadron, Hexadrol);

  • imatinib (Gleevec);

  • isoniazid (for treating tuberculosis);

  • St. John's wort;

  • steroid medicine (prednisone and others);

  • an antibiotic such as ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), rifapentine (Priftin), or telithromycin (Ketek);

  • an antidepressant such as nefazodone;

  • antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);

  • a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton);

  • a blood thinner such as warfarin (Coumadin, Jantoven);

  • heart or blood pressure medication such as nicardipine (Cardene) or quinidine (Quin-G);

  • the hepatitis C medications boceprevir (Victrelis) or telaprevir (Incivek);

  • HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Kaletra, Norvir), or saquinavir (Invirase);

  • medicines to treat narcolepsy, such as armodafinil (Nuvigil) or modafinil (Progivil);

  • NSAIDs (non-steroidal anti-inflammatory drugs) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others; or

  • seizure medication such as carbamazepine (Carbatrol, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenytoin (Dilantin), or primidone (Mysoline).

This list is not complete and there are many other drugs that can interact with erlotinib. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Where can I get more information?

  • Your pharmacist can provide more information about erlotinib.
  • 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 1996-2012 Cerner Multum, Inc. Version: 5.02. Revision Date: 2012-08-28, 4:41:44 PM.

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