Generic Name: erlotinib (Oral route)

er-LOE-ti-nib

Commonly used brand name(s)

In the U.S.

  • Tarceva

Available Dosage Forms:

  • Tablet

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Tyrosine Kinase Inhibitor

Uses For Tarceva

Erlotinib is used for the treatment of advanced or metastatic (cancer that has already spread) non-small cell lung cancer. It is also used together with another medicine called gemcitabine (eg, Gemzar®) to treat cancer of the pancreas. Erlotinib belongs to the group of medicines called antineoplastics (cancer medicines). It works by interfering with the growth of cancer cells, which are eventually destroyed.

Slideshow: Flashback: FDA Drug Approvals 2013

This medicine is available only with your doctor's prescription.

Before Using Tarceva

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of erlotinib in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of erlotinib in the elderly.

Pregnancy

Pregnancy Category Explanation
All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acenocoumarol
  • Apazone
  • Aspirin
  • Atorvastatin
  • Bromfenac
  • Carbamazepine
  • Celecoxib
  • Dexlansoprazole
  • Diclofenac
  • Dicumarol
  • Diflunisal
  • Esomeprazole
  • Etodolac
  • Fenoprofen
  • Flurbiprofen
  • Fluvastatin
  • Fosphenytoin
  • Ibuprofen
  • Ibuprofen Lysine
  • Indomethacin
  • Ketoconazole
  • Ketoprofen
  • Ketorolac
  • Lansoprazole
  • Lovastatin
  • Magnesium Salicylate
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Nabumetone
  • Naproxen
  • Nepafenac
  • Omeprazole
  • Oxaprozin
  • Pantoprazole
  • Phenobarbital
  • Phenprocoumon
  • Phenytoin
  • Piroxicam
  • Pitavastatin
  • Pravastatin
  • Rabeprazole
  • Rifabutin
  • Rifampin
  • Rifapentine
  • Rosuvastatin
  • Salicylic Acid
  • Salsalate
  • Simvastatin
  • St John's Wort
  • Sulindac
  • Tolmetin
  • Topotecan
  • Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Aluminum Carbonate, Basic
  • Aluminum Hydroxide
  • Aluminum Phosphate
  • Calcium Carbonate
  • Ciprofloxacin
  • Dihydroxyaluminum Aminoacetate
  • Dihydroxyaluminum Sodium Carbonate
  • Magaldrate
  • Magnesium Carbonate
  • Magnesium Hydroxide
  • Magnesium Oxide
  • Magnesium Trisilicate
  • Ranitidine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bleeding problems (eg, hemolytic anemia, thrombocytopenia) or
  • Dehydration or
  • Eye or vision problems (eg, corneal perforation or ulcer) or
  • Heart attack, history of or
  • Intestinal or stomach problems (eg, diverticular disease, peptic ulcer), or history of or
  • Lung or breathing problems (eg, interstitial lung disease), history of or
  • Stroke, history of—Use with caution. May make these conditions worse.
  • Liver disease—Use with caution. The effects may be increased because of slower removal from the body.

Proper Use of Tarceva

Medicines used to treat cancer are very strong and can have many side effects. Before using 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.

Take this medicine on an empty stomach, at least 1 hour before or 2 hours after food.

If you take a stomach medicine for heartburn or ulcers (such as cimetidine, famotidine, ranitidine, Pepcid®, Tagamet®, Zantac®), take the heartburn medicine at least 10 hours before or 2 hours after you take this medicine.

If you take antacids (such as Gaviscon®, Maalox®, Mylanta®, Rolaids®), take the antacid several hours before or after you take this medicine.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

If there is a change in your tobacco smoking status, call your doctor. This could result in a change in dose.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For lung cancer:
      • Adults—150 milligrams (mg) once a day. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.
    • For pancreas cancer:
      • Adults—100 milligrams (mg) once a day. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Tarceva

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. You should continue to use birth control for at least 14 days after your last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.

It is important that you talk to your doctor right away if you have severe or continuing diarrhea, nausea, loss of appetite, or vomiting.

Call your doctor right away if you have unexplained shortness of breath, cough, and fever that comes on suddenly. These could be symptoms of a serious lung condition.

Check with your doctor right away if you have bloody or black, tarry stools, severe stomach pain, or vomiting of blood or material that looks like coffee grounds. These could be symptoms of a serious stomach or bowel problem.

Tell your doctor right away if you have dark urine or pale stools, yellow skin or eyes, nausea or vomiting, or upper stomach pain. These could be symptoms of a liver problem.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

You may use alcohol-free emollient creams, sunscreen, or sun blocking lotions to prevent dry skin and other serious skin reactions.

Check with your doctor right away if blurred vision or any vision change, eye pain, or eye irritation occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (St. John's wort) or vitamin supplements.

Tarceva Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Burning, tingling, numbness or pain in the hands, arms, feet, or legs
  • cough or hoarseness
  • diarrhea (severe)
  • difficult or labored breathing
  • fever or chills
  • lower back or side pain
  • painful or difficult urination
  • rash (severe)
  • sensation of pins and needles
  • stabbing chest pain
  • tightness in the chest
Rare
  • Bloody or black, tarry stools
  • blurred vision
  • chest pain or discomfort
  • constipation
  • convulsions (seizures)
  • eye irritation or redness
  • inability to speak
  • pain or discomfort in the arms, jaw, back, or neck
  • severe stomach pain
  • slurred speech
  • sudden, severe chest pain
  • sudden, severe headache
  • sudden, severe weakness in the arm or leg on one side of the body
  • sweating
  • vision changes
  • vomiting of blood or material that looks like coffee grounds
Incidence not known
  • Agitation
  • blistering, peeling, or loosening of the skin
  • bloody nose
  • burning feeling in the chest or stomach
  • burning upper abdominal or stomach pain
  • confusion
  • dark-colored urine
  • darkening of the skin
  • decreased urine output
  • general feeling of tiredness or weakness
  • headache
  • increased thirst
  • irregular heartbeat
  • lethargy
  • light-colored stools
  • loss of appetite
  • mood changes
  • muscle pain or stiffness
  • muscle twitching
  • nausea or vomiting
  • rapid weight gain
  • red skin lesions, often with a purple center
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • stomach pain, continuing
  • stupor
  • swelling of the face, ankles, or hands
  • tenderness in the stomach area
  • trouble breathing
  • unusual tiredness or weakness
  • yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Acid or sour stomach
  • belching
  • blemishes on the skin
  • bloated or full feeling
  • bone pain
  • burning, dry, or itching eyes
  • diarrhea (mild)
  • difficulty with moving
  • dizziness
  • dry eyes
  • dry skin
  • excess air or gas in the stomach or intestines
  • excessive tearing
  • fear
  • feeling sad or empty
  • feeling unusually cold
  • hair loss
  • headache
  • heartburn
  • indigestion
  • irritability
  • itching skin
  • joint pain
  • loss of interest or pleasure
  • nervousness
  • passing gas
  • pimples
  • rash, mild
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • shivering
  • sleeplessness
  • stomach discomfort, upset, or pain
  • swelling
  • swelling or inflammation of the mouth
  • swollen joints
  • thinning of the hair
  • tiredness
  • trouble or inability to sleep
  • trouble with concentrating
  • weight loss
Less common
  • Loosening of the fingernails
  • redness or soreness around the fingernails
Incidence not known
  • Brittle and loose nails
  • discharge, excessive tearing
  • increased hair growth, especially on the face

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

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