Pronunciation:

er-LOE-ti-nib

Brand Names:

• Tarceva

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Tyrosine Kinase Inhibitor

Uses of This Medicine:

Erlotinib is used for the treatment of metastatic (cancer that has already spread) non-small cell lung cancer in patients who have certain types of abnormal epidermal growth factor (EGFR) gene mutations. Your doctor will perform a test before you take this medicine. This medicine 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.

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

Before Using This Medicine:

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.

Children—

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.

Older adults—

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

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.

Other 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
• Amiodarone
• Boceprevir
• Carbamazepine
• Cimetidine
• Ciprofloxacin
• Clarithromycin
• Cobicistat
• Conivaptan
• Dexlansoprazole
• Enzalutamide
• Esomeprazole
• Famotidine
• Fosphenytoin
• Idelalisib
• Indinavir
• Itraconazole
• Ketoconazole
• Lansoprazole
• Levoketoconazole
• Lopinavir
• Lumacaftor
• Methotrexate
• Mitotane
• Nefazodone
• Nelfinavir
• Nizatidine
• Omeprazole
• Pantoprazole
• Phenobarbital
• Phenprocoumon
• Phenytoin
• Posaconazole
• Rabeprazole
• Ranitidine
• Rifabutin
• Rifampin
• Rifapentine
• Ritonavir
• Saquinavir
• St John's Wort
• Telaprevir
• Telithromycin
• Voriconazole
• Warfarin

Other interactions—

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.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice
• Tobacco

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
• Kidney disease 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 This Medicine:

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 Pepcid®, Tagamet®), 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, taken with gemcitabine. 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 This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine 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 during treatment and for 1 month 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.

Kidney problems may occur while you are using this medicine. Tell your doctor right away if you have decreased urine output, dizziness, headache, irritability, rapid weight gain, seizures, swelling of the face, ankles, or hands, or unusual tiredness or weakness.

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 (eg, St. John's wort) or vitamin supplements.

Side Effects of This Medicine:

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

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.