Pronunciation:

er-LOE-tye-nib

Brand Names:

• Tarceva

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Tyrosine Kinase Inhibitor

Uses of This Medicine:

Erlotinib belongs to the group of medicines called antineoplastics. It is used to treat non-small cell lung cancer after the failure of other chemotherapy treatment. It is also used together with another medicine called gemcitabine (e.g., Gemzar®) to treat cancer of the pancreas .

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 geriatrics-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.

Other medicines—

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.

• Carbamazepine
• Fosphenytoin
• Phenobarbital
• Phenytoin
• Rifabutin
• Rifampin
• Rifapentine
• St John's Wort

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or 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:

• Liver disease—The chance of serious side effects is greatly increased .

Proper Use of This Medicine:

It is important that you take erlotinib one hour before or at least two hours after the ingestion of food .

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

Avoid smoking cigarettes or using other tobacco products while you are using this medicine .

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, non-small cell:
    • Adults—150 milligrams (mg) once a day.
    • Children—Use and dose must be determined by your doctor .
  • For cancer of the pancreas:
    • Adults—100 milligrams (mg) once a day.
    • 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 .

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

Call your doctor right away if you have unexplained shortness of breath, cough, and fever that comes on suddenly .

Contact your doctor if you develop eye irritation .

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

diarrhea, severe

difficult or labored breathing

fever

rash, severe

sensation of pins and needles

shortness of breath

stabbing chest pain

tightness in chest

wheezing

Rare

Bloody or black, tarry stool

blurred vision

chest pain or discomfort

constipation

convulsions (seizures)

eye irritation or redness

inability to speak

pain or discomfort in arms, jaw, back, or neck

severe stomach pain

shortness of breath

slurred speech

sudden, severe chest pain

sudden, severe headache

sudden, severe weakness in arm and/or leg on one side of the body

sweating

vision changes

vomiting of blood or material that looks like coffee grounds

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

bloated 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

fever or chills

hair loss

headache

heartburn

hoarseness

indigestion

irritability

itching skin

joint pain

lack or loss of appetite

loss of interest or pleasure

lower back or side pain

muscle aching or cramping

muscle pains or stiffness

nausea

nervousness

painful or difficult urination

passing gas

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 hair

tiredness

trouble concentrating

trouble or inability to sleep

unusual tiredness or weakness

vomiting

weight loss

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