ERLOTINIB

Please see Precautions section.

You should check with your doctor immediately if any of these side effects occur when taking erlotinib:

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

Some of the side effects that can occur with erlotinib may not need medical attention:

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

Precautions

General:

• Medical History: Before using this medication, tell your doctor or pharmacist if you had: liver disease, kidney problems, stomach/intestinal disease (such as ulcers, diverticulosis).
• This medicine may increase your risk of stomach bleeding. Limit alcoholic beverages.
• Sunlight may worsen any skin reactions that may occur while you are taking this drug. Use a sunscreen and wear protective clothing when outdoors.
• Interstitial Lung Disease: Stop erlotinib if new or progressive symptoms such as dyspnea, cough and fever occur.
• Renal failure: Renal failure during treatment with erlotinib may be due to worsening already existing liver problem or due to severe dehydration.  Stop erlotinib until toxicity is resolved if patients show signs of renal failure.
• Hpatotoxicity: Liver failure can occur in patients who never had liver problems and can increase the risk if the patient had liver problems.  Perform perdioc liver testing and stop erlotinib if results are abnormal.
• Gastrointestinal perforation: Patients receiving already taking anti-angiogenic agents, corticosteroids, NSAIDs, or taxane-based chemotherapy, or who have prior history of peptic ulceration or diverticular disease may be at increased risk of perforation. Permanently discontinue erlotinib in patients who develop gastrointestinal perforation.
• Bullous and Exfoliative Skin Disorders: Bullous, blistering and exfoliative skin conditions, including cases suggestive of Stevens-Johnson syndrome/Toxic epidermal necrolysis, which in some cases were fatal, can occur with erlotinib treatment. Discontinue treatment if this occurs.
• Myocardial Infarction/ Ischemia: One study showed that a patient treated with erlotinib died because of myocardial infarction.  However, incidence remain to be low.
• Ocular Disorders: Decreased tear production, abnormal eyelash growth, keratoconjunctivitis sicca or keratitis can occur with TARCEVA treatment and can lead to corneal perforation or ulceration. Interrupt or discontinue TARCEVA therapy if patients present with acute or worsening ocular disorders such as eye pain.

Pregnancy Risk: Category D.  This drug is not recommended for use during pregnancy. It may cause harm to an unborn baby or miscarriage.

Breastfeeding: It is not known whether this drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Interactions

• Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: “blood thinners” (e.g., warfarin), corticosteroids (such as prednisone), drugs that lower stomach acid (some examples are H2 blockers such as famotidine/ranitidine, proton pump inhibitors such as omeprazole), drugs affecting liver enzymes that remove erlotinib from your body (such as azole antifungals, including itraconazole; macrolide antibiotics, including erythromycin; cimetidine; rifamycins, including rifabutin; St. John’s wort; certain anti-seizure medicines, including carbamazepine; HIV protease inhibitors, including ritonavir).
• Check all prescription and nonprescription medicine labels carefully since many contain pain relievers/fever reducers (nonsteroidal anti-inflammatory drugs-NSAIDs such as aspirin, celecoxib, ibuprofen, naproxen) which may increase your risk for stomach bleeding while you are taking erlotinib.
• Cigarette smoking decreases blood levels of this medication.

Overdose

If overdose is suspected, contact a poison control center or emergency room immediately.

Notes

Do not share this medication with others.

Certain laboratory tests may be performed before giving erlotinib to check for the EGFR protein in your tumor.

Laboratory and/or medical tests (such as kidney/liver function tests) should be performed to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature (77 degrees F or 25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Brands

Tarceva [ Roche ]