Tarceva Side Effects

Generic name: erlotinib

Note: This document contains side effect information about erlotinib. Some of the dosage forms listed on this page may not apply to the brand name Tarceva.

Some side effects of Tarceva may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to erlotinib: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking erlotinib (the active ingredient contained in Tarceva) 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 of erlotinib 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.

For Healthcare Professionals

Applies to erlotinib: oral tablet

Respiratory

Respiratory side effects have included reports of serious interstitial lung disease, including fatalities in the treatment of non-small cell lung cancer or other advanced solid tumors. Dyspnea (41%) and cough (33%) have also been reported.

Dermatologic

Dermatologic side effects including rash (75%), pruritus (13%), dry skin (12%), alopecia, hirsutism, eyelash/eyebrow changes, paronychia, and brittle and loose nails have been reported. Bullous, blistering and exfoliative skin conditions have been reported including cases suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, which in some cases were fatal. Cases of rosacea-like folliculitis and Malassezia sympodialis have also been reported.

Treatment should be interrupted or discontinued if the patient develops severe bullous, blistering, or exfoliating conditions.

The appearance of a rash in cancer patients treated with erlotinib is strongly associated with longer survival, according to researchers from the drug's developer, OSI Pharmaceuticals, Inc.

Rash resulted in study discontinuation in 1.2% patients. Dose reduction or interruption for rash was needed in 5.1% of patients. In erlotinib-treated patients who developed rash, the onset was within two weeks in 66% and within one month in 81%.

Gastrointestinal

The median time to onset of diarrhea was 12 days. Diarrhea resulted in study discontinuation in 0.5% of patients. Dose reduction or interruption for diarrhea was needed in 2.8% of patients.

Patients receiving concomitant antiangiogenic agents, corticosteroids, NSAIDs, and/or taxane-based chemotherapy, or who have prior history of peptic ulceration or diverticular disease are at an increased risk for gastrointestinal perforation. Erlotinib (the active ingredient contained in Tarceva) should be permanently discontinued in patients who develop gastrointestinal perforation.

Gastrointestinal side effects including diarrhea (54%), nausea (33%), vomiting (23%), stomatitis (17%), and abdominal pain (11%) have been reported. Gastrointestinal perforation has been reported in patients receiving erlotinib, including fatalities. Gastrointestinal bleeding has been reported infrequently.

Hepatic

Hepatic side effects including hepatic failure, hepatorenal syndrome, and liver function test abnormalities such as elevated alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin have been reported. A case of hepatitis has also been reported.

These elevations were mostly transient or associated with liver metastases.

A pharmacokinetic study in patients with advanced solid tumors and moderate hepatic impairment according to the Child-Pugh criteria has been reported. In this study, 10 of the 15 patients died on treatment or within 30 days of the last erlotinib dose. Eight of these patients died from progressive disease, one patient died from hepatorenal syndrome, and one patient died from rapidly progressing liver failure. Six out of the 10 patients who died had baseline total bilirubin greater than 3 times the upper limit of normal suggesting severe, rather than moderate, hepatic impairment. All patients had hepatic impairment due to advanced cancer with liver involvement such as hepatocellular carcinoma, cholangiocarcinoma, or liver metastases.

Patients with hepatic impairment should be monitored closely during therapy with erlotinib, and dosing should be interrupted or discontinued if changes in liver function are severe.

Liver function test abnormalities (including elevated alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin) were observed in patients receiving single-agent erlotinib 150 mg in the Maintenance study. Grade 2 (>2.5 - 5 x ULN) ALT elevations occurred in 2% and 1%, and Grade 3 (>5 - 20 x ULN) ALT elevations were observed in 1% and 0% of erlotinib and placebo treated patients, respectively. The erlotinib treatment group had Grade 2 (>1.5-3 x ULN) bilirubin elevations in 4% and Grade 3 (>3-10 x ULN) in <1% compared with <1% for both Grades 2 and 3 in the placebo group.

General

General side effects including anorexia (52%) and fatigue (52%) have been reported.

Immunologic

Immunologic side effects including infection (24%) have been reported.

Ocular

Ocular disorders including abnormal eyelash growth, keratoconjunctivitis sicca, or keratitis are known risk factors for corneal ulceration/perforation.

Erlotinib (the active ingredient contained in Tarceva) therapy should be interrupted or discontinued if patients present with acute/worsening ocular disorders such as eye pain.

Ocular side effects including conjunctivitis (12%), keratoconjunctivitis sicca (12%), corneal perforation and ulceration, abnormal eyelash growth, and keratitis have been reported.

Renal

Renal side effects including cases of hepatorenal syndrome, acute renal failure or renal insufficiency (some with fatalities) have been reported.

Other

Other side effects including a case of bilateral eardrum perforation have been reported.

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