Gemzar Side Effects

Generic name: gemcitabine

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

Some side effects of Gemzar 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 gemcitabine: intravenous powder for injection, intravenous solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking gemcitabine (the active ingredient contained in Gemzar) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

If you receive gemcitabine during or after radiation treatment, tell your doctor right away if you have severe skin redness, swelling, oozing, or peeling.

Call your doctor at once if you have:

• pale skin, easy bruising, unusual bleeding (nose or mouth), feeling tired or irritable;

• vomiting, blood in your urine or stools;

• little or no urinating, swelling, rapid weight gain;

• fever, chills, body aches, flu symptoms;

• white patches or sores inside your mouth or on your lips;

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• chest pain or heavy feeling, sweating, pain spreading to the arm or jaw;

• sudden numbness or weakness, problems with vision or speech;

• anxiety, severe shortness of breath, wheezing, gasping for breath, cough with foamy mucus, fast or uneven heart rate;

• hearing problems, confusion; or

• pain, swelling, or skin changes where the needle was placed.

Common side effects may include:

• vomiting, diarrhea;

• numbness or tingly feeling;

• drowsiness; or

• temporary hair loss.

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 gemcitabine: intravenous powder for injection, intravenous solution

Hematologic

Myelosuppression is the major dose-limiting factor associated with gemcitabine (the active ingredient contained in Gemzar) therapy.

Dosage adjustments for hematologic toxicity are frequently necessary. Less than 1% of patients have had to discontinue therapy for either anemia, leukopenia, or thrombocytopenia. Grade 3/4 thrombocytopenia was more common in the elderly, especially older women.

The risk for thrombotic thrombocytopenic purpura increases as the cumulative dose of gemcitabine approaches 20,000 mg/m2.

Hematologic side effects including anemia (68%), leukopenia (62%), neutropenia (63%), thrombocytopenia (24%), petechiae (16%), thrombotic thrombocytopenic purpura (0.015% to 1.4%), and sepsis (less than 1%) have been reported. Red blood cell transfusions were required by 19% of patients.

Gastrointestinal

Gastrointestinal side effects including nausea and vomiting (69%), diarrhea (19%) and stomatitis (11%) have been reported. A case of severe anal pruritus has also been reported.

If the patient is not vomiting due to their disease state, nausea can generally be prevented by administration of prochlorperazine or low-dose oral serotonin antagonists and glucocorticoid therapy. One study of 790 patients found the rate of WHO grade 3 nausea and vomiting at a frequency of 22% in patients under 65 years of age, and 12% in patients 65 years of age or older.

Hepatic

No evidence of increased hepatic toxicity has been reported with longer duration or greater total cumulative dose.

Hepatic side effects including transient elevations in ALT (68%), AST (67%), alkaline phosphatase (55%), bilirubin (13%), and GGT have been reported. Serious hepatotoxicity including liver failure and death have been reported very rarely.

Renal

Renal side effects including proteinuria (45%), hematuria (35%), renal failure, hemolytic-uremic syndrome (0.25%), and nephrotoxicity have been reported.

Renal failure may not be reversible, even upon discontinuation of therapy.

Other

The flu-like symptoms usually take place a few hours after drug administration. The symptoms are usually self-limiting and recovery is generally within 24 to 48 hours. Less than 1% of patients discontinued use due to flu-like symptoms. Some patients get relief from nonsteroidal anti-inflammatory drugs or acetaminophen.

Out of the five reported cases of distal ischemic changes, four of those case related to combination chemotherapy with cisplatin and gemcitabine (the active ingredient contained in Gemzar) while one case was of gemcitabine as a single agent in first-line therapy.

Other side effects including fever (41%), frequently associated with other flu-like symptoms, has been reported. There was a 16% incidence of infection among the patients with fever. Both fever and asthenia have frequently been reported as isolated effects. Flu syndrome (19%), including fever, asthenia, anorexia, headache, cough, chills, and myalgia has been reported. Insomnia, rhinitis, sweating, and malaise have been reported infrequently. Vasculitis and gangrene have been reported very rarely. Five cases of distal ischemic changes have been reported.

A pattern of tissue injury typically associated with radiation toxicity has also been reported in association with the use of gemcitabine.

Dermatologic

Rash was generally a macular or finely granular maculopapular pruritic eruption, mild to moderate in severity, involving the trunk and extremities. Alopecia is usually minimal.

Dermatologic side effects including rash (30%), alopecia (15%), pruritus (13%), and radiation recall have been reported. Cellulitis has been reported rarely. Severe skin reactions including desquamation and bullous skin eruptions have been reported very rarely. Two cases of pseudocellulitis have been reported. A case of linear immunoglobulin A bullous dermatosis has also been reported.

Respiratory

Some of the dyspnea reported may have been due to underlying disease. Forty percent of the study population consisted of lung cancer patients, while some of the other study patients had pulmonary manifestations of other malignancies.

Different patterns of lung injury may be related to gemcitabine (the active ingredient contained in Gemzar) A rapid response following the administration of corticosteroids would mean the respiratory problem was probably due to a hypersensitivity reaction.

Respiratory side effects including dyspnea (23%), sometimes accompanied by bronchospasm (<2%) have been reported. Parenchymal toxicity, including interstitial pneumonitis, pulmonary fibrosis, pulmonary edema, and adult respiratory distress syndrome has been reported rarely. Respiratory failure and death have been reported very rarely (in some patients, despite the discontinuation of therapy).

Nervous system

Less than 1% of the paresthesias have been severe.

Nervous system side effects including paresthesias (10%) have been reported.

Local

Local side effects including "injection-site-related events" (4%) have been reported by the manufacturer.

Hypersensitivity

Hypersensitivity side effects including anaphylactoid reactions have been reported rarely.

Cardiovascular

Many of the patients that suffered cardiovascular effects had a prior history of cardiovascular disease. Two percent of patients discontinued therapy due to these effects. Less than 1% of patients discontinued due to edema.

Cardiovascular side effects including peripheral edema (20%), edema (13%), cerebrovascular accident, hypotension, hypertension, and generalized edema (less than 1%) have been reported. Atrial fibrillation has been reported rarely. Congestive heart failure, myocardial infarction, and arrhythmias (predominantly supraventricular in nature) have been reported very rarely.

Immunologic

Immunologic side effects including a scleroderma-like reaction have been reported.

Oncologic

Long term animal studies to evaluate carcinogenic potential have not been conducted.

Oncologic side effects have been reported in animal studies. Gemcitabine induced forward mutations in vitro in a mouse lymphoma assay and was clastogenic in an in vivo micronucleus assay.

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