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More frequently reported side effects include: signs and symptoms of injection site. See below for a comprehensive list of adverse effects.For the Consumer
Applies to gemcitabine: intravenous powder for solution, intravenous solution
Along with its needed effects, gemcitabine 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 or nurse immediately if any of the following side effects occur while taking gemcitabine:
Incidence not known
Some side effects of gemcitabine 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:
For Healthcare Professionals
Applies to gemcitabine: intravenous powder for injection, intravenous solutionHematologic
Very common (10% or more): Anemia (68%), neutropenia (63%), leucopenia (62%), thrombocytopenia (24%), petechiae (16%), hemorrhage (17%), bone marrow suppression (usually mild to moderate)
Common (1% to 10%): Febrile neutropenia
Very rare (less than 0.01%): Thrombocytosis
Postmarketing reports: Capillary leak syndrome (CLS)
Myelosuppression is the major dose-limiting factor associated with gemcitabine 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.Gastrointestinal
Very common (10% or more): Nausea/vomiting (69%), diarrhea (19%), stomatitis (11%), stomatitis and ulceration of the mouth (11%)
Common (1% to 10%): Constipation
Very rare (less than 0.01%): Ischemic colitis, anal pruritus
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.
Very common (10% or more): Increased ALT (68%), increased AST (67%), increased alkaline phosphatase (55%), hyperbilirubinemia (13%)
Common (1% to 10%):
Uncommon (0.1% to 1%): Serious hepatotoxicity (including liver failure and death), increased gamma-glutamyl transferase (GGT)
Postmarketing reports: Hepatic veno-occlusive diseaseRenal
Renal failure may not be reversible, even upon discontinuation of therapy.
Very common (10% or more): Proteinuria (45%), hematuria (35%), increased BUN (16%)
Common (1% to 10%): Increased creatinine (8%)
Uncommon (0.1% to 1%): Renal failure, hemolytic-uremic syndromeOther
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, while one case was of gemcitabine as a single agent in first-line therapy.
Very common (10% or more): Fever (41%), asthenia, chills
Common (1% to 10%): Paresthesia
Rare (less than 0.1%): Radiation toxicity, radiation recall
Frequency not reported: Cough, chills, pattern of tissue injury typically associated with radiation toxicityDermatologic
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.
Very common (10% or more): Allergic skin rash frequently associated with pruritus (30%), alopecia (15%)
Common (1% to 10%): Itching, sweating
Rare (0.01% to 0.1%): Severe skin reactions (including desquamation and bullous skin eruptions), ulceration, vesicle and sore formation, scaling
Very rare (less than 0.01%): Lyell's syndrome (toxic epidermal necrolysis, Stevens Johnson Syndrome
Postmarketing reports: CellulitisRespiratory
Very common (10% or more): Dyspnea (23%)
Common (1% to 10%): Cough, rhinitis
Uncommon (0.1% to 1%): Interstitial pneumonitis, bronchospasm
Rare (0.01% to 0.1%): Pulmonary edema, adult respiratory distress syndrome (ARDS)
Very rare (less than 0.01%): Respiratory failure/death
Frequency not reported: Pulmonary fibrosis, pulmonary edema
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. A rapid response following the administration of corticosteroids would mean the respiratory problem was probably due to a hypersensitivity reaction.Nervous system
Common (1% to 10%): Headache, insomnia, somnolence, paraesthesia
Uncommon (0.1% to 1%): Cerebrovascular accident
Postmarketing reports: Posterior reversible encephalopathy syndrome (PRES)
Less than 1% of the paresthesias have been severe.Local
Very common (10% or more): Injection site reactions (mainly mild)Hypersensitivity
Rare (less than 0.1%): HypersensibilityCardiovascular
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.
Uncommon (0.1% to 1%): Arrhythmias (predominantly supraventricular), heart failure
Rare (less than 0.1%): Hypotension, hypertension, myocardial infarction, atrial fibrillation
Very rare (less than 0.01%): Congestive heart failure
Postmarketing reports: Supraventricular arrhythmiasImmunologic
Very common (10% or more): Infection (16%), influenza-like symptoms
Rare (less than 0.1%): Anaphylactoid reaction
Frequency not reported: Scleroderma-like reactionMetabolic
Very common (10% or more): Edema/peripheral edema-including facial edema (usually reversible after stopping treatment)
Common (1% to 10%): AnorexiaMusculoskeletal
Common (1% to 10%): Back pain, myalgia
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