Sargramostim Side Effects

Brand Names: Leukine

Please note - some side effects for Sargramostim may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Sargramostim - for the Consumer

Sargramostim

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Sargramostim:

Bone, muscle, or joint pain; diarrhea; fever; general feeling of discomfort; hair loss; headache; loss of appetite; mild sweating of the hands, ankles, legs, or feet; nausea; sore mouth; stomach pain; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety; black or tarry stools; blood in urine; chest pain; emotional or mood changes; fainting; fast or irregular heartbeat; severe or persistent fever; severe stomach pain; severe swelling of the hands, ankles, legs, or feet; shortness of breath; unusual or excessive bleeding; unusual swelling; vomiting blood.

Side Effects by Body System

Musculoskeletal

Bone pain associated with sargramostim generally has been localized to the sternum, hips, and lower back. The incidence of bone pain increased with higher dosages and usually occurred just prior an increase in white blood cell (WBC) count. Analgesics are helpful, however, the pain may resolve with continued therapy. Bone pain resolves within a few hours of discontinuation of therapy.

Musculoskeletal side effects including bone pain (21%) have been reported.

Other

Many patients receiving sargramostim have serious underlying conditions and are on concurrent medications associated with high toxicity. It is sometimes difficult to discern true drug toxicity from disease activity. Many adverse effects of sargramostim are dose-related and alleviated by a dosage reduction.

Other side effects have included a "flu-like" syndrome that has included symptoms of headache, low-grade fever, myalgias, arthralgias, and malaise. Fever has occurred in up to 22% of patients and should be evaluated to determine whether it is related to sargramostim or an infection requiring antibiotic therapy.

Gastrointestinal

Gastrointestinal side effects of nausea, vomiting, and diarrhea frequently have been reported and were often part of a "flu-like" syndrome associated with sargramostim therapy.

Hematologic

Hematologic side effects have included reversible eosinophilia, thrombocytopenia, and anemia. An increased incidence of clot formation has been reported in patients treated with GM-CSF. Splenomegaly has also been reported and rupture has resulted in at least one death.

In one study of patients undergoing peripheral stem cell collection for bone marrow transplantation, 54% experienced catheter thrombosis when treated with GM-CSF compared to 3% of patients who were not treated.

Dermatologic

Dermatologic side effects have occurred frequently and included local bruising and erythema at the injection site and a generalized, pruritic, maculopapular rash. Rarely, immune-mediated dermatologic reactions have been reported. Exacerbation of psoriasis may occur.

Metabolic

Metabolic side effects have included edema, ascites, hypoalbuminemia, fluid retention resulting in pericardial/pleural effusions, and capillary-leak syndrome. The risk of occurrence is greater at higher dosages.

Immunologic

Immunologic side effects have included exacerbation of autoimmune diseases such as psoriasis, rheumatoid arthritis, thyroiditis, and vasculitis. Patients with autoimmune disease may be at risk for sargramostim-associated adverse effects.

Respiratory

Respiratory side effects of sargramostim have included pleural effusions and pleuritis. A "first-dose" reaction with symptoms of dyspnea, hypoxia, and hypotension has also been reported. It has not occurred with subsequent doses. The reaction appears to occur more frequently with an E. coli-derived GM-CSF, at higher dosages given by short term infusion, and in the presence of preexisting lung disease.

Endocrine

Endocrine side effects have been reported occasionally including exacerbation of hypothyroidism. An autoimmune response has been suggested due to the presence of thyroid peroxidase antibodies.

Cardiovascular

Cardiovascular side effects have been limited to occasional reports of reversible, transient supraventricular arrhythmias.

Renal

Renal side effects including increased plasma creatinine concentrations have occurred in patients with existing renal dysfunction.

Hepatic

Hepatic side effects including elevated plasma bilirubin and liver enzyme concentrations have been reported in patients with existing liver dysfunction.

Hypersensitivity

Hypersensitivity side effects including anaphylaxis have occurred.

Oncologic

Oncologic side effects, primarily myeloid malignancies, may result due to the action of sargramostim as a growth factor for tumors with myeloid characteristics.

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