Leukine Side Effects

Generic Name: sargramostim

Note: This page contains information about the side effects of sargramostim. Some of the dosage forms included on this document may not apply to the brand name Leukine.

Not all side effects for Leukine may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to sargramostim: intravenous powder for solution, intravenous solution

In addition to its needed effects, some unwanted effects may be caused by sargramostim (the active ingredient contained in Leukine). In the event that any of these side effects do occur, they may require medical attention.

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

More common
  • Abdominal pain
  • black, tarry stools
  • bloating or swelling of face, arms, hands, lower legs, or feet
  • blood in eye
  • bloody nose
  • bloody stools
  • blurred vision
  • body aches or pain
  • bone pain
  • chest pain
  • cloudy urine
  • congestion
  • cough
  • decrease in urine output or decrease in urine-concentrating ability
  • difficult or labored breathing
  • drowsiness
  • dry mouth
  • dryness or soreness of throat
  • eye pain
  • fast, pounding, or irregular heartbeat or pulse
  • fatigue
  • fever
  • flushed, dry skin
  • fruit-like breath odor
  • hoarseness
  • increased hunger
  • increased thirst
  • increased urination
  • irregular heartbeat
  • large amount of cholesterol in the blood
  • loss of appetite
  • mood or mental changes
  • muscle spasms [tetany] or twitching seizures
  • nausea or vomiting
  • rapid weight gain
  • redness in whites of eyes
  • runny nose
  • shortness of breath
  • sweating
  • tender, swollen glands in neck
  • tightness in chest
  • tingling of hands or feet
  • trouble in swallowing
  • troubled breathing
  • trembling
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • voice changes
  • vomiting of blood or material that looks like coffee grounds
  • wheezing
  • yellow eyes or skin

If any of the following symptoms of overdose occur while taking sargramostim, get emergency help immediately:

Symptoms of overdose
  • General feeling of discomfort or illness
  • headache
  • rash

Some of the side effects that can occur with sargramostim may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Chills
  • diarrhea
  • difficulty in moving
  • fear or nervousness
  • itching skin
  • lack or loss of strength
  • muscle pain or stiffness
  • pain in joints
  • sleeplessness
  • trouble sleeping
  • unable to sleep

For Healthcare Professionals

Applies to sargramostim: injectable powder for injection, injectable solution

Musculoskeletal

Bone pain associated with sargramostim (the active ingredient contained in Leukine) 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.[Ref]

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

Other

Many patients receiving sargramostim (the active ingredient contained in Leukine) 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.[Ref]

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.[Ref]

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 (the active ingredient contained in Leukine) therapy.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

Respiratory

Respiratory side effects of sargramostim (the active ingredient contained in Leukine) 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.[Ref]

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.[Ref]

Cardiovascular

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

Renal

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

Hepatic

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

Hypersensitivity

Hypersensitivity side effects including anaphylaxis have occurred.[Ref]

Oncologic

Oncologic side effects, primarily myeloid malignancies, may result due to the action of sargramostim (the active ingredient contained in Leukine) as a growth factor for tumors with myeloid characteristics.[Ref]

References

1. Scarffe JH "Emerging clinical uses for GM-CSF." Eur J Cancer 27 (1991): 1493-504

2. "Product Information. Leukine (sargramostim)." Immunex Corporation, Seattle, WA.

3. Rosenfeld CS, Sulecki M, Evans C, Shadduck RK "Comparison of intravenous versus subcutaneous recombinant human GM-CSF in patients with primary myelodysplasia." Exp Hematol 19 (1991): 273-7

4. Nemunaitis J, Buckner CD, Appelbaum FR, Higano CS, Mori M, Bianco J, Epstein C, Lipani J, Hansen J, Storb R, et al "Phase I/II trial of recombinant human granulocyte-macrophage colony- stimulating factor following allogeneic bone marrow transplantation." Blood 77 (1991): 2065-71

5. Stern AC, Jones TC "The side-effect profile of GM-CSF." Infection 20 (1992): s124-7

6. Grant SM, Heel RC "Recombinant granulocyte-macrophage colony-stimulating factor (rGM- CSF). A review of its pharmacological properties and prospective role in the management of myelosuppression." Drugs 43 (1992): 516-60

7. Thompson JA, Lee DJ, Kidd P, Rubin E, Kaufmann J, Bonnem EM, Fefer A "Subcutaneous granulocyte-macrophage colony-stimulating factor in patients with myelodysplastic syndrome: toxicity, pharmacokinetics, and hematological effects." J Clin Oncol 7 (1989): 629-37

8. Gonzales-Chambers R, Rosenfeld C, Winkelstein A, Dameshek L "Eosinophilia resulting from administration of recombinant granulocyte- macrophage colony-stimulating factor (rhGM-CSF) in a patient with T- gamma lymphoproliferative disease." Am J Hematol 36 (1991): 157-9

9. Wilkes BM, Reiner D, Kern M, Burke S "Simultaneous lowering of serum phosphate and LDL-cholesterol by sevelamer hydrochloride (RenaGel) in dialysis patients." Clin Nephrol 50 (1998): 381-6

10. Lane TA, Ho AD, Bashey A, Peterson S, Young D, Law P "Mobilization of blood-derived stem and progenitor cells in normal subjects by granulocyte-macrophage- and granulocyte-colony-stimulating factors." Transfusion 39 (1999): 39-47

11. Sunderland M, Abeloff M, Neidhart J, Ravdin P, Osborne K "Continuous GM-CSF failed to ameliorate neutropenia and worsened thrombocytopenia in a dose-intensive regimen for breast cancer (meeting abstract)." Breast Cancer Res Treat 19 (1991): 158

12. MacNeil N, Le TN, Phillips I, Beaulieu R, Vachereau A, Schechter MT, Montaner JS "GM-CSF induced eosinophilia in neutropenic AIDS patients." Int Conf AIDS 7 (1991): 259

13. Stephens LC, Haire WD, Schmit-Pokorny K, Kessinger A, Kotulak G "Granulocyte macrophage colony stimulating factor: high incidence of apheresis catheter thrombosis during peripheral stem cell collection." Bone Marrow Transplant 11 (1993): 51-4

14. Mehregan DR, Fransway AF, Edmonson JH, Leiferman KM "Cutaneous reactions to granulocyte-monocyte colony-stimulating factor." Arch Dermatol 128 (1992): 1055-9

15. Ward JC, Gitlin JB, Garry DJ, Jatoi A, Luikart SD, Zelickson BD, Dahl MV, Skubitz KM "Epidermolysis bullosa acquisita induced by GM-CSF: a role for eosinophils in treatment-related toxicity." Br J Haematol 81 (1992): 27-32

16. Steger GG, Locker G, Rainer H, Mader RM, Sieder AE, Gnant MF, Aberer W, Jakesz R "Cutaneous reactions to GM-CSF in inflammatory breast cancer ." N Engl J Med 327 (1992): 286

17. Horn TD, Burke PJ, Karp JE, Hood AF "Intravenous administration of recombinant human granulocyte- macrophage colony-stimulating factor causes a cutaneous eruption." Arch Dermatol 127 (1991): 49-52

18. Kelly R, Marsden RA, Bevan D "Exacerbation of psoriasis with GM-CSF therapy ." Br J Dermatol 128 (1993): 468-9

19. Potter MN, Mott MG, Oakhill A "Granulocyte-macrophage colony-stimulating factor (GM-CSF), hypocalcemia, and hypomagnesemia ." Ann Intern Med 112 (1990): 715

20. Kaczmarski RS, Mufti GJ "Hypoalbuminaemia after prolonged treatment with recombinant granulocyte macrophage colony stimulating factor." BMJ 301 (1990): 1312-3

21. Dreicer R, Schiller JH, Carbone PP "Granulocyte-macrophage colony-stimulating factor and vasculitis ." Ann Intern Med 111 (1989): 91-2

22. Hazenberg BP, Van Leeuwen MA, Van Rijswijk MH, Stern AC, Vellenga E "Correction of granulocytopenia in Felty's syndrome by granulocyte- macrophage colony-stimulating factor. Simultaneous induction of interleukin-6 release and flare-up of the arthritis." Blood 74 (1989): 2769-70

23. Hoekman K, von Blomberg-van der Flier BM, Wagstaff J, Drexhage HA, Pinedo HM "Reversible thyroid dysfunction during treatment with GM-CSF." Lancet 338 (1991): 541-2

24. de Vries EG, Willemse PH, Biesma B, Stern AC, Limburg PC, Vellenga E "Flare-up of rheumatoid arthritis during GM-CSF treatment after chemotherapy ." Lancet 338 (1991): 517-8

25. Hansen PB, Johnsen HE, Hippe E "Autoimmune hypothyroidism and granulocyte-macrophage colony- stimulating factor ." Eur J Haematol 50 (1993): 183-4

26. Riggs JE, Mansmann PT, Cook LL, Schochet SS, Hogg JP "Fulminant CNS perivascular lymphocytic proliferation: Association with sargramostim, a hematopoietic growth factor." Clin Neuropharmacol 22 (1999): 288-91

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