Medication Guide App

Gammagard S / D Side Effects

Generic Name: immune globulin intravenous

Note: This page contains information about the side effects of immune globulin intravenous. Some of the dosage forms included on this document may not apply to the brand name Gammagard S / D.

Not all side effects for Gammagard S / D 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 immune globulin intravenous: powder for solution, solution

In addition to its needed effects, some unwanted effects may be caused by immune globulin intravenous (the active ingredient contained in Gammagard S / D). In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking immune globulin intravenous, check with your doctor or nurse immediately:

More common
  • Chills
  • cough
  • fast, pounding, or irregular heartbeat or pulse
  • fever
  • noisy breathing
  • tightness in the chest
  • troubled breathing
  • unusual tiredness or weakness
Less common
  • Bluish coloring of the lips or nail beds
  • burning sensation in the head
  • faintness or lightheadedness
Rare
  • Difficulty with swallowing
  • hives or welts
  • itching, especially of the feet or hands
  • reddening of the skin, especially around the ears
  • swelling of the eyes, face, or inside of the nose
Incidence not known
  • Back, leg, or stomach pains
  • blistering, peeling, or loosening of the skin
  • change in vision
  • changes in urination
  • chest pain or discomfort
  • cold, clammy, or pale skin
  • confusion
  • convulsions
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fever
  • headache that is severe and occurs suddenly
  • light-colored stools
  • loss of consciousness
  • low blood pressure or pulse
  • muscle spasm or jerking of all extremities
  • nausea or vomiting
  • pains in the chest, groin, or legs, especially calves of the legs
  • shakiness in the legs, arms, hands, or feet
  • skin blisters
  • slow breathing
  • slurred speech that occurs suddenly
  • sores, ulcers, or white spots in the mouth or on the lips
  • sudden, severe weakness or numbness in the arm or leg
  • sweating
  • swelling in the legs and ankles
  • tightness in the chest
  • unusual bleeding or bruising
  • yellow eyes or skin

Some of the side effects that can occur with immune globulin intravenous 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
  • Diarrhea
  • dizziness
  • headache
  • joint pain
  • muscle pain
  • redness, swelling, itching, or pain at the injection site
  • skin rash
Less common
  • Hip pain
  • leg cramps
Incidence not known
  • Feeling of warmth
  • redness of the face, neck, arms, and occasionally, upper chest
  • stomach pain
  • swollen glands
  • tiredness
  • weakness

For Healthcare Professionals

Applies to immune globulin intravenous: intravenous powder for injection, intravenous solution

General

In general, immune globulin intravenous (the active ingredient contained in Gammagard S / D) human (IGIV) has been well tolerated. Mild infusion related symptoms of headache, myalgia, backache, fever, pruritus, hypotension/hypertension, tachycardia, chest tightness, chills, flushing, and nausea have been reported. Slowing or temporarily discontinuing the infusion has usually resulted in resolution of symptoms.[Ref]

Renal

Renal side effects have included acute renal failure, acute tubular necrosis, proximal tubular nephropathy, and osmotic nephrosis, primarily in patients with baseline renal impairment. Some patients have required dialysis. Elevations in creatinine and BUN have been noted within 1 to 2 days following infusion. The incidence of adverse reactions may be greater in products containing sucrose as a stabilizer. Maltose containing products may cause mild diuresis. At least one case of reversible oliguria requiring only supportive care and renal failure requiring transplantation in a patient with baseline renal dysfunction has also been reported.[Ref]

Twenty cases of IGIV related renal impairment have been reported.

Renal impairment, including renal failure, usually occurred in the first 5 days of therapy and more frequently in patients receiving high IGIV dosages for immune thrombocytopenia purpura.

Spontaneous reports to one manufacturer suggest that diabetic patients over the age of 70 years and patients with lupus nephritis receiving dosages greater than 400 mg/kg/day may be at increased risk of renal impairment. The mechanism has not been fully established, but may be related to renal tubular sucrose-induced osmotic injury or an immune mechanism.[Ref]

Hypersensitivity

Anaphylaxis has occurred more frequently in patients with previous severe hypersensitivity reactions to IGIV, but has been reported in patients without a history of IGIV allergy. Patients previously sensitized to antibodies, such as IgA, may be at increased risk for immediate hypersensitivity reactions. Epinephrine, oxygen, IV antihistamines, and IV corticosteroids should be immediately available as such reactions can occur seconds to hours after the initiation of the infusion.[Ref]

Hypersensitivity side effects have included responses in the form of an inflammatory reaction (fever, chills, nausea, vomiting, hypotension) in 10% of patients with agammaglobulinemia or severe hypogammaglobulinemia who have not received IGIV within 8 weeks or who have never received IGIV. True anaphylaxis, rarely resulting in death, has been reported.[Ref]

Nervous system

Nervous system side effects have been reported rarely. Mild, post infusion headache has been reported in 2% of patients with Immune Thrombocytopenic Purpura (ITP) who received dosages equal to or greater than 0.4 g/kg/day. An Aseptic Meningitis Syndrome (AMS), primarily associated with dosages greater than 2 g/kg, has occasionally been reported. Discontinuation of IGIV has resulted in AMS resolution without sequelae. Rarely, seizures have been reported.[Ref]

Limited data suggest that a history of migraine headaches may be associated with an increased risk of aseptic meningitis syndrome.[Ref]

Metabolic

Metabolic side effects have been reported rarely. Hyponatremia has been reported in products containing 10% maltose.[Ref]

Hematologic

Hematologic side effects have been reported rarely. These have included reports of mild hemolysis due to transfer of blood group antibodies, and thrombotic complications. At least 6 cases of disseminated intravascular coagulation (DIC) associated with acute hemoglinemia or hemoglobinuria following immune globulin intravenous (the active ingredient contained in Gammagard S / D) administration have been reported.[Ref]

A recent report of two women who received high dose IVIg and subsequently developed thromboembolic complications suggests that high-dose IVIg increases blood viscosity that may last for several weeks, which may increase susceptibility to thromboembolism in predisposed patients.

Out of the 6 patients who developed DIC, 1 child recovered without sequelae and 5 adults all died. The attending or consulting physicians assessed that acute hemolysis or DIC caused or contributed to each death.[Ref]

Cardiovascular

Cardiovascular side effects have included rare reports of cardiovascular and cerebrovascular thrombosis.[Ref]

Local

Local side effects have included injection site reactions. These have included erythema, pain, infection, venous thrombosis, thrombophlebitis, and eczema.[Ref]

IGIV products with a more acidic pH have been reported to cause greater vein irritation.[Ref]

Immunologic

Immunologic side effects have been reported rarely. All U.S. immune globulin products undergo viral inactivation and/or removal. However, no method has been totally effective in removing all risk and the potential exists for the presence of unknown infectious agents.[Ref]

References

1. Chen C, Danekas LH, Ratko TA, Vlasses PH, Matuszewski KA "A multicenter drug use surveillance of intravenous immunoglobulin utilization in US academic health centers." Ann Pharmacother 34 (2000): 295-9

2. NIH Consensus Development Conference "Intravenous immunoglobulin: prevention and treatment of disease." JAMA 264 (1990): 3189-93

3. Lederman HM, Roifman CM, Sasson L, Gelfand EW "Corticosteroids for prevention of adverse reactions to intravenous immune serum globulin infusions in hypogammaglobulinemic patients." Am J Med 81 (1986): 443-6

4. Rosenfeld EA, Shulman ST, Corydon KE, Mason W, Takahashi M "Comparative safety and efficacy of two immune globulin products in Kawasaki disease." J Pediatr 126 (1995): 1000-3

5. Duhem C, Dicato MA, Ries F "Side-effects of intravenous immune globulins." Clin Exp Immunol 97(suppl 1 (1994): 79-83

6. Wordell CJ "Use of intravenous immune globulin therapy: an overview." DICP 25 (1991): 805-17

7. Ratko TA, Burnett DA, Foulke GE, Matuszewski KA, Sacher RA "Recommendations for off-label use of intravenously administered immunoglobulin preparations. University Hospital Consortium Expert Panel for Off-Label Use of Polyvalent Intravenously Administered Immunoglobulin Preparations." JAMA 273 (1995): 1865-70

8. Tan E, Hajinazarian M, Bay W, Neff J, Mendell JR "Acute renal failure resulting from intravenous immunoglobulin therapy." Arch Neurol 50 (1993): 137-9

9. "Product Information. Immune Globulin IV (Human). Sandoglobulin (immune globulin intravenous)." Sandoz Pharmaceuticals Corporation, East Hanover, NJ.

10. Buckley RH, Schiff RI "The use of intravenous immune globulin in immunodeficiency diseases." N Engl J Med 325 (1991): 110-7

11. Hughes RAC, Swan AV, Cornblath DR, Hartung HP, Bril V, Feasby T, Hahn A, Ropper A, Steck A, Toyka KV, Vallat JM, Newsomda "Randomised trial of plasma exchange, intravenous immunoglobulin, and combined treatments in guillain-barre syndrome." Lancet 349 (1997): 225-30

12. Stigant C, Sapir D, Sweet J, Downey G, Bargman JM "A unique renal lesion in common variable immunodeficiency." Clin Nephrol 57 (2002): 74-9

13. FDA "Important drug warning Available from: URL: http://www.fda.gov/medwatch/safety/1998/igiv.htm." ([1998]):

14. Rault R, Piraino B, Johnston JR, Oral A "Pulmonary and renal toxicity of intravenous immunoglobulin." Clin Nephrol 36 (1991): 83-6

15. Arunabh, Arunabh S, Kumar G, Avila V "Acute renal failure induced by intravenous immune globulin." Am Fam Physician 53 (1996): 862,865

16. Dalakas MC "Mechanism of action of intravenous immunoglobulin and therapeutic considerations in the treatment of autoimmune neurologic diseases." Neurology 51 (1998): s2-8

17. Winward DB, Brophy MT "Acute renal failure after administration of intravenous immunoglobulin: review of the literature and case report." Pharmacotherapy 15 (1995): 765-72

18. Ahsan N, Palmer BF, Wheeler D, Greenlee RG Jr, Toto RD "Intravenous immunoglobulin-induced osmotic nephrosis." Arch Intern Med 154 (1994): 1985-7

19. Schifferli J, Leski M, Favre H, Imbach P, Nydegger U, Davies K "High-dose intravenous IgG treatment and renal function." Lancet 337 (1991): 457-8

20. Donatini B "Transient renal dysfunction in diabetic patients after IVIg therapy ." J Intern Med 232 (1992): 376

21. Cantu TG, Hoehn-Saric EW, Burgess KM, Racusen L, Scheel PJ "Acute renal failure associated with immunoglobulin therapy." Am J Kidney Dis 25 (1995): 228-34

22. Haskin JA, Warner DJ, Blank DU "Acute renal failure after large doses of intravenous immune globulin." Ann Pharmacother 33 (1999): 800-3

23. Veber B, Mohammedi I, Gachot B, Bedos JP, Wolff M "High-dose intravenous IgG treatment and acute renal failure." Intensive Care Med 21 (1995): 288-9

24. Kobosko J, Nicol P "Renal toxicity of intravenous immunoglobulin." Clin Nephrol 37 (1992): 216-7

25. Dalakas MC "Intravenous immune globulin therapy for neurologic diseases." Ann Intern Med 126 (1997): 721-30

26. Burkes AW, Sampson HA, Buckley RH "Anaphylactic reactions after gamma globulin administration in patients with hypogammaglobulinemia: detection of IgE antibodies to IgA." N Engl J Med 314 (1986): 560-4

27. Frankel SJ, Polmar SH, Grumet FC, Wedner HJ "Anti-IgA antibody associated reactions to intravenous gammaglobulin in a patient who tolerated intramuscular gammaglobulin." Ann Allergy 56 (1986): 436-9

28. Sorensen PS, Wanscher B, Jensen CV, Schreiber K, Blinkenberg M, Ravnborg M, Kirsmeier H, Larsen VA, Lee ML "Intravenous immunoglobulin G reduces MRI activity in relapsing multiple sclerosis." Neurology 50 (1998): 1273-81

29. Palevsky PM, Rendulic D, Diven WF "Maltose-induced hyponatremia." Ann Intern Med 118 (1993): 526-8

30. Ben-Chetrit E, Putterman C "Transient neutropenia induced by intravenous immune globulin ." N Engl J Med 326 (1992): 270-1

31. Gaines AR "Disseminated intravascular coagulation associated with acute hemoglobinemia and/or hemoglobinuria following Rho(D) immune globulin intravenous administration for immune thrombocytopenic purpura." Blood 106 (2005): 1532-7

32. Emerson GG, Herndon CN, Sreih AG "Thrombotic complications after intravenous immunoglobulin therapy in two patients." Pharmacotherapy 22 (2002): 1638-41

33. Comenzo RL, Malachowski ME, Meissner HC, Fulton DR, Berkman EM "Immune hemolysis, disseminated intravascular coagulation, and serum sickness after large doses of immune globulin given intravenously for Kawasaki disease." J Pediatr 120 (1992): 926-8

34. Go RS, Call TG "Deep venous thrombosis of the arm after intravenous immunoglobulin infusion: Case report and literature review of intravenous immunoglobulin-related thrombotic complications." Mayo Clin Proc 75 (2000): 83-5

35. Fazekas F, Deisenhammer F, Strasserfuchs S, Nahler G, Mamoli B "Randomised placebo-controlled trial of monthly intravenous immunoglobulin therapy in relapsing-remitting multiple sclerosis." Lancet 349 (1997): 589-93

36. Dalakas MC "High-dose intravenous immunoglobulin and serum viscosity - risk of precipitating thromboembolic events." Neurology 44 (1994): 223-6

37. Gomperts ED "Gammagard(r) and reported hepatitis c virus episodes." Clin Ther 18 ( Suppl (1996): 3-8

38. Bresee JS, Mast EE, Coleman FJ, Baron MJ, Schonberger LB, Alter MJ, Jonas MM, Yu MYW, Renzi PM, Schneider LC "Hepatitis c virus infection associated with administration of intravenous immune globulin: a cohort study." JAMA 276 (1996): 1563-7

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