Gamimune N 10% Side Effects

Please note - some side effects for Gamimune N 10% 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 by Body System

General

In general, immune globulin intravenous 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.

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.

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.

Hypersensitivity

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.

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.

Nervous system

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

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.

Metabolic

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

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 administration have been reported.

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.

Cardiovascular

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

Local

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

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

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.

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