BPL - Bio Products Laboratory

• About Gammaplex
• Help for patients
• Healthcare Professionals
• Ordering
• Contact us

• BPL website
• Home

Important Safety Information

Gammaplex is indicated for the replacement therapy of primary humoral immunodeficiency (PI). This includes, but is not limited to, the humoral immune defect in common variable immunodeficiency, X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome and severe combined immunodeficiencies.

WARNING: Renal dysfunction, acute renal failure, osmotic nephropathy and death may be associated with the administration of Immune Globulin Intravenous (Human) (IGIV) products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. Gammaplex does not contain sucrose. For patients at risk of renal dysfunction or failure, administer Gammaplex at the minimum infusion rate practicable. See full prescribing information for complete boxed warning.

Gammaplex is contraindicated in patients who have had a history of anaphylactic or severe systemic reactions to human immune globulin and in patients with selective IgA deficiency and in patients with a history of hypersensitivity.

In patients at risk of developing renal failure, monitor urine output and renal function including blood urea nitrogen (BUN) and serum creatinine. Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IGIV therapy.

Thrombotic events may occur following treatment with Gammaplex and other IGIV products. Monitor patients with risk factors for thrombotic events, including a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, coagulation disorders, prolonged periods of immobilization and/or known/suspected hyperviscosity.

Aseptic meningitis syndrome (AMS) may occur infrequently with IGIV treatment. AMS usually begins within several hours to 2 days following IGIV treatment. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae.

AMS may occur more frequently in association with high doses (2 g/kg) and/or rapid infusion of IGIV.

Hemolysis and hemolytic anemia can develop subsequent to IGIV treatments.

Noncardiogenic pulmonary edema may occur in patients following IGIV treatment (i.e. transfusion-related acute lung injury [TRALI]).

Monitor patients for pulmonary adverse reactions (TRALI). Test product and patient's serum for anti-neutrophil antibodies.

Gammaplex is made from human plasma and may contain infectious agents, e.g. viruses and, theoretically, the Creutzfeldt-Jakob disease agent. Based on effective donor screening and product manufacturing processes, Gammaplex carries an extremely remote risk of transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) is considered to be extremely remote. No cases of transmission of viral diseases or CJD have been associated with the use of Gammaplex.

In clinical studies, the most common adverse reactions with Gammaplex were headache, fatigue, nausea, pyrexia, hypertension, myalgia, pain and vomiting.

Please review the accompanying Gammaplex Prescribing Information for full prescribing details.