Bio Products Laboratory Inc. (BPL) announces NEW vial size of Gammaplex® for the treatment of Primary Immunodeficiency and Chronic Immune Thrombocytopenic Purpura
Raleigh, NC — 16th June 2014
BPL is pleased to announce that the United States Food and Drug Administration has approved a 20 g (400 mL) vial size for Gammaplex, BPL's immune globulin intravenous (human). The new 20 g vial size will offer improved choice and convenience for infusion nurses and pharmacists as fewer vials will be needed when 20 g or more Gammaplex are infused. The new vial size can also save valuable storage space compared with two 10 g vials.
With the addition of the 20 g vial, Gammaplex will be available in three sizes in the United States, including 5 g (100 mL), 10 g (200 mL) and 20 g (400 mL). The first supply of Gammaplex in this new vial size is now available to order.
Gammaplex is 5 percent liquid IGIV stabilized with sorbitol that has a viscosity similar to human plasma. In the United States, Gammaplex is indicated for replacement therapy in adults with Primary Humoral Immunodeficiency (PI). Gammaplex is also indicated for the treatment of adults with chronic Immune Thrombocytopenic Purpura (ITP) to raise platelet counts.
WARNING: Thrombosis may occur with immune globulin products, including Gammaplex. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients who receive immune globulin intravenous (lGIV) products, including Gammaplex. Patients predisposed to renal dysfunction include those with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs [see Warnings and Precautions (5.1)]. 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 thrombosis, renal dysfunction or acute renal failure, administer Gammaplex at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity [see Dosage and Administration (2.3), Warnings and Precautions (5.1)]. 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; a hereditary intolerance to fructose and infants with undiagnosed fructose intolerance; and IgA deficient patients with antibodies to IgA and a history of hypersensitivity.
Gammaplex is derived from human plasma. The risk of virus transmission cannot be completely eliminated.
For more information about Gammaplex, including full prescribing information, visit http://www.gammaplex.com/
BPL is committed to provide a continuous supply of safe, reliable, high quality plasma-derived products worldwide, supporting both healthcare professionals and patients every day
BPL's products are used to treat primary immune deficiencies but also to treat secondary immune deficiencies, coagulation disorders including hemophilia and von Willebrand disease and neurological disorders in certain markets. For more information, visit http://www.bpl-us.com/