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Notice of Gammaplex® Supply Disruption and Shortage

 

DECEMBER 1, 2017

Bio Products Laboratory Limited (BPL), the manufacturer of Gammaplex®, advised the FDA that there will be a short‐term supply disruption and immediate shortage of the following immune globulins in the United States as of the date of this notice:

 

NDC ‐ Vial

NDC ‐ Carton

Product Name

     

64208‐8234‐2

64208‐8234‐6

Gammaplex 5%, (immune globulin intravenous [human], 5% Liquid)

64208‐8234‐3

64208‐8234‐7

Gammaplex 5%, (immune globulin intravenous [human], 5% Liquid)

64208‐8234‐4

64208‐8234‐8

Gammaplex 5%, (immune globulin intravenous [human], 5% Liquid)

64208‐8235‐1

64208‐8235‐5

Gammaplex 10%, (immune globulin intravenous [human], 10% Liquid)

64208‐8235‐2

64208‐8235‐6

Gammaplex 10%, (immune globulin intravenous [human], 10% Liquid)

64208‐8235‐3

64208‐8235‐7

Gammaplex 10%, (immune globulin intravenous [human], 10% Liquid)

 

This supply interruption is a consequence of configuration issues with the donor management system used by BPL’s plasma supplier, BPL Plasma, Inc. BPL is working with the U.S. Food and Drug Administration (FDA) to limit the duration of the supply disruption. BPL has stopped shipping Gammaplex to the U.S. market and currently expects to resume shipping before the end of Q1 2018.

If you have any inquiries regarding this notification, please contact BPL at 844‐4BPLUSA (844‐427‐5872) or INFO@BPL‐US.com.

Please see the additional Important Safety Information about Gammaplex 10% and Gammaplex 5% below, and the full prescribing information at www.gammaplex.com.

Important Safety Information for Gammaplex® 10%

Gammaplex 10% (immune globulin intravenous [human], 10% liquid) is indicated for replacement therapy in primary humoral immunodeficiency (PI) in adults. 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.

Gammaplex 10% is also indicated for the treatment of chronic immune thrombocytopenic purpura (ITP) in adults.

Thrombosis may occur with immune globulin products, including Gammaplex 10%. 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 (IGIV) products, including Gammaplex 10%.

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. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. Gammaplex 10% does not contain sucrose.

For patients at risk of thrombosis, renal dysfunction or acute renal failure, administer Gammaplex 10% 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.

Gammaplex 10% is contraindicated in patients who have had a history of anaphylactic or severe systemic reactions to human immune globulin and IgA deficient patients with antibodies to IgA and a history of hypersensitivity.

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

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. Patient risk factors that may be associated with development of hemolysis include high dose (>2 g/kg), non‐O blood group, and underlying inflammatory state. Noncardiogenic pulmonary edema may occur in patients following IGIV treatment (i.e. transfusion‐related acute lung injury [TRALI]). Monitor patients for pulmonary adverse reactions. If TRALI is suspected, test product and patient’s serum for anti‐ neutrophil antibodies.

Gammaplex 10% is made from human plasma and may contain infectious agents, e.g. viruses and, theoretically, the Creutzfeldt‐Jakob disease agent. No cases of transmission of viral diseases or CJD have been associated with the use of Gammaplex 10%.

The most common adverse reactions in adult subjects receiving Gammaplex 10% in the PI clinical trial were headache, migraine, and pyrexia. There were no serious product‐related adverse reactions observed in adult clinical trial subjects with PI. The safety of Gammaplex 10% has not been established in patients with ITP. However, the safety profile for Gammaplex 5% has been studied in subjects with ITP, and it is anticipated that the safety profile for both formulations are comparable for ITP patients. The most common adverse reactions in adult subjects receiving Gammaplex 5% in the chronic ITP clinical trial were headache, vomiting, nausea, pyrexia, arthralgia, and dehydration. Serious adverse reactions observed in clinical trial subjects with ITP were headache, vomiting and dehydration.

Important Safety Information for Gammaplex® 5%

Gammaplex 5% (immune globulin intravenous [human], 5% liquid) is indicated for replacement therapy in primary humoral immunodeficiency (PI) in adults and pediatric patients two years of age and older. 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. Gammaplex 5% is also indicated for the treatment of chronic immune thrombocytopenic purpura (ITP).

Thrombosis may occur with immune globulin products, including Gammaplex 5%. 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 (IGIV) products, including Gammaplex 5%.

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. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. Gammaplex 5% does not contain sucrose.

For patients at risk of thrombosis, renal dysfunction or acute renal failure, administer Gammaplex 5% 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.

Gammaplex 5% 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 in infants and neonates for whom sucrose or fructose tolerance has not been established; and IgA deficient patients with antibodies to IgA and a history of hypersensitivity.

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

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. Patient risk factors that may be associated with development of hemolysis include high dose (>2 g/kg), non‐O blood group, and underlying inflammatory state. Noncardiogenic pulmonary edema may occur in patients following IGIV treatment (i.e. transfusion‐related acute lung injury [TRALI]). Monitor patients for pulmonary adverse reactions. If TRALI is suspected, test product and patient’s serum for anti‐ neutrophil antibodies.

Gammaplex 5% is made from human plasma and may contain infectious agents, e.g. viruses and, theoretically, the Creutzfeldt‐Jakob disease agent. No cases of transmission of viral diseases or CJD have been associated with the use of Gammaplex 5%.

In clinical studies, the most common adverse reactions with Gammaplex 5% were headache, pyrexia, vomiting, fatigue, nausea, sinusitis, and nasal congestion. Serious adverse reactions observed in clinical trial subjects with primary immunodeficiencies were thrombosis and chest pain. Serious adverse reactions observed in clinical trial subjects with Immune Thrombocytopenic Purpura were headache, vomiting and dehydration.

US/Gx/1217/0038

 

About Bio Products Laboratory, Ltd.

Bio Products laboratory, Limited (BPL) is a leading manufacturer of plasma-derived protein therapies with global headquarters in Elstree, England, US headquarters in Durham, NC, and a presence in more than 45 countries worldwide. The company has over 60 years of experience developing and manufacturing plasma-derived therapies since being established as part of the Lister Institute in 1950, and currently markets a wide range of products, including coagulation factors, human immunoglobulins, and albumin. BPL is committed to continued investment in research and development to maintain its key position as a reliable supplier of high-quality products to patients and healthcare providers worldwide.