Pivotal Trial Results—Tolerability

clock with tennis player

Gammaplex 10% was well-tolerated in a PI clinical trial

In the pivotal clinical trial, adverse reactions were similar for Gammaplex 10% and Gammaplex 5%1

  • Pre-infusion medications were used in 3/32 adult subjects who received Gammaplex 10% infusions
  • No adult subjects in the trial received supplemental IV hydration
  • Adverse reactions were measured up to 72 hours after infusion

Adverse Reactions in the Pivotal Trial in Adult Subjects

Adverse reaction Gammaplex 5%
n (%)
(N=163 Infusions)
Gammaplex 10%
n (%)
(N=166 Infusions)
Headache 15 (9.2) 12 (7.2)
Fatigue 7 (4.3) 5 (3.0)
Rhinitis/rhinorrhea 4 (2.5) 6 (3.6)
Migraine 3 (1.8) 2 (1.2)
Lower respiratory tract
infection/bronchitis/
fibrinous bronchitis
3 (1.8) 1 (0.6)
Sinusitis/chronic sinusitis 2 (1.2) 1 (0.6)
Nausea 1 (0.6) 1 (0.6)
Rash/rash generalized 0 4 (1.7)
Pyrexia 0 2 (1.2)

96% of Gammaplex 10% infusions followed the 15-minute titration protocol and reached maximum recommended infusion rate

Adherence to 15-Minute Titration Protocols in the Pivotal Trial

  Gammaplex 5%
n (%)
Gammaplex 10%
n (%)
Infusions that followed titration protocol 152/163 (93.2%) 159/166 (95.8%)

Reference: 1. Data on File, BPL-GMX07-0816.

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.

Please see Full Prescribing Information for complete prescribing details.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.

You may also call BPL at 1-844-4BPLUSA or email medinfo@bpl-us.com.