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Pivotal Trial Design—Infusion Protocol

Gammaplex 10% IVIG was studied with an infusion rate protocol that increased every 15 minutes to shorten overall infusion time1,2

Infusion Rate Protocol for Gammaplex 10%1,2

Elapsed Time (min) Gammaplex 10% Infusion Rate
(mL/kg/min) (mg/kg)
0–15 0.005* 30
16–30 0.01 60
31–45 0.02 120
46–60 0.04 240
61–75 0.06 360
76+ (maximum infusion rate) 0.08 480

*In this trial, patients who tolerated the first infusion with minimal adverse reactions could begin subsequent infusions at 0.01 mL/kg/min.3

  • Gammaplex 10% median infusion time was 53 minutes less than Gammaplex 5% in the pivotal trial2,3

Median Infusion Duration in the Pivotal Trial2,3

Median Infusion Duration chart

To calculate the infusion time or see the infusion protocol for an individual patient, please see the Gammaplex 10% Infusion Calculator.

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Gammaplex 10% Infusion Calculator

Infusion Considerations

  • Monitor vital signs throughout the infusion
  • Slow or stop the infusion if adverse reactions occur; if symptoms subside, the infusion may be resumed at a lower rate that is comfortable for the patient
  • Ensure that patients with pre-existing renal insufficiency are not volume depleted
  • For patients at increased risk of renal dysfunction, thrombotic events, or volume overload, administer Gammaplex 10% at the minimum infusion rate practicable. Consider discontinuing Gammaplex 10% administration if renal function deteriorates

Gammaplex 10% is administered using a rate escalation protocol with 15-minute intervals2

  • Gammaplex 10% rate escalation protocol allows patients to reach maximum recommended infusion rate in 1 hour and 15 minutes, compared to 2 hours and 30 minutes with a 30-minute rate escalation protocol2

Infusion Rate Protocols for Gammaplex 10% and a
10% IVIG with 30-min Rate Escalation Protocol2

Infusion rate protocols

Gammaplex 10% allows for shorter infusion times2

Example: Total Infusion Time for a 70-kg Patient Receiving
500 mg/kg IVIG (Total Dose of 35 g)2

Example: Total Infusion Time

References: 1. Wasserman RL, Melamed IR, Stein MR, et al. J Clin Immunol. 2017;37(3):301-310. 2. Gammaplex® 10% (Immune Globulin Intravenous [Human], 10% Liquid) Prescribing Information. Durham, NC: BPL Limited. 2019. 3. Data on File. BPL-GMX07-0816.

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

WARNING: THROMBOSIS, RENAL DYSFUNCTION and ACUTE RENAL FAILURE

  • 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 an anaphylactic or severe systemic reaction to the administration of 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 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. The most common adverse reaction in pediatric subjects receiving Gammaplex 10% in the PI clinical trial was headache. There were no serious product-related adverse reactions observed in adult or pediatric 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 Kedrion at 1-866-398-0825 or email US_Medicalinfo@kedrion.com.

IMPORTANT SAFETY INFORMATION