Study design of the pivotal 60-week trial 2
Primary efficacy endpoints were mean grip strength in the more affected hand (measured using a digital dynamometer) and deterioration of the upper-limbs [measured using the upper-limb subsection of Guy's Neurological Disability Scale (GNDS)].2
- Randomized withdrawal, double-blind, placebo-controlled, cross-over study consisted of five 12-week periods to evaluate the efficacy and safety/tolerability of GAMMAGARD LIQUID in 44 adult patients with MMN1
- Patients were maintained on a stable regimen of intravenous immunoglobulin (existing maintenance dose ranging from 0.5 to 2.0 grams/kg/month) prior to enrollment, therefore the results cannot be generalized to IVIG-naive patients1
- If a patient's function deteriorated, such that the patient had difficulty in activities of daily living or if a patient experienced ≥50% decline in grip strength in the more affected hand, he or she could move to the next open-label stabilization phase of GAMMAGARD LIQUID ("accelerated switch," a prespecified secondary endpoint) without breaking the blind1
*One patient (2.4%) switched to open-label treatment during GAMMAGARD LIQUID blinded cross-over period and did not switch during placebo administration and 28.6% (n= 12) did not switch.1
CI=confidence interval; SD=standard deviation.
GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10%
GAMMAGARD LIQUID is indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age or older. This includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
GAMMAGARD LIQUID is indicated as a maintenance therapy to improve muscle strength and disability in adult patients with Multifocal Motor Neuropathy (MMN).
Detailed Important Risk Information for Healthcare Professionals
- Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IGIV) products in predisposed patients. 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. GAMMAGARD LIQUID does not contain sucrose.
- For patients at risk of renal dysfunction or failure, administer GAMMAGARD LIQUID at the minimum infusion rate practicable.
Ensure that patients with pre-existing renal insufficiency are not volume depleted. For patients over 65 years of age or judged to be at risk for renal dysfunction or thrombotic events, administer GAMMAGARD LIQUID at the minimum infusion rate practicable. In such cases, the maximal rate should be less than 3.3 mg/kg/min (< 2mL/kg/hr), and consider discontinuation of administration if renal function deteriorates.
GAMMAGARD LIQUID is contraindicated in patients who have had a history of anaphylactic or severe systemic hypersensitivity reactions to the administration of human immune globulin.
GAMMAGARD LIQUID is contraindicated in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity. Anaphylaxis has been reported with the intravenous use of GAMMAGARD LIQUID and is theoretically possible following subcutaneous administration.
Severe hypersensitivity reactions may occur, even in patients who had tolerated previous treatment with human normal immune globulin. In case of hypersensitivity, discontinue GAMMAGARD LIQUID infusion immediately and institute appropriate treatment.
Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving GAMMAGARD LIQUID.
Thrombotic events, including myocardial infarction, cerebral vascular accident, deep vein thrombosis, and pulmonary embolism have been reported in association with intravenous use of GAMMAGARD LIQUID. Thrombotic events have also been reported with subcutaneous administration of immune globulin. Patients at risk for thrombotic events include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, coagulation disorders, prolonged periods of immobilization, obesity, diabetes mellitus, acquired or inherited thrombophilic disorder, a history of vascular disease, or a history of a previous thrombotic or thromboembolic event.
Aseptic Meningitis Syndrome may occur with IGIV treatment, and has been reported with intravenous use of GAMMAGARD LIQUID. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae. The syndrome usually begins within several hours to two days following IGIV treatment. AMS may occur more frequently with high dose (2 grams/kg) IGIV treatment and/or rapid infusion of IGIV.
GAMMAGARD LIQUID contains blood group antibodies that may act as hemolysins and induce in vivo coating of red blood cells (RBC) with immune globulin. Delayed hemolytic anemia can develop subsequent to GAMMAGARD LIQUID therapy due to enhanced RBC sequestration; acute hemolysis, consistent with intravascular hemolysis, has been reported. The following risk factors may be related to the development of hemolysis: high doses (e.g., ≥ 2 grams/kg, single administration or divided over several days) and non-O blood group. Monitor patients for clinical signs and symptoms of hemolysis.
Non-cardiogenic pulmonary edema (TRALI) has been reported in patients following treatment with IGIV products, including GAMMAGARD LIQUID. Monitor patients for pulmonary adverse reactions.
GAMMAGARD LIQUID should only be administered intravenously in MMN patients. Adverse reactions may occur more frequently in patient's naïve to immune globulin treatment. In such cases, initiate infusions at a lower rate and increase gradually as tolerated. In order to avoid worsening of muscle weakness in MMN patients, dose adjustment may be necessary.
GAMMAGARD LIQUID is made from human plasma. It may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the classic Creutzfeldt-Jakob disease agent. This also applies to unknown or emerging viruses and other pathogens. No cases of transmission of viral diseases or vCJD have been associated with GAMMAGARD LIQUID.
PI: Intravenous: The serious adverse reaction seen during intravenous treatment in the clinical trials for PI was aseptic meningitis. The most common adverse reactions for PI (observed in ≥ 5% of subjects) were headache, fatigue, pyrexia, nausea, chills, rigors, pain in extremity, diarrhea, migraine, dizziness, vomiting, cough, urticaria, asthma, pharyngolaryngeal pain, rash, arthralgia, myalgia, oedema peripheral, pruritus, and cardiac murmur.
PI: Subcutaneous: No serious adverse reactions were observed during the clinical trial for subcutaneous treatment. The most common adverse reactions during subcutaneous treatment (observed in ≥ 5% of PI subjects) were infusion site (local) event, headache, fatigue, heart rate increased, pyrexia, abdominal pain upper, nausea, vomiting, asthma, blood pressure systolic increased, diarrhea, ear pain, aphthous stomatitis, migraine, oropharyngeal pain, and pain in extremity.
MMN: Two serious adverse reactions in the clinical trial for MMN each impacting one subject, were pulmonary embolism and blurred vision both of which were judged to be treatment-related. The most common adverse reactions for MMN (observed in ≥ 5% of subjects) were headache, chest discomfort, muscle spasms, muscular weakness, nausea, oropharyngeal pain, and pain in extremity.
Please see the GAMMAGARD LIQUID Full Prescribing Information.
If you would like to report an adverse reaction, contact Baxter Global Pharmacovigilance: 1-866-888-2472 or email@example.com.
If you have a medical/clinical question regarding the use of GAMMAGARD products, contact Baxter Medical Information:
1-866-424-6724 or firstname.lastname@example.org
- Data on file, Baxter International Inc. 2011.
- Gammagard Liquid [Immune Globulin Infusion (Human)] 10% [package insert]. Westlake Village, CA: Baxter Healthcare Corporation.
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