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).
Important Risk Information
WARNING: THROMBOSIS, RENAL DYSFUNCTION and ACUTE RENAL FAILURE
- Thrombosis may occur with immune globulin products, including GAMMAGARD LIQUID. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.
- Renal dysfunction, acute renal failure, osmotic nephropathy, and death may occur with immune globulin intravenous (IGIV) products in predisposed patients. Renal dysfunction and acute failure occur more commonly in patients receiving IGIV products containing sucrose. GAMMAGARD LIQUID does not contain sucrose.
- For patients at risk of thrombosis, administer GAMMAGARD LIQUID 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 of hyperviscosity.
- GAMMAGARD LIQUID is contraindicated in patients who have 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.
WARNINGS and PRECAUTIONS
- HYPERSENSITIVITY: IgA deficient patients with antibodies to IgA are at greater risk of developing potentially severe hypersensitivity and anaphylactic reactions. In case of hypersensitivity, discontinue GAMMAGARD LIQUID infusion immediately and institute appropriate treatment.
- RENAL DYSFUNCTION/FAILURE: Monitor renal function, including blood urea nitrogen, serum creatinine, and urine output in patients at risk of acute renal failure. Ensure that patients with pre-existing renal insufficiency are not volume depleted. For patients at risk for renal dysfunction or thrombotic events, administer GAMMAGARD LIQUID at the minimum infusion rate practicable.
- Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving GAMMAGARD LIQUID.
- THROMBOSIS: Thrombosis may occur following treatment with immune globulin products, including GAMMAGARD LIQUID. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
- Aseptic Meningitis Syndrome (AMS) may occur with IGIV treatment, and has been reported with intravenous (IV) use of GAMMAGARD LIQUID. AMS may occur more frequently with high dose (2 g/kg) IGIV treatment and/or rapid infusion of IGIV.
- Hemolytic anemia can develop subsequent to GAMMAGARD LIQUID treatment due to enhanced RBC sequestration. Risk factors may include: high doses (e.g., ≥2 g/kg cumulative dose), non-O blood group, and underlying inflammation. Monitor patients for clinical signs and symptoms of hemolysis and delayed hemolytic anemia.
- Transfusion-Related Acute Lung Injury (TRALI): Non-cardiogenic pulmonary edema has been reported in patients following treatment with IGIV products, including GAMMAGARD LIQUID. Monitor patients for pulmonary adverse reactions.
- GAMMAGARD LIQUID is made from human plasma. It may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. No confirmed cases of viral transmission or CJD have been associated with GAMMAGARD LIQUID.
- Passive transfer of antibodies may transiently impair the immune responses to live attenuated virus vaccines such as mumps, rubella, varicella, and measles. It can also lead to a misinterpretation of serological testing.
The serious adverse reaction that occurred during the PI (IV administration) clinical trials was aseptic meningitis. No serious adverse reactions were observed during the PI subcutaneous (SC) administration clinical trial. The serious adverse reactions in the MMN (IV administration) clinical trial were pulmonary embolism and blurred vision. The most common adverse reactions observed in ≥ 5% of patients in the clinical trials were:
PI (IV administration): 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 (SC administration): 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 (IV administration): Headache, chest discomfort, muscle spasms, muscular weakness, nausea, oropharyngeal pain, and pain in extremity.
Please see the accompanying full Prescribing Information, including Boxed Warning.
- Data on file, Baxter Healthcare Corporation. 2011.
- Gammagard Liquid [Immune Globulin Infusion (Human)] 10% [package insert]. Westlake Village, CA: Baxter Healthcare Corporation.
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