 A Breakthrough in IGIV Production-
The process doesn't just make the product.
It is the product.
Every IGIV product is produced differently. Most products contain features that may increase the risk of adverse events. These product features may include volume load (concentration), osmolality, sodium and sugar content, pH and IgA content.
Gamunex® challenges the perception that all IGIVs are the same.
Gamunex® was the first completely new IGIV in more than a decade.
Gamunex® is a liquid, ready-to-use 10% IGIV formulation manufactured using a revolutionary new process. Gamunex® provides benefits to patients and healthcare professionals in terms of efficacy, tolerability, pathogen safety and convenience.
Click here for larger graphic.
Chromatography
Removes pathogens and other contaminants to help purify the IGIV.
Low pH
Acts as an additional virus inactivation step for increased pathogen safety AND stabilizes the IGIV, avoiding the use of sugar stabilizers.
Staying in solution
The fragile immunoglobulin molecule stays in solution during the entire production process, allowing a much gentler treatment that preserves the biological activity and efficacy of the IGIV.
The integration of all of those process steps is a significant improvement over longer retrofit processes.
Different product features can affect each patient differently.
The production process determines the product features of each individual IGIV. These product features can affect different patients in different ways. Finding the right match for a specific patient is a critical concern in product selection.
Click here for larger graphic.
Gamunex, Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified, is indicated as replacement therapy of primary humoral immunodeficiency disease (PI) and as immunomodulatory therapy for idiopathic thrombocytopenic purpura (ITP). Gamunex is contraindicated in individuals with known anaphylactic or severe systemic response to Immune Globulin (Human).
Immune Globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis and death. Patients should be instructed to immediately report symptoms of decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath (which may suggest kidney damage) to their physicians.
While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IGIV products, those containing sucrose as a stabilizer accounted for a disproportionate share of the total number. Gamunex does not contain sucrose. Glycine, a natural amino acid, is used as a stabilizer.
There have been reports of noncardiogenic pulmonary edema, rare reports of hemolytic anemia, and very rare reports of aseptic meningitis in patients administered with IGIV. Thrombotic events have been reported in association with IGIV. Patients at risk may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity. As with all plasma-derived therapeutics, the potential to transmit infectious agents cannot be totally eliminated.
Gamunex is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses. Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly hepatitis C.
Gamunex® Clinical Trials challenge the perception that all IGIVs are the same.
Talecris recognized that developing a different IGIV production process could potentially impact the efficacy, tolerability and convenience of the new product. Starting in 1995, Talecris began designing a new process with the needs of both patients and caregivers in mind.
Talecris' approach was validated by the results of the 2002 Immune Deficiency Foundation (IDF) national survey, The Treatment Experiences and Preferences of Patients with Primary Immune Deficiency Disease. This national survey of more than 1,200 patients with primary immune deficiency disease significantly challenges the old perception that all IGIVs are the same. Patients reported their experiences with different IGIV products over a range of characteristics including efficacy, tolerability and convenience.
The results of the survey suggest differences between IGIV products:
Efficacy:
- 57% of patients stated that one of the most important factors in switching IGIV products is product effectiveness.
- 68% feel the effects of treatment wear off (often within 2 weeks)
Tolerability:
- 58% have preferences for specific products (primarily due to side effects).
- 34% avoid specific products (due to side effects).
It's time to see IGIV in a whole new light.
Historically, licensure-relevant trials in Primary Immune Deficiency (PI) have lacked the necessary clinical rigors to establish comparisons in efficacy and tolerability.
Typically, clinical trials have been
- Small (20 to 40 patients).
- Without well-defined clinical endpoints.
- Without strong statistical trial design.
Clearly, to address the unmet needs of both patients and caregivers, the effects of critical differences in the production of IGIV products on efficacy, tolerability and convenience should be carefully evaluated in clinical trials.
"In the 20 years of IGIV use before this clinical study, there had never been a head-to-head comparison of this magnitude to determine product efficacy and tolerability. Although the healthcare community has long suspected differences between products, there was never any direct proof. These trial results support that view with a trend toward positive differences for Gamunex®. Future large, robust clinical studies will be necessary to ascertain the superiority of new products, such as Gamunex®."
Roifman C. Talecris Press Release, 2003.
Gamunex® demonstrates that different
processes may produce different results in efficacy and tolerability.
Although the trial demonstrated that Gamunex® was at least as effective as Gamimune® N 10%, immune globulin intravenous (human), Gamunex® showed surprising differences and significant positive results.
The results of these statistically relevant head-to-head trials in PI and ITP suggest that not all IGIVs provide similar clinical outcomes.
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