Expert Opinion Regarding Clinical and Other Outcome Considerations in the Formulary Review of Immune Globulin

Sorensen, Ricardo U.

doi:10.18553/jmcp.2007.13.3.278

Cited by 10 publications

(9 citation statements)

References 23 publications

(40 reference statements)

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“…[25][26][27] Shorter infusion time saves time for the patient (thus enhancing quality of life) and reduces nurse utilization time, which lowers costs for the facility. 28,29 The liquid formulations Flebogamma 5% DIF and Privigen remain stable when stored at room temperature (2°-25°C or 36°-77°F for Flebogamma DIF and up to 25°C or 77°F for Privigen) for up to 24 months and up to 36 months, respectively. 26,30,31 Room temperature storage permits immediate infusion, saving about 6 hours of warming time.…”

Section: % Liquid Productsmentioning

confidence: 99%

The New Generation of Liquid Intravenous Immunoglobulin Formulations in Patient Care: A Comparison of Intravenous Immunoglobulins

Stein

2010

Postgraduate Medicine

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Intravenous immunoglobulin (IGIV) replacement therapy is the standard of care for primary immunodeficiencies with impaired humoral immunity. It is also the immunomodulatory therapy of choice for some types of neuroimmunologic and autoimmune hematologic disorders and for immunomodulation in bone marrow and some solid organ transplants. Currently available IGIV products include older lyophilized formulations, 5% liquid products, and newer, liquid, ready-to-use, 10% formulations. Differences in the formulations, manufacturing processes, excipients, pH, and other physicochemical properties of IGIV products may affect their clinical efficacy and tolerability. Among at-risk patients, the possibility of serious complications such as renal insufficiency, heart failure, thrombotic events, and immunological reactions may be increased if an IGIV formulation has sugar as a stabilizer, has high sodium or immunoglobulin A (IgA) content, or is hyperosmolar. The 10% liquid formulations may offer advantages because of their lower IgA concentrations, optimal pH, glycine or proline stabilizers, low sodium content, and lower osmolality. Liquid formulations are more convenient for patients and health care providers due to shorter infusion times and easier preparation and administration.

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Section: % Liquid Productsmentioning

confidence: 99%

The New Generation of Liquid Intravenous Immunoglobulin Formulations in Patient Care: A Comparison of Intravenous Immunoglobulins

Stein

2010

Postgraduate Medicine

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“…The sodium content of 0.85% is comparatively higher than in other IVIG products. The content of IgA is ≤2.2 μg/ml, which is among the lowest found in IVIGs [6,8]. …”

Section: Specific Ivig Productsmentioning

confidence: 99%

“…It contains glycine [6,33] and has an osmolality of 258 mosm/kg. Its pH range is comparatively low at 4.0-4.5, thus preventing IgG aggregation [6,8,23]. It contains over 98% IgG, 46 μg/ml IgA, and <20 μg/ml albumin.…”

Section: Specific Ivig Productsmentioning

confidence: 99%

“…Gammagard Liquid 10% contains no sugar, sodium, or preservatives [8,51]. Its near-physiologic osmolality ranges from 240 to 300 mosm/kg.…”

Section: Specific Ivig Productsmentioning

confidence: 99%

“…Reducing the rate of infusion can diminish the most common side effects such as headache, low-grade fever, nausea, malaise, arthralgia, chest pain and tightness, rashes, hypotension, and myalgia [8]. Preinfusion medication such as acetaminophen, diphenhydramine, nonsteroidal anti-inflammatory drugs, and/or corticosteroids can also be used if patients experience any side effects.…”

Section: Introductionmentioning

confidence: 99%

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Immunoglobulin Replacement Therapy: A Twenty-Year Review and Current Update

Saeedian

Randhawa

2014

Int Arch Allergy Immunol

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Objective: The expansion of immunoglobulin replacement to multiple disease entities marks a decade-long advancement in immune therapy. Parallel to its extension, the characteristics and composition of immunoglobulin products have diversified. The aim of this study was to summarize a 20-year comprehensive literature review of currently commercially available immunoglobulin products, particularly examining individual product properties in a comparative format. Data Sources/Study Selections: The literature review was performed using PubMed and Ovid, screening a time span of 2 decades. Both authors reviewed the obtained articles for acceptable quality, and the selection was narrowed down based on criteria for randomized clinical and therapeutic trials. Results: Product-specific characteristics in terms of purification strategy, stabilizers, composition, and viral inactivation were found among the immunoglobulin products investigated. Such differing characteristics manifest in their variable clinical safety and efficacy as assessed by the comparative product analysis. In subgroups of patients, subcutaneous immunoglobulin therapy may be an alternative to intravenous immunoglobulin (IVIG) therapy with an equal efficacy and a lower number of systemic adverse events. Conclusion: Only few comprehensive clinical synopses are available to clearly demonstrate the differences in IVIG products despite the widespread clinical use of the therapy. This review defines significant characteristics of individual immunoglobulin products, noting important differences in product development and application and allowing informed clinical decisions to match a product with patients' risk factors and comorbidity. This balanced approach to gammaglobulin replacement therapy is imperative to produce the highest clinical efficacy and lowest number of adverse events.

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Dosing and Therapy Utilization: A Discussion of Updates on PI Treatment Guidelines

Ballow

2012

J Clin Immunol

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Treatment decisions made in clinical practice, based on current guidelines, often conflict with decisions by third-party payors that restrict the ability of patients with primary immunodeficiency disease (PI) to adhere to appropriate treatment. This is seen by many physicians as potentially placing the health of patients at risk. Key treatment decisions challenged by third-party payors and discussed here include dosing, product safety, and routes of administration. Data on safety issues emphasize that IgG products are not generic drugs and each of the products currently licensed by the Food and Drug Administration (FDA) must be regarded as an individual therapy, given the products' different manufacturing processes and stabilizing ingredients. The issue of switching patients to a different product needs careful consideration as evidence shows that infusion-related adverse events in many patients are frequently related to this activity. Decisions regarding the route of therapy should also be individualized to the patient, weighing such factors as side effects, adherence with therapy, and lifestyle.

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Expert Opinion Regarding Clinical and Other Outcome Considerations in the Formulary Review of Immune Globulin

Cited by 10 publications

References 23 publications

The New Generation of Liquid Intravenous Immunoglobulin Formulations in Patient Care: A Comparison of Intravenous Immunoglobulins

The New Generation of Liquid Intravenous Immunoglobulin Formulations in Patient Care: A Comparison of Intravenous Immunoglobulins

Immunoglobulin Replacement Therapy: A Twenty-Year Review and Current Update

Dosing and Therapy Utilization: A Discussion of Updates on PI Treatment Guidelines

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