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patients & families > IVIG Therapy for PI > plasma safety

IVIG Therapy for PI

Plasma Safety¹

The purity and safety of IVIGs is extremely important. Like some other IVIG therapies, GAMMAGARD LIQUID is made from pools of plasma collected at FDA-registered donor sites. Many precautions are taken at these sites to ensure the high quality and safety of all plasma, such as:

Evaluation of the donors' medical history
FDA-licensed laboratory tests for hepatitis B surface antigens and antibodies to HIV-1, HIV-2 and HCV
FDA-approved plasma pool tests for HIV-1, HBV, and HCV

As an additional precaution, GAMMAGARD LIQUID is treated with a dedicated 3-step process specifically designed for viral inactivation/removal. As with all plasma-derived therapeutics, the potential to transmit infectious agents cannot be totally eliminated.

Step 1:

Optimized solvent/detergent treatment

S/D treatment inactivates the lipid-enveloped viruses investigated to below detection limits
within minutes.

Step 2:

35 nm Nanofiltration

35 nm nanofiltration removes lipid-enveloped viruses to below detection limits and reduces the
non-lipid enveloped viruses HAV and B19V.

Step 3:

Low pH incubation

Treatment with low pH at elevated temperature of 30°C to 32°C inactivates lipid-enveloped
viruses and encephalomyocarditis virus (EMCV, model for HAV) to below detection limits, and
reduces mice minute virus (MMV, model for B19V).

GAMMAGARD LIQUID is indicated for the treatment of primary immunodeficiency disorders associated with defects in humoral immunity. These include but are not limited to congenital X-linked agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

Important Safety Information

GAMMAGARD LIQUID is contraindicated in patients with known anaphylactic or severe hypersensitivity responses to Immune Globulin (Human). Patients with severe selective IgA deficiency (IgA < 0.05 g/L) may develop anti-IgA antibodies that can result in a severe anaphylactic reaction.

Immune Globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Especially in such patients, IGIV products should be administered at the minimum concentration available and the minimum rate of infusion practicable. 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.

Glycine, an amino acid, is used as a stabilizer. GAMMAGARD LIQUID does not contain sucrose.

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.

Components used in the packaging of this product are latex-free.

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, hypercoagulable disorders, and prolonged periods of immobilization.

IGIV products can contain blood group antibodies that may cause a positive direct antiglobulin reaction and, rarely, hemolysis.

Aseptic meningitis syndrome (AMS) has been reported to occur infrequently in association with IGIV treatment. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae.

Various mild and moderate reactions, such as headache, fever, fatigue, chills, flushing, dizziness, urticaria, wheezing or chest tightness, nausea, vomiting, rigors, back pain, chest pain, muscle cramps, and changes in blood pressure may occur with infusions of Immune Globulin Intravenous (Human).

Visit Baxter Biolife Plasma or the Plasma Proteins Therapeutics Website to learn more about plasma and plasma collection.

1. GAMMAGARD LIQUID [Immune Globulin Intravenous (Human)] 10% Clinical Monograph. Deerfield, IL. Baxter Healthcare Corporation, 2005.

Find Answers At Our PI Panel

Submit questions about plasma safety to Thomas R. Kreil, Ph.D, Global Pathogen Safety Director, Baxter BioScience.

IVIG Formulations

Learn about the various GAMMAGARD formulations Baxter offers for Primary Immune Deficiency.

Patient Resources

Request helpful tools for patients who rely on IVIG.

Please see the Full Prescribing Information for GAMMAGARD LIQUID [Immune Globulin Intravenous (Human)] 10%

GAMMAGARD S/D and GAMMAGARD S/D, IgA less than 1 µg/mL in a 5% solution are indicated for the treatment of primary immunodeficiency disorders associated with defects in humoral immunity. These include but are not limited to congenital X-linked agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. GAMMAGARD S/D must not be used in patients with selective IgA deficiency (IgA < 0.05 g/L) where the IgA deficiency is the only abnormality of concern.

Please see the Important Safety Information and Full Prescribing Information for GAMMAGARD S/D [Immune Globulin Intravenous (Human)]

Please see the Important Safety Information and Full Prescribing Information for GAMMAGARD S/D [Immune Globulin Intravenous (Human)], IgA less than 1 µg/mL in a 5% solution.

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