Prolastin^®, Alpha₁-Proteinase Inhibitor (Human)
Prolastin^® is used in the treatment of alpha₁-antitrypsin deficiency, also known as AAT deficiency, a genetic (inherited) disorder that causes significant reduction in the naturally occurring blood protein alpha₁-antitrypsin. A low level of alpha₁-antitrypsin allows certain enzymes to attack healthy tissues in the body, primarily in the lungs. To replace missing or reduced levels of AAT, physicians often prescribe "augmentation" therapy with an alpha₁-proteinase inhibitor.
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Thrombate III^®, Antithrombin III (Human)
Thrombate III^® is indicated for the treatment of patients with hereditary antithrombin III deficiency. The human body typically maintains a balance of blood proteins that slow or stop blood flow (in the case of injury) and facilitate blood flow (to prevent blood clots). Antithrombin III (AT-III) is a blood protein that facilitates blood flow. AT-III deficiency is a rare inherited or spontaneously occurring disorder that can increase the risk of blood clots.
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Koāte^®-DVI, Antihemophilic Factor (Human)
Koāte^®-DVI is a plasma-derived product for the treatment of classic hemophilia (hemophilia A) in which there is a demonstrated deficiency of activity of the plasma clotting factor, factor VIII.
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Hypermunes™, Hyperimmune Globulin Therapy Products
Hypermunes™ products for hyperimmune globulin therapy are concentrated immunoglobulins used for prophylaxis against diseases such as hepatitis B, rabies, and tetanus. Constant monitoring in steps of the manufacturing and delivery processes makes these biological products safe, easy, and convenient to use.
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Plasbumin^®, Albumin (Human) / Plasmanate^®, Plasma Protein Fraction (Human)5%
Albumin and Plasma Protein Fraction (PPF) act as "plasma expanders" in situations where large amounts of blood (and therefore protein) are lost as a result of trauma, disease, or surgery. Plasbumin^® comes in three concentrations: 5%, 20%, and 25%. The different concentrations are used in different situations.
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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.

Please see Gamunex full Prescribing Information (PDF).

Prolastin^®, Alpha₁-Proteinase Inhibitor (Human), is indicated for chronic replacement therapy of individuals having congenital deficiency of alpha₁- PI (alpha₁-antitrypsin deficiency) with clinically demonstrable panacinar emphysema.

Weekly Prolastin therapy has demonstrated a low occurrence of side effects. In clinical studies with Prolastin, reactions were observed in 1.16% of infusions, the most common events being fever (0.77%), light-headedness (0.19%), and dizziness (0.19%). As with all plasma-derived therapeutics, the potential to transmit infectious agents cannot be totally eliminated. Individuals with selective IgA deficiencies who have known antibody against IgA (anti-IgA antibody) should not receive Prolastin, since these patients may experience severe reactions, including anaphylaxis, to IgA which may be present.

Please see Prolastin full Prescribing Information (PDF).

Thrombate III^®, Antithrombin III (Human) therapy has demonstrated a low occurrence of side effects.

In clinical studies with Thrombate III^®, the most common side effects were dizziness, chest tightness, nausea, and a foul taste in the mouth. As with all plasma-derived therapeutics, the potential to transmit infectious agents, such as viruses, cannot be totally eliminated. Individuals who receive infusions of blood or blood plasma may develop signs and/or symptoms of some viral infections, particularly hepatitis C.

Please see Thrombate III full Prescribing Information (PDF).

Koāte^®-DVI, Antihemophilic Factor (Human)
Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly hepatitis C. It is emphasized that hepatitis B vaccination is essential for patients with hemophilia and it is recommended that this be done at birth or diagnosis. Hepatitis A vaccination is also recommended for hemophilic patients who are hepatitis A seronegative. As with all plasma-derived therapeutics, the potential to transmit infectious agents cannot be totally eliminated.

Please see Koāte-DVI full Prescribing Information (PDF).

Hypermunes™
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. The physician should discuss the risks and benefits of this product with the patient, before prescribing or administering it to a patient.

Plasbumin^®/Plasmanate^®
These products are 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.

Certain patients, eg, those with a history of congestive cardiac failure, renal insufficiency, or stabilized chronic anemia, are at special risk of developing circulatory overload. Albumin is contraindicated in patients with a history of allergic reaction to albumin human products are made from human plasma. Products made from human plasma may contain infectious agents, such as viruses that can cause disease.

Please see Plasbumin/Plasmanate full Prescribing Information.