Talecris Therapies Made from Plasma

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.
Important Safety Information
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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.
Important Safety Information

View the full prescribing information:
HyperTET^® S/D, Tetanus Immune Globulin (Human) (PDF)
HyperHEP B^® S/D, Hepatitis B Immune Globulin (Human) (PDF)
HyperRAB^®S/D, Rabies Immune Globulin (Human) (PDF)
HyperRHO^®S/D, Rh₀(D) Immune Globulin (Human) Full Dose (PDF)
HyperRHO^®S/D, Rh₀(D) Immune Globulin (Human) Mini-Dose (PDF)
GamaSTAN^®S/D, Immune Globulin (Human) (PDF)

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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Important Safety Information

Gamunex^®, Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified, is indicated for the treatment of primary humoral immunodeficiency disease (PI), idiopathic thrombocytopenic purpura (ITP), and chronic inflammatory demyelinating polyneuropathy (CIDP). Gamunex is contraindicated in individuals with known anaphylactic or severe systemic response to Immune Globulin (Human).

Immune Globulin Intravenous (Human) (IGIV) 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 [Transfusion-Related Lung Injury (TRALI)], hemolytic anemia, and aseptic meningitis in patients administered with IGIV. Thrombotic events have been reported in association with IGIV. Patients at risk for thrombotic events may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity. Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IGIV therapy.

Gamunex is made from human plasma. As with all plasma-derived therapeutics, the potential to transmit infectious agents, such as viruses and theoretically, the Creutzfeldt-Jakob (CJD) agent that can cause disease, cannot be totally eliminated. There is also the possibility that unknown infectious agents may be present in such products.

Please see Gamunex full Prescribing Information (PDF).
 

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Prolastin^®, Alpha₁-Proteinase Inhibitor (Human), is indicated for chronic replacement therapy of individuals having congenital deficiency of alpha-1 PI (alpha₁-antitrypsin deficiency) with clinically demonstrable panacinar emphysema.

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%).

Prolastin is made from human plasma. As with all plasma-derived therapeutics, the potential to transmit infectious agents, such as viruses and theoretically, the Creutzfeldt-Jakob (CJD) agent that can cause disease, cannot be totally eliminated. There is also the possibility that unknown infectious agents may be present in such products.

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) is indicated for the treatment of patients with hereditary antithrombin deficiency in connection with surgical or obstetrical procedures or when they suffer from thromboembolism.

In clinical studies with Thrombate III, the most common side effects were dizziness, chest tightness, nausea, and a foul taste in the mouth.

The anticoagulant effect of heparin is enhanced by concurrent treatment with Thrombate III in patients with hereditary AT-III deficiency. Thus, in order to avoid bleeding, reduced dosage of heparin is recommended during treatment with Thrombate III.

Thrombate III is made from human plasma. As with all plasma-derived therapeutics, the potential to transmit infectious agents, such as viruses and theoretically, the Creutzfeldt-Jakob (CJD) agent that can cause disease, cannot be totally eliminated. 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.

Please see Thrombate III full Prescribing Information (PDF).
 

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Koāte^®-DVI, Antihemophilic Factor (Human)
Koāte-DVI is indicated for the treatment of classical hemophilia (hemophilia A) in which there is a demonstrated deficiency of activity of the plasma clotting factor, factor VIII.

Allergic-type reactions may result from the administration of Antihemophilic Factor (Human) preparations. Reactions include tingling in the arm, ear, and face, blurred vision, headache, nausea, stomach ache, and jittery feeling.

Koāte-DVI is made from human plasma. As with all plasma-derived therapeutics, the potential to transmit infectious agents, such as viruses and theoretically, the Creutzfeldt-Jakob (CJD) agent that can cause disease, cannot be totally eliminated. There is also the possibility that unknown infectious agents may be present in such products.

Hepatitis B vaccination is essential for patients with hemophilia A; vaccination is recommended at birth or at the time of diagnosis. Hepatitis A vaccination is also recommended for hemophilia who are hepatitis A seronegative.

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.

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