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NEWS / CORPORATE / .........

CORPORATE - 13-09-2016

Kedrion Biopharma set for strong presence at 2016 IgNS Meeting

Kedrion Biopharma will be a bronze sponsor at the Immunoglobulin National Society (IgNS) 2016 5th National Conference scheduled for September 15-18, 2016 at the Intercontinental Hotel in Miami, Florida. IgNS is a professional organization dedicated to nurses and pharmacists with an emphasis on education, management, practice, and research in immunoglobulin (Ig) therapy.

 

The IgNS conference will bring together leaders from the clinical, research, and business fields to provide participants with the latest updates in practice, research and drug discovery, business and legislative climate. 

 

Kedrion Biopharma’s participation demonstrates their dedication to the IGIV nursing community and the IGIV community in general. With two products in their portfolio, Kedrion Biopharma has one of the largest immunoglobulin portfolios of branded therapy options in the US:

 

  • •    GAMMAKED™ [Immune Globulin Injection (Human), 10% Caprylate/Chromatography Purified] is indicated for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP), primary humoral immunodeficiency (PI) and idiopathic thrombocytopenic purpura (ITP)

For more information about GAMMAKED, please see Full Prescribing Information at www.GAMMAKED.com

 

  • •    BIVIGAM® [Immune Globulin Intravenous (Human), 10% Liquid] is indicated for the treatment of primary humoral immunodeficiency (PI)

For more information about BIVIGAM, please see Full Prescribing Information at www.BIVIGAM.com

 

Last year’s meeting—one of their most impactful yet—saw nearly 450 attendees representing a variety of areas of practice and clinical specialties coming together to advance their level of knowledge and expertise. Kedrion Biopharma will be a featured company at the exposition hall as this represents a strong opportunity to interact with this important IGIV audience. 


BIVIGAM Indication

BIVIGAM [Immune Globulin Intravenous (Human), 10% Liquid] is indicated for the treatment of primary humoral immunodeficiency (PI). This includes, but is not limited to, the humoral immune defect in common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

 

Important Safety Information for BIVIGAM

Warning: THROMBOSIS, RENAL DYSFUNCTION, AND ACUTE RENAL FAILURE

  • •    Thrombosis may occur with immune globulin intravenous (IGIV) products, including BIVIGAM. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, a history of venous or arterial thrombosis, the use of estrogens, indwelling vascular catheters, hyperviscosity and cardiovascular risk factors.
  • •    Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of Immune Globulin Intravenous (Human) (IGIV) products in predisposed patients.
  • •    Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. BIVIGAM does not contain sucrose.
  • •    For patients at risk of thrombosis, renal dysfunction, or renal failure, administer BIVIGAM at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. 

 

BIVIGAM is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin and in IgA-deficient patients with antibodies to IgA and history of hypersensitivity.

 

Hyperproteinemia, increased serum viscosity, and hyponatremia or pseudohyponatremia can occur in patients receiving IGIV therapy.

 

Aseptic meningitis syndrome (AMS) has been reported with IGIV treatments; AMS may occur more frequently in association with high doses (2 g/kg) and/or rapid infusion of IGIV.

 

As hemolysis can develop subsequent to treatment with IGIV products, monitor patients for hemolysis and hemolytic anemia.

 

Monitor patients for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]). If TRALI is suspected, test the product and patient for antineutrophil antibodies.

 

Because BIVIGAM is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

 

Serious adverse reactions observed in clinical trial subjects receiving BIVIGAM were vomiting and dehydration in one subject. The most common adverse reactions to BIVIGAM (reported in >5% of clinical study subjects) were headache, fatigue, infusion site reaction, nausea, sinusitis, blood pressure increased, diarrhea, dizziness, and lethargy.

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088. You may also report side effects to Biotest Pharmaceuticals Corporation at 1-800-458-4244.

 

For more information about BIVIGAM please see Full Prescribing Information at www.BIVIGAM.com.

 

GAMMAKED Indication

GAMMAKED, Immune Globulin Injection (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).

 

 

Important Safety Information for GAMMAKED

WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACTUE RENAL FAILURE

  • •    Thrombosis may occur with immune globulin products, including GAMMAKED. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.
  • •    For patients at risk of thrombosis, administer GAMMAKED at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
  • •    Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IGIV) products in predisposed patients. 
  • •    Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. GAMMAKED does not contain sucrose.
  • •    For patients at risk of renal dysfunction or failure, administer GAMMAKED at the minimum concentration available and the minimum infusion rate practicable. 

 

GAMMAKED is contraindicated in individuals with acute severe hypersensitivity reactions to Immune Globulin (Human). It is contraindicated in IgA deficient patients with antibodies against IgA and history of hypersensitivity.

 

GAMMAKED is not approved for subcutaneous use in patients with ITP or CIDP. Due to the potential risk of hematoma formation, GAMMAKED should not be administered subcutaneously in patients with ITP.

 

Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IGIV therapy.

 

There have been reports of noncardiogenic pulmonary edema [Transfusion-Related Acute Lung Injury (TRALI)], hemolytic anemia, and aseptic meningitis in patients administered with IGIV.

 

The high dose regimen (1g/kg x 1-2 days) is not recommended for individuals with expanded fluid volumes or where fluid volume may be a concern.

 

GAMMAKED is made from human plasma. Because this product 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.

 

After infusion of IgG, the transitory rise of the various passively transferred antibodies in the patient’s blood may yield positive serological testing results, with the potential for misleading interpretation.

 

In clinical studies, the most common adverse reactions with GAMMAKED were headache, fever, chills, hypertension, rash, nausea, and asthenia (in CIDP); headache, cough, injection site reaction, nausea, pharyngitis, and urticaria with intravenous use (in PI) and infusion site reactions, headache, fatigue, arthralgia and pyrexia with subcutaneous use (in PI); and headache, vomiting, fever, nausea, back pain, and rash (in ITP).

 

The most serious adverse reactions in clinical studies were pulmonary embolism (PE) in one subject with a history of PE (in CIDP), an exacerbation of autoimmune pure red cell aplasia in one subject (in PI), and myocarditis in one subject that occurred 50 days post-study drug infusion and was not considered drug related (in ITP).

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088.

 

For more information about GAMMAKED, please see Full Prescribing Information at www.GAMMAKED.com

 

About Kedrion Biopharma

Kedrion Biopharma is an international company that collects and fractionates blood plasma to produce and distribute plasma-derived therapeutic products for use in treating and preventing serious diseases, disorders and conditions such as hemophilia, primary immune system deficiencies and Rh sensitization. Kedrion Biopharma Inc., the US subsidiary of Kedrion Biopharma, is headquartered in Fort Lee, New Jersey. Kedrion Biopharma launched US operations in 2011, but the company’s international roots stretch back several decades in the production of blood and plasma-derived products. Kedrion Biopharma places a high value on the welfare of those who benefit from its products, as well as on the people and the communities it serves. 

 

Additional information about Kedrion Biopharma can be found at www.kedrion.com  and www.kedrion.us.

 

 

©2016 Kedrion Biopharma Inc. All Rights Reserved. August 2016 CO-0406-00-2016

 

 

For more information please contact: [email protected]