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

CORPORATE - 22-08-2016

Kedrion Biopharma to attend 14th International Symposium of GBS/CIPD Foundation

KEDRION BIOPHARMA TO ATTEND 14TH INTERNATIONAL SYMPOSIUM OF GBS|CIDP FOUNDATION


Demonstrating their support of patient communities, Kedrion Biopharma will be a silver sponsor at the 14th International Symposium of the GBS|CIDP Foundation. This preeminent global non-profit organization supports individuals and their families affected by Guillain-BarrĂ© syndrome (GBS), chronic inflammatory demyelinating polyneuropathy (CIDP), and related syndromes such as multifocal motor neuropathy (MMN). Kedrion Biopharma’s sponsorship will allow for continued support in the areas of education, research, and advocacy. 

 

Scheduled for September 23-24, in San Antonio, Texas, the biennial symposium will feature a wide array of presentations and workshops led by leading medical professionals.  It will also offer a unique opportunity for those affected by GBS, CIDP, and variants to meet with other patients and families from around the world.

 

It’s likely that many attendees of the conference are familiar with or have been prescribed Kedrion Biopharma’s GAMMAKED™ [Immune Globulin Injection (Human), 10% Caprylate/Chromatography Purified], which 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.

 

The GBS|CIDP Foundation is an international organization of approximately 30,000 members with 182 chapters in 33 countries, all of whom are dedicated to providing support and assistance to GBS/CIDP patients and their families. Kedrion Biopharma is proud to support and collaborate with the Foundation and participate in this deeply inspiring event. 

 

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 GM-0407-00-2016

For more information please contact: [email protected]