Fort Lee, NJ—August 3, 2011 -- Kedrion Biopharma (www.kedrionusa.com) today announced the approval and U.S. availability of Gammaked®, a ready-to-use sterile solution of human immune globulin proteins for intravenous and subcutaneous (primary Immune deficiency only) administration. Kedrion, a biopharmaceutical company that develops, manufactures and distributes human plasma-derived medicines, has entered into an agreement with Grifols, SA to manufacture Gammaked for the next seven years. As part of its ongoing expansion in the United States, Kedrion will begin distribution of Gammaked on August 3, 2011 through designated channel partners.
Gammaked is an immune globulin human injection, 10 percent liquid indicated for treatment of:
- Primary Immunodeficiency (PI)
- Idiopathic Thrombocytopenic Purpura (ITP)
- Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Created from large pools of human plasma by a combination of cold ethanol fractionation, caprylate precipitation and filtration and anion-exchange chromatography, Gammaked is supplied in 1 gram, 2.5 grams, 5 grams, 10 grams or 20 grams single-use bottles. The distribution of IgG subclasses is similar to that found in normal serum. For all indications Gammaked is administered intravenously, but PI patients have another option of subcutaneous administration.
“We are thrilled to welcome Kedrion and the Gammaked product to the U.S. Market,” said Fred Modell, Co-Founder of the Jeffrey Modell Foundation (JMF). “This is a meaningful contribution to patients with Primary Immunodeficiency and their treating physicians, who will now have a greater choice to assure the most effective and appropriate therapy. We look forward to working together in close collaboration with Kedrion to best serve the Primary Immunodeficiency Community.”
“The entire Kedrion team has worked tirelessly and is incredibly proud to be able to provide a treatment solution to the rare disorder community,” said Paolo Marcucci, CEO of Kedrion. “Gammaked is only the second preparation with a CIDP indication in the United States. Kedrion is committed to offering more treatment solutions to healthcare providers in the United States. Gammaked marks our ongoing efforts in this important market.”
For more information, please contact your Kedrion representative or call customer service at 1-855-353-7466.
Important Safety Information
Renal Dysfunction and Acute Renal Failure – renal dysfunction, acute renal failure, osmotic nephrosis and death may occur with immune globulin intravenous (IGIV) products in predisposed patients. Patients predisposed to renal dysfunction include those with any degree of pre-existing renal insufficiency, diabetes milletus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving nephrotoxic drugs. 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.
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, coagulation disorders, prolonged periods of immobilization and/or known or suspected hyperviscosity.
There have been reports of noncardiogenic pulmonary edema [Transfusion-Related 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).
Please see accompanying full Prescribing Information for Gammaked for complete prescribing details.
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.
Kedrion develops, manufactures and distributes human plasma derived medicines that improve people’s quality of life. With over 40 years of experience and expertise, the company plays a major role worldwide providing critical therapies in 40 other countries. International headquarters are in Italy with a focus on high quality products, relentless commitment to research and development and substantial industrial capacity to ensure continuous supply. Additional information about Kedrion can be found at www.kedrionusa.com.
The Gammaked package insert is attached to the press release and can be accessed at www.gammaked.com.