HOBOKEN, N.J. (August 29, 2013) – Octapharma USA today announced that Octaplas™ is available for ordering within the U.S.
Octaplas™ is a solvent/detergent (S/D) treated, pooled human plasma indicated for the replacement of multiple coagulation factors in patients with acquired deficiencies due to liver disease or undergoing cardiac surgery or liver transplant. It is also indicated for plasma exchange in patients with thrombotic thrombocytopenic purpura (TTP).1
Approved by the U.S. Food and Drug Administration (FDA) in January, Octaplas™ utilizes an optimized production process which:
- Retains essential coagulation factors and other proteins1,2
- Reduces the risk of transmitting non-enveloped and enveloped viruses2
- Minimizes single-donor variability2,3
- Eliminates cells and cellular debris 2,3
The content and distribution of plasma proteins in Octaplas™ are comparable to reference ranges for healthy blood donors, except for Protein S and alpha2-antiplasmin. Protein S and alpha2-antiplasmin, which are labile to S/D treatment, are controlled to ensure levels in the final product of = 0.4 International Units (IU) per mL.
“More than 13 million bags of Octaplas™ products have been transfused to more than 4.3 million patients worldwide since January 1992,”4,* said Octapharma USA President Flemming Nielsen. “We are excited to bring Octaplas™ to the medical community because we are committed to providing life saving and enhancing therapies to U.S. patients. Additionally, from a corporate perspective, our product portfolio continues to grow in a very important marketplace, which is good news for our future as a company.”
To order Octaplas™ call your local Blood Center or call National Hospital Specialties (NHS) at 201-488-1174 or 800-344-6087. To request product information or an on-label in-service program by an Octapharma representative, please call 201-604-1130. For Octaplas™ Full Prescribing Information, please visit www.octaplasus.com.
About Octaplas™
Contraindications & Adverse Events
Octaplas™ is contraindicated in patients with IgA deficiency; severe deficiency of Protein S; history of hypersensitivity to fresh frozen plasma (FFP) or to plasma-derived products including any plasma protein; or a history of hypersensitivity reaction to Octaplas™.
Serious adverse reactions seen in clinical trials were anaphylactic shock, citrate toxicity and severe hypotension. The most common adverse reactions observed in = 1% of patients included pruritis, urticaria, nausea, headache, paresthesia.
Warnings and Precautions
- Transfusion reactions can occur with AB0 blood group mismatches.
- High infusion rates can induce hypervolemia with consequent pulmonary edema or cardiac failure.
- Excessive bleedings due to hyperfibrinolysis can occur due to low levels of alpha2-antiplasmin.
- Thrombosis can occur due to low levels of Protein S.
- Citrate toxicity can occur with volumes exceeding one milliliter of Octaplas™ per kg per minute.
- Octaplas™ is made from human plasma; therefore, may carry the risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
About the Octapharma Group
Headquartered in Lachen, Switzerland, Octapharma AG is the world’s largest independent human protein products manufacturer and has been committed to patient care and medical innovation for 30 years. With a broad and expanding pipeline, Octapharma’s core business is the development, production, and sale of high quality human protein therapies from both human plasma and human cell-lines, including intravenous immunoglobulin and von Willebrand Factor/Coagulation Factor VIII Complex. Octapharma employs 5,000 people and has biopharmaceutical experience in 80 countries worldwide, including the United States, where Octapharma USA is located in Hoboken, New Jersey. Octapharma operates two state-of-the-art production sites licensed by the U.S. Food and Drug Administration (FDA), providing a high level of production flexibility. For more information, please visit www.octapharma.com, www.octaplasus.com, or www.wilateusa.com.
Footnote
* Data includes Octaplas™, Octaplas LG, Uniplas and other S/D-treated plasma products manufactured using the Octapharma process.
References
1. Octaplas™, Pooled Plasma (Human), Solvent/Detergent Treated Solution for Intravenous Infusion, complete prescribing information. 2013.
2. Hellstern P, Solheim BG. The Use of Solvent/Detergent Treatment in Pathogen Reduction of Plasma. Transfus Med Hemother. 2011;38:65-70.
3. Heger A, Romisch J, Svae T-E. Stability of solvent/detergent-treated plasma and single-donor fresh-frozen plasma during 48h after thawing: Transfus Apher Sci. 2005;33:257-267.
4. Octapharma, Data on file. 2013.
Forward-looking Statements
This news release contains forward-looking statements, which include known and unknown risks, uncertainties, and other factors not under the company’s control. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. These factors include results of current or pending research and development activities and action by the FDA or other regulatory authorities.
MEDIA CONTACT:
Fred Feiner
Yankee Public Relations
(908) 425-4878
fred@yankeepr.com
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