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Pathogen Safety

Two specific virus clearance steps plus additional process steps

AlphaNine SD has 2 specific virus clearance steps (Solvent Detergent and Nanofiltration) with the capacity to act against both enveloped and non-enveloped viruses. These 2 steps plus additional process steps (such as dual-affinity chromatography) contribute to virus safety.


Prion-elimination steps

Grifols has investigated the manufacturing process of AlphaNine SD for the capacity to decrease infectivity of prions, such as the Creutzfeld-Jakob Disease (CJD) or variant CJD agents. These studies provide reasonable assurance that low levels of CJD or vCJD, if present in the starting material, would be removed.1,2


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Proven safety profile

AlphaNine SD is made from human plasma. Plasma products carry a risk of transmitting infectious agents, including viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, despite steps designed to reduce this risk.

 

Allergic type hypersensitivity reactions, including anaphylaxis, have been reported for all factor IX products. The administration of plasma preparations may cause allergic reactions, mild chills, nausea or stinging at the infusion site.


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Indication

AlphaNine® SD (coagulation factor IX [human]) is indicated for the prevention and control of bleeding in patients with Factor IX deficiency due to hemophilia B.


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Important Safety Information

AlphaNine SD is made from human plasma. Plasma products carry a risk of transmitting infectious agents, including viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent, despite steps designed to reduce this risk.

Incidences of thrombosis or disseminated intravascular coagulation (DIC) have been reported following administration of Factor IX Complex concentrates which contain high amounts of Factor II, VII, and X. AlphaNine SD contains low, nontherapeutic levels of Factor II, VII, and X.

Following administration in surgery patients and individuals with known liver disease, the physician should closely observe the patient for signs and symptoms of potential disseminated intravascular coagulation.

Allergic type hypersensitivity reactions, including anaphylaxis, have been reported for all factor IX products. The administration of plasma preparations may cause allergic reactions, mild chills, nausea or stinging at the infusion site.

Nephrotic syndrome has been reported following attempted immune tolerance induction with factor IX products in hemophilia B patients with factor IX inhibitors and a history of severe allergic reactions to Factor IX.

In order to minimize the possibility of thrombogenic complications, dosing guidelines should be strictly followed.

AlphaNine SD should not be administered at a rate exceeding 10 mL/ minute. Rapid administration may result in vasomotor reactions.

Please see full Prescribing Information for AlphaNine SD.


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References

  1. Belda FJ et al. 64th National Hemophilia Foundation Annual Meeting 2012. Abstract.
  2. Herring S. Grifols' factor IX concentrates: new findings in biochemical characteristics and safety profiles. Haemophilia. 2010 Jul;16 Suppl 6:3-8.