AlphaNine® S/D
(coagulation factor IX [human])


Visit the official brand website: www.alphaninesd.com



Solvent/detergent treated/virus filtered

A high-purity factor IX product for your patients with hemophilia B







 

Indications:

  • Hemophilia B
    • 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

Broad pathogen safety margin:

  • State-of-the-art safety profile with 2 specific virus-elimination steps:
  • Prion removal step: nanofiltration step has the capacity to decrease infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents

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

Related information:

  • High purity based on dual affinity chromatography
  • Reliable control of factor level with surgery, when it matters most*
  • Ease in dosing: 1 IU of AlphaNine SD infused per kg of body weight raises the recipient's plasma factor IX level by 1%**

* Quon D et al. Haemophilia 2011; 17(1): 196-201
** Recommended dosages are presented as general guidelines. If dosing studies have revealed that a particular patient exhibits a lower response, the dose should be adjusted accordingly

How supplied:

Diluent size Product description NDC number Assay color code
10 mL 500 IU 68516-3601-2 500 IU FIX Range
10 mL 1000 IU 68516-3602-2 1000 IU FIX Range
10 mL 1500 IU 68516-3603-2 1500 IU FIX Range

Storage conditions:

  • AlphaNine SD is stable for up to 3 years, up to the expiration date printed on its label, provided that the storage temperature is between 2 and 8 °C (36 and 46 °F). Do not freeze to prevent damage to diluent vial
  • May be stored at room temperature not to exceed 30 °C for 1 month

PediGri®

  • A commitment to providing healthcare professionals with transparent information. A unique service that offers all the information on the origin and quality of Grifols plasma derivatives (www.pedigri.grifols.com)

Important safety information:

AlphaNine® SD is indicated for the prevention and control of bleeding in patients with factor IX deficiency due to hemophilia B.

AlphaNine® SD is made from human plasma. Plasma products carry a risk of transmitting infectious agents, such as 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.

Contact information:

Do not use the contact information on this website for medical emergencies. For medical emergencies dial 911, or contact your healthcare professional.

For Grifols USA Customer Service: Tel. 888-GRIFOLS, option. Email. customer.service@grifols.com.

For clinical or technical information or to report an adverse drug event involving a Grifols biological product, please contact Grifols Medical Information at 1.800.520.2807.

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.

Please download full prescribing information from the link below

Prescribing Information

  • 17 Feb, 2015

    Prescribing information Download (74.23 Kb)

Documents

  • 19 Feb, 2013

    AlphaNine Product Brochure Download (1.46 MB)