Every package of AlphaNine SD comes with a Mix2Vial® device for easy reconstitution

 

Watch the Mix2Vial® reconstitution demo:

 

View instructions for Mix2Vial Reconstitution*

*Mix2Vial® is a registered trademark of Medimop Medical Projects, Ltd., a subsidiary of West Pharmaceutical Services, Inc.


Administration

AlphaNine® SD (coagulation factor IX [human]) should be administered intravenously promptly following reconstitution. Administration of AlphaNine SD within three hours after reconstitution is recommended to avoid the potential ill effect of any inadvertent bacterial contamination occurring during reconstitution. Discard any unused contents into the appropriate safety container. 


Practice With DemoPacks

DemoPacks are available for instructional purposes so patients, parents, and nurses can become familiar with easy-to-use transfer set.

To request DemoPacks, please contact Grifols Costumer Service at 888-GRIFOLS (888-474-3657) or by submitting an electronic request.

Contents include: Empty product vial, diluent (sterile water for injection USP 5mL) and Mix2Vial® 15-µm filter transfer set.


Indications

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.


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.

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 see full Prescribing Information for AlphaNine SD.