concontact_form_info

Thank you for your interest in learning more about ALPHANINE SD. We care about your questions and concerns, and we will reply as soon as possible. You can write to us or complete the form below with all required fields, as this will enable us to process your request more efficiently.


write_to_us

Write to us

GRIFOLS USA, LLC

2410 Lillyvale Ave

Los Angeles, CA 90032-3514

Tel: 1-888-GRIFOLS (1-888-474-3657)

Email: customer.service@grifols.com

www.grifolsusa.com


Contact Form Portlet

Contact form

Contact Form Portlet

 

 



callout_learn_about_grifols_usa

GrifolsGrifols

Learn about Grifols, a global healthcare company

 GrifolsUSA.com

indication

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.


isi

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.