Grifols, founded in 1940 by Dr. José Antonio Grifols, is a global healthcare company whose mission is to improve the health and well being of people around the world. We accomplish this mission by producing protein therapies for patients and by providing hospitals, pharmacies, and healthcare professionals with the tools they need to deliver expert medical care. Our three divisions–Bioscience, Diagnostic, and Hospital–develop, produce, and market our innovative products and services to medical professionals in more than 100 countries around the world.

Our extensive network of donor centers throughout the US helps ensure a reliable, consistent source of protein therapies worldwide. Grifols has established a vertical integration system, meaning we have an all-inclusive process beginning with plasma collection and continuing through the fractionation, purification, and production of our life-changing therapies. Our three plasma fractionation and production facilities, located in Barcelona (Spain), Clayton, North Carolina, and Los Angeles, California (US), carry out these processes. Each of these facilities operates in accordance with current Good Manufacturing Practice (GMP) and is FDA-licensed and certified by the European Union health authorities.

Our diagnostic division provides clinical analysis and lab testing tools to labs, hospitals, and blood banks to satisfy the demands of clinical laboratory professionals who require precise results and a reliable diagnosis. Our hospital division supplies pharmacies with standard parenteral solutions for intravenous therapy and products for clinical nutrition, as well as a wide variety of sterile products and medical devices.

While working toward improving healthcare worldwide, Grifols approaches all aspects of business with the Grifols Spirit. This is our way of relating to each other and the outside world and has made us the company we are today. As a company committed to serving people, we seek to hire and retain the very best employees and strive to create a dynamic, energetic organization. Ensuring quality, integrity, and safety in all activities is a crucial aspect of what we stand for, as our products are of vital importance to the health and quality of life of patients we serve.


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Learn about Grifols, a global healthcare company

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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.