Grifols is a global healthcare company that since 1909 has enhanced the health and well-being of people around the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative solutions and services in more than 100 countries.

As pioneers in the field of the plasma science, the Bioscience Division is one of the largest plasma companies, with a growing network of centers worldwide. We develop this plasma into essential medicines used to treat rare, chronic and, at times, life-threatening conditions. To ensure a safe and consistent source of plasma-derived medicines worldwide, we have a vertically integrated production process from plasma collection through fractionation and purification at our facilities in Spain and the United States.

Key essential plasma-derived products include immunoglobulins, alpha-1 antitrypsin, albumin, clotting factors and specialty plasma products.

Grifols, with more than 24,000 employees in 30 countries and regions, is committed to a sustainable business model that sets the standard for continuous innovation, quality, safety and ethical leadership in the industry.

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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.