Grifols is a global healthcare company founded in Barcelona in 1909 committed to improving the health and well-being of people around the world. The company develops, produces, and provides innovative healthcare services and solutions in more than 110 countries.
A pioneer in the plasma industry, Grifols develops innovative plasma-derived medicines and other biopharmaceutical solutions that treat patients with chronic, rare and, at times, life-threatening conditions.
Grifols is focused on treating conditions across a broad range of therapeutic areas: immunology, hepatology and intensive care, pulmonology and hematology, neurology, and infectious diseases.
Grifols has the largest network of donation centers in the world, with more than 390 across North America, Europe, Africa and the Middle East, and China.
As a recognized leader in transfusion medicine, Grifols offers a comprehensive portfolio of solutions designed to enhance safety from donation to transfusion, in addition to clinical diagnostic technologies. The company provides high-quality biological supplies for life-science research, clinical trials, and for manufacturing pharmaceutical and diagnostic products. In addition, Grifols supplies tools, information, and services that enable hospitals, pharmacies, and healthcare professionals to efficiently deliver expert medical care.
Grifols, with more than 26,000 employees in more than 30 countries and regions, is committed to a sustainable business model that sets the standard for continuous innovation, quality, safety, and ethical leadership.
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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.
Please see full Prescribing Information for AlphaNine SD.