AlphaNine SD (Coagulation Factor IX (human))

Grifols Biologicals Inc.

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Miscellaneous Coagulation Modifiers

Hemophilia B

Coagulation factor IX is a man-made protein that is similar to a natural protein in the body that helps the blood to clot. Coagulation factor IX is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VII deficiency. Coagulation factor IX may also be used for purposes other than those listed here.

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.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects: fever or chills; continued bleeding after treatment; feeling like you might pass out; sudden numbness or weakness, especially on one side of the body; sudden headache, confusion, problems with vision, speech, or balance; or swelling in your feet or ankles, weight gain, loss of appetite. Less serious side effects may be more likely to occur, such as: headache; warmth, redness, or tingly feeling under your skin; nausea, vomiting; dizziness; or pain, redness, or swelling where the medicine was injected.

There may be other drugs that can interact with coagulation factor IX. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Seek emergency medical attention if you think you have used too much of this medicine.

Contact your doctor if you miss a dose of this medication.