Home » Drug Information » FDA Approved Drugs » 1996
Medical Areas: Hematology | Genetic Disease
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AlphaNine SD Coagulation Factor IX (Human)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Alpha Therapeutic Corporation
Approval Status: Approved July 1996
Treatment Area: Hemophilia B
AlphaNine SD Coagulation Factor IX (Human) has been approved for
the prevention and control of bleeding in subjects with Factor IX
deficiency due to hemophilia B.
The efficacy of AlphaNine SD has been evaluated in clinical
trials involving 13 surgical subjects. Control of bleeding was
judged to be excellent. Another study found that AlphaNine SD did
not lead to the formation of prothrombin in the bloodstream. This
means that AlphaNine is less likely to cause unwanted blood clots
(thrombosis) than Factor IX Complex preparations. These contain
larger amounts of other proteins such as Factors II, VII and X.
Thrombosis can be a serious problem with the use of certain Factor
Side effects included headache, fever, chills, flushing, nausea,
and vomiting. In rare cases, subjects may have an allergic reaction
to AlphaNine SD. Signs of an allergic reaction are hives, rash,
tightness of the chest, wheezing, low blood pressure and difficulty
in breathing. If such a reaction happens, infusion should be
stopped at once.
Hemophilia B, also called Christmas Disease, affects one in
25,000 males. Mild forms of the condition can also affect female
carriers. People with hemophilia B suffer from a deficiency in the
Factor IX protein, necessary in blood clotting. The condition is
characterized by prolonged bleeding, especially into joints and