Factor ix complex

Profilnine, Factor IX Complex, is indicated for the prevention and control of bleeding in patients with factor IX deficiency (hemophilia B). Profilnine contains non-therapeutic levels of factor VII and is not indicated for use in the treatment of factor VII deficiency.

Dose Each vial of Profilnine is labeled with total units expressed as International Units (IU). According to the WHO International Standard, one unit approximates the activity in one mL of normal plasma. A 1% increase in factor IX (0.01 units) per unit administered per kg body weight can be expected 1. The amount of Profilnine required to establish hemostasis will vary with each patient and circumstance. Use the following formula and example as guides in determining the number of units to be administered: Body weight (in kg) X Desired increase in Plasma Factor IX (Percent) X 1 Units/kg = Number of Factor IX Units Required Example: 50 kg X 25 (% increase) X 1 Units/kg = 1,250 Units of factor IX Due to variability among patients and their clinical condition, monitor the factor IX level of each patient frequently during replacement therapy.

None known.

Transmissible Infectious Agents Because Profilnine is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. Inhibitors Patients can develop neutralizing antibodies (inhibitors) after treatment with Profilnine. Monitor patients for inhibitors, which should be quantified in Bethesda Units (BU) using appropriate laboratory testing. Hypersensitivity Hypersensitivity, including anaphylaxis, has been reported. Inform patients of the early symptoms and signs of hypersensitivity reaction, including hives, generalized urticaria, angioedema, chest tightness, dyspnea, wheezing, faintness, hypotension, tachycardia, and anaphylaxis.

Adverse reactions with Profilnine may include headache, fever, chills, flushing, nausea, vomiting, tingling, lethargy, urticaria, and manifestations of allergic reactions. The following adverse reactions have been identified during post-approval use of Profilnine: hypersensitivity reactions including shortness of breath, diaphoresis, and hypotension, as well as thrombosis including pulmonary embolism and deep vein thrombosis, disseminated intravascular coagulation, and inhibitor development. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Profilnine is stable for three years, up to the expiration date printed on its label, provided that the storage temperature does not exceed 25 °C (77 °F). Do not freeze.