LABORATORIOS GRIFOLS SA

Clinical summary

Indications and usage 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. Standard dosing 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. Table 2 below provides treatment guidelines for hemorrhagic events and surgery in patients with factor IX deficiency. Table 2: Treatment Guidelines Type of Bleeding or Surgical Procedure Factor IX Level Required, % of Normal (Dose) Frequency of Doses Duration of Therapy (Days) Minor to Moderate Hemorrhages 20% to 30% (20 IU FIX/kg to 30 IU FIX/kg) until hemorrhage stops and healing has been achieved. Every 16 to 24 hours Minor: 1 to 2 days Moderate: 2 to 7 days Major Hemorrhages 30% to 50% (30 IU FIX/kg to 50 IU FIX/kg). Following this treatment period, maintain FIX levels at 20% (20 IU FIX/kg) until healing has been achieved. Every 16 to 24 hours 3 to 10 days Surgery Prior to surgery, 30% to 50% (30 IU FIX/kg to 50 IU FIX/kg). For dental extractions, bring FIX levels to 50% immediately prior to the procedure. Maintain FIX levels at 30% to 50% (30 IU FIX/kg to 50 IU FIX/kg) until healing has been achieved. Every 16 to 24 hours 7 to 10 days Dosing requirements and frequency of dosing are calculated on the basis of an initial response of 1% FIX increase achieved per IU of FIX infused per kg body weight and an average half-life for FIX of 24 hours. If dosing studies reveal that a particular patient exhibits a lower response, monitor blood levels and adjust the dose accordingly. Contraindications None known. Key warnings 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. Pregnancy guidance Animal reproduction studies have not been conducted with Profilnine. It is also not known whether Profilnine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Only give Profilnine to a pregnant woman if clearly indicated.