Octanine F
Generic: Coagulation Factor IX
Daily Dose:
Course Duration:
Cheaper & Alternative Brands (500 IU/vial)
Same active generic (Coagulation Factor IX), same form (IV Infusion), exact same strength (500 IU/vial)No other brands currently registered with this exact active generic and dosage form.
Clinical Prescribing Information
Medical monograph and safety information for healthcare professionals & patients.Indications & Clinical Uses
Octanine F (Recombinant), is a human blood coagulation factor indicated in adults and children ≥ 12 years of age with hemophilia B for:
On-demand treatment and control of bleeding episodes
Perioperative management
Routine prophylaxis to reduce the frequency of bleeding episodes
Octanine F is not indicated for induction of immune tolerance in patients with hemophilia B
Dosage & Administration
For intravenous use after reconstitution only.
On-demand treatment and control of bleeding episodes and perioperative management of bleeding
: One international unit (IU) of coagulation factor IX per kg body weight increases the circulating activity of factor IX by 0.98 IU/dL.
Initial dose:
Required factor IX units (IU)= body weight (kg) x desired factor IX increase (% of normal or IU/dL) x reciprocal of observed recovery (IU/kg per IU/dL).
The maintenance dose depends on the type of bleed or surgery, the intensity of the hemostatic challenge, and number of days until adequate wound healing is achieved.
Pediatric Use
: The safety and effectiveness of coagulation factor IX in pediatric patients below the age of 12 years have not been established.
Geriatric Use
: Clinical studies of coagulation factor IX did not include subjects aged 65 and over. It is not known whether elderly patients respond differently than younger patients. Individualize dose selection for elderly patients
Contraindications
Do not use in patients with known hypersensitivity to Coagulation Factor IX or its excipients, including hamster protein
Warnings & Precautions
Hypersensitivity reactions, including anaphylaxis has occurred. Should symptoms occur, discontinue Octanine F and administer appropriate treatment. Patients may also develop hypersensitivity to hamster (CHO) protein, which is present in trace amounts in the product
Development of neutralizing antibodies (inhibitors) to Octanine F may occur. If expected factor IX activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, perform an assay that measures factor IX inhibitor concentration
Nephrotic syndrome has been reported following immune tolerance induction with factor IX products in hemophilia B patients with factor IX inhibitors
Thromboembolism has occurred with Octanine F use
Pharmacology & Mechanism of Action
Hemophilia B is a sex-linked hereditary disorder of blood coagulation caused by a deficiency in factor IX and results in bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma. Treatment with this preparation replaces factor IX, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies.