Coagulation Factor IX

Coagulation Factor IX (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

Coagulation Factor IX is not indicated for induction of immune tolerance in patients with hemophilia B

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.

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

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

Do not use in patients with known hypersensitivity to Coagulation Factor IX or its excipients, including hamster protein

There are no data with coagulation factor IX use in pregnant women to inform a drug-associated risk. Animal reproduction studies have not been conducted with coagulation factor IX. In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. There is no information regarding the presence of coagulation factor IX in human milk, the effect on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for coagulation factor IX and any potential adverse effects on the breastfed infant from coagulation factor IX or from the underlying maternal condition.

Hypersensitivity reactions, including anaphylaxis has occurred. Should symptoms occur, discontinue coagulation factor IX 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 coagulation factor IX 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 coagulation factor IX use

Anti-fibrinolytic drugs