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 the induction of immune tolerance in patients with hemophilia B.

Hemophilia B is a sex-linked (X-linked) hereditary bleeding disorder caused by a deficiency of clotting factor IX. This deficiency leads to bleeding into joints, muscles, or internal organs. Bleeding may occur spontaneously or as a result of injury or surgery.Treatment with Coagulation Factor IX (Recombinant) works by replacing the missing factor IX in the blood. This provides a temporary correction of the factor deficiency and helps restore normal blood clotting, thereby controlling or preventing bleeding episodes.

For intravenous use only after reconstitution.

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 circulating factor IX activity by approximately 0.98 IU/dL.

Initial dose:

• Required factor IX units (IU) = body weight (kg) × desired factor IX increase (% of normal or IU/dL) × reciprocal of observed recovery (IU/kg per IU/dL)
• Maintenance dose depends on the type of bleed or surgery, severity of the hemostatic challenge, and duration required for adequate wound healing

Pediatric Use: Safety and effectiveness of coagulation factor IX have not been established in children below 12 years of age.

Geriatric Use: Clinical studies have not included sufficient subjects aged 65 years and older. It is not known whether elderly patients respond differently from younger patients. Dose selection should be individualized in elderly patients.

Do not use in patients with known hypersensitivity to Coagulation Factor IX or any of its excipients, including hamster-derived proteins.

There are no adequate data on the use of coagulation factor IX in pregnant women to assess drug-related risks. Animal reproduction studies have not been conducted with coagulation factor IX. In the general population, the estimated background risk of major birth defects and miscarriage is 2–4% and 15–20%, respectively. There is no information regarding the presence of coagulation factor IX in human milk, its effects on the breastfed infant, or its influence on milk production. The benefits of breastfeeding should be weighed against the mother’s clinical need for coagulation factor IX and any potential risks to the infant from the drug or the underlying maternal condition.

Hypersensitivity reactions, including anaphylaxis, have been reported. If such reactions occur, discontinue coagulation factor IX immediately and initiate appropriate treatment. Patients may also develop hypersensitivity to hamster (CHO) proteins, which may be present in trace amounts.

Neutralizing antibodies (inhibitors) against coagulation factor IX may develop. If expected plasma levels of factor IX are not achieved or bleeding is not adequately controlled, testing for factor IX inhibitors should be performed.

Nephrotic syndrome has been observed in hemophilia B patients with factor IX inhibitors following immune tolerance induction therapy.

Thromboembolic events have been reported with the use of coagulation factor IX.

Anti-fibrinolytic drugs

Store at 2°C to 8°C. Do not freeze.