Factor IX


Alphanine SD

PRODUCT NAME: Alphanine SD

FORMULATION & CONCENTRATION: Coagulation Factor IX (Human)

MANUFACTURER: Grifols

INDICATIONS:
Factor IX deficiency due to Hemophilia B

SHELF LIFE:
3 years, up to the date printed on the label

STORAGE:
2°-8°C, do not freeze diluent. Stable at room temperature not to exceed 30°C for up to 1 month

Full Prescribing Information for Alphanine SD

Vial Size NDC # Size
500 IU 68516-3601-2 10ml
1000 IU 68516-3602-2 10ml
1500 IU 68516-3603-2 10ml

Alprolix

FORMULATION & CONCENTRATION: Coagulation Factor IX (Recombinant), Fc Fusion Protein

MANUFACTURER: Biogen Idec

INDICATIONS:
ALPROLIX™ Coagulation Factor IX (Recombinant), Fc Fusion Protein, is a recombinant DNA derived, coagulation Factor IX concentrate indicated in adults and children with Hemophilia B for control and prevention of bleeding episodes, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes. ALPROLIX™ is not indicated for induction of immune tolerance in patients with Hemophilia B.

SIZE:
5ml

SHELF LIFE:
36 Months

STORAGE:
Store ALPROLIX™ in the original package in order to protect it from light. Store ALPROLIX™ at 2°C to 8°C (36°F to 46°F). Do not freeze. Freezing will damage the pre-filled diluent syringe. Do not use product or diluent after the expiration date printed on the carton, vial or syringe. Discard any product not used within 3 hours after reconstitution.

Vial Size NDC #
500 IU 64406-911-01
1000 IU 64406-922-01
2000 IU 64406-933-01
3000 IU 64406-944-01

BeneFIX

PRODUCT NAME: BeneFIX R/T

FORMULATION & CONCENTRATION: [Coagulation Factor IX (Recombinant)]

MANUFACTURER: Pfizer

INDICATIONS:
BeneFIX®, Coagulation Factor IX (Recombinant), is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with hemophilia B (congenital factor IX deficiency or Christmas disease). BeneFIX®, Coagulation Factor IX (Recombinant), is indicated for peri-operative management in adult and pediatric patients with hemophilia B. BeneFIX®, Coagulation Factor IX (Recombinant), is NOT indicated for: (1) treatment of other factor deficiencies (e.g., factors II, VII, VIII, and X), (2) treatment of hemophilia A patients with inhibitors to factor VIII, (3) reversal of coumarin-induced anti coagulation, (4) treatment of bleeding due to low levels of liver-dependent coagulation factors

SHELF LIFE:
24 months

STORAGE:
Product as packaged for sale: BeneFIX®, Coagulation Factor IX (Recombinant), can be stored at room temperature or under refrigeration, at a temperature of 2 to 30°C (36 to 86°F) . Do not use BeneFIX® after the expiration date on the label. Do not freeze to prevent damage to the diluent syringe. Product after reconstitution: The product does not contain a preservative and should be used within 3 hours

Full Prescribing Information for BeneFIX R/T

Vial Size NDC # Size
250 IU 58394-633-03 5ml
500 IU 58394-634-03 5ml
1000 IU 58394-635-03 5ml
2000 IU 58394-636-03 5ml

Mononine

PRODUCT NAME: Mononine

FORMULATION & CONCENTRATION: Coagulation Factor IX (Human) Monoclonal Antibody Purified

MANUFACTURER: CSL

INDICATIONS:
Prevention and control of bleeding in factor IX deficiency, also known as hemophilia B or Christmas disease.

SHELF LIFE:
24 Months

STORAGE:
"Store in refrigerator, 2-8°C (36-46°F) for the period indicated by the expiration date on the label. Within this period, Mononine® may be stored at room temperature not to exceed 25°C (77°F), for up to one month. Avoid freezing, which may damage container for the diluent"

Full Prescribing Information for Mononine

Vial Size NDC # Size
500 IU 0053-6232-02 5ml
1000 IU 0053-6233-02 10ml

Rixubis

RECOMBINANT: Factor IX
Rixubus

MANUFACTURER: Baxalta

INDICATIONS:
Indicated in adults and children with hemophilia B for:
• Control and prevention of bleeding episodes, perioperative management, and routine prophylaxis

  • Store Rixubis at refrigerated temperature; 2° to 8° C (36° to 46°F) for up to 24 months
  • Do not freeze Rixubis
  • May store at room temperature not to exceed 30°C (86°F) for up to 12 months within the 24-month time period.
Vial Size NDC # Color Code
250 IU 0944-3026-02 Light Blue
500 IU 0944-3028-02 Pink
1000 IU L0944-3030-02 Green
2000 IU 0944-3032-02 Orange
3000 IU 0944-3034-02 Silver