Factor VIII


Plasma

Alphanate

FORMULATION & CONCENTRATION: Antihemophilic Factor/von Willebrand Factor Complex (Human)

MANUFACTURER: Grifols

INDICATIONS:
Alphanate® is indicated for:
1. Control and prevention of bleeding in patients with hemophilia A.
2. Surgical and/or invasive procedures in adult and pediatric patients with von Willebrand Disease in whom desmopressin (DDAVP) is either ineffective or contraindicated. It is not indicated for patients with severe VWD (Type 3) undergoing major surgery.

SHELF LIFE:
Stable for three years, up to the expiration date

STORAGE:
Store at or below 25°C (77°F). Do not freeze.

Vial Size NDC # Size
250 IU 68516-4601-1 5ml
500 IU 68516-4602-1 5ml
1000 IU 68516-4603-2 10ml
1500 IU 68516-4604-2 10ml

Corifact

PRODUCT NAME: Corifact

FORMULATION & CONCENTRATION: Factor XIII Concentrate (Human)

MANUFACTURER: CSL Behring

INDICATIONS:
Approved for patients with congenital FXIII deficiency

Corifact is indicated for routine prophylactic treatment and perioperative management of surgical bleeding in adult and pediatric patients with congenital Factor XIII (FXIII) deficiency. Corifact must be administered intravenously.

SHELF LIFE:
24 Months

STORAGE:
Store Corifact under refrigeration at a temperature of 36°F-46°F (2°C – 8°C) for up to 24 months from the date of manufacture until the expiration date stated on the label. Corifact may also be stored at room temperature not to exceed 77°F (25°C) for up to six (6) months.

Vial Size NDC #
1000-1600 IU 63833-0518-02

Hemofil M

PRODUCT NAME: Hemofil M

FORMULATION & CONCENTRATION: [Antihemophilic Factor (Human) Method M, Monoclonal Purified]

MANUFACTURER: Baxter

INDICATIONS:
Prevention and control of bleeding episodes in patients with Hemophilia A; can be of therapeutic value in patients with FVIII inhibitors not exceeding 10 BU. See PI for additional details.

SHELF LIFE:
30 months

STORAGE:
Refrigeration 2° – 8°C (36° – 46°F) or room temperature, not to exceed 30°C or 86°F until expiration date noted on package

Full Prescribing Information for Hemofil M

Vial Size NDC # Manufacturer # Size
220-400 IU 0944-2930-01 1501805 10ml
401-800 IU 0944-2931-01 1501806 10ml
801–1700 IU 0944-2932-01 1501807 10ml
1701-2000 IU 0944-2933-01 1501808 10ml

Humate-P

PRODUCT NAME: Humate

FORMULATION & CONCENTRATION: Antihemophilic Factor/von Willebrand Factor Complex (Human)

MANUFACTURER: CSL

INDICATIONS:
Prevention and treatment of bleeding in adult patients with Hemophilia A. Also indicated for adult and pediatric patients with von Willebrand disease for (1) treatment of spontaneous and trauma-induced bleeding episodes and (2) prevention of excessive bleeding during and after surgery. This applies to patients with severe vWD as well as patients with mild to moderate vWD where use of desmopressin is known or suspected to be inadequate

SHELF LIFE:
24 months

STORAGE:
When stored up to 25°C (up to 77°F), Humate-P® is stable up to the expiration printed on the label. Avoid freezing.

Full Prescribing Information for Humate

Vial Size NDC # Size
600 Rcof (250 IU) 63833-615-02 5ml
1200 Rcof (500 IU) 63833-616-02 10ml
2400 Rcof (1000 IU) 63833-616-02 15ml

Koate DVI

PRODUCT NAME: Koate DVI

INDICATIONS & USAGE:
Koate-DVI is indicated for the treatment of classical hemophilia (hemophilia A) in which there is a demonstrated deficiency of activity of the plasma clotting factor, factor VIII.
Koate-DVI, a plasma-derived factor VIII concentrate, contains naturally occurring von Willebrand factor, which is co-purified as part of the manufacturing process.
Koate-DVI has not been investigated for efficacy in the treatment of von Willebrand disease, and is not approved for such usage.

IMPORTANT SAFETY INFORMATION:
Koāte-DVI is indicated for the treatment of classical hemophilia (hemophilia A) in which there is a demonstrated deficiency of activity of the plasma clotting factor, factor VIII.
Allergic-type reactions may result from the administration of Antihemophilic Factor (Human) preparations. In clinical studies, adverse reactions included tingling in the arm, ear, and face, blurred vision, headache, nausea, stomach ache, and jittery feeling.
Koāte-DVI is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent that can cause disease. There is also the possibility that unknown infectious agents may be present in such products.
Hepatitis B vaccination is essential for patients with hemophilia A; vaccination is recommended at birth or at the time of diagnosis. Hepatitis A vaccination is also recommended for hemophilia patients who are hepatitis A seronegative.

Full Prescribing Information for Koate DVI

YOU ARE ENCOURAGED TO REPORT NEGATIVE SIDE EFFECTS OF PRESCRIPTION DRUGS TO THE FDA. VISIT WWW.FDA.GOV/MEDWATCH, OR CALL 1-800-FDA-1088.


Monoclate-P

PRODUCT NAME: Monoclate P

FORMULATION & CONCENTRATION: Antihemophilic Factor (Human) Factor VIII:C Pasteurized Monoclonal Antibody Purified

MANUFACTURER: CSL

INDICATIONS:
Treatment of classical hemophilia (hemophilia A).

SHELF LIFE:
24 Months

STORAGE:
Store in refrigerator, 2-8°C (36-46°F) through expiration date on label. Within this period, Monoclate-P® may be stored at room temperature, not to exceed 25°C (77°F), for up to 6 months. Avoid freezing which may damage container for the diluent.

Full Prescribing Information for Monoclate P

Vial Size NDC # Size
250 IU 0053-7656-01 2.5ml
500 IU 0053-7656-02 5ml
1000 IU 0053-7656-04 10ml
1500 IU 0053-7656-05 10ml

Recombinant

Advate

PRODUCT NAME: Advate

FORMULATION & CONCENTRATION: [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method]

MANUFACTURER: Baxter

INDICATIONS:
ADVATE is indicated in hemophilia A (classical hemophilia) for the control and prevention of bleeding episodes and perioperative management in adults and children with hemophilia A and for the peri-operative management in adults and children with hemophilia A. ADVATE is not indicated for the treatment of von Willebrand’s disease.

SHELF LIFE:
24 Months

STORAGE:
2°-8°C (36°-46°F). May be stored at room temperature, up to 30°C (86°F) for up to 6 months or until expiration date, whichever comes first

Full Prescribing Information for Advate

Vial Size NDC # Manufacturer #
200-400 IU 0944-2941-10 1500243
401-800 IU 0944-2942-10 1500244
801-1200 IU 0944-2943-10 1500245
1201-1800 IU 0944-2944-10 1500246
1801-2400 IU 0944-2945-10 1501376
2401-3600 IU 0944-2946-10 1501486

Adynovate

FORMULATION & CONCENTRATION: Antihemophilic Factor (Recombinant), PEGylated Lyophilized Powder for Solution

For Intravenous Injection

MANUFACTURER: Baxalta

INDICATIONS:
ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is a human antihemophilic factor indicated in adolescent and adult patients (12 years and older) with hemophilia A (congenital factor VIII deficiency) for the on-demand treatment and control of bleeding episodes and for routine prophylaxis to reduce the frequency of bleeding episodes.

ADYNOVATE is not indicated for the treatment of von Willebrand disease.

STORAGE:
Store Adynovate under refrigeration at a temperature of 36°F-46°F (2°C – 8°C). Adynovate may also be stored at room temperature not to exceed 86°F (30°C) for up to one (1) month.

Vial Size NDC #
200 – 400 IU 00944-4252-02
401 – 800 IU 00944-4254-02
801 – 1250 IU 00944-4256-02
1251 – 2500 IU 00944-4258-02

Eloctate

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

MANUFACTURER: Biogen Idec

INDICATIONS:
"ELOCTATE Antihemophilic Factor (Recombinant), Fc Fusion Protein, is a recombinant DNA derived, antihemophilic factor indicated in adults and children with Hemophilia A (congenital Factor VIII deficiency) for control and prevention of bleeding episodes, perioperative management (surgical prophylaxis), and routine prophylaxis to prevent or reduce the frequency of bleeding episodes. ELOCTATE is not indicated for the treatment of von Willebrand disease."

SIZE:
3ml

SHELF LIFE:
30 Months

STORAGE:
Store ELOCTATE in the original package to protect vials from light. Store ELOCTATE in powder form at 2°C to 8°C (36°F to 46°F). Do not freeze to avoid damage to the pre-filled diluent syringe. After reconstitution, if the product is not used within 3 hours, it must be discarded

Vial Size NDC #
250 IU 64406-801-01
500 IU 64406-802-01
750 IU 64406-803-01
1000 IU 64406-804-01
1500 IU 64406-805-01
2000 IU 64406-806-01
3000 IU 64406-807-01

Helixate FS

PRODUCT NAME: Helixate FS

FORMULATION & CONCENTRATION: Antihemophilic Factor (Recombinant) Formulated with Sucrose

MANUFACTURER: CSL

INDICATIONS:
For control and prevention of bleeding episodes in adults and children with Hemophilia A; peri-operative management in adults and children and routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children with Hemophilia A with no pre-existing joint damage

SHELF LIFE:
24 months under refrigeration

STORAGE:
Store in refrigerator at 2-8°C (36-46°F) for period indicated by the expiration date on the label. Within this period, Helixate®® FS may also be stored at room temperature, not to exceed 25°C (77°F), for up to 12 months, such as in home treatment situations. Do not freeze. Protect from extreme exposure to light and store the lyophilized powder in the carton prior to use.

Full Prescribing Information for Helixate FS

Vial Size NDC # Size
250 IU 0053-8131-02 2.5ml
500 IU 0053-8132-02 2.5ml
1000 IU 0053-8133-02 5ml
2000 IU 0053-8134-02 5ml
3000 IU 0053-8135-02 5ml

Kogenate FS

PRODUCT NAME: Kogenate FS

FORMULATION & CONCENTRATION: antihemophilic factor (recombinant)

MANUFACTURER: Bayer Healthcare

INDICATIONS:
Control and prevention of bleeding episodes in adults and children (0-16 years) with Hemophilia A; Peri-operative management in adults and children with Hemophilia A; Routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children with Hemophilia A with no pre-existing joint damage.

SHELF LIFE:
30 Months

STORAGE:
Product as Packaged for Sale: Store Kogenate® FS at +2°C to +8°C (36°F to 46°F) for up to 30 months from the date of manufacture. Within this period, Kogenate® FS may be stored for a period of up to 12 months at temperatures up to +25°C or 77°F, such as in home treatment situations. The starting date of room temperature storage should be clearly recorded on the unopened product carton.
Once stored at room temperature, the product must not be returned to the refrigerator. The shelf-life then expires after the storage at room temperature, or the expiration date on the product vial, whichever is earlier. Do not use Kogenate® FS after the expiration date indicated on the vial. Do not freeze. Protect from extreme exposure to light and store the lyophilized powder in the carton prior to use. Product After Reconstitution: Administer Kogenate® FS within 3 hours after reconstitution. It is recommended to use the administration set provided

Full Prescribing Information for Kogenate FS

Vial Size NDC # Size
250 IU 0026-3782-20 2.5ml
500 IU 0026-3783-30 2.5ml
1000 IU 0026-3785-50 2.5ml
2000 IU 0026-3786-60 5ml
250 IU w/ Bioset 0026-3792-20 2.5ml
500 IU w/ Bioset 0026-3793-30 2.5ml
1000 IU w/ Bioset 0026-3795-50 2.5ml
2000 IU w/ Bioset 0026-3796-60 5ml
3000 IU w/ Bioset 0026-3797-70 5ml

Novoeight

FORMULATION & CONCENTRATION: Novoeight®, Antihemophilic Factor (Recombinant) For Intravenous Injection. Lyophilized Powder for Solution Initial

MANUFACTURER: Novo Nordisk

INDICATIONS:
Novoeight is indicated for use in adults and children with hemophilia A for the control and prevention of bleeding, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

Novoeight® is not indicated for the treatment of von Willebrand disease.

SHELF LIFE:
Refrigerated up to thirty (30) months

Room temperature up to twelve (12) months

STORAGE:
Store Novoeight under refrigeration at a temperature of 36°F-46°F (2°C – 8°C). Novoeight may also be stored at room temperature not to exceed 86°F (30°C).

Vial Size NDC #
250 IU 0169-7825-01
500 IU 0169-7850-01
1000 IU 0169-7810-01
1500 IU 0169-7815-01
2000 IU 0169-7820-01
3000 IU 0169-7830-01

NUWIQ

FORMULATION & CONCENTRATION: Antihemophilic Factor (Recombinant)

MANUFACTURER:
Octapharma

INDICATIONS:
NUWIQ is a recombinant antihemophlic factor (blood coagulation factor VIII) indicated in adults and children with Hemophilia A for:

  • On-demand treatment and control of bleeding episodes
  • Perioperative management of bleeding
  • Routine prophylaxis to reduce the frequency of bleeding episodes

STORAGE:

  • Store NUWIQ in original package to protect the vials from light
  • Store NUWIQ in powder form at 2-8°C (35-46°F) for up to 24 months
  • During the shelf life, the product may be kept at room temperature (up to 25°C/77°F) for a single period not exceeding 3 months. After storage at room temperature, do not return the product to the refrigerator
  • Keep the reconstituted solution at room temperature. Do not refrigerate after reconstitution. Use the reconstituted solution immediately or within 3 hours of reconstitution
  • Do not freeze
Vial Size NDC #
250 IU 68982-139-01
500 IU 68982-141-01
1000 IU 68982-143-01
2000 IU 68982-145-01

Recombinate

PRODUCT NAME: Recombinate

GENERIC NAME: [Antihemophilic Factor (Recombinant)]

MANUFACTURER: Baxter

INDICATIONS:
RECOMBINATE is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes and for the perioperative management of patients with hemophilia A. RECOMBINATE is not indicated for von Willebrand’s disease.

SHELF LIFE:
36 Months

STORAGE:
Refrigeration 2° – 8°C (36° – 46°F) or room temperature, not to exceed 30°C or 86°F until expiration date noted on package.

Full Prescribing Information for Recombinate supplied with 5mL diluent
Full Prescribing Information for Recombinate supplied with 10mL diluent

Vial Size NDC # Manufacturer # Size
220-400 IU 0944-2831-10 501592 10ml w/ Baxjet II Device
401-800 IU 0944-2832-10 1501593 10ml w/ Baxjet II Device
801-1240 IU 0944-2833-10 1501594 10ml w/ Baxjet II Device
1241-1800 IU 0944-2834-10 1502946 10ml w/ Baxjet II Device
1801-2400 IU 0944-2835-10 1502947 10ml w/ Baxjet II Device
220-400 IU 0944-2841-10 1502735 5ml w/ Baxjet II Device
401-800 IU 0944-2842-10 1502736 5ml w/ Baxjet II Device
801-1240 IU 0944-2843-10 1502737 5ml w/ Baxjet II Device
1241-1800 IU 0944-2844-10 1503132 5ml w/ Baxjet II Devic
1801-2400 IU 0944-2845-10 1503133 5ml w/ Baxjet II Device

Xyntha

PRODUCT NAME: Xyntha

FORMULATION & CONCENTRATION: [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free]

MANUFACTURER: Pfizer

INDICATIONS:
XYNTHA™ Antihemophilic Factor (Recombinant), Plasma/Albumin-Free is indicated for the control and prevention of bleeding episodes in patients with Hemophilia A (congenital factor VIII deficiency or classic Hemophilia). XYNTHA™ does not contain von Willebrand factor, and therefore is not indicated in patients with von Willebrand’s disease. XYNTHA™ Antihemophilic Factor (Recombinant), Plasma/Albumin-Free is indicated for surgical prophylaxis in patients with Hemophilia A.

SIZE:
4ml

SHELF LIFE:
36 Months

STORAGE:
Product as Packaged for Sale: (1) Store XYNTHA™ under refrigeration at a temperature of 2° to 8°C (36° to 46°F) for up to 36 months from the date of manufacture until the expiration date stated on the label. Within the expiration date, XYNTHA™ may also be stored at room temperature not to exceed 25°C (77°F) for up to 3 months. After room temperature storage, XYNTHA™ can be returned to the refrigerator until the expiration date. Do not store XYNTHA™ at room temperature and return it to the refrigerator more than once. (2) The starting date at room temperature storage should be clearly recorded in the space provided on the outer carton. At the end of the 3-month period, the product must be used immediately, discarded, or returned to refrigerated storage. The diluent syringe may be stored at 2° to 25°C (36° to 77°F). (3) Do not use XYNTHA™ after the expiration date. (4) Do not freeze to prevent damage to the prefilled diluent syringe. (5) During storage, avoid prolonged exposure of XYNTHA™ vial to light. Product After Reconstitution: Administer XYNTHA™ within 3 hours after reconstitution. The reconstituted solution may be stored at room temperature prior to administration.

Full Prescribing Information for Xyntha

Vial Size NDC #
250 IU 58394-012-01
500 IU 58394-013-01
1000 IU 58394-014-01
2000 IU 58394-015-01
3000 IU 58394-016-03