VWF


Alphanate

PRODUCT NAME: 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.

Full Prescribing Information for Alphanate

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

Humate-P

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

MANUFACTURER: CSL Behring

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.

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

Stimate

PRODUCT NAME: Stimate

FORMULATION & CONCENTRATION: (desmopressin acetate) Nasal Spray

MANUFACTURER: CSL

INDICATIONS:
Stimate® Nasal Spray is indicated for patients with hemophilia A with factor VIII coagulant activity levels greater than 5%. Stimate® Nasal Spray is indicated for patients with mild to moderate von Willebrand disease (type 1) with factor VIII levels greater than 5%.

May be used prophylactically to maintain hemostasis during minor surgical procedures and postoperatively
May be used to treat bleeding associated with minor injuries, mucosal bleeding, and menorrhagia; patients should be counseled to seek medical attention for certain bleeds
Effectively elevates levels of FVIII:C, VWF:Ag, and ristocetin cofactor activity

STORAGE:
Store at room temperature not to exceed 25°C (77°F) for the period indicated by the expiration date on the label. Discard six months after being opened. Store bottle in upright position.

Full Prescribing Information for Stimate

Vial Size NDC #
3.75 mg 0053-6871-00

Wilate

PRODUCT NAME: Wilate

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

MANUFACTURER: Octapharma

INDICATIONS:
wilate® is a von Willebrand Factor/Coagulation Factor VIII Complex (Human) indicated for the treatment of spontaneous and trauma-induced bleeding episodes in patients with severe von Willebrand disease (vWD) as well as patients with mild or moderate vWD in whom the use of desmopressin is known or suspected to be ineffective or contraindicated

SHELF LIFE:
N/A

STORAGE:
Store wilate® for up to 36 months at +2°C to +8°C (36°F to 46°F), protected from light, from the date of manufacture. Within this period, wilate® may be stored for a period of up to 6 months at room temperature (maximum of +25°C or 77°F). Do not freeze.

Full Prescribing Information for Wilate

Vial Size NDC #
450 Rcof 67467-181-01
500 Rcof 67467-182-01
900 Rcof 67467-181-02
1000 Rcof 67467-182-02