Dosing & Uses
Dosage Forms & Strengths
Product strength listed as Factor VIII (FVIII) potency as international units (IU)
Also labeled with VWF:RCo activity expressed in IU VWF:RCo/vial
IV solution (lyophilized powder for reconstitution)
- 250 IU (Alphanate, Humate P)
- 450 IU FVIII/450 VWF:RCo (Wilate)
- 500 IU (Alphanate, Humate P)
- 900 IU FVIII/900 VWF:RCo (Wilate)
- 1000 IU (Alphanate, Humate P)
- 1500 IU (Alphanate)
Hemophilia A
Wilate
Indicated for hemophilia A as routine prophylaxis to reduce the frequency of bleeding episodes and for on-demand treatment and control of bleeding episodes
-
On-demand hemorrhage treatment
- Minor: 30-40 IU/kg IV q12-24hr for at least 1 day until hemorrhage resolved
- Moderate: 30-40 IU/kg IV q12-24hr for at least 3-4 days until hemorrhage resolved
- Major: 35-50 IU/kg IV q12-24hr for at least 3-4 days until hemorrhage resolved
- Life-threatening: 35-50 IU/kg IV q8-12hr until threat has resolved
-
Routine prophylaxis
- 20-40 IU/kg IV every 2-3 days
Alphanate
- Indicated for control and prevention of bleeding episodes and perioperative management of Factor VIII (FVIII) deficiency due to hemophilia A
- Dose (units) = body weight (kg) x desired FVIII rise (IU/dL or % of normal) x 0.5 (IU/kg per IU/dL)
- Frequency of intravenous injection of the reconstituted product is determined by the type of bleeding episode and the recommendation of the treating physician
-
Bleeding episode control
- Minor: 15 IU/kg IV q12hr for 1-2 days until hemorrhage stops and healing achieved
- Moderate: 25 IU/kg IV q12hr for 2-7 days (average) until healing achieved
- Major: 40-50 IU/kg IV q12hr for at least 3-5 days until healing achieved for up to 10 days; intracranial hemorrhage may require prophylaxis therapy for up to 6 months
-
Surgery
- Before surgery: 40-50 IU/kg IV once
- After surgery: 30-50 IU/kg IV q12hr for the next 7-10 days, or until healing has been achieved
Humate P
- Minor hemorrhage: Loading dose is 15 IU/kg IV should achieve FVIII:C plasma level ~30% of normal; may repeat using 50% of loading dose once or twice daily for 1-2 days
- Moderate hemorrhage: Loading dose is 25 IU/kg IV should achieve FVIII:C plasma level ~50% of normal, followed by 15 IU/kg q8-12hr for 1-2 days to maintain FVIII:C levels at 30% normal, and then the same dose once or twice daily for up to 7 days or until adequate wound healing
- Life-threatening hemorrhage: 40-50 IU/kg IV initially, followed by 2-25 IU q8-12hr to maintain FVIII:C level at 80-100% of normal for 7 days, then continue the same dose once or twice daily for another 7 days to maintain FVIII:C level at 30-50% of normal
Von Willebrand Disease
Alphanate
- Indicated for surgical and/or invasive procedures in adult and pediatric patients with von Willebrand disease in whom desmopressin is either ineffective or contraindicated; it is not indicated for patients with severe VWD (Type 3) undergoing major surgery
- Preoperative dose of 60 IU VWF:RCo/kg IV; maintenance dose is 40-60 IU VWF:RCo/kg IV at 8-12 hr intervals postoperative as clinically needed
- Minor surgery/bleeding: 1-3 days; target FVIII activity is 40-50 IU/dL
- Major surgery/bleeding: 3-7 days; target FVIII activity is 100 IU/dL
Humate P
- Indicated in 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
- VWD type 1, mild (major hemorrhage): Loading dose of 40-60 IU/kg IV, then 40-50 IU/kg q8-12hr for 3 days to keep trough level of VWF:RCo >50%; then 40-50 IU/kg/day for up to 7 days
- VWD type 1, moderate or severe (minor hemorrhage): 40-50 IU/kg IV x1-2 doses
- VWD type 1, moderate or severe (major hemorrhage): Loading dose of 50-75 IU/kg IV, then 40-60 IU/kg q8-12hr for 3 days to keep trough level of VWF:RCo >50%; then 40-60 IU/kg/day for up to 7 days
- VWD type 2 and 3 (minor hemorrhage): 40-50 IU/kg IV x1-2 doses
- VWD type 2 and 3 (major hemorrhage): Loading dose of 60-80 IU/kg IV, then 40-60 IU/kg q8-12hr for 3 days to keep trough level of VWF:RCo >50%; then 40-60 IU/kg/day for up to 7 days
- Major surgery: IU = Target peak plasma (100 IU/dL) – baseline plasma VWF:RCo x kg / incremental recovery
- Minor/oral surgery: IU = Target peak plasma (50-60 IU/dL) – baseline plasma VWF:RCo x kg / incremental recovery
Wilate
- Indicated in children and adults with von Willebrand disease for on-demand treatment and control of bleeding episodes, and also for perioperative management of bleeding (for minor or major surgery)
- Minor hemorrhage: Loading dose is 20-40 IU/kg IV, then 20-30 IU/kg q12-24hr; VWF:RCo and FVIII trough level of >30% normal, may continue for up to 3 days
- Major hemorrhage: Loading dose is 40-60 IU/kg IV, then 20-40 IU/kg q12-24hr; VWF:RCo and FVIII trough level of >50% normal, may continue for 5-7 days
- Minor surgeries: Loading dose is 30-60 IU/kg IV, then 15-30 IU/kg q12-24hr; VWF:RCo and FVIII trough level of >30% normal, may continue until wound healing achieved for up to 3 days
- Major surgeries: Loading dose is 40-60 IU/kg IV, then 20-40 IU/kg q12-24hr; VWF:RCo and FVIII trough level of >50% normal, may continue until wound healing achieved for up to 6 days or more
Dosing Considerations
VWF:RCo activity is not less than 0.4 VWF:RCo IU per 1 IU of FVIII:C
One IU of FVIII or one IU of VWF:RCo is approximately equal to the amount of FVIII or VWF:RCo activity in 1 mL of freshly-pooled human plasma
Alphanate contains heparin not exceeding 1 U/mL
Albumin: 3-9 mg/mL (Alphanate); 8-16 mg/mL (Humate P)
Dosage Forms & Strengths
Product strength listed as Factor VIII (FVIII) potency as international units (IU)
Also labeled with VWF:RCo activity expressed in IU VWF:RCo/vial
IV solution (lyophilized powder for reconstitution)
- 250 IU (Alphanate, Humate P)
- 450 IU FVIII/450 VWF:RCo (Wilate)
- 500 IU (Alphanate, Humate P)
- 900 IU FVIII/900 VWF:RCo (Wilate)
- 1000 IU (Alphanate, Humate P)
- 1500 IU (Alphanate)
Hemophilia A
Humate P: Adequate and well-controlled studies with long-term evaluation of joint damage have not been done
Wilate
- Indicated for adolescents with hemophilia A as routine prophylaxis to reduce the frequency of bleeding episodes and for on-demand treatment and control of bleeding episodes
-
On-demand hemorrhage treatment
- Minor: 30-40 IU/kg IV q12-24hr for at least 1 day, until hemorrhage resolved
- Moderate: 30-40 IU/kg IV q12-24hr for at least 3-4 days, until hemorrhage resolved
- Major: 35-50 IU/kg IV q12-24hr for at least 3-4 days, until hemorrhage resolved
- Life-threatening: 35-50 IU/kg IV q8-12hr until threat has resolved
-
Routine prophylaxis
- 20-40 IU/kg IV every 2-3 days
Alphanate
- Indicated for control and prevention of bleeding episodes and perioperative management of Factor VIII (FVIII) deficiency due to hemophilia A
- Dose (units) = body weight (kg) x desired FVIII rise (IU/dL or % of normal) x 0.5 (IU/kg per IU/dL)
- Frequency of intravenous injection of the reconstituted product is determined by the type of bleeding episode and the recommendation of the treating physician
-
Bleeding episode control
- Minor: 15 IU/kg IV q12hr for 1-2 days until hemorrhage stops and healing achieved
- Moderate: 25 IU/kg IV q12hr for 2-7 days (average) until healing achieved
- Major: 40-50 IU/kg IV q12hr for at least 3-5 days until healing achieved for up to 10 days; intracranial hemorrhage may require prophylaxis therapy for up to 6 months
-
Surgery
- Before surgery: 40-50 IU/kg IV once
- After surgery: 30-50 IU/kg IV q12hr for the next 7-10 days, or until healing has been achieved
Von Willebrand Disease
Alphanate
- Indicated for surgical and/or invasive procedures in adult and pediatric patients with von Willebrand disease in whom desmopressin is either ineffective or contraindicated; it is not indicated for patients with severe VWD (Type 3) undergoing major surgery
- Preoperative dose of 60 IU VWF:RCo/kg IV; maintenance dose is 40-60 IU VWF:RCo/kg IV at 8-12 hr intervals postoperative as clinically needed
- Minor surgery/bleeding: 1-3 days; target FVIII activity is 40-50 IU/dL
- Major surgery/bleeding: 3-7 days; target FVIII activity is 100 IU/dL
Humate P
- VWD type 1, mild (major hemorrhage): Loading dose of 40-60 IU/kg IV, then 40-50 IU/kg q8-12hr for 3 days to keep trough level of VWF:RCo >50%; then 40-50 IU/kg/day for up to 7 days
- Indicated in 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
- VWD type 1, moderate or severe (minor hemorrhage): 40-50 IU/kg IV x1-2 doses
- VWD type 1, moderate or severe (major hemorrhage): Loading dose of 50-75 IU/kg IV, then 40-60 IU/kg q8-12hr for 3 days to keep trough level of VWF:RCo >50%; then 40-60 IU/kg/day for up to 7 days
- VWD type 2 and 3 (minor hemorrhage): 40-50 IU/kg IV x1-2 doses
- VWD type 2 and 3 (major hemorrhage): Loading dose of 60-80 IU/kg IV, then 40-60 IU/kg q8-12hr for 3 days to keep trough level of VWF:RCo >50%; then 40-60 IU/kg/day for up to 7 days
- Major surgery: IU = Target peak plasma (100 IU/dL) – baseline plasma VWF:RCo x kg / incremental recovery
- Minor/oral surgery: IU = Target peak plasma (50-60 IU/dL) – baseline plasma VWF:RCo x kg / incremental recovery
Wilate
- Indicated in children and adults with von Willebrand disease for on-demand treatment and control of bleeding episodes, and also for perioperative management of bleeding (for minor or major surgery)
- Minor hemorrhage: Loading dose is 20-40 IU/kg IV, then 20-30 IU/kg q12-24hr; VWF:RCo and FVIII trough level of >30% normal, may continue for up to 3 days
- Major hemorrhage: Loading dose is 40-60 IU/kg IV, then 20-40 IU/kg q12-24hr; VWF:RCo and FVIII trough level of >50% normal, may continue for 5-7 days
- Minor surgeries: Loading dose is 30-60 IU/kg IV, then 15-30 IU/kg q12-24hr; VWF:RCo and FVIII trough level of >30% normal, may continue until wound healing achieved for up to 3 days
- Major surgeries: Loading dose is 40-60 IU/kg IV, then 20-40 IU/kg q12-24hr; VWF:RCo and FVIII trough level of >50% normal, may continue until wound healing achieved for up to 6 days or more
Dosing Considerations
VWF:RCo activity is not less than 0.4 VWF:RCo IU per 1 IU of FVIII:C
One IU of FVIII or one IU of VWF:RCo is approximately equal to the amount of FVIII or VWF:RCo activity in 1 mL of freshly-pooled human plasma
Alphanate contains heparin not exceeding 1 U/mL
Albumin: 3-9 mg/mL (Alphanate); 8-16 mg/mL (Humate P)
Adverse Effects
>10%
Pain (14-31%)
1-10%
Respiratory distress (>5%)
Pruritus (>5%)
Rash (>5%)
Urticaria (>5%)
Face edema (>5%)
Paresthesia (>5%)
Pain (>5%)
Fever (>5%)
Chills (>5%)
Joint pain (>5%)
Fatigue (>5%)
Headache (3-4%)
Asthenia (1%)
Cellulitis (1%)
Chest pain (1%)
Flu syndrome (1%)
Dyspepsia (1%)
GI disorder (1%)
Hepatitis (1%)
Nausea (1%)
Vomiting (1%)
Increased cough (1%)
Lung disorder (1%)
Pharyngitis (1%)
Rhinitis (1%)
Warnings
Contraindications
Hypersensitivity
Cautions
May cause hypersensitivity reactions, including anaphylaxis
Procoagulant activity-neutralizing antibodies have been detected; suspect this if FVIII activity levels are not attained, or if bleeding is not controlled
Thromboembolic events reported in patients with VWD receiving AHF/VWF complex
Massive doses may result in acute hemolytic anemia
Made from pooled human plasma; risk of transmitting infectious agents (eg, viruses, CJD)
Pregnancy & Lactation
Pregnancy
Data are limited regarding use in pregnant women to inform a drug-associated risk
Animal reproduction studies have not been conducted
Do not administer to pregnant women unless clearly needed
Lactation
No human or animal data are available; use only if clearly needed
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Antihemophilic Factor (FVIII) and von Willebrand Factor (VWF) are constituents of normal plasma, which are required for clotting
Temporarily increases the plasma level of FVIII, thus minimizing the hazard of hemorrhage in patients with hemophilia A; FVIII is an essential cofactor in activation of factor X leading to formation of thrombin and fibrin
VWF promotes platelet aggregation and platelet adhesion on damaged vascular endothelium; it also serves as a stabilizing carrier protein for the procoagulant protein FVIII
Pharmacokinetics
Alphanate
- Half-life: 17.9 hr (FVIII)
- Recovery at 10 min postinfusion: 96.7% (determined as 2.4 IU FVIII rise/cL plasma per IU FVIII infused/kg)
- Median bleeding time decreased from 30 min (preinfusion) to 10.38 min (1 hr postinfusion)
Humate P
- Half-life: 10-11 hr
- Clearance: 4.8-31 mL/hr/kg
- Vd: 53-59 mL/kg
Wilate
- Peak plasma concentration: 76 IU/dL
- AUC: 1235 IU•hr/dL
- Half-life: 15.8 hr
- Clearance: 3.7 mL/hr/kg
- Vd: 69.7 mL/kg
Administration
IV Preparation
Warm diluent (sterile water for injection) and concentrate to at least room temperature (not to exceed 37°C)
Use Mix2Vial to reconstitute lyophilized powder with diluent
Gently swirl product vial to ensure dissolution; do not shake
Administer IV within 3 hr following reconstitution
IV Administration
Too rapid of infusion rate may cause vasomotor reactions (eg, hypotension)
IV infusion rate
- Alphanate: Not to exceed 10 mL/min
- Humate P: Not to exceed 4 mL/min
- Wilate: Infuse IV at 2-4 mL/min
Storage
Do not freeze
Reconstituted solution may be stored at room temperature (not to exceed 30°C) prior to administration for up to 3 hr; do not refrigerate after reconstitution
Alphanate
- Store unopened vials between 2-8°C [34-46°F]) in original carton and protect from light
- May store at room temperature (not to exceed 30°C) for up to 2 months
Humate P
- Store unopened vials up to 25°C (up to 77°F); stable up to the expiration date printed on its label
Wilate
- Store unopened vials for up to 36 months at 2-8°C (36-46°F) protected from light from the date of manufacture
- Within this period, may store for a period of up to 6 months at room temperature (not to exceed 25°C or 77°F)
- Once stored at room temperature, the product must not be returned to the refrigerator
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Alphanate intravenous - | 1,500 (600 vWF) unit/10 mL vial |  | |
| Alphanate intravenous - | 500 (200 vWF) unit/5 mL vial |  | |
| Alphanate intravenous - | 1,000 (400 vWF) unit/10 mL vial |  | |
| Alphanate intravenous - | 250 (100 vWF) unit/5 mL vial |  | |
| Humate-P intravenous - | 250-600 unit vial |  | |
| Humate-P intravenous - | 500-1,200 unit vial |  |
Copyright © 2010 First DataBank, Inc.
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