WILATE - VON WILLEBRAND FACTOR/COAGULATION FACTOR VIII COMPLEX (HUMAN) (von willebrand factor/coagulation factor viii complex- h

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

ANTIHEMOPHILIC FACTOR HUMAN (UNII: 839MOZ74GK) (ANTIHEMOPHILIC FACTOR HUMAN - UNII:839MOZ74GK), VON WILLEBRAND FACTOR HUMAN (UNII: ZE22NE22F1) (VON WILLEBRAND FACTOR HUMAN - UNII:ZE22NE22F1)

Dostupno od:

Octapharma USA Inc

INN (International ime):

ANTIHEMOPHILIC FACTOR HUMAN

Sastav:

ANTIHEMOPHILIC FACTOR HUMAN 100 [iU] in 1 mL

Administracija rute:

INTRAVENOUS

Terapijske indikacije:

WILATE is indicated in children and adults with von Willebrand disease for: - On-demand treatment and control of bleeding episodes - Perioperative management of bleeding WILATE is indicated in adolescents and adults with hemophilia A for: - Routine prophylaxis to reduce the frequency of bleeding episodes - On-demand treatment and control of bleeding episodes WILATE is contraindicated in patients with known hypersensitivity reactions, including anaphylactic or severe systemic reactions, to human plasma-derived products, any ingredient in the formulation [see Description (11) ] , or components of the container. Risk Summary There are no data with WILATE use in pregnant women to inform a drug-associated risk. Animal reproduction studies have not been conducted with WILATE. WILATE was given to four subjects (3 type 3 and 1 type 2B) during labor and delivery in one clinical study. Two subjects underwent vaginal delivery (type 3) and two subjects had a cesarean section (type 3/type 2B). In this study all pro

Proizvod sažetak:

How Supplied Storage and Handing

Status autorizacije:

Biologic Licensing Application

Svojstava lijeka

WILATE - VON WILLEBRAND FACTOR/COAGULATION FACTOR VIII COMPLEX
(HUMAN)- VON WILLEBRAND FACTOR/COAGULATION FACTOR VIII COMPLEX (HUMAN)
POWDER, FOR SOLUTION
OCTAPHARMA USA INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
WILATE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR WILATE.
WILATE, VON WILLEBRAND FACTOR/COAGULATION FACTOR VIII COMPLEX (HUMAN)
LYOPHILIZED POWDER FOR SOLUTION FOR INTRAVENOUS INJECTION
INITIAL U.S. APPROVAL: 2009
RECENT MAJOR CHANGES
INDICATIONS AND USAGE (1) 09/2019
DOSAGE AND ADMINISTRATION (2.1) 09/2019
WARNINGS AND PRECAUTIONS (5) 09/2019
INDICATIONS AND USAGE
WILATE is indicated in children and adults with von Willebrand disease
for:
• On-demand treatment and control of bleeding episodes
• Perioperative management of bleeding
WILATE is indicated in adolescents and adults with hemophilia A for:
• Routine prophylaxis to reduce the frequency of bleeding episodes
• On-demand treatment and control of bleeding episodes ( 1 )
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS USE ONLY
VWD
• Use the following formula to determine required dosage ( 2.1 ):
Required IU = body weight (BW) in kg x desired VWF:RCo rise (%)
(IU/dL) x 0.5 (IU/kg per IU/dL)
• Adjust dosage and duration of the substitution therapy depending
on the severity of the VWD, on the location and extent
of the bleeding, and on the patient’s clinical condition ( 2.1 )
• Dosing recommendations ( 2.1 ):
TYPE OF
HEMO RRHAG ES/SURG ERY
LOADING DOSAGE
(IU VWF:RCO/
KG BW)
MAINTENANCE DOSAGE (IU
VWF:RCO/ KG BW)
THERAPEUTIC GOAL
Minor Hemorrhages
20-40 IU/kg
20-30 IU/kg every 12-24 hours
VWF:RCo and FVIII activity trough levels
of >30%
Major Hemorrhages
40-60 IU/kg
20-40 IU/kg every 12-24 hours
VWF:RCo and FVIII activity trough levels
of >50%
Minor Surgeries
(including tooth
e xtractions)
30-60 IU/kg
15-30 IU/kg or half the loading
dose every 12-24 hours for up to
3 days
VWF:RCo peak level of 50% after loading
dose and trough levels of > 30% during
ma