VONVENDI (von willebrand factor- recombinant kit

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

VON WILLEBRAND FACTOR HUMAN (UNII: ZE22NE22F1) (VON WILLEBRAND FACTOR HUMAN - UNII:ZE22NE22F1)

Dostupné z:

Takeda Pharmaceuticals America, Inc.

INN (Medzinárodný Name):

VON WILLEBRAND FACTOR HUMAN

Zloženie:

VON WILLEBRAND FACTOR HUMAN 650 [iU] in 5 mL

Terapeutické indikácie:

VONVENDI [von Willebrand factor (recombinant)] is a recombinant von Willebrand factor (rVWF) indicated for use in adults (age 18 and older) diagnosed with von Willebrand disease (VWD) for: - On-demand treatment and control of bleeding episodes. - Perioperative management of bleeding. - Routine Prophylaxis to reduce the frequency of bleeding episodes in patients with severe Type 3 VWD receiving on-demand therapy. VONVENDI is contraindicated in patients who have had life-threatening hypersensitivity reactions to VONVENDI or constituents of the product (tri-sodium citrate-dihydrate, glycine, mannitol, trehalose-dihydrate, polysorbate 80, and hamster or mouse proteins) [see Description (11)] . Risk Summary Adequate and well-controlled studies with VONVENDI have not been conducted in pregnant women. Animal developmental and reproductive toxicity studies have not been conducted with VONVENDI. It is not known whether VONVENDI can cause fetal harm when administered to a pregnant woman or whether it can affect reprodu

Prehľad produktov:

How Supplied VONVENDI is packaged with Sterile Water for Injection (sWFI), one Mix2Vial reconstitution device, one full prescribing physician insert, and one patient insert. VONVENDI is available in single-dose vials that contain the following product strengths: The actual von Willebrand factor activity in international units is printed on the label of each VONVENDI vial and carton. Components are not made with natural rubber latex. Storage and Handling

Stav Autorizácia:

Biologic Licensing Application

Súhrn charakteristických

VONVENDI- VON WILLEBRAND FACTOR (RECOMBINANT)
TAKEDA PHARMACEUTICALS AMERICA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VONVENDI SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VONVENDI.
VONVENDI [VON WILLEBRAND FACTOR (RECOMBINANT)] LYOPHILIZED POWDER FOR
SOLUTION, FOR
INTRAVENOUS INJECTION
INITIAL U.S. APPROVAL: 2015
INDICATIONS AND USAGE
VONVENDI [von Willebrand factor (recombinant)] is a recombinant von
Willebrand factor (rVWF) indicated
for use in adults (age 18 and older) diagnosed with von Willebrand
disease (VWD) for:
On-demand treatment and control of bleeding episodes. (1)
Perioperative management of bleeding. (1)
Routine prophylaxis to reduce the frequency of bleeding episodes in
patients with severe Type 3 von
Willebrand disease receiving on-demand therapy. (1)
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS USE AFTER RECONSTITUTION ONLY.
On-Demand Treatment and Control of Bleeding Episodes
For each bleeding episode, administer the first dose of VONVENDI with
an approved recombinant (non-
von Willebrand factor containing) factor VIII, if factor VIII baseline
levels are below 40% or are unknown.
(2.1)
Initial dose is 40 to 80 International Units (IU) per kg body weight
(BW). Adjust the dosage based on the
extent and location of bleeding. (2.1)
BLEEDING EPISODE
INITIAL DOSE
SUBSEQUENT DOSE
MINOR
40 to 50 IU/kg
40 to 50 IU/kg every 8 to 24 hours
MAJOR
50 to 80 IU/kg
40 to 60 IU/kg every 8 to 24 hours for
approximately 2 to 3 days
Perioperative Management of Bleeding
_For Elective Surgical Procedure_
A dose of VONVENDI may be given 12 to 24 hours prior to surgery to
allow the endogenous factor VIII
levels to increase to at least 30 IU/dL (minor surgery) or 60 IU/dL
(major surgery). (2.1)
Assess FVIII:C levels within 3 hours prior to surgery. If the FVIII:C
levels are at or above the
recommended minimum target levels, administer a dose of VONVENDI alone
within 1 hour prior to the
procedure. If the FVIII:C levels are below