ALTUVIIIO (antihemophilic factor- recombinant, fc-vwf-xten fusion protein-ehtl kit

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

EFANESOCTOCOG ALFA (UNII: WH7BHQ0RB4) (EFANESOCTOCOG ALFA - UNII:WH7BHQ0RB4)

Предлага се от:

Bioverativ Therapeutics Inc.

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

ALTUVIIIO [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl] is a von Willebrand Factor (VWF) independent recombinant DNA-derived, Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital factor VIII deficiency) for: - Routine prophylaxis to reduce the frequency of bleeding episodes - On-demand treatment and control of bleeding episodes - Perioperative management of bleeding Limitation of Use ALTUVIIIO is not indicated for the treatment of von Willebrand disease. ALTUVIIIO is contraindicated in patients who have had severe hypersensitivity reactions, including anaphylaxis, to the product or its excipients [see Description (11)] . Risk Summary There are no data with ALTUVIIIO use in pregnant women to inform a drug-associated risk. Animal developmental and reproductive studies have not been conducted with ALTUVIIIO. Therefore, it is not known whether ALTUVIIIO can affect reproductive capacity or cause fetal harm when given to pregnant women. In the U.S.

Каталог на резюме:

How Supplied ALTUVIIIO is supplied in kits comprising a single-dose vial containing nominally, 250, 500, 750, 1000, 2000, 3000, or 4000 international units (IU) of Factor VIII potency, a prefilled syringe with 3 mL sterile water for injection, and a sterile vial adapter (reconstitution device). The actual amount of ALTUVIIIO in IU is stated on the label and carton of each vial. Not made with natural rubber latex. Not all pack sizes may be marketed. Storage and Handling Prior to reconstitution: After Reconstitution:

Статус Оторизация:

Biologic Licensing Application

Данни за продукта

ALTUVIIIO- ANTIHEMOPHILIC FACTOR (RECOMBINANT), FC-VWF-XTEN FUSION
PROTEIN-
EHTL
BIOVERATIV THERAPEUTICS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ALTUVIIIO SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ALTUVIIIO.
ALTUVIIIO™ [ANTIHEMOPHILIC FACTOR (RECOMBINANT), FC-VWF-XTEN FUSION
PROTEIN-EHTL],
LYOPHILIZED POWDER FOR SOLUTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2023
INDICATIONS AND USAGE
ALTUVIIIO [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion
protein-ehtl] is a recombinant DNA-
derived, Factor VIII concentrate indicated for use in adults and
children with hemophilia A (congenital factor
VIII deficiency) for:
Routine prophylaxis to reduce the frequency of bleeding episodes
On-demand treatment & control of bleeding episodes
Perioperative management of bleeding (1)
Limitation of Use:
ALTUVIIIO is not indicated for the treatment of von Willebrand
disease. (1)
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS USE ONLY.
Each ALTUVIIIO vial label states Factor VIII activity in international
units (IU or unit). (2.1)
For routine prophylaxis: 50 IU/kg once weekly. (2.1)
For on-demand treatment and control of bleeding episodes and
perioperative management: 50 IU/kg
(2.1)
Estimated Increment of Factor VIII (IU/dL or % of normal) = 50 IU/kg
× 2 (IU/dL per IU/kg.) (2.1)
To achieve a specific target Factor VIII activity level, use the
following formula: Dosage (IU) = Body Weight
(kg) × Desired Factor VIII Increase (IU/dL or % normal) × 0.5 (IU/kg
per IU/dL). (2.1).
DOSAGE FORMS AND STRENGTHS
For injection: nominally 250, 500, 750, 1000, 2000, 3000, or 4000 IU,
lyophilized powder in single-dose vials
for reconstitution. (3)
CONTRAINDICATIONS
Do not use in patients who have had severe hypersensitivity reactions,
including anaphylaxis, to ALTUVIIIO
or excipients of ALTUVIIIO. (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity reactions, including anaphylaxis, may occur. Should
symptoms occur, immediately
discontinue ALTUVIIIO