KOVALTRY (antihemophilic factor- recombinant kit

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT (UNII: P89DR4NY54) (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT - UNII:P89DR4NY54)

Dostopno od:

Bayer HealthCare LLC

INN (mednarodno ime):

ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT

Sestava:

ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT 250 [iU] in 2.5 mL

Terapevtske indikacije:

KOVALTRY is not indicated for the treatment of von Willebrand disease. KOVALTRY is contraindicated in patients who have a history of hypersensitivity reactions to the active substance, to any of the excipients, or to mouse or hamster proteins [see Description (11)]. There are no data with KOVALTRY use in pregnant women to inform on drug-associated risk. Animal reproduction studies have not been conducted using KOVALTRY. It is not known whether KOVALTRY can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. There is no information regarding the presence of KOVALTRY in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for KOVALTRY and any potential adverse effects on the breastfed infant from KOVALTRY or from the underlying maternal condition. Safety and efficacy studies with KOVALTRY have been performed in 51 pediatric PTPs ≤12 years of age and 43 pediatric PUPs/MTPs <6 years of age [see Clinical Studies (14)]. Body weight adjusted clearance of Factor VIII in children ≤12 years of age is higher than in adults and adolescents. Consider higher or more frequent dosing in children to account for this difference in clearance [see Clinical Pharmacology (12.3)] . Clinical studies with KOVALTRY did not include patients aged 65 and over to determine whether or not they respond differently from younger patients. However, clinical experience with other Factor VIII products has not identified differences between the elderly and younger patients. As with any patient receiving recombinant Factor VIII, dose selection for an elderly patient should be individualized.

Povzetek izdelek:

How Supplied KOVALTRY is available as a lyophilized powder in single-dose glass vials, one vial per carton. It is supplied with a sterile vial adapter with 15-micrometer filter and a prefilled diluent glass barrel syringe, which together serve as a needleless reconstitution system. The prefilled diluent syringe contains Sterile Water for Injection, USP. An administration set is also provided in the package. Available sizes: Nominal Strength (IU) Diluent (mL) Kit NDC Number Color Code 250 2.5 0026-3821-25 Blue 500 2.5 0026-3822-25 Green 1000 2.5 0026-3824-25 Red 2000 5.0 0026-3826-50 Yellow 3000 5.0 0026-3828-50 Gray Actual Factor VIII activity in IU is stated on the label of each KOVALTRY vial. The product vial and diluent syringe are not made with natural rubber latex. Storage and Handling Product as Packaged for Sale Product After Reconstitution

Status dovoljenje:

Biologic Licensing Application

Lastnosti izdelka

KOVALTRY- ANTIHEMOPHILIC FACTOR (RECOMBINANT)
BAYER HEALTHCARE LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
KOVALTRY SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR KOVALTRY.
KOVALTRY [ANTIHEMOPHILIC FACTOR (RECOMBINANT)]
LYOPHILIZED POWDER FOR SOLUTION FOR INTRAVENOUS INJECTION –
RECONSTITUTION WITH VIAL ADAPTER
INITIAL U.S. APPROVAL: 2016
INDICATIONS AND USAGE
KOVALTRY , Antihemophilic Factor (Recombinant), is a recombinant,
human DNA sequence derived, full
length Factor VIII concentrate indicated for use in adults and
children with hemophilia A (congenital Factor
VIII deficiency) for:
• On-demand treatment and control of bleeding episodes
• Perioperative management of bleeding
• Routine prophylaxis to reduce the frequency of bleeding episodes
KOVALTRY is not indicated for the treatment of von Willebrand disease
(1).
DOSAGE AND ADMINISTRATION
For intravenous use after reconstitution only.
Control of bleeding episodes and perioperative management (2.1)
•
•
Routine prophylaxis (2.1)
•
•
DOSAGE FORMS AND STRENGTHS
CONTRAINDICATIONS
Do not use in patients who have history of hypersensitivity reactions
to the active substance, mouse or
hamster protein, or other constituents of the product (4).
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
The most frequently reported adverse reactions in clinical trials
(≥5%) were inhibitors in previously
untreated patients (PUPs)/minimally treated patients (MTPs), pyrexia,
headache, and rash (6).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BAYER HEALTHCARE AT
1-888-842-2937 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
USE IN SPECIFIC POPULATIONS
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 12/2022
®
Required dose (IU) = body weight (kg) x desired Factor VIII rise (% of
normal or IU/dL) x reciprocal of
expected/observed recovery (e.g., 0.5 for a recovery of 2 IU/dL per
IU/kg).
Estimated Increment of Factor VIII (IU/dL or % of