REBINYN ((coagulation factor ix- recombinant, glycopegylated kit

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

COAGULATION FACTOR IX RECOMBINANT HUMAN (UNII: 382L14738L) (COAGULATION FACTOR IX RECOMBINANT HUMAN - UNII:382L14738L)

Dostupné s:

Novo Nordisk

INN (Mezinárodní Name):

COAGULATION FACTOR IX RECOMBINANT HUMAN

Složení:

COAGULATION FACTOR IX RECOMBINANT HUMAN 500 [iU] in 1 mL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

REBINYN, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA-derived coagulation Factor IX concentrate indicated for use in adults and children with hemophilia B (congenital Factor IX deficiency) for: Limitations of Use : REBINYN is not indicated for immune tolerance induction in patients with hemophilia B. REBINYN is contraindicated in patients who have known hypersensitivity to REBINYN or its components (including hamster proteins) [see Warnings and Precautions (5.1) and Description (11) ] Risk Summary There are no data with REBINYN use in pregnant women to determine whether there is a drug-associated risk. Animal reproduction studies have not been conducted with REBINYN. It is unknown whether REBINYN can cause fetal harm when administered to a pregnant woman or can affect fertility. In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Risk Summary There is no informati

Přehled produktů:

How Supplied Table 12: REBINYN Presentations Presentation (Nominal Product Strength; IU) Cap Color Indicator Carton NDC Number Components 500 Red NDC 0169 7905 01 1000 Green NDC 0169 7901 01 2000 Yellow NDC 0169 7902 01 3000 Dark Gray NDC 0169 7903 01 Storage and Handling

Stav Autorizace:

Biologic Licensing Application

Charakteristika produktu

REBINYN- (COAGULATION FACTOR IX (RECOMBINANT), GLYCOPEGYLATED)
NOVO NORDISK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
REBINYN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR REBINYN.
REBINYN (COAGULATION FACTOR IX (RECOMBINANT), GLYCOPEGYLATED)
LYOPHILIZED POWDER FOR SOLUTION FOR INTRAVENOUS INJECTION
INITIAL U.S. APPROVAL: 2017
RECENT MAJOR CHANGES
INDICATIONS AND USAGE (1)
………………………………………07/2022
DOSAGE AND ADMINISTRATION
(2.1)…………………………………07/2022
INDICATIONS AND USAGE
REBINYN, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a
recombinant DNA-derived
coagulation Factor IX concentrate indicated for use in adults and
children with hemophilia B (congenital
Factor IX deficiency) for:
•
•
•
Limitations of Use: REBINYN is not indicated for immune tolerance
induction in patients with hemophilia B
(1).
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS INFUSION AFTER RECONSTITUTION ONLY (2).
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
REBINYN is available as a lyophilized powder in single-dose vials of
500, 1000, 2000, and 3000 IU (3).
CONTRAINDICATIONS
Do not use in patients who have known hypersensitivity to REBINYN or
its components, including hamster
proteins (4).
WARNINGS AND PRECAUTIONS
•
•
•
•
•
®
On-demand treatment and control of bleeding episodes
Perioperative management of bleeding
Routine prophylaxis to reduce the frequency of bleeding episodes
Each carton and vial label for REBINYN states the actual Factor IX
potency in international units (IU)
(2.1).
On-demand treatment and control of bleeding episodes:
40 IU/kg body weight for minor and moderate bleeds, and 80 IU/kg body
weight for major bleeds.
Additional doses of 40 IU/kg can be given (2.1).
Perioperative management:
Pre-operative dose of 40 IU/kg body weight for minor surgery, and 80
IU/kg body weight for major
surgery. As clinically needed for the perioperative management of
bleeding, repeated