TRETTEN (coagulation factor xiii a-subunit- recombinant kit

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

CATRIDECACOG (UNII: NU23Q531G1) (CATRIDECACOG - UNII:NU23Q531G1)

Tilgængelig fra:

Novo Nordisk

INN (International Name):

FACTOR XIII CONCENTRATE - UNII:F7R0FBC1XD)

Sammensætning:

FACTOR XIII CONCENTRATE (HUMAN) 2500 [iU] in 3 mL

Terapeutiske indikationer:

TRETTEN, Coagulation Factor XIII A-Subunit (Recombinant), is indicated for routine prophylaxis for bleeding in patients with congenital factor XIII A-subunit deficiency. TRETTEN is not for use in patients with congenital factor XIII B‑subunit deficiency TRETTEN is contraindicated in patients who have known hypersensitivity to the active substance or to any of the excipients [See Description (11)]. Risk Summary There are no adequate and well-controlled studies using TRETTEN in pregnant women to determine whether there is a drug-associated risk. Animal reproduction studies have not been conducted with TRETTEN. 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. Miscarriage is a known complication of congenital FXIII deficiency. Pooling data from 39 publications, the miscarriage rate was 66% in 63 patients with 192 pregnancies (70% in 179 pregnancies in FXIII A-subunit deficiency women). Miscar

Produkt oversigt:

How Supplied TRETTEN, Coagulation Factor XIII A-Subunit (Recombinant), is supplied as a white, lyophilized powder in single-dose vial along with the diluent (Sterile Water for Injection) vial. The actual amount of TRETTEN in international units (IU) is stated on each carton and vial. TRETTEN and the sterile water vials provided in the package are not made with natural rubber latex. Presentation Carton NDC Number Components NDC Number 2000 - 3125 IU 0169-7013-01 Storage and Handling

Autorisation status:

Biologic Licensing Application

Produktets egenskaber

TRETTEN- COAGULATION FACTOR XIII A-SUBUNIT (RECOMBINANT)
NOVO NORDISK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRETTEN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR TRETTEN.
TRETTEN, COAGULATION FACTOR XIII A-SUBUNIT (RECOMBINANT)
FOR INTRAVENOUS USE. LYOPHILIZED POWDER FOR SOLUTION FOR INJECTION
INITIAL U.S. APPROVAL: 2013
INDICATIONS AND USAGE
TRETTEN, Coagulation Factor XIII A-Subunit (Recombinant), is indicated
for routine prophylaxis of bleeding in patients
with congenital factor XIII A-subunit deficiency. (1)
TRETTEN is not for use in patients with congenital factor XIII B
subunit deficiency. (1)
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS USE ONLY.
Dose :
•
•
•
Rate: Do not exceed 1-2 mL per minute. (2.3)
DOSAGE FORMS AND STRENGTHS
•
•
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
(4)
WARNINGS AND PRECAUTIONS
•
•
•
ADVERSE REACTIONS
The most common adverse reactions reported in the clinical trials
(≥1%) were headache, pain in the extremities, injection
site pain, D dimer increase. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT NOVO NORDISK INC. AT
1-844-873-8836 OR FDA AT 1-800-
FDA-1088 OR WWW.FDA.GOV/MEDWATCH
DRUG INTERACTIONS
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 6/2020
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
35 international units per kilogram body weight once monthly to
achieve a target trough level of FXIII activity at or
above 10% using a validated assay. (2.1)
Consider dose adjustment if adequate coverage is not achieved with a
35 IU/kg dose. (2.1)
Once reconstituted, TRETTEN may be diluted with 0.9% sodium chloride
to facilitate measurement of small
volumes. (2.2)
Lyophilized powder in single-dose vial containing 2000 - 3125 IU of
recombinant coagulation factor XIII A-subunit.
After reconstitution with 3.2 mL of sterile water for injection, each
vial