CORIFACT (factor xiii concentrate- human kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Factor XIII Concentrate (Human) (UNII: F7R0FBC1XD) (Factor XIII Concentrate (Human) - UNII:F7R0FBC1XD)

Available from:

CSL Behring GmbH

INN (International Name):

Factor XIII Concentrate - UNII:F7R0FBC1XD)

Composition:

Factor XIII Concentrate (Human) 1600 [iU] in 20 mL

Therapeutic indications:

CORIFACT is a Factor XIII Concentrate indicated for routine prophylactic treatment and peri-operative management of surgical bleeding in adult and pediatric patients with congenital FXIII deficiency. CORIFACT is contraindicated in patients with known anaphylactic or severe systemic reactions to human plasma-derived products [see Description (11)] . Risk Summary Animal reproduction studies have not been conducted with CORIFACT. 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. Clinical Considerations: Disease-associated maternal and/or embryo/fetal risk Miscarriage is a known complication of congenital FXIII deficiency with a rate of 91% observed in 136 pregnancies without routine FXIII supplementation prophylaxis and 11% in 45 pregnancies with routine FXIII prophylaxis1 . Risk Summary There is no information available on the presence of CORIFACT in human milk, the effects on the breastfed

Product summary:

Storage and Handling

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

CORIFACT- FACTOR XIII CONCENTRATE (HUMAN)
CSL BEHRING GMBH
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CORIFACT SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR CORIFACT.
CORIFACT , FACTOR XIII CONCENTRATE (HUMAN)
LYOPHILIZED POWDER FOR SOLUTION FOR INJECTION
FOR INTRAVENOUS USE ONLY.
INITIAL U.S. APPROVAL: 2011
INDICATIONS AND USAGE
CORIFACT is a Factor XIII concentrate indicated for adult and
pediatric patients with congenital Factor XIII deficiency for:
Routine prophylactic treatment
Peri-operative management of surgical bleeding. (1)
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS USE ONLY.
DOSE (2.1)
40 International Units (IU) per kg body weight; rate not to exceed 4
mL per min.
Adjust dose ±5 IU per kg to maintain 5% to 20% trough level of FXIII
activity.
DOSE ADJUSTMENT USING THE BERICHROM ACTIVITY ASSAY (2.1)
FXIII ACTIVITY TROUGH LEVEL (%)
DOSAGE CHANGE
One trough level of <5%
Increase by 5 IU per kg
Trough level of 5% to 20%
No change
Two trough levels of >20%
Decrease by 5 IU per kg
One trough level of >25%
Decrease by 5 IU per kg
ADMINISTRATION (2.2)
Administer at a rate not exceeding 4 mL per minute
For routine prophylaxis, administer every 28 days
For peri-operative management of surgical bleeding, individualize dose
based on the patient's FXIII activity level, type
of surgery, and clinical response
Following are dose adjustment examples for peri-operative management
in reference to the patient's last prophylactic
dose :
DOSE ADJUSTMENT FOR PERI-OPERATIVE MANAGEMENT
TIME SINCE LAST DOSE
DO SE
Within 7 days
Additional dose may not be needed
8 – 21 days
Additional partial or full dose may be needed based on FXIII activity
le ve l
21 – 28 days
Full prophylactic dose
DOSAGE FORMS AND STRENGTHS
Each single-dose vial contains 1000-1600 units of lyophilized powder
for reconstitution. (3)
CONTRAINDICATIONS
Do not use in patients with known anaphylactic or severe systemic
reactions to human plasma-derived products. (4)
WARNING