CINRYZE- human c1-esterase inhibitor injection, powder, lyophilized, for solution CINRYZE- human c1-esterase inhibitor kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HUMAN C1-ESTERASE INHIBITOR (UNII: 6KIC4BB60G) (HUMAN C1-ESTERASE INHIBITOR - UNII:6KIC4BB60G)

Available from:

Takeda Pharmaceuticals America, Inc.

INN (International Name):

HUMAN C1-ESTERASE INHIBITOR

Composition:

HUMAN C1-ESTERASE INHIBITOR 500 [iU] in 5 mL

Administration route:

INTRAVENOUS

Therapeutic indications:

CINRYZE is a C1 esterase inhibitor indicated for routine prophylaxis against angioedema attacks in adults, adolescents, and pediatric patients (6 years old and above) with Hereditary Angioedema (HAE). CINRYZE is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product. Risk Summary There are no data with CINRYZE use in pregnant women to inform a drug associated risk. Animal reproduction studies have not been conducted with CINRYZE. It is unknown whether CINRYZE can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. CINRYZE should be given to a pregnant woman only if clearly needed. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal data In an embryo fetal development study (C1 inhibitor administered during the period of organogenesis) in rats, there

Product summary:

How Supplied CINRYZE 500 IU is a lyophilized powder supplied in the following presentations. Not all presentations may be marketed. One single-dose glass vial without Sterile Water for Injection, USP One single-dose glass vial with one Sterile Water for Injection, USP Storage and Handling

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

CINRYZE- HUMAN C1-ESTERASE INHIBITOR INJECTION, POWDER, LYOPHILIZED,
FOR
SOLUTION
CINRYZE- HUMAN C1-ESTERASE INHIBITOR
TAKEDA PHARMACEUTICALS AMERICA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CINRYZE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CINRYZE.
CINRYZE (C1 ESTERASE INHIBITOR [HUMAN])
FOR INTRAVENOUS USE, FREEZE-DRIED POWDER FOR RECONSTITUTION
INITIAL U.S. APPROVAL: 2008.
INDICATIONS AND USAGE
CINRYZE is a C1 esterase inhibitor indicated for routine prophylaxis
against angioedema attacks in adults,
adolescents, and pediatric patients (6 years of age and older) with
Hereditary Angioedema (HAE). (1)
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS USE ONLY
Prior to reconstitution, protect from light. (2.2)
A silicone-free syringe is recommended. (2.2)
Store at 36°F to 77°F (2°C to 25°C). Do not freeze. (16)
To obtain a 500 International Units (IU) CINRYZE dose, reconstitute
one CINRYZE vial with one vial of
Sterile Water for Injection, USP (5 mL). To obtain a 1,000 IU CINRYZE
dose, reconstitute two CINRYZE
vials with two vials of Sterile Water for Injection, USP (5 mL each).
Use aseptic sterile technique. (2.2)
Administer at room temperature within 3 hours of reconstitution. (2.2)
ROUTINE PROPHYLAXIS DOSING (2.1)
_Adults and adolescents (12 years old and above)_
INDICATION
DOSE
INFUSION RATE
*
Routine prophylaxis against HAE
attacks
1,000 IU Intravenous every 3
or 4 days
1 mL/min
(10 min)
_Children (6 to 11 years old)_
INDICATION
DOSE
INFUSION RATE
*
Routine prophylaxis against HAE
attacks
500 IU Intravenous every 3 or
4 days
1 mL/min
(5 min)
DOSAGE FORMS AND STRENGTHS
500 IU freeze-dried lyophilized powder in a single-dose vial for
reconstitution with 5 mL of Sterile Water for
Injection, USP. (3)
CONTRAINDICATIONS
Patients who have manifested life-threatening immediate
hypersensitivity reactions, including anaphylaxis,
to the product (4).
WARNINGS AND PRECAUTIONS
Hypersensitivity reactions may occur. Have epinephrin