Data from FDA - Curated by Toby Galbraith - Last updated 21 April 2017

Licensing authority

FDA (Food and Drug Administration, USA)

Indication(s)

CINRYZE is a C1 esterase inhibitor indicated for routine prophylaxis against angioedema attacks in adolescent and adult patients with Hereditary Angioedema (HAE).

Full Prescribing information

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Advisory information

contraindications

Patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product (4).

Special warnings and precautions
● Hypersensitivity reactions may occur. Have epinephrine immediately available for treatment of acute severe hypersensitivity reaction (5.1).
● Serious arterial and venous thromboembolic (TE) events have been reported at the recommended dose of C1 Esterase Inhibitor (Human)
products, including CINRYZE, following administration in patients with HAE. Risk factors may include presence of an indwelling venous catheter/access device, prior history of thrombosis, underlying atherosclerosis, use of oral contraceptives, certain androgens, morbid obesity, and immobility. Benefits of CINRYZE for routine prophylaxis of HAE attacks should be weighed against the risks of TE events in patients with underlying risk factors. Monitor patients with known risk factors for TE events during and after CINRYZE administration.
TE events have been reported following administration of a C1 Esterase Inhibitor (Human) product when used off-label at higher than labeled doses. (5.2).
● CINRYZE is made from human plasma and may contain infectious agents e.g. viruses and, theoretically, the Creutzfeldt-Jakob disease agent. (5.3)
Adverse reactions
The most common adverse reactions observed were headache, nausea, rash and vomiting. (5.1, 6.1)

Usage information

Dosing and administration
• Intravenous Use Only
• Prior to reconstitution, protect from light.
• A silicone-free syringe is recommended
• Store at 2 oC - 25 oC (36 oF - 77 oF). Do not freeze.
• To obtain the required dose, reconstitute two CINRYZE vials with two vials SterileWater for Injection, USP (5 mL each) using aseptic sterile technique.
• Administer at room temperature within 3 hours of reconstitution.

Routine Prophylaxis Dosing
Indication Dose Infusion rate
Routine
prophylaxis
against
HAE attacks
1,000 Units
Intravenous every 3 or 4
days
1 mL/min
(10 min)
Use in special populations
Pregnancy: No human or animal data. Use only if clearly needed. (8.1)

More information

Category Value
Authorisation number BLA125267
Orphan designation No
Product NDC 42227-081
Date First Approved 01-12-2008
Marketing authorisation holder ViroPharma Incorporated