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CINRYZE has been proven to reduce the frequency, severity, duration of attacks, and the number of days of swelling of hereditary angioedema (HAE) attacks in adults and adolescents. In pediatric patients (age 7 to 11), CINRYZE was shown to reduce the number of HAE attacks, lessen the severity of attacks, and reduce the use of acute treatment compared to baseline.
Reduction in frequency of attacks in pediactric patients
A randomized, single-blind, multi-center, dose-ranging cross-over study in 12 pediatric patients with HAE (7 to 11 years old). After an observation period of 12 weeks, patients were randomized to receive either CINRYZE 500 U or CINRYZE 1,000 U every 3 to 4 days for 12 weeks. Patients were then crossed-over to the alternative dose for an additional 12-week period. Efficacy endpoints which were met included reduction in the number of attacks, along with lessened severity of attacks and reduction in the use of acute treatment compared with baseline.
The efficacy of CINRYZE in preventing HAE attacks in adult and adolescent patients was evaluated based on the number of HAE attacks during the 12-week treatment period with CINRYZE compared with the number of attacks during the 12-week placebo treatment period.
CINRYZE significantly reduced the mean number of HAE attacks vs. placebo (p<0.0001). The number (standard deviation) of HAE attacks was 6.1 (5.4) while taking CINRYZE vs. 12.7 (4.8) on placebo.
|Subject||Percent Reduction in Attack Frequency|
|Subject||Percent Reduction in Attack Frequency|
The effectiveness of CINRYZE prophylaxis in reducing the number of HAE attacks was variable among the 22 subjects in a controlled clinical trial.
The pivotal trial was a randomized, double-blind, placebo-controlled, multicenter, crossover study of adults and adolescents designed to establish the safety (n=24) and efficacy (n=22) of CINRYZE prophylaxis in patients with a history of at least 2 HAE attacks per month. In addition to the primary efficacy analysis of attack frequency, secondary endpoints included the duration and severity of attacks and the number of days of swelling.
Severity: 1=Mild, 2=Moderate, 3=Severe
CINRYZE significantly reduced the mean severity of HAE attacks vs. placebo (p<0.01).
CINRYZE significantly reduced the mean duration of HAE attacks vs. placebo (p<0.01).
Reduced number of days of swelling
REDUCTION IN DAYS OF SWELLING OVER 12 WEEKS
CINRYZE significantly reduced the mean number of days of swelling vs. placebo (p<0.01).
Contraindications: CINRYZE is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product.
Hypersensitivity Reactions: Severe hypersensitivity reactions may occur during or after administration of CINRYZE. Consider treatment methods carefully, because hypersensitivity reactions may have symptoms similar to HAE attacks. In case of hypersensitivity, discontinue CINRYZE infusion and institute appropriate treatment. Have epinephrine immediately available for treatment of an acute severe hypersensitivity reaction.
Thromboembolic Events: 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.
Transmissible Infectious Agents: Because CINRYZE is made from human blood, it may carry a risk of transmitting infectious agents, e.g. viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. ALL infections thought by a physician possibly to have been transmitted by CINRYZE should be reported to Shire Medical Information at 1-800-828-2088.
Adverse Reactions: The only serious adverse reaction observed in clinical studies of CINRYZE was cerebrovascular accident. The most common adverse reactions (≥5%) observed were headache, nausea, rash, vomiting, and fever. Post marketing adverse reactions include local infusion site reactions and hypersensitivity. Post marketing thromboembolic events have been reported, including catheter-related and deep venous thromboses, transient ischemic attack, and stroke.
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To report SUSPECTED ADVERSE REACTIONS, contact Shire Medical Information at 1-800-828-2088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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