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Cinryze is approved to treat hereditary angioedema

Cinryze is a powder and solvent that are made up into a solution for injection. It contains the active substance C1 inhibitor (human).

Cinryzeis used to treat ‘swelling attacks’ in adults and adolescents with hereditary angioedema. Patients with hereditary angioedema have attacks of swelling that can occur anywhere in the body, such as in the face or limbs, or around the gut, causing discomfort and pain.

Cinryze is also used for the prevention of angioedema attacks that can be triggered by medical, dental or surgical procedures.

Cinryze is also used for routine prevention in patients who have severe and frequent attacks for which prevention with oral medicines is not adequate or in patients whose attacks are not adequately treated.

The medicine can only be obtained with a prescription.

Treatment with Cinryze should be started under the supervision of a doctor experienced in treating hereditary angioedema. Cinryze is given as an injection into a vein.

For treatment of angioedema attacks, the patient is given 1,000 Units at the first sign of an attack. A second dose of 1,000 Units may be given if the patient has not responded adequately after one hour, or sooner for severe attacks or if the start of the treatment had been delayed.

For routine prevention, Cinryze is given as 1,000 Units every three or four days. The doctor should review the need for routine prevention on a regular basis and can adjust the frequency of the injections according to how the patient is responding. For prevention before a medical, dental or surgical procedure, Cinryze is given as 1,000 Units within the 24 hours before the procedure.

The doctor may decide that the caregivers and patients can carry out the injection provided that they have been adequately trained.

The active substance in Cinryze, human C1 inhibitor, is a protein extracted from human blood.

The C1 inhibitor protein is required to control the ‘complement’ and ‘contact’ systems, collections of proteins in the blood that fight against infection and cause inflammation. Patients with low levels of this protein have excessive activity of these two systems, which leads to the symptoms of angioedema. Cinryze is used to replace the missing C1 inhibitor, correcting the deficiency and helping to prevent or treat angioedema attacks.

The effects of Cinryze were first tested in experimental models before being studied in humans.

In one main study, Cinryze and placebo (a dummy treatment) were used to treat angioedema attacks in 71 patients with hereditary angioedema. The main measure of effectiveness in this study was how long it took for the symptoms to start improving.

A second main study, involving 24 patients from the first study, looked at the number of attacks over 12-week periods when patients were given Cinryze or placebo as prevention. The patients chosen for the second study were those with frequent attacks, at least two attacks per month on average.

The company also provided data on the use of Cinryze in 91 patients to prevent attacks in patients undergoing a medical, surgical or dental procedure.

Cinryze was more effective than placebo in treating and preventing attacks of angioedema. In the first study, over 50% of patients receiving Cinryze had started having improvements two hours into treatment, compared with 33% of patients given placebo. In the second study, the average number of attacks experienced in patients treated with Cinryze was 6.1 over a 12-week period compared with 12.7 for patients on placebo.

Cinryze was also effective in preventing attacks triggered by medical, surgical, or dental procedures with 98% of procedures not triggering an attack within 72 hours.

The only common side effect seen in studies with Cinryze (seen in between 1 and 10 patients in 100) is rash, which is not serious and typically involves the arms, chest, abdomen or the injection site. For the full list of all side effects with Cinryze, see the package leaflet.

Cinryze should not be used in people who may be hypersensitive (allergic) to C1 inhibitor or any of the other ingredients.

Based on the evidence from the studies, the CHMP concluded that Cinryze’s benefits are greater than its risks in the treatment and prevention of angioedema attacks in adults and adolescents with hereditary angioedema.

The company that makes Cinryze will ensure that healthcare professionals in all Member States who are expected to prescribe Cinryze are provided with an educational pack instructing them to ensure that caregivers and patients who will administer the medicine at home are properly trained. There will also be a training leaflet for patients that should be kept at home.

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Source :

European Medicine Agency

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