Posted from: Friday, July 06, 2018 - 04:53 PM - Present

Expanded Indication for Cinryze

June 21, 2018 – The U.S. FDA has approved an expanded indication for Cinryze® (C1 esterase inhibitor [human]), manufactured by Shire. The drug is now approved to prevent angioedema attacks in children as young as 6 years who have hereditary angioedema (HAE).

Hereditary angioedema causes episodes of severe swelling. These episodes can occur in response to stress or even minor physical trauma. Swelling can also occur with no known trigger. Commonly affected areas include the face, airways, limbs, and intestinal tract. Without treatment, most patients experience an attack once or twice a week, with each attack often lasting up to four days. Angioedema attacks can be life-threatening, particularly if the airway is affected. On average, children diagnosed with HAE will experience their first attack at around age ten.

In a clinical study, Cinryze (1,000 units) reduced the number of angioedema attacks by 84.5% compared to baseline in children 7 to 11 years old. It also reduced the severity of attacks, as well as the need for acute treatment. The drug is administered via intravenous infusion every three to four days.

Cinryze originally received FDA approval in 2008 to provide routine prophylaxis against angioedema in adult patients diagnosed with HAE.

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Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

 

Last Updated Tuesday, July 17, 2018 - 01:20 PM.