Posted from: Wednesday, June 29, 2016 - 11:10 AM - Present

Glassia Approved for Self-Infusion

June 15, 2016 – The U.S. Food and Drug Administration (FDA) approved Glassia (Alpha1-Proteinase Inhibitor (Human)), manufactured by Shire and Kamada, for self-infusion at home after appropriate training. Glassia was originally approved in 2010 for the treatment of alpha1-antitrypsin (AAT) deficiency. AAT is a chronic, genetic disorder that can lead to the destruction of lung tissue and cause chronic lung disease such as emphysema. The recommended dose of Glassia is 60mg/kg administered by intravenous infusion once weekly.

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.

Actual drug patent expiration dates and a 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 Saturday, July 22, 2017 - 02:34 AM.