New VZIG product available under IND
Ever since the sole U.S. manufacturer of varicella zoster immune globulin (VZIG) discontinued its production in October 2004, supply has dwindled to the point of depletion. This February, however, an investigational VZIG product, called VariZIG, has become available under an investigational New Drug Application (IND) for patients who have been exposed to varicella and are at increased risk for severe disease and complications.
New VZIG product available under IND
Ever since the sole U.S. manufacturer of varicella zoster immune globulin (VZIG) discontinued its production in October 2004, supply has dwindled to the point of depletion. This February, however, an investigational VZIG product, called VariZIG, has become available under an investigational New Drug Application (IND) for patients who have been exposed to varicella and are at increased risk for severe disease and complications. VariZIG is produced by Cangene Corp. and distributed by FFF Enterprises, Temecula, Calif. The expanded access protocol has received central institutional review board (IRB) approval and will allow patients who meet the enrollment criteria to use the drug. Although the FDA will not require additional approval by an IRB at the treatment site, some institutions may require notification before physicians participate in a study reviewed by a central IRB. The new product is a purified human immune globulin containing anti-varicella antibodies similar to the licensed VZIG, but is lyophilized. After reconstitution, the 5% solution can be administered intramuscularly. Providers with a patient in need or pharmacists interested in acquiring inventory in advance for an expected need may contact FFF Enterprises' via a 24-hour telephone line at 1-(800) 843-7477 and request a product release form.
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