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A New Product (VariZIG™) for Postexposure Prophylaxis of Varicella Available Under an Investigational New Drug Application Expanded Access Protocol

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Abstract

Immunization Practices (ACIP) was informed by the only U.S.-licensed manufacturer of varicella zoster immune globulin (VZIG) (Massachusetts Public Health Biologic Laboratories, Boston, Massachusetts) that the company had discontinued production of VZIG. The supply of the licensed VZIG product is now nearly depleted. In February 2006, an investigational (not licensed) VZIG product, VariZIG ™ (Cangene Corporation, Winnipeg, Canada) became available under an investigational new drug application (IND) submitted to the Food and Drug Administration (FDA). * This product can be requested from the sole authorized U.S. distributor, FFF Enterprises (Temecula, California), for patients who have been exposed to varicella and who are at increased risk for severe disease and complications (1). The investigational VariZIG, similar to licensed VZIG, is a purified human immune globulin preparation made from plasma containing high levels of anti-varicella antibodies (immunoglobulin class G [IgG]). Unlike the previous product, the investigational product is lyophilized. When properly reconstituted, VariZIG is approximately a 5 % solution of IgG that can be administered intramuscularly. As with any product used under IND, patients must be informed of potential risks and benefits and must give informed consent before receiving the product. Indications for Use of Investigational VariZIG Patients without evidence of immunity to varicella (i.e., without history of disease or age-appropriate vaccination) who are at high risk for severe disease and complications, who have been exposed to varicella, and from whom informed consent has been obtained, are eligible to receive * Available a

Year: 2004
OAI identifier: oai:CiteSeerX.psu:10.1.1.412.940
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