VZIG — No Longer Readily Available
VZIG — No Longer Readily Available
By Carol A. Kemper, MD, FACP
Dr. Kemper is Clinical Associate Professor of Medicine, Stanford University; Division of Infectious Diseases, Santa Clara Valley Medical Center
Dr. Kemper reports no financial relationships relevant to this field of study.
This article originally appeared in the October 2006 issue of Infectious Disease Alert. It was edited by Stan Deresinski, MD, and peer reviewed by Connie Price, MD.
Synopsis: A halt in production of varicella immune globulin within the United States means physicians will be required to obtain via mail, and an investigational new drug protocol is described below. As in the past, it is produced from pooled human plasma.
Source: VariZIG for Prophylaxis after Exposure to Varicella. Med Lett Drugs Ther. 2006:48:69-70.
The only manufacturer of vzig in the united States recently stopped its production. An alternate product, VariZIG, which is manufactured by a Canadian company and has not been approved for use in the United States by the FDA, can be obtained in the United States, but only through expanded access as an investigational new drug. VariZIG is prepared from pooled human plasma, similar to VZIG, and has been treated with filtration and inactivation methods. As such, there remains a small risk of transmission of blood-born pathogens.
Varicella immune globulin is indicated for those exposed patients who are at high risk for complications from varicella infection, for whom varicella vaccination is contraindicated. In the United States, these include: non-immune pregnant women; non-immune immunocompromised persons; neonates born to mothers with varicella infection between 5 days before and 2 days after delivery; premature infants > 28 weeks gestation born to non-immune mothers; and premature infants < 28 weeks gestation, or who weigh < 1000 grams, who are exposed regardless of the mothers immune status.
The expanded access protocol has central IRB approval, but local institutional approval may be needed. In order to receive VariZIG in the United States, contact FFF Enterprise, which is the only authorized distributor (24 hour telephone number 1-800-843-7477). The company will review eligibility before shipping the drug within 24 hrs. Signed informed consent is required, and a brief case record form with 4 visits is required.
The only manufacturer of vzig in the united States recently stopped its production. An alternate product, VariZIG, which is manufactured by a Canadian company and has not been approved for use in the United States by the FDA, can be obtained in the United States, but only through expanded access as an investigational new drug.Subscribe Now for Access
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