The FDA made the following announcement February 8 regarding VZIG:Varicella Zoster Immune Globulin (VZIG) — Anticipated Short Supply and Alternate Product Availability Under an Investigational New Drug Application Expanded Access Protocol.
SummaryThe only manufacturer of U.S.-licensed VZIG, Massachusetts Public Health Biologic Laboratories (Boston, MA), has discontinued production of this product, which is indicated for patients in need of passive immunization to prevent severe varicella zoster infection. The supply of the licensed VZIG product is nearly depleted. However, an investigational (not licensed) VZIG product (manufactured and currently under development by Cangene Corporation, Winnipeg, Canada) is available under an investigational new drug application (IND) protocol. This product may be requested through FFF Enterprises (Temecula, CA) for individuals who have been exposed to varicella and who are at increased risk of complications from varicella (see below — "What Patients Are Eligible to Participate" section).
The investigational VZIG, like licensed VZIG, is a purified human immune globulin preparation made from high anti-varicella antibody-containing plasma. The investigational product is lyophilized. When properly reconstituted, it is a 5% solution of IgG, which is intended to be administered intramuscularly. As with any product used under IND, patients must be informed of potential risks and benefits and give informed consent before receiving the product.
If a decision is made to use VZIG, it should be administered as soon as possible after exposure, and within 96 hours of exposure.
Click here to see the entire announcement.
What patients are eligible to participate in the IND protocol for VZIG?
At-risk, susceptible patients who have been exposed to varicella, and for whom informed consent is obtained, are eligible to receive the IND product under an expanded access protocol. The patient groups include:
- Immune compromised pediatric and adult patients
- Neonates and infants < 1 year of age
- Premature infants
- Pregnant women
- Newborns whose mothers had varicella infection < 5 days prior to delivery, to < 2 days after delivery
Note: Licensed VZIG is not indicated for prophylactic use in immunodeficient children or adults who have a known past history of varicella, unless the patient has undergone bone marrow transplantation. The expanded access protocol also does not include this use.
For additional information and ordering procedures, please call FFF Enterprises at 800-843-7477.
