Fall 2013 - Innovation

CDC Updates VariZIG Use Recommendations

The Centers for Disease Control and Prevention (CDC) has updated its recommendations for the use of VariZIG, which are now harmonized with the American Academy of Pediatrics. VariZIG is a varicella zoster immune globulin preparation manufactured by Cangene Corp. for use in the U.S. for postexposure prophylaxis of varicella for persons at high risk for severe disease who lack evidence of immunity to varicella and for whom varicella vaccine is contraindicated. VariZIG is currently approved by the U.S. Food and Drug Administration for administration as soon as possible following varicella-zoster virus exposure, ideally within 96 hours (four days) for greatest effectiveness. However, CDC now recommends administration of VariZIG as soon as possible after exposure to the varicella-zoster virus and within 10 days. Limited experience from outside the U.S. with use of other immune globulin products with high levels of anti-varicella-zoster virus antibodies suggested that, compared with administration of the immune globulins within four days of exposure, administration greater than four days and up to 10 days after exposure resulted in comparable incidence of varicella and attenuation of disease. One study indicated an increase in varicella incidence with increasing time between exposure and administration of ZIG, but disease was attenuated in all cases.

CDC also has revised the patient groups recommended by the Advisory Committee on Immunization Practices to receive VariZIG. Patient groups recommended to receive VariZIG include immunocompromised patients without evidence of immunity; newborn infants whose mothers have signs and symptoms of varicella around the time of delivery (five days before to two days after); hospitalized premature infants born at greater than or equal to 28 weeks of gestation whose mothers do not have evidence of immunity to varicella; hospitalized premature infants born at less than 28 weeks of gestation or who weigh less than or equal to 1,000 grams at birth, regardless of their mothers’ evidence of immunity to varicella; and pregnant women without evidence of immunity. Now, CDC extends the period of eligibility for previously recommended premature infants from exposures to varicella-zoster virus during the neonatal period to exposures that occur during the entire period for which they require hospital care for their prematurity.

VariZIG can be ordered from the exclusive U.S. distributor, FFF Enterprises Inc., at (800) 843-7477 or online at www.fffenterprises.com.

BSTQ Staff
BioSupply Trends Quarterly [BSTQ] is the definitive source for industry trends, news and information for the biopharmaceuticals marketplace. With timely and critical information, each themed issue covers topics ranging from product breakthroughs, industry insights and innovations, up-to-the-minute news on the latest clinical trials, accessibility, and service and safety concerns.