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VARIZIG Now FDA-Approved

VARIZIG®, a hyperimmune globulin indicated for post-exposure prophylaxis of varicella zoster virus (VZV) in high-risk patients, has been approved by the U.S. Food and Drug Administration (FDA). Manufactured by Cangene Corporation, it is the only FDA-approved hyperimmune globulin for VZV after exposure available in the United States. An earlier FDA-licensed VZIG was removed from the U.S. market by the manufacturer in 2006, and VARIZIG has previously been available only under an investigational expanded access protocol during the licensing process. It was designated as an orphan drug by the FDA and received a priority review.

For reimbursement, providers are advised to use CPT code 90396 with diagnosis codes V01.71 (Contact with or exposure to communicable diseases, varicella) and/or V05.4 (Need for other prophylactic vaccination and inoculation against single diseases, varicella). For full prescribing information or reimbursement information, contact Cangene at (855) 898-2446.

Click here to view the product sheet and prescribing information.

VARIZIG is now exclusively distributed by FFF Enterprises.

IMPORTANT SAFETY INFORMATION ABOUT VARIZIG® [Varicella Zoster Immune Globulin (Human)] In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, only administer VARIZIG® if the expected benefits outweigh the potential risks. Thrombotic events may occur following treatment with VARIZIG® and other immune globulin products. Individuals known to have severe, potentially life-threatening reactions to human globulin should not receive VARIZIG® or any other immune globulin (Human). Individuals who are deficient in IgA may have the potential for developing IgA antibodies and have severe, potentially life-threatening allergic reactions. Products made from human plasma may carry a risk of transmitting infectious agents, e.g. viruses and, theoretically, the Creutzfeldt-Jakob disease agent. The most common adverse drug reactions observed in clinical trials for all subjects and patients were injection site pain, headache, chills, fatigue, rash and nausea.