VARIZIG [Varicella Zoster Immune Globulin (Human)] is indicated in the United States for post-exposure prophylaxis of varicella (chickenpox) in high risk patient groups including immunocompromised children, newborns, and pregnant women. VARIZIG is intended to reduce the severity of chickenpox infections in these patients.1
VARIZIG is a hyperimmune product that contains antibodies specific for the Varicella zoster virus which causes the viral infection known as chickenpox. VARIZIG is distributed through specialty distributors.
VARIZIG is indicated for, and the Centers for Disease Control (CDC) recommends VARIZIG for postexposure prophylaxis of varicella for persons at high risk for severe disease who lack evidence of immunity to varicella. VARIZIG is approved for administration as soon as possible following varicella-zoster virus exposure, ideally within 96 hours (4 days) for greatest effectiveness. VARIZIG administration is intended to reduce the severity of varicella.
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The CDC recommendations can be found here:
VARIZIG PRODUCT INQUIRIES |
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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 serious adverse drug reactions observed in clinical trials for all subjects and patients include pyrexia, nausea, chills and vomiting. 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.
Please see Prescribing Information for full prescribing details.
References:
1 VARIZIG Prescribing Information
2 CDC. Updated Recommendations for Use of VariZIG — United States, 2013. MMWR, Morb Mortal Wkly Rep 2013;
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To report SUSPECTED ADVERSE REACTIONS, contact Kamada Therapeutics at +972-8-9406472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.