VARIZIG is a Varicella Zoster Immune Globulin (Human) indicated for post-exposure prophylaxis in high-risk individuals. High-risk groups include: immunocompromised children and adults, newborns of mothers with varicella shortly before or after delivery, premature infants, neonates and infants less than one year of age, adults without evidence of immunity, pregnant women.
VARIZIG administration is intended to reduce the severity of varicella.
Important Safety Information:
VARIZIG contains trace amounts of IgA. Individuals known to have anaphylactic or severe systemic (hypersensitivity) reactions to human immune globulin preparations should not receive VARIZIG. IgA-deficient patients with antibodies against IgA and a history of hypersensitivity may have an anaphylactoid reaction. Thrombotic events may occur during or following treatment with immune globulin products. Administer VARIZIG intramuscularly only. 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. Severe hypersensitivity reactions may occur following VARIZIG administration. In case of hypersensitivity, discontinue administration of VARIZIG immediately and provide appropriate treatment. Because VARIZIG is made from human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease agent, 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, 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 full Prescribing Information for complete prescribing details.
To report SUSPECTED ADVERSE REACTIONS, contact Kamada at pharmacovigilance@kamada.com or 1-(866)-916-0077 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
