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
[email protected] or
1‑(866)‑916‑0077 or FDA at 1‑800‑FDA‑1088 or
www.fda.gov/medwatch.