Important Safety Information
Immune Globulin Subcutaneous (Human), Hizentra®, and Immune Globulin Subcutaneous
(Human), Vivaglobin®, are indicated as replacement therapy for patients with primary
humoral immunodeficiency (PI). This includes but is not limited to the humoral immune
defect in congenital agammaglobulinemia, common variable immunodeficiency, X-linked
agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
Hizentra® and Vivaglobin® are contraindicated in patients with a history of anaphylactic
or severe systemic reaction to human immune globulin preparations or their components.
Because it contains the stabilizer L-proline, Hizentra® is also contraindicated
in patients with hyperprolinemia. Both treatments are contraindicated in patients
with immunoglobulin A deficiency who have antibodies against IgA and a history of
Hizentra® and Vivaglobin® should be administered subcutaneously only. Do not administer
intravenously (into a blood vessel).
All IgA-deficient patients with anti-IgA antibodies are at greater risk of developing
potentially severe hypersensitivity and anaphylactic reactions. If hypersensitivity
occurs or anaphylactic reactions are suspected, discontinue administration of these
treatments immediately and treat as medically appropriate.
Hizentra® and Vivaglobin® are derived from human plasma. The risk of transmission
of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob
disease (CJD) agent, cannot be completely eliminated.
The most common drug-related adverse reactions with Hizentra® (observed in 5% or
more of subjects in the clinical trial) were local reactions (i.e., swelling, redness,
heat, pain, and itching at the injection site), headache, vomiting, pain, and fatigue.
The most common drug-related adverse reactions with Vivaglobin® (observed in 5%
or more of subjects in the clinical trial) were local injection-site reactions (e.g.,
swelling, redness, and itching), headache, nausea, rash, asthenia, and gastrointestinal
Aseptic meningitis syndrome (AMS) has been reported to occur infrequently with IVIg
treatment and treatment with Vivaglobin®, and might also occur with Hizentra®. AMS
is usually evidenced within 2 days of administration. Also monitor patients for
other reactions reported to occur with IVIg treatment that might also occur with
Vivaglobin® or Hizentra®, including renal dysfunction/failure, thrombotic events,
hemolysis, and transfusion-related acute lung injury (TRALI).
Ig administration can transiently impair the efficacy of live attenuated virus vaccines,
such as measles, mumps and rubella. It can also lead to misinterpretation of serologic
Please read full Prescribing Information for Vivaglobin.
Please read full Prescribing Information for Hizentra.
You are encouraged to report negative side effects of prescription drugs to the
www.fda.gov/medwatch or call 1-800-FDA-1088.