Important Safety Information
Hizentra and Vivaglobin are indicated for the treatment of various forms of primary
immunodeficiency (PI).
If you have a history of anaphylactic or severe systemic response to immune globulin
preparations or selective immunoglobulin A deficiency, check with your physician,
as you should not use Hizentra or Vivaglobin.
Hizentra and Vivaglobin are to be infused under your skin only; do not inject into
a blood vessel.
Hypersensitivity reactions may occur with Hizentra or Vivaglobin. If you have antibodies
to IgA, you face a greater risk of developing severe hypersensitivity or going into
shock. If your physician suspects you are having a negative reaction or are going
into shock, treatment will be discontinued. Because Hizentra contains proline, you
cannot be treated with Hizentra if you have hyperprolinemia (a high level of proline
in your blood).
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 (seen in 5% or more
of subjects in the clinical trial) were local reactions (swelling, redness, heat,
pain, and itching at the injection site), headache, vomiting, pain, and fatigue.The
most common drug-related adverse reactions with Vivaglobin (seen in 5% or more of
subjects in the clinical trial) were injection-site reactions (eg, swelling, redness,
and itching), headache, nausea, rash, reduced strength and energy, and gastrointestinal
disorders.
Your physician will monitor for potentially serious reactions associated with intravenous
immunoglobulin treatment that might also occur with Hizentra or Vivaglobin, including
aseptic meningitis syndrome (AMS), renal dysfunction/failure, osmotic nephropathy,
thrombotic events, hemolysis, and transfusion-related acute lung injury (TRALI).
Ig administration may impair the effect of virus vaccines, such as measles, mumps
and rubella. Before getting any vaccination, inform your doctor that you are using
Hizentra or Vivaglobin.
Please read full Prescribing Information and Patient Product Information for Vivaglobin.
Please read full Prescribing Information and Patient Product Information for Hizentra.
You are encouraged to report negative side effects of prescription drugs to the
FDA. Visit
www.fda.gov/medwatch or call 1-800-FDA-1088.