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.