Important Safety Information
Immune Globulin Subcutaneous (Human), Hizentra®, treats various forms of primary immunodeficiency (PI) in patients age 2 and over.
Hizentra should not be used if you have had serious negative reactions to immune globulin (Ig) preparations or a deficiency of an Ig known as IgA. Because Hizentra contains the amino acid proline as stabilizer, patients with hyperprolinemia (too much proline in the blood) should not take Hizentra.
Infuse Hizentra under your skin only; do not inject into a blood vessel.
Allergic reactions can occur with Hizentra. If your doctor suspects you are having a bad allergic reaction or are going into shock, treatment will be discontinued. Immediately tell your doctor or go to the emergency room if you have signs of such a reaction, including hives, trouble breathing, wheezing, dizziness, or fainting.
Tell your doctor about any side effects that concern you. Your doctor will monitor for potentially serious reactions that have been seen with Ig treatment, including thrombotic events (blood clotting); aseptic meningitis syndrome (brain swelling); osmotic nephropathy (a kidney condition); hemolysis (a blood problem) and transfusion-related acute lung injury.
The most common drug-related adverse reactions in the clinical trial for Hizentra were injection-site reactions (swelling, pain, redness, heat or itching); headache; back pain; diarrhea; tiredness; cough; rash; itching; nausea and vomiting.
Hizentra is made from components of human blood. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.
Vaccines (such as measles, mumps and rubella) might not work as well if you are using Hizentra. Before receiving a vaccination, tell the healthcare professional that you are being treated with Hizentra. Also tell your doctor if you are pregnant or nursing, or if you plan to become pregnant.
Please see full prescribing information for Hizentra, including the patient product information.
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.