Important Safety Information
Immune Globulin Subcutaneous (Human), Hizentra®, is indicated as replacement therapy for patients with primary humoral immunodeficiency (PI), age 2 and older. 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 is contraindicated in patients with a history of anaphylactic or severe systemic reaction to human immune globulin preparations or components of Hizentra, such as polysorbate 80. Because it contains the stabilizer L-proline, Hizentra is contraindicated in patients with hyperprolinemia. Hizentra is also contraindicated in patients with immunoglobulin A deficiency who have antibodies against IgA and a history of hypersensitivity.
Hizentra should be administered subcutaneously only. Do not administer intravenously.
IgA-deficient patients with anti-IgA antibodies may be at greater risk of developing potentially severe hypersensitivity and anaphylactic reactions with administration of
Hizentra. If hypersensitivity occurs or anaphylactic reactions are suspected, discontinue administration immediately and treat as medically appropriate.
Monitor patients for thrombotic events and aseptic meningitis (AMS), which have been reported with SCIg. Also look for reactions reported to occur with IVIG treatment that might also occur with Hizentra, including renal dysfunction/failure, hemolysis, and transfusion-related acute lung injury (TRALI).
Hizentra is 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 (observed in 5% or more of study subjects receiving Hizentra) were local reactions (ie, swelling, redness, heat, pain, and itching at the injection site), headache, diarrhea, fatigue, back pain, nausea, extremity pain, cough, rash, pruritus, vomiting, upper abdominal pain, migraine and pain.
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 testing.
Please see full prescribing information for Hizentra.