Patient care FAQs

How do I know which patients Hizentra may right for?
Research studies and experience have identified characteristics that might indicate whether certain patients might be a good fit for an SCIg treatment, such as Hizentra³.

Hizentra patients are likely to have the following characteristics³:

Have active lifestyles, full-time work/school routines, or busy family schedules
Prefer freedom and flexibility of self-administration
A sharp increase in serum IgG levels during or after an IVIg infusion causes systemic adverse reactions
Poor venous access
Prefer to manage their own health
Can work individually or in tandem with a caregiver to self-administer or infuse SCIg therapy
Have a clear understanding of SCIg therapy

What are the most common adverse reactions of infusion with Hizentra?
In the clinical trial (n=49), most adverse reactions (ARs) reported were nonserious. The most common ARs, observed in ≥5% of study subjects, were local injection-site reactions, headache, vomiting, pain, and fatigue.

Injection-site reactions were primarily mild (93.4%) or moderate (6.3%). These are to be expected. Symptoms can include edema, erythema, local heat, local pain, and itching. In moderate cases, the affected area can be tender and larger than a half dollar.⁵

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.

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, pruritis, vomiting, upper abdominal pain, pain, and migraine.

Monitor patients for thrombotic events and aseptic meningitis (AMS), which have been reported with SCIg. Also look forreactions reported to occur with IVIg treatment that might also occur with Hizentra, including renal dysfunction/failure, 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 testing.