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Dosage and Administration

Dosage

The dosage of Hizentra should be individualized based on the patient's clinical response to therapy and serum immunoglobulin G (IgG) trough levels.

Treatment with Hizentra should begin 1 week after the last IVIg treatment. The initial weekly dose of Hizentra is calculated by converting the IVIg dose into a weekly equivalent and then increasing it by using a dose adjustment factor of 1.53. The goal is to achieve a systemic serum IgG exposure not inferior to that of the previous IVIg treatment.

To calculate the recommended starting dose, use this formula:

An easy way to calculate this is to use the Hizentra dosage calculator.

Over time, the dose may have to be adjusted to achieve the desired results. To determine if a dose adjustment is needed, measure the patient's serum IgG trough level 2 to 3 months after switching from IVIg. To learn how to adjust the dose, please see the full Prescribing Information.

Administration

Hizentra is infused subcutaneously on a weekly basis, using an infusion pump and small needle(s). Infusion sites include the thighs, upper arms, stomach, or hips. The dose may need to be infused into multiple injection sites, but in no more than four sites during the same infusion. You can assist your patient in selecting the exact location and number of infusion sites that are right for them.5 For the list of infusion steps, please see the full Prescribing Information.

Questions about infusion?

These frequently asked questions can help you learn more about infusing Hizentra.

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Watch the Hizentra self-administration video

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.

Please see full prescribing information for Hizentra.