Patient Dosing & Administration

While there are guidelines on how to begin Hizentra therapy, the dosage should be individualized based on the patient's clinical response to therapy and serum immunoglobulin G (IgG) through 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 apply 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 (if applicable).

To calculate the recommended starting dose, use this formula:

Initial recommended dose of Hizentra
= 1.53 x
Previous IVIg dose(grams)
Number of weeks between scheduled IVIg doses

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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 through level 2 to 3 months after transitioning to Hizentra. To learn how to adjust the dose, please see the full Prescribing Information.

Administration

Hizentra should be administered subcutaneously only. Do not administer intravenously. Hizentra was approved as a weekly infusion, using an infusion pump and small needle(s).

  • Hizentra can be infused in up to 4 sites at the same time, with at least 2 inches between sites; new sites should be at least 1 inch from a previous site
  • Recommended infusion sites include the stomach, thighs, upper arms, or hips
  • SC needles are smaller than IV needles. Depending on a patient’s size and weight, a needle as short as 4 mm or as long as 14 mm can be used
  • Infusion should not exceed 25 mL/hour per site and 50 mL/hr for all sites combined
Subcutaneous Infusion Sites
Professionals Using Hizentra Dosing & Administration
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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.

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© 2013 CSL Behring. The product information presented on this site is intended for US residents only. HIZ10-12-0023 11/2012