Hizentra® PID

HIZENTRA is indicated as replacement therapy for primary humoral immunodeficiency (PI) in adults and pediatric patients 2 years of age 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.

WARNING: Thrombosis may occur with immune globulin products, including Hizentra. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.

For patients at risk of thrombosis, administer Hizentra at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

• History of anaphylactic or severe systemic reaction to human immune globulin or inactive ingredients of HIZENTRA, such as polysorbate 80.  
• Hyperprolinemia Type I or II (HIZENTRA contains stabilizer L-proline). 
• IgA-deficient patients with antibodies against IgA and a history of hypersensitivity.

Before switching to HIZENTRA, obtain the patient’s serum IgG trough level to guide subsequent dose adjustments.

• Weekly: Start HIZENTRA 1 week after last Immune Globulin Intravenous (Human) (IVIG) infusion.

Initial weekly dose = Previous IVIG dose (in grams)           x 1.37
                                        No. of weeks between IVIG doses

• Biweekly (every 2 weeks): Start HIZENTRA 1 or 2 weeks after the last IVIG infusion or 1 week after the last weekly SCIG infusion. Administer twice the calculated weekly dose. 
• Frequent dosing (2 to 7 times per week): Start HIZENTRA 1 week after the last IVIG or SCIG infusion. Divide the calculated weekly dose by the desired number of times per week.
• Adjust the dose based on clinical response and serum IgG trough levels.

• Administer at regular intervals from daily up to every two weeks.
• Infusion sites – Up to 8 infusion sites are allowed simultaneously, with at least 2 inches between sites
• HIZENTRA is for subcutaneous infusion only. HIZENTRA is intended for subcutaneous administration using an infusion pump.
• Infuse HIZENTRA in the abdomen, thigh, upper arm, and/or lateral hip
• Infusion sites - A HIZENTRA dose my be infused into multiple infusion sites.  Use up to 8 infusion sites in parallel.  More than one infusion device can be used simultaneously.  Infusion sites should be at lease 2 inches apart.  Change the actual site of the infusion for each administration.

*As tolerated

1 gram (g) of Hizentra is equal to 5 mL