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Longest record of proven efficacy and safety of any SCIg in PI

Supported by multiple clinical studies and over a decade of real-world experience.

Jump to study results:

US Phase 3 Trial
US Extension Study

Delivering results you can trust

#1 Ig Prescribed for PI

#1 Ig prescribed for PI1

Only 20% SCIg with proven experience since 20101

Only 20% SCIg with proven experience since 20101

More than 12.7 million doses delivered worldwide1*

More than 13.2 million doses delivered worldwide1*

*Estimated doses based on grams of Hizentra sold worldwide from 2010 through June 2023.

Proven in US Phase 3 Trial Results (1 year)2†‡

ZERO

Serious bacterial infections

(per subject year, annualized rate)§

2.76

Any infections

(per subject year, annualized rate)

ZERO

Serious adverse reactions||

Demonstrated further by US Extension Study Results (1.7 years)3

0.06

Serious bacterial infections

(per subject year, annualized rate)§

2.38

Any infections

(per subject year, annualized rate)

ZERO

Treatment-related serious
adverse events#

†Demonstrated in patients 5–72 years of age in the 12-month US phase 3 trial with Hizentra weekly (n=38). ‡Hizentra was initiated at a weekly dose of 153% of the previous weekly equivalent IVIg dose in the US study. §Serious bacterial infections were defined as bacterial pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. ||Two subjects withdrew from the study due to adverse reactions. During the US extension study, 2 SBIs (bacterial pneumonia) in 2 subjects were reported, giving an annualized rate of 0.06 infections per subject (n=21). #Zero subjects discontinued because of treatment-related adverse events.

See study designs

US Phase 3 Trial

A prospective, open-label, multicenter, single-arm, clinical study conducted in the US evaluated the efficacy, tolerability, and safety of Hizentra in 49 adult and pediatric subjects with PI. Subjects previously receiving monthly treatment with IVIg were switched to weekly subcutaneous administration of Hizentra.

US Extension Study

Phase 3, prospective, open-label, single-arm extension study in 21 patients with PI who had previously been treated with Hizentra in pivotal studies.

Dosing

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Dosing calculator

Administration

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Administration guidance
References: 1. Data on File. Available from CSL Behring as DOF HIZ-005. 2. Hagan JB, Fasano MB, Spector S, et al. Efficacy and safety of a new 20% immunoglobulin preparation for subcutaneous administration, IgPro20, in patients with primary immunodeficiency. J Clin Immunol. 2010;30(5):734-745. doi: 10.1007/s10875-010-9423-4. 3. Jolles S, Borte M, Nelson R, et al. Long-term efficacy, safety, and tolerability of Hizentra for treatment of primary immunodeficiency disease. Clin Immunol. 2013;150:161-169.
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