Proven Efficacy and Safety in PI
Choose Hizentra—the SCIg with the longest record of proven efficacy and safety in PI
Hizentra is the only SCIg with proven experience since 2010
and over 9.3 million exposures worldwide4
Based on grams of Hizentra sold worldwide from 2010 through September 2020.
The US Phase 3 Trial confirmed the efficacy and tolerability of Hizentra, indicated in patients age 2 and older6*
US Phase 3 Trial Results (1 year)6†
Serious bacterial infections‡
(per subject year, annualized rate)
Any infections
(per subject year, annualized rate)
Serious adverse reactions
Two subjects withdrew from the study due to adverse reactions.
†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.
See US Phase 3 Trial and US Extension Study Designs
US Phase 3 Trial
A prospective, open-label, multicenter, single-arm, clinical study conducted in the U.S. 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.
A long-term extension study (1.7 years) demonstrated safe, sustained,
effective protection from infections7
US Extension Study Results (1.7 years)7
Serious bacterial infections||
(per subject year, annualized rate)
Any infections
(per subject year, annualized rate)
Treatment-related serious adverse events
Zero subjects discontinued because of treatment-related adverse events.
||Serious bacterial infections were defined as bacterial pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess.
Want to know more about Hizentra? See the answers to prescribers’ frequently asked questions.
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