Proven Efficacy and Safety in PI

#1 Ig Prescribed for 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 6 million exposures* worldwide4


The US Phase 3 Trial confirmed the efficacy and tolerability of Hizentra, indicated in patients age 2 and older6†

US Phase 3 Study Results6‡

ZERO

Serious bacterial infections§ (per subject year, annualized rate)

2.76

Any infections (per subject year, annualized rate)

ZERO

Serious adverse reactions||

||Two subjects withdrew from the study due to adverse reactions.
*Estimate based on Hizentra grams sold worldwide from 2010 through June 2018.
Demonstrated in patients 5–72 years of age in the 12-month US phase 3 trial with Hizentra weekly (n=38) and in patients 2–65 years of age in the 7-month EU trial with Hizentra weekly (n=46).
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.
Low rates of lost days of work/school: 2.06 days/subject year6

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 Results7

ZERO

Serious bacterial infections# (per subject year, annualized rate)

2.38

Any infections (per subject year, annualized rate)

ZERO

Treatment-related serious adverse events**

**Zero subjects discontinued because of treatment-related adverse events.
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).
#Serious bacterial infections were defined as bacterial pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess.
Continued low rates of infection over the long term7

Clinical perspectives: goals of Ig therapy

Douglas Jones, MD, discusses the goals of Ig therapy and how he works to customize therapy for each patient's unique circumstances.

Frequently asked questions about Hizentra for PI

Want to know more about Hizentra? See the answers to prescribers' frequently asked questions.

Frequently asked questions about PI
Flexibility with Hizentra for self-administration for PI

Create personalized treatment plans to meet each patient's clinical needs and personal perferences.

See why Hizentra might be right for your patients
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