Hizentra provides proven protection against infection. In the US clinical trial,
the rate of serious bacterial infections4
(SBIs) was 0 per subject-year, while the annual rate of infections was 2.76 per
subject-year. This means that patients did not experience any serious infections
(meaning pneumonia, bronchitis, etc). On average, all patients had fewer than 3
infections of any type per year.
The following is information from the US pivotal clinical study used by the FDA
to approve Hizentra for PI therapy.
Serious Bacterial Infections*
2.06 missed days of work/school/daycare per subject-year due to infections
0.2 days of hospitalizations per subject-year due to infections
In the US clinical trial for Hizentra, the most common adverse reactions to Hizentra
were redness, swelling, itching, heat, or pain at the infusion site (ie, local site
reactions). 93% were mild, while 6% were moderate. Other common side effects observed
were headache, vomiting, pain, and fatigue.
Mild Local-Site Reaction
- Minor swelling
- Mild redness, itching, discomfort, and/or pain
Moderate Local-Site Reaction
- Greater swelling than with a mild reaction
- Moderate redness, itching, discomfort, and/or pain
Serious bacterial infections (SBIs), defined as bacterial pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess