Steady-state Ig levels.1,2
Reliable infection protection
and steady-state Ig levels.1,2
Infused every 3 or 4 weeks, HYQVIA [Immune Globulin Infusion 10%
(Human) with Recombinant Human Hyaluronidase] delivered reliable
protection against infection in the clinical study.1,2
- HYQVIA was studied in a prospective, open-label, non-controlled, multicenter clinical trial conducted to determine the efficacy, tolerability, and pharmacokinetics (PK) of HYQVIA in patients with primary immunodeficiency (PI). The primary outcome measure was the annualized rate of acute serious bacterial infections (ASBI), which was evaluated in 83 patients over a median treatment duration of 366 days (42 to 507 days)
- 66 subjects who completed the efficacy clinical trial enrolled in a prospective, open-label, multicenter extension trial to assess the long-term safety and tolerability of HYQVIA. The cumulative exposure of HYQVIA across the two trials was 188 subject-years and 2,959 infusions, and a maximum exposure up to approximately 3.5 years
Patients taking once-monthly*
‡<1 ASBI per patient year is the threshold for substantial evidence of efficacy
- Acute serious bacterial infections (ASBIs) included 2 episodes of pneumonia1
- Both episodes of pneumonia were treated as outpatients with oral antibiotics.1
- An additional episode of pneumonia requiring hospitalization occured during the ramp-up period1
in hospitals per year
due to infection
(95% Cl, 0.0-0.12)
off work or school per
year due to infection
(95% Cl, 2.44-4.5)
*Every 3 or 4 weeks.
steady-state Ig levels
Pharmacokinetic (PK) comparison
between mean Ig values1‡
- HYQVIA Ig concentration over time is similar to IVIG without the high peak
- Peak-to-trough variation with HYQVIA is more similar to conventional SCIG
- The mean serum IgG trough with HYQVIA was 1,077 mg/dL compared with 1,095 mg/dL with IVIG
‡IVIG and HYQVIA data at 28-day dosing interval.
§HYQVIA PK curve achieved with 8% larger dose than IVIG.
This graph shows a mean concentration-time plot of IgG in subjects 12 years and older. HYQVIA is not approved to treat PI in pediatric patients.
- HYQVIA [prescribing information]. Lexington, MA: Baxalta US Inc.
- Food and Drug Administration. Safety, efficacy, and pharmacokinetic studies to support marketing of immune globulin intravenous (human) as replacement therapy for primary humoral immunodeficiency. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-efficacy-and-pharmacokinetic-studies-support-marketing-immune-globulin-intravenous-human. Accessed May 28, 2019.