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monthly* SCIG protection

*Every 3 or 4 weeks.

Reliable infection protection and consistent IG levels between infusions1,2

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

Reliable infection protection and consistent IG levels between infusions1,2

  • HyQvia was studied in a prospective, open-label, noncontrolled, 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 (ASBIs), 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 2959 infusions, and a maximum exposure up to approximately 3.5 years 

Patients taking once-monthly* HyQvia experienced1:

0.025 (<1)

ASBIs per patient-year with
HyQvia, P<0.0001
(upper 99% CI, 0.089)†

Yellow and purple infection icon.

<3

infections per
patient-year
(2.97; 95% Cl, 2.51-3.47)

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0 days

in hospital per year
due to infection
(0.037; 95% CI, 0.009 to 0.095)

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3.31 days

per year off
work or school
(95% Cl, 2.37-4.47)

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  • Acute serious bacterial infections (ASBIs) included 2 episodes of pneumonia
  • Both episodes of pneumonia were treated on an outpatient basis with oral antibiotics 
  • An additional episode of pneumonia requiring hospitalization occurred during the ramp-up period

*Every 3 or 4 weeks.

†<1 ASBI per patient-year is the FDA threshold for substantial evidence of efficacy.2

HyQvia provides consistent IG levels between infusions1‡

Pharmacokinetic (PK) comparison between mean IG values1§

  • HyQvia IG concentration over time is similar to IVIG but does not include the high initial peak
  • The mean serum IgG trough with HyQvia was 1077 mg/dL compared to 1095 mg/dL with IVIG
  • Peak-to-trough variation is more similar to conventional SCIG
HYQVIA PK chart with dose adjustment.

‡IVIG and HyQvia data at 28-day dosing interval; IGSC data at 7-day dosing interval; IGSC dotted line shows weekly dose extrapolated over 21 additional days.

§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.

Review safety information

Review Important Safety Information, including Contraindications and other specific Warnings and Precautions to consider when prescribing and monitoring patients treated with HyQvia.

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Get answers to your questions. Talk to a representative about HyQvia.

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References

  1. HyQvia. Prescribing information. Takeda Pharmaceuticals U.S.A., Inc.; 2024.
  2. US Food and Drug Administration. Guidance for industry: safety, efficacy, and pharmacokinetic studies to support marketing of immune globulin intravenous (human) as replacement therapy for primary humoral immunodeficiency. June 2008. Accessed July 13, 2022. https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm078526.pdf.

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