Purple "hy," inside of a speech bubble icon.

pediatric* indication

*Two years of age and older.

Protection against infection for pediatric* patients
The mean rate of acute serious bacterial infections (ASBIs) per patient-year was 0.04. This was significantly lower (with an upper 1-sided 99% confidence interval of 0.21, P<0.001) than the regulatory-defined threshold rate of 1.0.1,2

  • One subject experienced two ASBIs of bacterial pneumonia.
  • The mean rate of all infections was 3.20 per patient-year (95% upper CI, 4.05)
    • Consistent with results in adult clinical trial

*Two years of age and older.

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0.04 ASBIs
per patient-year with HyQvia

  • A prospective, open-label, noncontrolled, multicenter clinical trial was conducted to determine the efficacy, safety, tolerability, immunogenicity, and pharmacokinetics of HyQvia in pediatric patients (2 to 16 years of age) with primary immunodeficiency (PI) who had received prior IV or SC immunoglobulin therapy. The primary outcome measure was the annualized rate of acute serious bacterial infections (ASBIs) which was evaluated in 44 patients (ranging in age from 3 to 15 years) when all subjects had completed 12 months of participation

Demonstrated safety and tolerability in pediatric patients

In a 12-month study of pediatric patients (N=44), 99.8% of infusions were completed; 94.1% were completed without interruption.3 Similar to safety profile in adults.

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of infusions were completed

The most common adverse reactions observed in >5% of patients in the clinical trials were: local adverse reactions including pain, erythema, edema, and pruritus, and systemic adverse reactions including headache, antibody formation against Recombinant Human Hyaluronidase (rHuPH20), fatigue, nausea, pyrexia, and vomiting.

Short, once-monthly* infusions with <3 infusion sites

In a study of pediatric patients:

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Median duration of infusion was less than 1.5 hours3†

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Median number of infusions per month was 1.1 (range, 1.0 to 1.5) and were comparable across the age groups1

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The median number of infusion sites per month was 2.2 (range, 1.1 to 2.9), with a similar median number of infusion sites per month for all the age categories1

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Median infusion volume per site was 85 mL (range; 35 to 300)3

*Every 3 or 4 weeks.
84 (45-215) minutes.

Hyaluronidase (Hy) helps make monthly* SCIG dosing possible

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HyQvia is the only SCIG that uses Recombinant Human Hyaluronidase to increase the dispersion and absorption of IG into the bloodstream, making once-monthly* SCIG dosing possible for pediatric patients.1

*Every 3 or 4 weeks.

Similar access

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Must meet eligibility requirements.

Review safety information

Review Important Safety Information, including contraindications and other specific warnings and precautions to consider when prescribing and monitoring pediatric patients treated with HyQvia.

Get answers to your questions. Talk to your representative about HyQvia — the only long-lasting,* once-monthly SCIG infusion option for pediatric PI patients.

*Between infusions. Every 3 to 4 weeks. Two years of age and older.

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 June 30, 2023. https://www.fda.gov/media/124333/download
  3. Data on file. Takeda US Inc. 2023.