"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.

In a clinical study, patients experienced acute serious bacterial infections per patient-year P&lt;0.0001 (upper 99% CI, 0.089).

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.

Yellow almost-closed pie chart depicting 99.8% of infusions were completed.

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:

White stopwatch icon with purple hands.

Median duration of infusion was less than 1.5 hours3†

White and yellow calendar icon with one purple square.

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

White infusion body icon depicting infusion sites.

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

Mean infusion volume icon.

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

&#34;Hy&#34; and &#34;IG&#34; letters inside of 2 interlocking circles.

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

Coverage card icon.

†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.

See safety information

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

Contact a Rep

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

References

  1. HyQvia. Prescribing information. Takeda Pharmaceuticals U.S.A., Inc.; 2023
  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.

Thank you for visiting

You are now leaving this site and being redirected to a non-Takeda owned/managed website.

Continue
Never mind, I want to stay

Thank you for visiting

You are being directed to another website.

Continue
Never mind, I want to stay

Healthcare professionals

The information on this website is technical in nature and has been specifically created for healthcare professionals. If you are not a healthcare professional and would like to visit the consumer site, please click the appropriate link below.

Continue
Take me to the patient site