HyQvia— the only long-lasting,*
once-a-month SCIG infusion

No matter if you have patients who are on a monthly IVIG or a more frequently administered SCIG, HyQvia [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] may be an option for them.

*Between infusions.

Every 3 or 4 weeks.

IVIG=intravenous immune globulin; SCIG=subcutaneous immune globulin.

In a clinical study HyQvia delivered

0.025

acute serious bacterial infections per patient-year1‡ P<0.0001 (upper 99% CI, 0.089)

 In a clinical study, patients experienced acute serious bacterial infections per patient-year P&lt;0.0001 (upper 99% CI, 0.089).
  • Acute serious bacterial infections (ASBIs) included 2 episodes of pneumonia1
  • Both episodes of pneumonia were treated on an outpatient basis with oral antibiotics1
  • An additional episode of pneumonia requiring hospitalization occurred during the ramp-up period1

52%

reduction in adverse reactions (fatigue and headache) vs IVIG

In a clinical study, on average, patients saw a 52% reduction in adverse reactions (fatigue and headache) vs IVIG.

Insurance coverage

for HyQvia is similar to that of other SCIGs2

In a clinical study, insurance coverage for HyQvia is similar to that of other SCIGs.
  • Acute serious bacterial infections (ASBIs) included 2 episodes of pneumonia1
  • Both episodes of pneumonia were treated on an outpatient basis with oral antibiotics1
  • An additional episode of pneumonia requiring hospitalization occurred during the ramp-up period1

  • 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)
  • The most common adverse reactions (ARs) observed in >5% of patients were local reactions including pain, erythema, edema, and pruritus, and systemic reactions including headache, antibody formation against rHuPH20, fatigue, nausea, pyrexia, and vomiting

<1 ASBI per patient-year is the threshold for substantial evidence of efficacy.3

§Rate of systemic ARs per HyQvia infusion (n=1129) was 0.20 and the rate of systemic ARs per IVIG infusion (n=365) was 0.42. IVIG was administered for a median of 91 days (range, 84 to 122 days) and HyQvia for a median of 42 days (range, 20 to 49 days) during the dose ramp-up period and 366 days (range, 42 to 507 days) during the efficacy period. Adverse reactions (ARs) were defined as causally related events and/or temporally associated adverse events occurring within 72 hours, excluding infections. Rate was calculated as the total number of events divided by total number of infusions.

Recombinant Human Hyaluronidase.

Hyaluronidase (Hy) helps make monthly* SCIG dosing possible1

Up to 28 days* between infusions

Hyaluronidase allows patients to go up to 28 days* between infusions.

~2-hour infusions

This is less infusion time than IVIG. Median infusion time was 2.08 (0.83-4.68) hours vs 2.33 (0.92-6.33) hours for IVIG in the clinical trial.

Hyaluronidase has approximately 2-hour infusions for patients, less infusion time than IVIG.

Patients can infuse at home, after adequate training, or in-center

Hyaluronidase allows patients to infuse at home after adequate training, or in-center.

*Every 3 or 4 weeks.

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

Reliable protection against infection demonstrated in the clinical trial1,3

0.025 ASBIs

<1 acute serious bacterial infection 
per patient-year with HyQvia, 
P<0.0001 (upper 99% CI, 0.089)

<3 infections

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

  • Acute serious bacterial infections (ASBIs) included 2 episodes of pneumonia1
  • Both episodes of pneumonia were treated on an outpatient basis with oral antibiotics1
  • An additional episode of pneumonia requiring hospitalization occurred during the ramp-up period1

<1 ASBI per patient-year is the threshold for substantial evidence of efficacy.3

Reduced Rates of systemic ARs vs IVIG

Purple lighting icon depicting reduction in adverse reactions.

Demonstrated local tolerability in a clinical study1

52% reduction in systemic ARs (fatigue and headache) vs IVIG.

52% reduction in systemic ARs
(fatigue and headache) vs IVIG1*

97.7% of infusions were completed without a rate reduction, interruption, or discontinuation due to tolerability concerns.

97.7% of infusions were completed without a rate reduction, interruption, or discontinuation due to tolerability concerns1

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.

The rate of systemic ARs per HyQvia infusion (n=1129) was 0.20 and the rate of systemic ARs per IVIG infusion (n=365) was 0.42.

*IVIG was administered for a median of 91 days (range, 84 to 122 days) and HyQvia for a median of 42 days (range, 20 to 49 days) during the dose ramp-up period and 366 days (range, 42 to 507 days) during the efficacy period. Adverse reactions (ARs) were defined as causally related events and/or temporally associated adverse events occurring within 72 hours, excluding infections. Rate was calculated as the total number of events divided by total number of infusions.

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.

In a clinical study, insurance coverage for HyQvia is similar to that of other SCIGs.

Similar insurance coverage

Coverage for HyQvia is similar to that of other SCIGs.2

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

Reference

  1. HyQvia. Prescribing information. Takeda Pharmaceuticals U.S.A., Inc.; 2023.
  2. Data on file. Takeda US Inc.
  3. 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.