low rate of
systemic ARs vs IVIG

Low rates of systemic ARs vs IVIG. Demonstrated local tolerability.1

Compared to IVIG, HyQvia® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] demonstrated lower rates of systemic reactions.

In this study, 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.

IVIG was administered for a median of 91 days (range, 84-122 days) and HyQvia for a median of 42 days (range, 20-49 days) during the dose ramp-up period and 366 days (range, 42-507 days) during the efficacy period.

  • A 12-month prospective, open-label, noncontrolled, multicenter trial including 83 patients receiving 1359 infusions. Thirty-one patients had been treated with IVIG for 3 months and then with SCIG each week at 137% of the IVIG dose for approximately 1 year before transitioning to the HyQvia trial. The remaining patients were treated with 3- or 4-week treatment intervals (following ramp-up period). The dose of HyQvia was 300 to 600 mg/kg (administered at 108% of the IVIG dose). Ninety-four percent of patients maintained their IVIG dosing frequency

HyQvia demonstrated 52% lower rate of systemic ARs vs IVIG1

0.20

rate of systemic ARs per HyQvia infusion (n=1129)

vs

0.42

rate of systemic ARs per IVIG infusion (n=365)

=

HYQVIA showed a 52% reduction in the rate of systemic adverse reactions when compared to IVIG infusions.

52%

reduction in the rate of systemic ARs with HyQvia

Systemic ARs*† in >5% of patients1

The most common systemic ARs

HYQVIA infusions demonstrated fewer systemic adverse reactions than IVIG infusions.

*Causally related adverse events and/or temporally associated adverse events occurring within 72 hours.

Excluding infections.

Rate=total number of events divided by total number of infusions.

Demonstrated local tolerability1

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

  • None of the subjects withdrew from the clinical trials due to a severe or serious local or systemic adverse reaction
  • Two children and four adults withdrew from the trial during the efficacy treatment period with HyQvia due to mild to moderate ARs

~99%

of local side effects were considered mild to moderate


70.5%were mild (n=165)

Mild side effect: causes temporary discomfort that goes away on its own, or with little medical intervention.

28.2%were moderate (n=66)

Moderate side effect: causes a slight decline in function that goes away on its own, or with little medical intervention, and has no further consequences.

1% were severe (n=3)

Severe side effect: results in impairment of function and can lead to temporary inability to resume normal lifestyle, as it requires prolonged medical intervention and/or results in further consequences.

Most common local ARs reported in >1% of infusions1

Infusion-site reactionRate (per infusion) and number of local ARs (N=1129)
Discomfort/pain 0.11 (112)
Swelling/edema0.03 (35)
Erythema0.03 (32)
Pruritus0.02 (22)

Three local severe reactions occurred during the clinical study: infusion site pain, infusion site swelling, and infusion site edema that extended from the abdominal infusion site to the genitalia. All were transient and resolved without sequelae.1

Sixty-six 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.1

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.1

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REFERENCE

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