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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


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



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.


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


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

Review safety information

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  1. HyQvia. Prescribing information. Baxalta US, Inc.; 2021.