HYQVIA safety and tolerability
Once a month* dosing.1
Low rate of systemic ARs vs IVIG.

*Every 3 or 4 weeks.
HYQVIA is indicated for the treatment of primary immunodeficiency (PI) in adults. HYQVIA is for subcutaneous use only. Safety and efficacy of chronic use of Recombinant Human Hyaluronidase in HYQVIA have not been established in conditions other than PI.
*Every 3 or 4 weeks.
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.1
IVIG was administered for a median of 91 days (range 84 to 122 days) and HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] for a median of 42 days (range 20 to 49) during the dose ramp-up period and 366 days (range 42 to 507 days) during the efficacy period.1
a Causally related adverse events and/or temporally associated adverse events occurring within 72 hours.
b Excluding infections
c Rate = total number of events divided by total number of infusions.
Mild side effect causes temporary discomfort that goes away on its own, or with little medical intervention.
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.
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.
3 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.1 All were transient and resolved without sequelae.
66 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 2 trials was 188 subject-years and 2,959 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