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.

HYQVIA safety and tolerability

Once a month* dosing.1
Low rate of systemic ARs vs IVIG.

*Every 3 or 4 weeks.

Demonstrated local tolerability. Low rates of systemic ARs vs IVIG.1,2

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

HYQVIA demonstrated low rates of systemic ARs vs IVIG

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

The most common systemic ARs1

Systemic ARsa,b in >5% of patients1

HYQVIA infusions demonstrated fewer adverse reactions than IVIG infusions.

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.

Demonstrated local tolerability1

In the efficacy trial:

  • 97.7% of infusions were completed without a rate reduction, interruption, or discontinuation due to tolerability concerns2
  • None of the subjects withdrew from the clinical trials due to a severe or serious local or systemic adverse reaction1
  • Two children and 4 adults withdrew from the trial during the efficacy treatment period with HYQVIA due to mild to moderate ARs1

~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

Most common local adverse reactions were reported in >1% of HYQVIA infusions

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

References:
  1. HYQVIA [prescribing information]. Lexington, MA: Baxalta US Inc.
  2. Wasserman RL, Melamed I, Stein MR, et al; and IGSC, 10% with rHuPH20 Study Group. Recombinant human hyaluronidase-facilitated subcutaneous infusion of human immunoglobulins for primary immunodeficiency. J Allergy Clin Immunol, 2012;130(4):951-957.