HYQVIA safety and tolerability
Once a month* dosing.1
Low rate of systemic ARs vs IVIG.
*Every 3 or 4 weeks.
Once a month* dosing.1
- About HYQVIA
- HYQVIA Safety and Tolerability
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
Please see additional Important Safety Information throughout this page, in the tray below and in the Full Prescribing Information.
The most common systemic ARs1
Systemic ARsa,b in >5% of patients1
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.
IMPORTANT SAFETY INFORMATION
WARNING: THROMBOSIS
- Thrombosis may occur with immune globulin (IG) products, including HYQVIA. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.
- For patients at risk of thrombosis, administer HYQVIA at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration.
- Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity.
Contradictions
- History of anaphylactic or severe systemic hypersensitivity reactions to human IG
- IgA-deficient patients with antibodies to IgA and a history of hypersensitivity to human IG
- Known systemic hypersensitivity to hyaluronidase including Recombinant Human Hyaluronidase of HYQVIA
- Known systemic hypersensitivity to human albumin (in the hyaluronidase solution)
Please see additional Important Safety Information throughout this page, in the tray below and in the Full Prescribing Information.
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.
Important Safety Information (continued)
HyQvia has the following Warnings and Precautions: Hypersensitivity, Thrombosis, Immunogenicity of Recombinant Human Hyaluronidase (rHuPH20), Aseptic Meningitis Syndrome, Hemolysis, Renal Dysfunction/Failure, Spread of Localized Infection, Transfusion-Related Acute Lung Injury, Transmittable Infectious Agents, and Interference with Lab Tests.
Please see additional Important Safety Information throughout this page, in the tray below and in the Full Prescribing Information.
Most common local ARs reported
in >1% of infusions1
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
Important Safety Information (continued)
DRUG INTERACTIONS
Passive transfer of antibodies may transiently interfere with the immune responses to live attenuated virus vaccines (e.g., measles, mumps, rubella, and varicella).
Please see additional Important Safety Information throughout this page, in the tray below and in the Full Prescribing Information.
HyQvia Safety Information
Review the full safety information, including contraindications and specific warnings and precautions to take when prescribing and monitoring patients with HyQvia.
References:
- HYQVIA [prescribing information]. Lexington, MA: Baxalta US Inc.
- 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.