Systemic Adverse Reaction and Local Tolerability Data

Review the rate of systemic adverse reactions with HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] Solution vs. intravenous IG (IVIG), plus the most common systemic adverse reactions seen with HYQVIA. You'll also find the rate of local adverse reactions, as well as the most frequent local adverse reactions seen with HYQVIA.

Please click for Important Safety Information and Full Prescribing Information, including Boxed Warning regarding Thrombosis.

Fewer Systemic Adverse Reactions Compared With IVIG Treatment1

In the efficacy trial1:

Rate of systemic adverse reactions with HYQVIA vs IVIG1*

 

0.20 HYQVIA

vs

0.42 IVIG

52% reduction

in the rate of
systemic adverse
reactions per infusion1

The most common systemic adverse reactions1

Adverse Reactions*ठin >5% of Subjects
Rate of adverse reactions per infusion

*Rate = total number of events divided by total number of infusions.
IVIG was administered for a median of 91 days and HYQVIA for a median of 366 days per subject during the efficacy period.
Excluding infections.
§Causally related adverse events and/or temporally associated adverse events occurring within 72 hours.

Demonstrated Local Tolerability1,6

In the efficacy trial1:
  • The rate of causally related local adverse reactions was comparable with published rates of conventional subcutaneous IG despite the larger infusion volume.6
  • 99% of local adverse reactions seen with HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] Solution were considered mild to moderate.1
    • 71% were mild
    • 28% were moderate
    • 1% were severe
    100% were transient and resolved without sequelae1

Mild: The adverse reaction causes transient discomfort and resolves spontaneously or may require minimal therapeutic intervention. Moderate: The adverse reaction produces limited impairment of function and resolves spontaneously or with minimal intervention. The adverse reaction produces no sequelae. Severe: The adverse reaction results in a marked impairment of function and can lead to temporary inability to resume normal life pattern. The adverse reaction requires prolonged intervention or results in sequelae.6

The percentage of subjects with local adverse reactions decreased over the 3.5-year study period.1#

  • None of the subjects withdrew from the clinical trials due to a severe or serious local or systemic adverse reaction.1
Most Frequent Local Adverse Reactions Reported in >1% of Infusions
Infusion-site reaction
Rate and number of infusions affected
(N=1,129)
Discomfort/pain
0.11 (122)
Swelling/edema
0.03 (35)
Erythema
0.03 (32)
Pruritus
0.02 (22)

3 local severe reactions: local infusion-site pain, infusion-site swelling, and infusion-site edema that extended from the abdominal infusion site to the genitalia.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

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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.

INDICATION AND LIMITATION OF USE

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.

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.
CONTRAINDICATIONS

  • 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)
WARNINGS and PRECAUTIONS

Hypersensitivity: Severe hypersensitivity reactions may occur, even in patients who have tolerated previous treatment with human IG. If a hypersensitivity reaction occurs, discontinue infusion immediately and institute appropriate treatment. IgA-deficient patients with antibodies to IgA are at greater risk of developing potentially severe hypersensitivity reactions, including anaphylaxis.

Thrombosis: May occur following treatment with IG products and in the absence of known risk factors. In patients at risk, administer at the minimum dose and infusion rate practicable. Ensure adequate hydration before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

Immunogenicity of Recombinant Human Hyaluronidase (rHuPH20): Non-neutralizing antibodies to the Recombinant Human Hyaluronidase component can develop. The clinical significance of these antibodies or whether they interfere with fertilization in humans is unknown.

Aseptic Meningitis Syndrome: Has been reported with use of IG and may occur more frequently in females. Conduct a thorough neurological exam on patients exhibiting signs and symptoms, to rule out other causes of meningitis. Discontinuing IG treatment has resulted in remission within several days without sequelae.

Hemolysis: HYQVIA contains blood group antibodies which may cause a positive direct antiglobulin reaction and hemolysis. Monitor patients for signs and symptoms of hemolysis and delayed hemolytic anemia and, if present, perform appropriate confirmatory lab testing.

Renal Dysfunction/Failure: Acute renal dysfunction/failure, acute tubular necrosis, proximal tubular nephropathy, osmotic nephrosis and death may occur with intravenous (IV) use of IG products, especially those containing sucrose. Ensure patients are not volume depleted prior to infusion. In patients at risk due to pre-existing renal insufficiency or predisposition to acute renal failure, assess renal function before initiation and throughout treatment, and consider lower, more frequent dosing. If renal function deteriorates, consider discontinuation.

Spread of Localized Infection: Do not infuse HYQVIA into or around an infected area due to potential risk of spreading a localized infection.

Transfusion-Related Acute Lung Injury: Non-cardiogenic pulmonary edema may occur with IV administered IG. Monitor patients for pulmonary adverse reactions. If suspected, perform appropriate tests for presence of anti-neutrophil and anti-HLA antibodies in both product and patient serum. May be managed using oxygen therapy with adequate ventilatory support.

Transmittable Infectious Agents: Because HYQVIA is made from human plasma, it may carry a risk of transmitting infectious agents (e.g. viruses, other pathogens). No cases of transmission of viral diseases or variant Creutzfeldt-Jakob disease (vCJD) have been associated with HYQVIA.

Interference with Lab Tests: False positive serological test results and certain assay readings, with the potential for misleading interpretation, may occur as the result of passively transferred antibodies.

The most common adverse reactions observed in >5% of patients in the clinical trials were: local adverse reactions including pain, erythema, edema, and pruritis, and systemic adverse reactions including, headache, antibody formation against Recombinant Human Hyaluronidase (rHuPH20), fatigue, nausea, pyrexia, and vomiting.

Passive transfer of antibodies may transiently interfere with the immune responses to live attenuated virus vaccines (e.g., measles, mumps, rubella, and varicella).

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