to an established safety profile

Established safety profile

Most common ARs in CIDP clinical studies with HyQvia were local reactions, headache, pyrexia, nausea, fatigue, erythema, pruritus, abdominal pain, and back pain.¹*^† Please see additional Important Safety Information below, including Boxed Warning regarding Thrombosis.

Low rate of treatment discontinuation

In the pivotal ADVANCE-1 trial and extension ADVANCE-3 clinical trial, most ARs were mild to moderate^‡ and did not require treatment discontinuation.¹*^†

In ADVANCE-1 trial:

4.8% of patients in the HYQVIA group discontinued due to ARs.

of patients in the HyQvia group discontinued due to ARs (n=3/62)

1.4% of patients in the HYQVIA group discontinued due to ARs.

of patients in the placebo group discontinued due to ARs (n=1/70)

Three subjects withdrew during the HyQvia treatment period due to a cerebrovascular accident (with underlying cardiovascular risk factors), infusion site edema and infusion site pain, and nausea and chills¹

In the ADVANCE-3 Trial:¹

3.8% of patients in the HYQVIA group discontinued due to ARs.

of patients in the HyQvia group discontinued due to ARs (n=3/79)

Three patients withdrew during the HyQvia treatment period due to: mantle cell lymphoma in 1 patient, muscular weakness and worsening of CIDP in another patient, and abdominal pain in the third patient.¹
One patient died prior to the time of the interim analysis. The cause of death in the 1 patient was cholangiocarcinoma.¹

Established safety profile

Demonstrated local tolerability

Immunogenicity data

ARs in >5% of patients (N=100) associated with infusions of HyQvia¹

AR, % (n)*	Rate of systemic ARs per infusion (N=3188)^†
Local ARs	9.5% (303)
Systemic ARs	9.1% (291)
Headache	2.51% (80)
Erythema	2.51% (80)
Pyrexia	2.01% (64)
Pruritis	0.57% (18)
Nausea	0.53% (17)
Fatigue	0.50% (16)
Abdominal pain	0.31% (10)
Back pain	0.188% (6)

*Excluding infection.¹^†Rate=total number of events divided by total number of infusions.¹

AR=adverse reaction; CI=confidence interval; CIDP=chronic inflammatory demyelinating polyneuropathy; IVIG=intravenous immune globulin.

*ADVANCE-1 was a Phase III, prospective, randomized, double-blind, multicenter, placebo-controlled study in which adults with CIDP on a stable dose of IVIG for ≥12 weeks before screening were randomized to be switched to HyQvia (n=62) or placebo (n=70). Median duration of exposure was 5.3 months in the HyQvia group and 4.7 months in the placebo group. The analysis of the primary endpoint demonstrated a statistically significant difference between the relapse rates for HyQvia (14.0%) and placebo (32.3%); p=0.0314. There was a treatment difference of -18.3% (a two-sided 95% CI: -32.1%,-3.1%).1 ADVANCE-3 was a Phase IIIb, single-arm, open-label, multicenter, extension study which assessed the long-term safety and tolerability of HyQvia for maintenance therapy for CIDP. At interim analysis, data included 79 patients with a range of follow-ups from 0 to 5.1 years.¹

^†Causally related ARs and/or temporally associated ARs occurring within 72 hours.¹

^‡Mild is defined as transient discomfort that resolves spontaneously or with minimal intervention; moderate is defined as limited impairment of function that resolves spontaneously or with minimal intervention with no sequelae.¹

ADVANCE-1 and ADVANCE-3 data

The safety of HyQvia was evaluated in 2 clinical studies of 100 unique patients who received a total of 3188 infusions of HyQvia.¹*

Adverse Reactions (ARs)^a in Greater Than 5% of Subjects Associated With Infusions of HyQvia in the Pivotal ADVANCE-1 Trial^1b

Table of HYQVIA adverse reactions in the pivotal ADVANCE-1 Trial.

^aCausally related adverse events and/or temporally associated adverse events occurring within 72 hours.
^bExcluding infections
^cRate = total number of events divided by total number of infusions.

Most Frequent Local ARs Reported in >1% of Infusions During Treatment With HyQvia (ADVANCE-1: all safety subjects)¹

Table of HYQVIA most frequent local ARs reported in >1% of infusions in ADVANCE-1 Trial.

All HyQvia local reactions (100%) were either mild (88.41%) or moderate (11.59%) in severity¹

ARs^a in >5% of Subjects Associated With Infusions of HyQvia in the ADVANCE-3 Trial¹

Table of ARs in >5% of subjects associated with infusions of HYQVIA in the ADVANCE-3 Trial.

^aCausally related adverse events and/or temporally associated adverse events occurring within 72 hours.
^bExcluding infections
^cRate = total number of events divided by total number of infusions.

Most Frequent Local ARs Reported in >1% of Infusions During Treatment with HyQvia (ADVANCE-3: all safety subjects)¹

Table of HYQVIA most frequent local ARs reported in >1% of infusions in ADVANCE-3 Trial.

Most of the local reactions (95%) were either mild (85.44%) or moderate (9.34%) in severity¹

ADVANCE-3 (Study 2) was a single-arm, open-label, multicenter extension study that included 79 patients, 2590 infusions, and a follow-up of 0 to 5.1 years.

Binding antibody positivity rate was comparable to other clinical development programs

rHuPH20 antibody binding rates with HyQvia in ADVANCE-1 and ADVANCE-3 trials were comparable to other development programs^1*

A total of 15 patients (15%) treated with HyQvia developed binding antibodies (≥1:160) to rHuPH20 in ADVANCE-1¹

Over 3188 HyQvia infusions in 132 unique patients, one incidence of anti-rHuPH20 neutralizing antibody positivity was observed in both studies¹

Elevation in neutralizing antibody titers was transient and occurred at a single measurement over a 3-year follow-up period¹

No safety or efficacy issues were identified with the occurrence of neutralizing antibody positivity.¹

rHuPH20=recombinant human hyaluronidase.

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IMPORTANT SAFETY INFORMATION including BOXED WARNING for Thrombosis

INDICATION

HYQVIA is indicated for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment in adults. HYQVIA is for subcutaneous use only.

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: Has been reported to occur following treatment with IG products, including HYQVIA 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, including HYQVIA and may occur more frequently in females. The syndrome usually begins within several hours to two days following IG treatment.

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.

Adverse Reactions

The most common adverse reactions observed in clinical trials in >5% of patients were: local reactions, headache, pyrexia, nausea, fatigue, erythema, pruritus, increased lipase, abdominal pain, back pain, and pain in extremity.

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).

Use In Specific Populations

Pregnancy: Limited human data are available on the use of HYQVIA during pregnancy. The effects of antibodies to the Recombinant Human Hyaluronidase on the human embryo or fetal development are unknown. It is not known whether HYQVIA can cause fetal harm when administered to a pregnant woman or if it can affect reproductive capacity. HYQVIA should be given to a pregnant woman only if clearly needed.

Please click for Full Prescribing Information.

INDICATION

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

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

Adverse Reactions

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).

Use In Specific Populations

Please click for Full Prescribing Information.

References:

HyQvia. Prescribing information. Takeda Pharmaceuticals U.S.A., Inc.; 2024.
Rosengren S, et al. AAPS J. 2015;17(5):1144-1156.

to an established safety profile

Established safety profile

Low rate of treatment discontinuation

Binding antibody positivity rate was comparable to other clinical development programs

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