Say Hy to an established
safety profile

The safety of HyQvia was evaluated in 2 clinical studies, including the
longest prospective CIDP safety trial¹*

*Pharmaceutical sponsored.

Safety in ADVANCE-1 and ADVANCE-3^2,3

In both studies, there were 104* unique patients who received a total of 4085 infusions of HyQvia^2,3

ARs in >5% of Patients Associated With Infusions of HyQvia^a

Adverse reactions^b	Placebo (N=70) Median: 4.7 months	HyQvia (N=62) Median: 5.3 months
Local ARs	7%	27%
Systemic ARs	10%	29%
Nausea	0%	11%
Fatigue	1%	8%
Pruritus	1%	8%
Headache	7%	7%
Pyrexia	0%	7%
Erythema	-	-
Abdominal pain	-	-
Back pain	-	-
Lipase increase	-	-
Pain in extremity	-	-

Adverse reactions^b	HyQvia (N=79) Median: 23 months (0 to 61 months)
Local ARs	24%
Systemic ARs	41%
Nausea	9%
Fatigue	8%
Pruritus	-
Headache	20%
Pyrexia	15%
Erythema	8%
Abdominal pain	6%
Back pain	5%
Lipase increase	5%
Pain in extremity	5%

Adverse reactions^b	HyQvia (N=85) Median: 33 months (0 to 77 months)
Local ARs	32%
Systemic ARs	49%
Nausea	7%
Fatigue	6%
Pruritus	-
Headache	17%
Pyrexia	12%
Erythema	6%
Abdominal pain	-
Back pain	-
Lipase increase	-
Pain in extremity	-

Rate^a of events per 100 infusions: Nausea

ADVANCE-1²

Placebo

Event of nausea
per 100 infusions
(644 infusions)

HyQvia

Event of nausea
per 100 infusions
(598 infusions)

ADVANCE-3 INTERIM²

HyQvia

Event of nausea
per 100 infusions
(2590 infusions)

ADVANCE-3 FINAL^3*

HyQvia

Event of nausea
per 100 infusions
(3487 infusions)

Studies were not designed to compare adverse reactions between treatment groups and trials.

*A single-arm, open-label extension safety study.²

^aRate=total number of events divided by total number of infusions.

Rate^a of events per 100 infusions: Fatigue

ADVANCE-1²

Placebo

Event of fatigue
per 100 infusions
(644 infusions)

HyQvia

Event of fatigue
per 100 infusions
(598 infusions)

ADVANCE-3 INTERIM²

HyQvia

Event of fatigue
per 100 infusions
(2590 infusions)

ADVANCE-3 FINAL^3*

HyQvia

Event of fatigue
per 100 infusions
(3487 infusions)

Studies were not designed to compare adverse reactions between treatment groups and trials.

*A single-arm, open-label extension safety study.²

^aRate=total number of events divided by total number of infusions.

Rate^a of events per 100 infusions: Pruritus

ADVANCE-1²

Placebo

Event of pruritus
per 100 infusions
(644 infusions)

HyQvia

Events of pruritus
per 100 infusions
(598 infusions)

ADVANCE-3 INTERIM²

HyQvia

Data not available
(2590 infusions)

ADVANCE-3 FINAL^3*

HyQvia

Data not available
(3487 infusions)

Studies were not designed to compare adverse reactions between treatment groups and trials.

*A single-arm, open-label extension safety study.²

^aRate=total number of events divided by total number of infusions.

Rate^a of events per 100 infusions: Headaches

ADVANCE-1²

Placebo

Headaches per
100 infusions
(644 infusions)

HyQvia

Headaches per
100 infusions
(598 infusions)

ADVANCE-3 INTERIM²

HyQvia

Headaches per
100 infusions
(2590 infusions)

ADVANCE-3 FINAL^3*

HyQvia

Headaches per
100 infusions
(3487 infusions)

Studies were not designed to compare adverse reactions between treatment groups and trials.

*A single-arm, open-label extension safety study.²

^aRate=total number of events divided by total number of infusions.

Rate^a of events per 100 infusions: Pyrexia

ADVANCE-1²

Placebo

Event of pyrexia
per 100 infusions
(644 infusions)

HyQvia

Event of pyrexia
per 100 infusions
(598 infusions)

ADVANCE-3 INTERIM²

HyQvia

Events of pyrexia
per 100 infusions
(2590 infusions)

ADVANCE-3 FINAL^3*

HyQvia

Events of pyrexia
per 100 infusions
(3487 infusions)

Studies were not designed to compare adverse reactions between treatment groups and trials.

*A single-arm, open-label extension safety study.²

^aRate=total number of events divided by total number of infusions.

Rate^a of events per 100 infusions: Erythema

ADVANCE-1²

Placebo

Data not available
(644 infusions)

HyQvia

Data not available
(598 infusions)

ADVANCE-3 INTERIM²

HyQvia

Events of erythema
per 100 infusions
(2590 infusions)

ADVANCE-3 FINAL^3*

HyQvia

Event of erythema
per 100 infusions
(3487 infusions)

Studies were not designed to compare adverse reactions between treatment groups and trials.

*A single-arm, open-label extension safety study.²

^aRate=total number of events divided by total number of infusions.

Studies were not designed to compare adverse reactions between treatment groups and trials.

In ADVANCE-1, a prospective, randomized, double blind, multicenter, placebo-controlled study, two serious TEAEs were reported in the HyQvia group: otitis media chronic and cerebrovascular accident.^2,5

In ADVANCE-3 (n=85), a single-arm, open-label extension study, three serious AEs were deemed to be related to HyQvia: infection at the infusion site, exacerbation of migraine and fibromyalgia after infusion, and exacerbation of heart failure that resolved following treatment. One AE leading to death was reported; the patient died due to cholangiocarcinoma, which was considered unrelated.³

AE=adverse event; AR=adverse reaction; TEAE=treatment-emergent adverse event(s).

*62 subjects from ADVANCE-1 HyQvia group and 42 subjects from ADVANCE-1 placebo group that crossed over to treatment with HyQvia in ADVANCE-3.³

^aCausally related adverse events and/or temporally associated adverse events occurring within 72 hours.²

^bExcluding infections.

Demonstrated local tolerability

ADVANCE-1

>7/10 HyQvia patients did not report any local ARs  
(17/62 HyQvia patients experienced local ARs vs 5/70 placebo patients).²

ADVANCE-3 INTERIM

>7/10 HyQvia patients did not report any local ARs 
(19/79 HyQvia patients experienced local ARs).²

ADVANCE-3 FINAL

~7/10 HyQvia patients did not report any local ARs 
(27/85 HyQvia patients experienced local ARs).³

Most Frequent Local Adverse Reactions Reported in >1% of Infusion With CIDP Treated With HyQvia

Infusion site reaction	Placebo (N=644) ARs per Infusion	HyQvia (N=598) ARs per Infusion
Discomfort/pain	2%	7%
Swelling/edema	1%	6%
Erythema	0%	6%
Pruritus	0%	3%

Infusion site reaction	HyQvia (N=2590) ARs per Infusion
Discomfort/pain	-
Swelling/edema	2%
Erythema	9%
Pruritus	-

Infusion site reaction	HyQvia (N=3487) ARs per Infusion
Discomfort/pain	-
Swelling/edema	-
Erythema	10%
Pruritus	-

Studies were not designed to compare adverse reactions between treatment groups and trials.

All or most of the local reactions (95%–100%) were either mild (85.44%–88.41%) or moderate (9.34%–11.59%) in severity.²

AR=adverse reaction.

*A prospective, randomized, double-blind, multicenter, placebo-controlled study.²

^†A single-arm, open-label extension safety study.⁶

Discontinuation rates

ADVANCE-1²*

in the HyQvia group
discontinued due to AEs
(n=3/26)

in the placebo group
discontinued due to AEs
(n=1/70)

Three patients 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 chills.²

ADVANCE-3 INTERIM ANALYSIS: Three patients discontinued due to AEs with HyQvia: mantle cell lymphoma, muscular weakness and worsening of CIDP, and abdominal pain. 1 patient died prior to the time of the interim analysis due to cholangiocarcinoma.⁷

ADVANCE-3 FINAL^7†

(5/85) discontinued
due to TEAE

died prior to
study completion

At the final analysis of ADVANCE-3, two additional patients discontinued due to additional TEAEs reported which included cardiac failure, inguinal hernia, and hypoventilation.

AE=adverse event; CIDP=chronic inflammatory demyelinating polyneuropathy; IVIG=intravenous immune globulin; TEAE=treatment-emergent adverse event(s).

*A prospective, randomized, double-blind, multicenter, placebo-controlled study.²

^†A single-arm, open-label extension safety study.⁷

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Study Data

Review MOA

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 after treatment with IG products, including HyQvia, even in patients previously treated with IG products. 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 to occur with use of IG, including HyQvia. 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, may occur with IG products, including HyQvia. 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, administer HyQvia at the minimum rate of infusion practicable. 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. Manage using oxygen therapy with adequate ventilatory support.

Transmissible Infectious Agents: Because HyQvia is made from human plasma, there is a risk of transmitting infectious agents (e.g. viruses, other pathogens).

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

Aseptic Meningitis Syndrome: Has been reported to occur with use of IG, including HyQvia. The syndrome usually begins within several hours to two days following IG treatment.

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

Transmissible Infectious Agents: Because HyQvia is made from human plasma, there is a risk of transmitting infectious agents (e.g. viruses, other pathogens).

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 Data on File. ADVANCE-3 Longest safety trial.
HyQvia. Prescribing information. Takeda Pharmaceuticals U.S.A., Inc.; 2025.
Hadden RDM, Andersen H, Bril V, et al. Long-term safety and tolerability of hyaluronidase-facilitated subcutaneous immunoglobulin 10% as maintenance therapy for chronic inflammatory demyelinating polyradiculoneuropathy: Results from the ADVANCE-CIDP 3 trial. J Peripher Nerv Syst. 2024;29(4):441-452. doi:10.1111/jns.12672.
HyQvia Data on File. CIDP ADVANCE-3 Interim median treatment duration.
Bril V, Hadden RDM, Brannagan TH 3rd, et al. Hyaluronidase-facilitated subcutaneous immunoglobulin 10% as maintenance therapy for chronic inflammatory demyelinating polyradiculoneuropathy: The ADVANCE-CIDP 1 randomized controlled trial. J Peripher Nerv Syst. 2023;28(3):436-449. doi:10.1111/jns.12573
ADVANCE-3 Data on File.
HyQvia Data on File. CIDP ADVANCE-3 Discontinuation Due to AEs Final Dataset.

Say Hy to an established safety profile

ADVANCE-12

ADVANCE-3 INTERIM2

ADVANCE-3 FINAL3

ADVANCE-12

ADVANCE-3 INTERIM2

ADVANCE-3 FINAL3

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Say Hy to an established
safety profile