HyQvia— the only long-lasting,*
once-a-month SCIG infusion

No matter if you have patients who are on a monthly IVIG or a more frequently administered SCIG, HyQvia [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] may be an option for them.

See what makes monthly dosing possible

*Between infusions.

^†Every 3 or 4 weeks.

IVIG=intravenous immune globulin; SCIG=subcutaneous immune globulin.

In a clinical study HyQvia delivered

0.025

acute serious bacterial infections per patient-year^1‡P<0.0001 (upper 99% CI, 0.089)

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Acute serious bacterial infections (ASBIs) included 2 episodes of pneumonia¹
Both episodes of pneumonia were treated on an outpatient basis with oral antibiotics¹
An additional episode of pneumonia requiring hospitalization occurred during the ramp-up period¹

52%

reduction in adverse reactions (fatigue and headache) vs IVIG^1§

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Insurance coverage

for HyQvia is similar to that of other SCIGs²

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Acute serious bacterial infections (ASBIs) included 2 episodes of pneumonia¹
Both episodes of pneumonia were treated on an outpatient basis with oral antibiotics¹
An additional episode of pneumonia requiring hospitalization occurred during the ramp-up period¹

HyQvia was studied in a prospective, open-label, noncontrolled, multicenter clinical trial conducted to determine the efficacy, tolerability, and pharmacokinetics (PK) of HyQvia in patients with primary immunodeficiency (PI). The primary outcome measure was the annualized rate of acute serious bacterial infections (ASBIs), which was evaluated in 83 patients over a median treatment duration of 366 days (42 to 507 days)
The most common adverse reactions (ARs) observed in >5% of patients were local reactions including pain, erythema, edema, and pruritus, and systemic reactions including headache, antibody formation against rHuPH20,^¶ fatigue, nausea, pyrexia, and vomiting

^‡<1 ASBI per patient-year is the threshold for substantial evidence of efficacy.³

^§Rate of systemic ARs per HyQvia infusion (n=1129) was 0.20 and the rate of systemic ARs per IVIG infusion (n=365) was 0.42. IVIG was administered for a median of 91 days (range, 84 to 122 days) and HyQvia for a median of 42 days (range, 20 to 49 days) during the dose ramp-up period and 366 days (range, 42 to 507 days) during the efficacy period. 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.

^¶Recombinant Human Hyaluronidase.

**Hyaluronidase (Hy) helps make monthly^* SCIG dosing possible¹**

Up to 28 days* between infusions

~2-hour infusions

This is less infusion time than IVIG. Median infusion time was 2.08 (0.83-4.68) hours vs 2.33 (0.92-6.33) hours for IVIG in the clinical trial.

Patients can infuse at home, after adequate training, or in-center

Explore the MOA of HyQvia

^*Every 3 or 4 weeks.

Reliable protection against infection demonstrated in the clinical trial^1,3

0.025 ASBIs

<1 acute serious bacterial infection
per patient-year with HyQvia,
P<0.0001 (upper 99% CI, 0.089)^†

<3 infections

per patient-year (2.97; 95% CI, 2.51-3.47)

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Acute serious bacterial infections (ASBIs) included 2 episodes of pneumonia¹
Both episodes of pneumonia were treated on an outpatient basis with oral antibiotics¹
An additional episode of pneumonia requiring hospitalization occurred during the ramp-up period¹

^†<1 ASBI per patient-year is the threshold for substantial evidence of efficacy.³

Reduced Rates of systemic ARs vs IVIG

Demonstrated local tolerability in a clinical study¹

52% reduction in systemic ARs
(fatigue and headache) vs IVIG¹*

97.7% of infusions were completed without a rate reduction, interruption, or discontinuation due to tolerability concerns¹

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.

The rate of systemic ARs per HyQvia infusion (n=1129) was 0.20 and the rate of systemic ARs per IVIG infusion (n=365) was 0.42.

View safety and tolerability data

^*IVIG was administered for a median of 91 days (range, 84 to 122 days) and HyQvia for a median of 42 days (range, 20 to 49 days) during the dose ramp-up period and 366 days (range, 42 to 507 days) during the efficacy period. 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.

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Review Important Safety Information, including Contraindications and other specific Warnings and Precautions to consider when prescribing and monitoring patients treated with HyQvia.

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Similar insurance coverage

Coverage for HyQvia is similar to that of other SCIGs.²

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Get answers to your questions. Talk to a representative about HyQvia.

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Review Efficacy Data

Reference

HyQvia. Prescribing information. Takeda Pharmaceuticals U.S.A., Inc.; 2024.
Data on file. Takeda US Inc.
US Food and Drug Administration. Guidance for industry: safety, efficacy, and pharmacokinetic studies to support marketing of immune globulin intravenous (human) as replacement therapy for primary humoral immunodeficiency. June 2008. Accessed July 13, 2022. https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm078526.pdf.

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IMPORTANT SAFETY INFORMATION including BOXED WARNING for Thrombosis

INDICATION

HYQVIA is indicated for the treatment of primary immunodeficiency (PI) in adults and pediatric patients two years of age and older. 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 >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.

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.

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