Say Hy to the unique combination of IG + Hy. HyQvia can meet patients where they are.*

^*HyQvia may be administered across multiple sites of care, including hospitals, infusion centers, offices, and at home (HCP-supported, or administered by the patient or their caregiver, after appropriate training).¹ Formulary status varies by plan and may be subject to change. Depending on a patient’s medical and prescription drug benefit, prior authorization (PA) submission may be required before a patient can receive treatment with HyQvia.

IG=Immune Globulin (Human),10%; Hy=Recombinant Human Hyaluronidase.

HyQvia was studied in a 6-month placebo-controlled trial. HyQvia was also part of the longest prospective open-label extension CIDP safety trial.^1,2*

*Pharmaceutical sponsored.

LEARN MORE

HyQvia is an IG maintenance therapy for CIDP that may offer your adult patients dosing and site of care choices:

Control

In the pivotal ADVANCE-1 trial, patients with CIDP were treated in a maintenance setting transitioning from a stable dose of IVIG^1,3*^†
In the pivotal trial, the relapse rate was 14.0% (n=8/57) vs 32.3% with placebo (n=21/65), P=0.0314, after up to 6 months of dosing^1‡

REVIEW STUDY DATA

Choice

Patients have the option of infusing¹:

In center
At their doctor's office
At home with a nurse or self-infusion after appropriate training^1§

SEE SITE OF CARE OPTIONS

Time

Up to once monthly (every 2, 3 or 4 weeks), which can give your patients time, between infusions for things that matter¹
Median infusion time was approximately 2 hours in a clinical trial^4II

VIEW DOSING INFORMATION

Review safety information

Safety Information, including contraindications and other specific warnings and precautions to consider when prescribing and monitoring patients treated with HyQvia.

SEE SAFETY INFORMATION

AE=adverse event; AR=adverse reaction; CIDP=chronic inflammatory demyelinating polyneuropathy; HCP=healthcare professional; INCAT=Inflammatory Neuropathy Cause and Treatment; IVIG=intravenous immune globulin; MITT=modified intent to treat; TEAE=treatment-emergent adverse event.

*ADVANCE-1 was a phase 3, prospective, randomized, double-blind, multicenter, placebo-controlled study in which adults with CIDP on a stable dose of IVIG for ≥2 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.¹

†ADVANCE-3 was a phase 3b, 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 Final analysis, inclusive of data previously reported in the interim analysis, included 78 subjects with a range of follow-ups from 0 to 6.7 years.³

‡Relapse was defined as an increase of ≥1 point relative to the pre-subcutaneous treatment baseline score in 2 consecutive adjusted INCAT disability scores obtained <7 days apart. MITT data set (N=122) analysis set.¹

§Patients can receive HyQvia treatment at an infusion center, in hospital, or at home. It can be given by an HCP, self-administered after appropriate training, or given by a trained caregiver. A choice of home administration must be a joint decision between HCP and patient; patients cannot make this decision themselves.¹ Formulary status varies by plan and may be subject to change. Depending on a patient’s medical and prescription drug benefit, prior authorization (PA) submission may be required before a patient can receive treatment with HyQvia.

‖Infusion time median (range): 116.5 (65, 259) minutes.⁴

Ready to start patients on HyQvia?

Calculate their transition and ramp-up in just 3 inputs

EXPLORE THE TOOL

HyQvia: A unique combination of IG + Hy

HyQvia is not a conventional SCIG (cSCIG). It is an IG + hyaluronidase (Hy) with a different mechanism of delivery of IG compared to IVIG and cSCIG. Hy facilitates the dispersion of IG.¹

LEARN ABOUT IG + Hy

SCIG=subcutaneous immune globulin.

Meet HyHub™ and HyHub™ Duo for HyQvia—infusion trays designed to help simplify the infusion preparation process for your patients 17 and older, as prescribed, without the use of transfer needles by reducing the number of steps required to prepare Hy and IG^5-7*

*Compared to preparing with a pooling bag using 2-4 dual-vial units (DVUs).

After the patient has trained with an infusion nurse, the specialty pharmacy will send the tray that accommodates the prescribed dose free of cost.

HyHub/HyHub Duo Important Information for Healthcare Providers

Intended Use: HyHub/HyHub Duo are stand-alone, single-use, disposable vial access devices. 

Indications for Use: HyHub/HyHub Duo are indicated for patients 17 years of age and older to allow HyQvia to be transferred from vials without using a needle, as prescribed, in a home environment or clinical setting.

Contraindications: 

Do not use HyHub/HyHub Duo with a pooling bag.
Do not connect HyHub/HyHub Duo to a syringe driver infusion pump.

Selected Information for Patients:

HyHub/HyHub Duo are for SINGLE USE ONLY, even if all docks are not used during a single infusion. Re-use will increase risk of infection. Patients should always use a new HyHub/HyHub Duo for each infusion.
Only use HyHub/HyHub Duo when patients are ready to administer HyQvia.
Patients should not use HyHub/HyHub Duo at home until receiving instructions and training from a healthcare provider.
HyQvia is the only medication that may be used with HyHub/HyHub Duo.
Patients should not exceed the maximum infusion volume per infusion site or infusion rate as indicated in the HyQvia prescribing information.

For safe and proper use of HyHub/HyHub Duo, please refer to the complete Instructions for Use included with the devices. For information about HyQvia, including warnings for thrombosis, please see Prescribing Information for HyQvia.  

WATCH THE VIDEO

Talk to a representative

Get answers to your questions about HyQvia

CONTACT A REP

Access and coverage

We have several resources to help you help answer your patient's questions along the insurance journey.

LEARN MORE

Review Study Data

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.