"Say Hy" icon.

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 hospital, infusion centers, offices, 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 10% (Human); Hy=Recombinant Human Hyaluronidase. 

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

A plus sign inside of two circular arrows depicting HYQVIA efficacy in controlling relapses.

Control

  • In the pivotal ADVANCE-1 trial, patients with CIDP were treated in a maintenance setting transitioning from a stable dose of IVIG1*
  • Relapse rate 14.0% (n=8/57) vs. 32.3% with placebo (n=21/65), p=0.0314, after up to 6 months of dosing (median treatment exposure 5.3 months for HyQvia and 4.7 months for placebo)
Hospital and home icon depicting HYQVIA offers choices of reimbursement across multiple sites of care.

Choice

  • HyQvia offers choices for you and your patients: it may be reimbursed across multiple sites of care, to give your patients the option of infusing in-center or at home (HCP supported, or administered by the patient or their caregiver after appropriate training)1‡
Calendar icon depicting HYQVIA allows time between infusion.

Time

  • HyQvia allows for up to 28 days between infusions based on clinical response, which can give your patients time for the things they enjoy1
  • HyQvia can be administered every 2, 3, or 4 weeks1
  • Median infusion time was approximately 2 hours in a clinical trial2‖
Yellow hand icon depicting HYQVIA safety profile.

Safety Profile

Please see Important Safety Information and Boxed Warning regarding Thrombosis

  • The most common adverse reactions observed in >5% of study patients in both studies for HyQvia were local reactions, headache, pyrexia, nausea, fatigue, erythema, pruritus, increased lipase, abdominal pain, back pain, and pain in extremity.1*#¶§
  • The majority of ARs with HyQvia across both studies were mild or moderate and did not require treatment discontinuation1#¶§
  • In ADVANCE-1, one serious AR of cerebrovascular accident occurred during and 3 patients discontinued treatment due to ARs with HyQvia1*
  • In ADVANCE-3, 3 patients discontinued due to ARs with HyQvia and 1 patient died prior to the time of the interim analysis due to cholangiocarcinoma.1

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.

*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.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

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.2

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

In ADVANCE-1, a total of 4 patients (3.0%) experienced ARs that led to discontinuation from the study; 3 patients in the HyQvia group and 1 in the placebo group. The ARs leading to discontinuation in the 3 HyQvia patients included: a cerebrovascular accident in 1 patient (with underlying cardiovascular risk factors), infusion site edema and infusion site pain in another patient, and nausea and chills in the third patient.1

§In ADVANCE-3 a total of 3 patients (3.8%) experienced ARs that led to discontinuation from the study and 1 patient (1.3%) died prior to the time of the interim analysis. The ARs leading to discontinuation in the 3 patients included: mantle cell lymphoma in one patient, muscular weakness and worsening of CIDP in another patient, and abdominal pain in the third patient. The cause of death in the 1 patient was cholangiocarcinoma.1

Two circles with letter IG and Hy inside depicting the unique combination for IG &#43; Hy of HYQVIA.

HyQvia: A unique combination of IG + Hy

HyQvia is not a conventional SCIG (cSCIG). It is an IG + Hy with a different mechanism of delivery of IG compared to IVIG and cSCIG1

MOA=mechanism of action; SCIG=subcutaneous immune globulin.

Review safety information

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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Questions about access and coverage?

We have several educational resources to help you help your patient along the insurance journey.

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

References:

  1. HyQvia. Prescribing information. Takeda Pharmaceuticals U.S.A., Inc.; 2024.
  2. HyQvia Data on File, CSR, table 14 2.5, 2.1 page 1564.