What is HYQVIA?

Whether you're still considering your options, switching to subcutaneous immune globulin (subQ Ig) treatment, or already using HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase], this section can help you become more informed about HYQVIA, the only once-a-month* subQ Ig for adults with PI.1

HYQVIA is a Once-a-Month* SubQ Ig1

HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] needle, infusion site, infusion frequency
A second site can be used at the discretion of the physician and patient based on tolerability and total volume1

With HYQVIA, you have the option to infuse using 1 needle, 1 infusion site, 1 time a month, in the comfort of your own home. If you would feel more comfortable, HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] can also be administered by a healthcare professional at your doctor's office, clinic, or hospital.

See what makes HYQVIA different from other subQ Ig treatments.

More Free Time Every Month

Infusing once a month (every 3 or 4 weeks) instead of every week offers more flexibility and can mean more free time every month.

Median time of individual infusions per month
*Once-a-month means every 3 to 4 weeks.

Help Your Body Fight Off Infections1

Just 1 HYQVIA infusion a month (every 3 or 4 weeks) can help your body fight off bacterial and viral infections. As demonstrated in the clinical trial, once-a-month HYQVIA helped reduce the risk of serious infections.

The FDA standards for efficacy (if a treatment works) is only one acute serious infection per year. In the HYQVIA clinical study, patients experienced significantly less than that.

The study included 87 patients with primary immunodeficiency (PI) with the main goal of measuring how many serious bacterial infections patients taking HYQVIA experienced over the course of one year.

What Makes HYQVIA Different?1,2

Conventional subQ Ig treatments require multiple infusions a month, with multiple needles, to receive your monthly dose.

HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] needle and multiple needles with conventional subQ Ig treatments

HYQVIA is the only once-a-month (taken every 3 or 4 weeks) subQ Ig with Recombinant Human Hyaluronidase (hy–al–uron–i–dase) and Ig. The Recombinant Human Hyaluronidase temporarily increases the amount of Ig that can be absorbed in the body compared to other subQ treatments.

It's the reason you can infuse your monthly dose of HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] using 1 needle, 1 infusion site, 1 time a month. A second site can be used at the discretion of the physician and patient based on tolerability and total volume.

HYQVIA is supplied

as a dual-vial unit and is infused sequentially through 1 needle set: 1. Recombinant Human Hyaluronidase (HY) and 2. Human Immune Globulin Infusion 10% (IG).

HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] is supplied as a dual-vial unit with HY and IG

Please expand for Indication and Important Safety Information.

IMPORTANT SAFETY INFORMATION

What is the most important information that I should know about HYQVIA?

  • HYQVIA can cause blood clots.
  • Call your healthcare professional (HCP) if you have pain, swelling, warmth, redness, or a lump in your legs or arms, other than at the infusion site(s), unexplained shortness of breath, chest pain or discomfort that worsens on deep breathing, unexplained rapid pulse, numbness or weakness on one side of the body.

HYQVIA is a liquid medicine that is given under the skin (subcutaneously) to treat primary immunodeficiency (PI) in adults.

Important Safety Information
    • HYQVIA can cause blood clots.
    • Call your healthcare professional (HCP) if you have pain, swelling, warmth, redness, or a lump in your legs or arms, other than at the infusion site(s), unexplained shortness of breath, chest pain or discomfort that worsens on deep breathing, unexplained rapid pulse, numbness or weakness on one side of the body.
    • Your HCP may perform blood tests regularly to check your IgG level.
    • With your consent, your HCP may provide blood samples to Shire plc, to test for antibodies that may form against the hyaluronidase part of HYQVIA.
    • Do not infuse HYQVIA into or around an infected or red swollen area because it can cause infection to spread.
    • Talk to your HCP if you become pregnant. Women who become pregnant during HYQVIA treatment are encouraged to enroll in the HYQVIA Pregnancy Registry by calling 1-866-424-6724.

    Do not take HYQVIA if you:

    • Are allergic to IgG, hyaluronidase, other blood products, or any ingredient in HYQVIA.
    • HYQVIA can make vaccines (like measles/mumps/rubella or chickenpox vaccines) not work as well for you. Before you get any vaccines, tell your HCP that you take HYQVIA.

    Before starting HYQVIA, tell your HCP if you:

    • Have or had any kidney, liver, or heart problems or history of blood clots because HYQVIA can make these problems worse.
    • Have IgA deficiency or a history of severe allergic reactions to IgG or other blood products.
    • Are pregnant, trying to become pregnant or are breast feeding.

    HYQVIA can cause serious side effects. If any of the following problems occur after starting HYQVIA, stop the infusion immediately and contact your HCP or call emergency services:

    • Hives, swelling in the mouth or throat, itching, trouble breathing, wheezing, fainting or dizziness. These could be signs of a serious allergic reaction.
    • Bad headache with nausea, vomiting, stiff neck, fever, and sensitivity to light. These could be signs of irritation and swelling of the lining around your brain.
    • Reduced urination, sudden weight gain, or swelling in your legs. These could be signs of a kidney problem.
    • Pain, swelling, warmth, redness, or a lump in your legs or arms, other than at the infusion site(s). These could be signs of a blood clot.
    • Brown or red urine, fast heart rate, yellow skin or eyes. These could be signs of a liver or blood problem.
    • Chest pain or trouble breathing, blue lips or extremities. These could be signs of a serious heart or lung problem.
    • Fever over 100°F. This could be a sign of an infection.

    After HYQVIA infusion a temporary, soft swelling may occur around the infusion site, which may last 1 to 3 days, due to the volume of fluid infused. The following possible side effects may occur at the site of infusion and generally go away within a few hours, and are less likely after the first few infusions.

    • Mild or moderate pain
    • Redness
    • Swelling
    • Itching

    The most common side effects of HYQVIA are:

    • Headache
    • Fatigue
    • Nausea
    • Fever
    • Vomiting

    These are not all the possible side effects. Talk to your HCP about any side effect that bothers you or that does not go away.

    For additional safety information, click for Information For Patients and discuss with your HCP.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.