How HYQVIA Works to Treat PI Within Your Body1

Learn how HYQVIA is delivered subcutaneously (under the skin). HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] is a two-part infusion treatment combining Recombinant Human Hyaluronidase with immune globulin (Ig) treatment.

What is HYQVIA?

The antibodies (Ig) in HYQVIA, collected from human plasma donated by healthy people, help your body to fight off bacterial and viral infections. The hyaluronidase part of HYQVIA helps more of the Ig antibodies get absorbed into your body. It's the reason HYQVIA can be infused using 1 needle, 1 infusion site, 1 time a month.

HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] uses Ig antibodies and Recombinant Human Hyaluronidase

The Inside Story of Recombinant Human Hyaluronidase

Information about Recombinant Human Hyaluronidase
Without Recombinant Human Hyaluronidase, hyaluronan limits the flow of Ig.1

The subQ tissue (directly beneath the skin) is filled with a substance called hyaluronan. Hyaluronan turns over naturally in your body every day because of an enzyme called hyaluronidase. Because hyaluronan limits the flow of fluids through subQ tissue at local infusion sites, conventional subQ Ig treatments may require that you infuse more frequently and at multiple infusion sites.

Recombinant Human Hyaluronidase locally increases the natural turnover of hyaluronan.1

As part of your HYQVIA infusion, Recombinant Human Hyaluronidase locally increases the amount of hyaluronan that is turned over, temporarily increasing the amount of Ig that can be absorbed in the body.

With HYQVIA, Recombinant Human Hyaluronidase increases the flow of Ig into the body.1

Recombinant human hyaluronidase increases the flow of Ig into the subQ tissue and into the bloodstream, compared to other Ig treatments. The effect of Recombinant Human Hyaluronidase, on hyaluronan is reversible and the hyaluronan is restored within 24 to 48 hours after your infusion.

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.