Patient on HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase]

Frequently Asked Questions About HYQVIA

These questions and answers can help you learn important information about HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase].

For specific questions about how HYQVIA may work for you, please consult with your physician.

Download the complete list of HYQVIA frequently asked questions.

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Prescribing Information

About HYQVIA

Q: What is HYQVIA?
A: HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] is a liquid medicine containing Recombinant Human Hyaluronidase and immune globulin (Ig) and is used to treat adult patients with primary immunodeficiency (PI) diseases.1

HYQVIA is infused under the skin into the fatty subcutaneous, or subQ, tissue. With HYQVIA you have the option to infuse using 1 needle, 1 infusion site,1 time a month (every 3 or 4 weeks), in the comfort of your own home or in a healthcare facility (doctor's office or infusion center). Your doctor may consider the use of a second infusion site based on the total volume to be infused and how well you tolerate your infusions.1 More about HYQVIA.
Q: Why am I being prescribed HYQVIA?
A: HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] is used to treat adults with PI. Just 1 subQ infusion a month (every 3 or 4 weeks) can help your body fight off bacterial and viral infections. As demonstrated in the clinical trial, the rate of acute serious bacterial infections was 0.025 per patient per year, and there were 0 days spent in the hospital due to infection.1 More about HYQVIA.
Q: How does HYQVIA work?
A: The Immune Globulin Infusion 10% (Human), or Ig, part of HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] contains IgG antibodies collected from human plasma donated by healthy people. The antibodies help your body to fight off bacterial and viral infections. The Recombinant Human Hyaluronidase part of HYQVIA helps more of the infused Ig get absorbed into the body to fight infection.1 See how HYQVIA works.
Q: How Does Recombinant Human Hyaluronidase work?
A: Recombinant Human Hyaluronidase increases the flow of Ig into the subQ tissue and into the bloodstream.1 See how HYQVIA works.
Q: Is Recombinant Human Hyaluronidase used in the treatment of other things?
A: Recombinant Human Hyaluronidase has other medical uses besides in HYQVIA. It has been added as an "adjuvant" or aid in treatment:3
  • In subcutaneous fluid administration for achieving hydration
  • To help increase the absorption of other drugs injected into the skin
  • In subcutaneous urography (method for examining urinary system)
Q: What makes HYQVIA different from other subQ Ig treatments?
A: Conventional subQ Ig treatments require multiple infusions a month, with multiple needles, to receive your monthly dose.2

HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] is the only once-a-month (every 3 or 4 weeks) subQ Ig with Recombinant Human Hyaluronidase and Ig. The hyaluronidase temporarily opens up the subQ space, allowing a larger amount of Ig to reach the subQ tissue and be absorbed into the bloodstream to help fight infection.1

It's the reason you can infuse your monthly dose of HYQVIA 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.1 Learn more about how HYQVIA works.

Infusing HYQVIA

Q: How can HYQVIA be administered?
A: You can self-administer HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] after receiving the appropriate training, or a caregiver can administer HYQVIA in your home after receiving appropriate training. Do not use HYQVIA at home until you get instructions and training from your healthcare professional. If you would feel more comfortable, HYQVIA can also be administered by a healthcare professional at your doctor's office, clinic, or hospital.1 Learn more about administering HYQVIA.
Q: How often do I need to infuse HYQVIA?
A: HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] is infused under the skin into the fatty subcutaneous (subQ) tissue using 1 needle, 1 infusion site, 1 time a month (every 3 or 4 weeks). Your doctor may consider the use of a second infusion site based on the total volume to be infused and how well you tolerate your infusions. Follow your healthcare professional's instructions regarding the dose, schedule, and how to infuse, so your treatment with HYQVIA will be individualized for you. Your healthcare professional may perform blood tests from time to time after you start HYQVIA to check your serum IgG level.1 Learn more about infusing HYQVIA.
Q: How long does it take to infuse HYQVIA?
A: Infusing 1 time a month (every 3 or 4 weeks) doesn't mean your infusions will take longer. Typically, HYQVIA infusions take less than 3 hours. During the clinical trial, the median duration of an individual HYQVIA infusion was 2 hours and 5 minutes after the initial ramp-up period.1 Learn more about infusing HYQVIA.
Q: How do I infuse HYQVIA?
A: The 2 components of HYQVIA are infused sequentially through the same subcutaneous needle set. The Recombinant Human Hyaluronidase is infused first by manually hand-pushing it. The IG of HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] is administered within approximately 10 minutes of the Recombinant Human Hyaluronidase using a variable rate infusion pump at a rate recommended by your physician or infusion provider.1

HYQVIA can be self-administered at home after receiving the appropriate training or at your doctor's office, clinic, or hospital by a healthcare professional. If you and your doctor decide that self-administration is right for you, a healthcare professional will train you on how to infuse HYQVIA at home and make sure you're comfortable doing it on your own. Do not use HYQVIA at home until you get instructions and training from your healthcare professional.1
See how to infuse HYQVIA.
Q: What does HYQVIA look like?
A: 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).The Recombinant Human Hyaluronidase component should be clear and colorless. The Ig component should be clear and colorless or pale yellow.1
Q: Which vial do I infuse first?
A:Infuse the two components of HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] sequentially, beginning with the Recombinant Human Hyaluronidase. The IG is administered within ~10 minutes of the Recombinant Human Hyaluronidase. HYQVIA is infused under the skin into the fatty, or SubQ, tissue.

See how to infuse HYQVIA.
Q: What supplies will I need for infusing at home?
A: When you infuse at home, you will need the HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] dual vials, ancillary supplies for infusions, 24 gauge needle set labeled for high flow rates, a sharps container, an infusion log, and an infusion pump (you should receive all these supplies from your speciality pharmacy provider). The infusion pump should be programmed according to your healthcare professional's recommendation and the manufacturer's instructions.1 Watch an administration video.
Q: What infusion sites should I use?
A: The suggested sites for the infusion of HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] are the middle to upper abdomen and thighs. If 2 sites are used, the 2 infusion sites should be on opposite sides of the body. Avoid bony areas, visible blood vessels, or areas that are scarred, inflamed, or infected. HYQVIA should not be infused into or around an infected or red swollen area because it could cause an infection to spread.1 Learn more about infusing HYQVIA.
Q: How should I store HYQVIA at home?
A: Protect HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] from light by keeping the vials in their original boxes.1

Do not freeze HYQVIA. It can be stored in a refrigerator (36°F to 46°F [2°C to 8°C]) for up to 36 months from the date of manufacture (Mfg Date). Check the box and vial label for the date of expiration.1

You can store HYQVIA at room temperature up to 77°F (25°C) for up to 3 months during the first 24 months from the date of manufacturing. HYQVIA must be used within 3 months after removal to room temperature but within the expiration date on the outer carton and vial label.1

After you remove HYQVIA from the refrigerator and store it at room temperature, do not refrigerate it again.1

Always check the expiration date printed on the box and vial label. You should not use HYQVIA after the expiration date.1 For more information, read the Full Prescribing Information.
Q: Do I use the same pump as I did for other Ig treatments?
A: Infusion of HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] requires an infusion pump capable of infusing full therapeutic dose at infusion rates up to 300 mL/hr/site. The pump must have the ability to titrate the flow rate up or down if required to improve tolerability.1 Watch how to infuse HYQVIA.
Q: How will my skin feel and look after my HYQVIA infusions?
A: After infusing with HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase], a temporary soft swelling, which may last 1-3 days, can occur due to the volume of fluid infused.

Mild-to-moderate pain, itching, swelling, and redness at the infusion site are common local infusion-site reactions, but they usually go away within a few hours. Local infusion-site reactions are less likely to occur after the first few infusions.1

Learn more about what to expect with HYQVIA.
Q: Will HYQVIA affect my skin long term?
A: In the clinical trials, there were no observable changes in the skin or subcutaneous tissue in almost 2959 infusions and maximum exposure of over 3 years (2959 infusions and 188 subject-years).1 Learn more about what to expect with HYQVIA.
Q: What if I have trouble infusing HYQVIA?
A: Your healthcare professional will train you on how to self-infuse HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] at home and make sure you're comfortable doing it on your own. Talk to your healthcare professional immediately if you have trouble infusing HYQVIA. The frequency and number of infusion sites of HYQVIA can be adjusted by your healthcare professional, taking into consideration volume, total infusion time, tolerability, and clinical response.1 Get support for managing your treatment.

Infusion Schedule and Dosing

Q: What will my infusion schedule be like when I start HYQVIA?
A: You will receive the first dose of HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] and will ramp up gradually. Your dose will eventually shift from 1 time a week to 1 time a month (every 3 to 4 weeks).1

You will receive your first dose of HYQVIA approximately 1 week after your last infusion of your previous treatment.1

Everyone taking HYQVIA will start with the ramp-up period, regardless of whether you are new to SubQ Ig treatment or just new to HYQVIA. Your HYQVIA dose and infusion frequency may need to be adjusted based on your clinical response.1 Learn more about the ramp-up period.
Q: Why do I need to ramp-up my dose?
A: The initial ramp-up period allows you to become familiar with the large volumes required for a subQ infusion of a full 3- to 4-week dose of HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase]. You will receive your first dose of HYQVIA and gradually increase the dose and decrease the frequency from once a week to once every 3 to 4 weeks. Learn more about the ramp-up period.
Q: How much will I need to infuse after the ramp-up?
A: Follow your healthcare professional's instructions regarding the dose, schedule, and how to infuse, so that your treatment with HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] will be individualized for you. Your healthcare professional may perform blood tests from time to time after you start HYQVIA to check your IgG level.
Q: I'm on intravenous Ig treatment now. Will my infusion schedule change with HYQVIA?
A: For most people who switch from intravenous Ig (IVIG) infusion, HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] will be administered at the same dose and frequency as IVIG (after the ramp-up period). However, if HYQVIA is administered at a different interval than your previous treatment, your doctor may need to adjust the dose of HYQVIA based on your clinical response.1 For more information, see the Full Prescribing Information.
Q: I'm on a different SubQ Ig treatment now. Will my infusion schedule change with HYQVIA?
A: For most people who switch from a different subQ Ig, HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] will be administered at 300 to 600 mg/kg at 3- to 4-week intervals, after initial ramp-up. However, your healthcare professional may need to adjust the dose and frequency of HYQVIA based on your clinical response.1 For more information, see the Full Prescribing Information.

Safety Considerations

Q: What is the most important safety information I should know about HYQVIA?
A:
  • HYQVIA can cause blood clots.
  • Call your healthcare professional 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 healthcare professional may perform blood tests regularly to check your IgG level.
  • With your consent, your healthcare professional 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 healthcare professional 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.

Please see Information for Patients and discuss with your doctor.
Q: What are the serious side effects that can be caused by HYQVIA?
A: If any of the following problems occur after starting HYQVIA, stop the infusion immediately and contact your healthcare provider 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 swelling and irritation 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.

Please see Information for Patients and discuss with your doctor.
Q: What are the possible or reasonably likely side effects of HYQVIA?
A: 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. Mild or moderate pain, redness, swelling, or itching may occur at the site of infusion and generally go away in a few hours. Local reactions are less likely after the first few infusions. The most common side effects of HYQVIA are headache, fatigue, nausea, fever, and vomiting.

Antibodies to the hyaluronidase component of HYQVIA were formed in some patients taking HYQVIA. It is not known if there is any long term effect. In theory, these antibodies could react with your body's own PH20. PH20 is present in the male reproductive tract. So far, these antibodies have not been associated with increased or new side effects.

These are not all the possible side effects with HYQVIA. Talk to your healthcare professional about any side effects that bother you or that don't go away.

Please see Information for Patients and discuss with your doctor.
Q: What do I need to tell my doctor before starting HYQVIA?
A: Before starting HYQVIA, tell your healthcare professional if you have or had any kidney, liver, or heart problems, or a history of blood clots, because HYQVIA can make these problems worse. Also tell your doctor if you have IgA deficiency or a history of severe allergic reactions to immune globulin (IgG) or other blood products, or are pregnant, trying to become pregnant or are breast feeding. Before you get any vaccines, tell your HCP that you take HYQVIA. HYQVIA can make vaccines (like measles/mumps/rubella or chickenpox vaccines) not work as well for you.

Please see Information for Patients and discuss with your doctor.
Q: Who should not take HYQVIA?
A: Do not take HYQVIA if you are allergic to IgG, hyaluronidase, or other blood products, or any ingredient in HYQVIA.

Please see Information for Patients and discuss with your doctor.
Q: Can pregnant women take HYQVIA?
A: Talk to your doctor if you are pregnant, trying to become pregnant or are breastfeeding while on HYQVIA. Women who become pregnant during HYQVIA treatment are encouraged to enroll in the HYQVIA Pregnancy Registry by calling 1-866-424-6724.1 Studies in pregnant women have not been conducted with HYQVIA. HYQVIA should be given to a pregnant woman only if clearly indicated.
Q: Can taking HYQVIA affect fertility?
A: Talk to your doctor if you are pregnant, trying to become pregnant or are breastfeeding while on HYQVIA. Women who become pregnant during HYQVIA treatment are encouraged to enroll in the HYQVIA Pregnancy Registry by calling 1-866-424-6724.1 Long-term studies on fertility have not been conducted with the Immune Globulin Infusion 10% (Human) component of HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase]. It is not known whether HYQVIA can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.1

Antibodies to the hyaluronidase component of HYQVIA were formed in some patients taking HYQVIA. It is not known if there is any effect on human fertility. In theory, these antibodies could react with your body's own hyaluronidase. Hyaluronidase is present in the male reproductive tract. So far, these antibodies have not been associated with increased or new side effects.1

HYQVIA Support

Q: Does HYQVIA cost more than other Ig treatments?
A: Your costs for HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] will depend on many factors, including your pharmacy provider and your insurance plan. To help support patients, Shire has created the MyIgCoPayCard Program for eligible patients with commercial insurance. Learn more about the MyIgCoPayCard Program, including eligibility.
Q: Will my insurance cover HYQVIA?
A: HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] is covered similarly to other treatments of PI, but coverage may vary by plan. If you need help navigating your insurance plan or understanding your coverage, talk to your infusion provider, call 1-855-250-5111, or visit MyIgSource.com to learn more.
Q: What if I need help paying for HYQVIA?
A: If you are an adult PI patient on a prescribed Shire Ig treatment with commercial insurance you may be able to save up to $5,000 within a 12-month period on your out of pocket co-payment, co-insurance, or deductible for medication costs with MyIgCoPayCard. Terms and conditions apply. Learn more about the MyIgCoPayCard Program, including eligibility requirements.
Q: What if I have a medical question or experience side effects?
A: If you have a medical question regarding the use of HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase], or if you experience side effects, please contact your healthcare provider.
Q: Where can I turn if I have general questions or need support?
A: MyIgSource is a free support program for people living with or caring for someone with primary immunodeficiency (PI). With MyIgSource, you'll receive insurance information and financial support, support from Patient Advocates, HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] support from a Nurse Advocate, plus educational tools and resources to help you manage PI. Reach out for support today. Call 1-855-250-5111 or visit MyIgSource.com to enroll in the program.

Additional Questions About HYQVIA

Q: When was HYQVIA approved in the US?
A: On September 12, 2014 the FDA approved HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] for the treatment of adult patients with PI.
Q: Is HYQVIA approved for adults?
A: Yes, HYQVIA is approved to treat PI in adults. HYQVIA is not approved to treat PI in children.1
Q: Has Recombinant Human Hyaluronidase been used chronically in other conditions?
A: Safety and efficacy of chronic use of Recombinant Human Hyaluronidase of HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] has not been established in conditions other than PI.1

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.