Check out frequently asked questions.

Chances are, if you’re thinking of it, others have too.

You should always talk to your doctor or someone from your healthcare team first. Those conversations are the best way to get answers, but here’s a list of frequently asked questions.

About HyQvia

HyQvia is a liquid medicine containing Recombinant Human Hyaluronidase and immune globulin (IG). It is used to treat patients 2 years of age and older with primary immunodeficiency (PI) diseases.

HyQvia is infused under the skin into the fatty subcutaneous, or subQ, tissue. With HyQvia you can infuse just 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 will help you understand your infusion site options based on the total volume to be infused and how well you tolerate your infusions. Learn more about HyQvia.

HyQvia is used to treat people 2 years of age and older with primary immunodeficiency. One subcutaneous (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. Learn more.

Recombinant Human Hyaluronidase helps more of the immune globulin get absorbed into the body to fight infection. See how HyQvia works.

Other subQ IG treatments require multiple infusions each month to receive your dose.
HyQvia is the only once-a-month* subQ IG with Recombinant Human Hyaluronidase and IG. The hyaluronidase temporarily opens up the subcutaneous space, allowing a larger amount of IG to reach the subQ tissue and be absorbed into the bloodstream to help HyQvia fight infections. It’s the reason you can infuse your dose monthly.* Learn more about how HyQvia works.

*Every 3 or 4 weeks.

Infusing HyQvia

You can self-infuse HyQvia after you’ve trained with a nurse, or a family member or friend can infuse 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 infused by a healthcare professional at your doctor's office, clinic, or hospital.

Learn more about administering HyQvia.

HyQvia is infused under the skin into the fatty subcutaneous (subQ) tissue one time a month (every 3 or 4 weeks). HyQvia offers some flexibility when it comes to your infusion site options—your doctor will help you decide what’s best for you. Follow your healthcare professional's instructions regarding the dose, schedule, and how to infuse, so your treatment with HyQvia will be personalized for you. Your healthcare professional may perform blood tests from time to time after you start HyQvia to check your serum IgG level.  Learn more about infusing HyQvia.

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. Learn more about infusing HyQvia and the ramp-up period.

The 2 components of HyQvia are infused sequentially through the same subcutaneous needle set. Hyaluronidase is infused first by manually hand-pushing it. The immune globulin (IG) of HyQvia is infused within approximately 10 minutes of the Hy using a variable rate infusion pump at a rate recommended by your physician or infusion provider.

HyQvia can be self-infused 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-infusing 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. See how to infuse HyQvia.

HyQvia is supplied as a dual-vial unit and is infused sequentially through one needle set: first, Hy, and then, second, Human Immune Globulin Infusion 10% (IG). The Hy should be clear and colorless. The IG should be clear and colorless or pale yellow.

Remember not to self-infuse HyQvia unless you’ve been properly trained by a healthcare provider. Infuse the two components of HyQvia sequentially, beginning with the Hy. The IG is then infused within ~10 minutes of the Hy. HyQvia is infused under the skin into the fatty, or subcutaneous (subQ), tissue. See what the vials look like.

Remember not to self-infuse HyQvia unless you’ve been properly trained by a healthcare provider. When you infuse at home, you will need:

  • HyQvia dual vials
  • Ancillary supplies for infusions
  • 24-gauge needle set labeled for high flow rates
  • Sharps container
  • Infusion log (the Wellness Journal)
  • Infusion pump

You should receive all these supplies from your specialty pharmacy provider. The infusion pump should be programmed according to your healthcare professional’s recommendation and the manufacturer’s instructions. Learn more about infusing HyQvia.

The suggested sites for the infusion of HyQvia are the middle to upper abdomen and thighs. If two sites are used, the two 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. Learn more about infusing HyQvia.

Protect HyQvia from light by keeping the vials in their original boxes.

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.

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.

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

Always check the expiration date printed on the box and vial label. You should not use HyQvia after the expiration date. For more information, read the Full Prescribing Information.

Infusion of HyQvia requires an infusion pump capable of infusing full therapeutic doses 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.

After infusing with HyQvia, a temporary soft swelling, which may last 1-3 days, can occur due to the volume of fluid infused. This is common and is casually referred to as a “pancake,” because of its appearance.

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.

Learn more about what to expect with HyQvia.

In the clinical trials, there were no observable changes in the skin or subcutaneous tissue in almost 3,000 infusions and a maximum exposure of over 3 years (3,000 infusions and ~3.5 years). Learn more about what to expect with HyQvia.

Your healthcare professional will train you on how to self-infuse HyQvia at home and will 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.

When you’re prescribed a Takeda treatment, Takeda Patient Support can arrange for at-home treatment support, such as virtual or in-person infusion training with a nursing professional. Our support specialists are never more than a tap or a call away— 1-866-861-1750, Monday through Friday, 8 AM to 8 PM ET.

Not enrolled? You can join Takeda Patient Support in a few simple steps at TakedaPatientSupport.com/HyQvia.

If English is not your preferred language, let us know. We can assist you in a language of your choosing.

Infusion schedule and dosing

Over a short ramp-up period to adjust to HyQvia, your dose will shift from one time a week to one time a month (every 3 or 4 weeks).

You will receive your first dose of HyQvia approximately one week after your last infusion of your previous treatment. 

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 by your healthcare provider based on your clinical response. Learn more about the ramp-up period.

The initial ramp-up period allows you to become familiar with the large volumes required for a subcutaneous (subQ) infusion of a full 3- or 4-week dose of HyQvia. You will increase the dose and decrease the frequency from once a week to once every 3 or 4 weeks. Learn more about the ramp-up period.

Follow your doctor’s instructions regarding the dose, schedule, and how to infuse, so that your treatment with HyQvia is individualized for you. Your doctor may perform blood tests from time to time after you start HyQvia to check your IgG level.

For most people who switch from intravenous IG (IVIG) infusion, HyQvia will be infused 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. For more information, talk to your healthcare provider.

For most people who switch from a different subQ IG, HyQvia will be infused at 300 to 600 mg/kg at 3- or 4-week intervals, after initial ramp-up. However, your doctor may need to adjust the dose and frequency of HyQvia based on your clinical response. For more information, talk to your healthcare provider.

Safety considerations

  • 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
  • Do not infuse HyQvia into or around an infected or red swollen area because it can cause infection to spread

Learn more about possible HyQvia side effects.

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

These are not all of the possible side effects with HyQvia. Tell your healthcare provider about any side effect that bothers you or that does not go away, and learn more about other possible HyQvia side effects.

Do not take HyQvia if you are allergic to IgG, hyaluronidase, other blood products, or any ingredient in HyQvia.

Find out more about HyQvia safety and possible side effects.

Tell your HCP if you:

  • Have or had any kidney, liver, or heart problems, or a history of blood clots, because HyQvia can make these problems worse
  • Have IgA deficiency or a history of severe allergic reactions to immune globulin (IgG) or other blood products
  • Are pregnant, trying to become pregnant, or are breastfeeding. It is not known whether HyQvia can harm the unborn baby or breastfed infant.

HyQvia can make vaccines (like measles/mumps/rubella or chickenpox vaccines) not work as well for you. Before you get any vaccines, tell your healthcare professional that you take HyQvia.

Be sure to discuss any concerns or potential side effects with your healthcare professional.

Talk to your doctor if you are pregnant, trying to become pregnant or are breastfeeding. It is not known whether HyQvia can harm the unborn baby or breastfed infant.

HyQvia support

Your costs for HyQvia will depend on many factors, including your pharmacy provider and your insurance plan. When you’re prescribed HyQvia, Takeda Patient Support is dedicated to helping you get the answers, resources, and tools you need. Some of the ways we can help include:

  • Enrolling you in the Takeda Patient Support Co-Pay Assistance Program, if you qualify*
  • Offering insurance and financial support by walking you through the insurance process step by step

If you have government insurance, we are here to help answer questions about your prescribed Takeda treatment coverage. This includes federal or state insurance such as Medicare, Medicare Advantage, or Medicaid. If you can’t afford your treatment, we may be able to connect you to programs that may help.

*To be eligible, you must be enrolled in Takeda Patient Support and have commercial insurance. Other terms and conditions apply. Call us for more details.

HyQvia is covered similarly to other treatments of primary immunodeficiency, but coverage may vary by plan. Your infusion provider may be able to help explain out-of-pocket costs. Takeda Patient Support also offers insurance and financial support by walking you through the insurance process step by step. We’ll also help you understand what’s covered, what’s not, and what to do next.

The Takeda Patient Support Co-Pay Assistance Program can help you save on HyQvia.*

The program can cover up to 100% of your out-of-pocket co-pay costs, if you’re eligible. To be eligible for this program, you must:

  1. Be prescribed a Takeda treatment for a condition that's approved by the Food and Drug Administration (FDA) to treat. This is called an “approved indication.” Ask your doctor if you’re not sure.
  2. Have commercial insurance. This includes Health Insurance Marketplace plans.
    • Commercial insurance does not include Medicare, Medicaid, Veterans Affairs (VA), or other federal or state health plans.
  3. Be enrolled in Takeda Patient Support.

If you have government insurance, we are here to help answer questions about your prescribed Takeda treatment coverage. This includes federal or state insurance such as Medicare, Medicare Advantage, or Medicaid. If you can’t afford your treatment, we may be able to connect you to programs that may help.

*IMPORTANT NOTICE: The Takeda Patient Support Co-Pay Assistance Program (the Program) is not valid for prescriptions eligible to be reimbursed, in whole or in part, by Medicaid, Medicare (including Medicare Part D), Tricare, Medigap, VA, DoD, or other federal or state programs (including any medical or state prescription drug assistance programs). No claim for reimbursement of the out-of-pocket expense amount covered by the Program shall be submitted to any third party payer, whether public or private. The Program cannot be combined with any other rebate/coupon, free trial, or similar offer. Copayment assistance under the Program is not transferable. The Program only applies in the United States, including Puerto Rico and other U.S. territories, and does not apply where prohibited by law, taxed, or restricted. This does not constitute health insurance. Void where use is prohibited by your insurance provider. If your insurance situation changes you must notify the Program immediately at 1-855-268-1825. Coverage of certain administration charges will not apply for patients residing in states where it is prohibited by law. Takeda reserves the right to rescind, revoke, or amend the Program at any time without notice.

If you have a medical question regarding the use of HyQvia, or if you experience side effects, please contact your doctor. 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.

If you have a medical question, talk to your doctor. To learn more about primary immunodeficiency (PI) and connect with someone who is living with PI or has a loved one with PI, you can go to MyIgSource.com or call 1-855-250-5111.

Additional questions about HyQvia

On September 12, 2014, the FDA approved HyQvia for the treatment of adult patients with primary immunodeficiency (PI). On April 7th, 2023, the FDA approved HYQVIA for the treatment of children ages 2-16.

Yes, HyQvia is approved to treat primary immunodeficiency (PI) in people 2 years and older.

Primary immunodeficiency is considered a complex and rare disease and the treatments are considered specialty drugs. HyQvia is a specialty drug and only select specialty pharmacy providers (SPPs) have this medication in stock. So, your doctor’s office will order HyQvia through an SPP. Rather than pick up your prescription at a retail pharmacy in your neighborhood, specialty drugs are mailed to your home or your doctor’s office. You may be contacted by the SPP to coordinate the delivery.

Resources

Several organizations have started offering co-pay assistance programs. To learn more about them in detail, you can visit their specific websites. Additionally, the following websites intermittently offer co-pay assistance or guidance from time to time:

*NORD and the NORD logo are registered trademarks of the National Organization for Rare Disorders. NORD is a registered 501(c)(3) charity.

The Immune Deficiency Foundation and the Jeffrey Modell Foundation are both dedicated to providing resources for people with primary immunodeficiency (PI).

The Immune Deficiency Foundation has a number of resources that are available for people living with primary immunodeficiency (PI).

They have local events and every other year in June hold a national conference. In the off years, they hold family retreat weekends. The Immune Deficiency Foundation is available to help in many ways—register with them at primaryimmune.org.

The Jeffrey Modell Foundation also has a number of resources that are available to people living with PI. Additionally, they are committed to empowering the community with “Calls to Action,” which are meant to bring the global medical community together to help enhance early diagnosis with access to equal and appropriate treatments for all patients around the world. Learn more here.

Learn more about primary immunodeficiency (PI) and connect with someone who is living with PI or has a loved one with PI. Go to MyIgSource.com or call 1-855-250-5111. MyIgSource is open to PI patients and their caregivers regardless of therapy.

  1. The Immune Deficiency Foundation’s discussion boards. More information can be found at idffriends.org.
  2. The Jeffrey Modell Foundation website, jmfworld.com, which can also be found on Facebook, YouTube, Instagram, and Flickr.

World PI Week aims to raise awareness and diagnosis of primary immunodeficiency (PI) on a global level. On their website, you can learn all about PI and the events that occur all across the world during World PI Week. World PI Week is founded by a variety of organizations including the Immune Deficiency Foundation and Jeffrey Modell Foundation.

Additionally, the Jeffrey Modell Foundation is dedicated to global awareness of PI, physician education, research, patient support, and advocacy. In 2004, they created the first-ever public service advertising (PSA) campaign for primary immunodeficiency, to coincide with their focus on public awareness and physician education. Since then, they have continued to expand the reach of the campaign to help bring knowledge to members of the PI community and the public. Learn more about the Jeffrey Modell Foundation's PSA campaign./

Insurance

When you’re prescribed a Takeda treatment, our specialists are here for you. They’ll review your coverage and help you understand what financial options may be available. Our specialists can walk you through the insurance process step by step. They’ll help you understand what’s covered, what’s not, and what to do next. Because our goal is to help make your journey a little easier.

NEED ASSISTANCE?
Our support specialists are never more than a tap or a call away—1-866-861-1750, Monday through Friday, 8 AM to 8 PM ET.

Additionally, the Immune Deficiency Foundation has a great handbook on how to handle insurance issues and questions. Search for the IDF Health Insurance Toolkit at their website, primaryimmune.org.

As always, your insurer and your insurance policy can affect coverage for any drugs your doctor prescribes, including treatments that you receive on a regular basis, such as IG. Many insurance companies have a list of prescription medications that they will cover under the benefit plan. This list is called a formulary.

It’s important to know if the drugs you take are on your insurance carrier’s formulary. Check the formulary by visiting your insurance company’s web page and see if the drug your doctor prescribes is listed. Also look to see if the list includes the type of drug you receive, as well as the specific brand your doctor recommends. Sometimes insurance formularies will list only some of the brands that are available for a medication.

If your brand of medication is—or is not—on the formulary, it can affect how much money you or your family will have to pay for the drug as out-of-pocket costs or co-pays.

When you’re prescribed HyQvia, our specialists are here for you. They’ll help you understand what’s covered, what’s not, and what to do next. Because our goal is to help make your journey a little easier.

When it comes to immune globulin (IG) treatment, each brand of IG is considered to be a different treatment, because there are important differences in how each brand of these plasma-derived products is made. As a result, different brands of IG treatment are not considered to be interchangeable (or identical), according to medical experts and the Immune Deficiency Foundation.

Some insurance carriers have begun limiting access to specific brands of IG, but many of these insurers also have exception policies in place that may allow continued access to the IG brand your physician recommends.

When you’re prescribed HyQvia, our specialists are here for you. They’ll help you understand what’s covered, what’s not, and what to do next. Because our goal is to help make your journey a little easier. Visit TakedaPatientSupport.com for details.

If your insurance plan has special rules for brand-name drugs, you or your family should make sure your doctor is aware of them. For example, tell your doctor if your prescription for IG needs to be worded in a special way to make sure you get exactly what the doctor wants you to receive. Depending on the state you live in, the doctor may need to write “Dispense as written (DAW),” “Brand necessary,” or other statements on the prescription to ensure that the pharmacy dispenses the exact brand of IG that was prescribed.

The Patient & Family Handbook for Primary Immunodeficiency Disease, developed by the Immune Deficiency Foundation, devotes an entire chapter to health insurance. A copy of the 6th edition of the handbook can be downloaded here.

HyQvia is covered under many commercial health plans. If you have commercial health insurance, for example Aetna, BCBS, or UnitedHealthcare, chances are you may be covered, but coverage may vary by plan. Ask your provider’s office staff to help explain out-of-pocket costs. When you’re prescribed HyQvia, our specialists can also walk you through the insurance process step by step. They’ll help you understand what’s covered, what’s not, and what to do next.

The Takeda Patient Support Co-Pay Assistance Program can help you save on HyQvia.*

The program can cover up to 100% of your out-of-pocket co-pay costs, if you’re eligible. To be eligible for this program, you must:

  1. Be prescribed a Takeda treatment for a condition that's approved by the Food and Drug Administration (FDA) to treat. This is called an “approved indication.” Ask your doctor if you’re not sure.
  2. Have commercial insurance. This includes Health Insurance Marketplace plans. Commercial insurance does not include Medicare, Medicaid, Veterans Affairs (VA), or other federal or state health plans.
  3. Be enrolled in Takeda Patient Support.

If you have government insurance, we are here to help answer questions about your prescribed Takeda treatment coverage. This includes federal or state insurance such as Medicare, Medicare Advantage, or Medicaid. If you can’t afford your treatment, we may be able to connect you to programs that may help.

Not enrolled? You can join Takeda Patient Support in a few simple steps at TakedaPatientSupport.com/HyQvia. If English is not your preferred language, let us know. We can assist you in a language of your choosing.

*IMPORTANT NOTICE: The Takeda Patient Support Co-Pay Assistance Program (the Program) is not valid for prescriptions eligible to be reimbursed, in whole or in part, by Medicaid, Medicare (including Medicare Part D), Tricare, Medigap, VA, DoD, or other federal or state programs (including any medical or state prescription drug assistance programs). No claim for reimbursement of the out-of-pocket expense amount covered by the Program shall be submitted to any third party payer, whether public or private. The Program cannot be combined with any other rebate/coupon, free trial, or similar offer. Copayment assistance under the Program is not transferable. The Program only applies in the United States, including Puerto Rico and other U.S. territories, and does not apply where prohibited by law, taxed, or restricted. This does not constitute health insurance. Void where use is prohibited by your insurance provider. If your insurance situation changes you must notify the Program immediately at 1-855-268-1825. Coverage of certain administration charges will not apply for patients residing in states where it is prohibited by law. Takeda reserves the right to rescind, revoke, or amend the Program at any time without notice.

Want downloadable resources? Get them here.

From supplies to the infusion process itself, there are multiple resources designed to help, whether you’re new or experienced.

Gear icon.