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

Frequently asked questions

You have questions. We have answers.

Talk to your doctor. Learn more here.

What is the best place to get information about HyQvia [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase]? Your healthcare team. Any time you have a question about managing your primary immunodeficiency (PI), you should reach out to your doctor.

And remember, if you have a question about how to access your treatment, please contact OnePath®, a free product support program for eligible patients who have been prescribed HyQvia.

What is HyQvia?

What is HyQvia?

HyQvia is a liquid medicine containing Recombinant Human Hyaluronidase and immune globulin (Ig) and is used to treat adult patients with primary immunodeficiency (PI) diseases.

HyQvia is infused under the skin into the fatty subcutaneous, or subQ, tissue. With HyQvia you can infuse just one 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.

Why am I being prescribed HyQvia?

HyQvia is used to treat adults 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.

How does Recombinant Human Hyaluronidase work?

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

What makes HyQvia different from other subcutaneous (subQ) Ig treatments?

Other subQ Ig treatments require multiple infusions a month to receive your monthly dose.

HyQvia 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 subcutaneous space, allowing a larger amount of Ig to reach the subQ tissue and be absorbed into the bloodstream to help your body fight infection. It's the reason you can infuse your dose one time a month.* Learn more about how HyQvia works.

*Every 3 or 4 weeks.

Infusing HyQvia

How can HyQvia be administered?

You can self-administer HyQvia 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. Learn more about administering HyQvia.

How often do I need to infuse 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 individualized 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.

How long does it take to infuse HyQvia?

Infusing one 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.

How do I infuse HyQvia?

The two 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 Immune Globulin (Ig) of HyQvia 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.

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. See how to infuse HyQvia.

What does HyQvia look like?

HyQvia is supplied as a dual-vial unit and is infused sequentially through 1 needle set: first, Recombinant Human Hyaluronidase (Hy) and then, second, 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.

Which vial do I infuse first?

Remember not to self-administer HyQvia unless you’ve been properly trained by a healthcare provider. Infuse the two components of HyQvia 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 subcutaneous (subQ), tissue. See how to infuse HyQvia.

What supplies will I need for infusing at home?

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

What infusion sites should I use?

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.

How should I store HyQvia at home?

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.

Do I use the same pump as I did for other Ig treatments?

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.

How will my skin feel and look after my HyQvia infusions?

After infusing with HyQvia, 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.

Learn more about what to expect with HyQvia.

Will HyQvia affect my skin long-term?

In the clinical trials, there were no observable changes in the skin or subcutaneous tissue in almost 2,959 infusions and maximum exposure of over 3 years (2,959 infusions and ~3.5 years). Learn more about what to expect with HyQvia.

What if I have trouble infusing HyQvia?

Your healthcare professional will train you on how to self-infuse HyQvia 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. If you would like to learn more about scheduling additional infusion training, and are enrolled in OnePath, your OnePath® Patient Support Manager can help. To contact OnePath, Call: 1-866-888-0660 Monday through Friday, 8:30 a.m. to 8:00 p.m. ET.

Infusion schedule and dosing

What will my infusion schedule be like when I start HyQvia?

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.

Why do I need to ramp-up my dose?

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.

How much will I need to infuse after the ramp-up?

Follow your healthcare professional's instructions regarding the dose, schedule, and how to infuse, so that 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 IgG level.

I'm on intravenous Ig treatment now. Will my infusion schedule change with HyQvia?

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

I'm on a different subcutaneous (subQ) Ig treatment now. Will my infusion schedule change with HyQvia?

For most people who switch from a different subQ Ig, HyQvia will be administered at 300 to 600 mg/kg at 3- or 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. For more information, talk to your healthcare provider.

Safety considerations

What is the most important safety information I should know about HyQvia?

  • 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 Takeda, 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.

Please see Information for Patients

What are the serious side effects that can be caused by HyQvia?

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

Who should not take HyQvia?

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

What do I need to tell my doctor before starting HyQvia?

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
  • 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

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.

Please see Information for Patients

Can pregnant women take HyQvia?

Talk to your doctor if you are pregnant, trying to become pregnant, or are breastfeeding while on HyQvia. Studies in pregnant women have not been conducted with HyQvia. HyQvia should be given to a pregnant woman only if clearly indicated.

HyQvia support

Does HyQvia cost more than other Ig treatments?

Your costs for HyQvia will depend on many factors, including your pharmacy provider and your insurance plan. If you are enrolled in OnePath, you may receive additional information about financial assistance options.

Once you and your healthcare provider have made the decision to begin therapy with HyQvia, you may be eligible for Takeda’s OnePath product support program. Patients enrolled in this program will be provided with information about financial assistance options. One option includes OnePath’s Co-Pay Assistance Program, which helps eligible* patients cover certain out-of-pocket treatment costs. OnePath can also provide assistance with navigating the health insurance process. To begin the enrollment process, a signed start form is required from you and your physician.

*At a minimum to be eligible for OnePath’s Co-Pay Assistance program, patients must be enrolled in OnePath and have commercial insurance. Other terms and conditions apply. Contact OnePath for more information.

Will my insurance cover HyQvia?

HyQvia is covered similarly to other treatments of PI, but coverage may vary by plan. Your infusion provider may be able to help explain out-of-pocket costs. Or, if you’re enrolled, OnePath can provide assistance with navigating the health insurance process.

What if I need help paying for HyQvia?

Once you and your healthcare provider have made the decision to begin therapy with HyQvia, you may be eligible for Takeda’s OnePath product support program. Patients enrolled in this program will be provided with information about financial assistance options. One option includes OnePath’s Co-Pay Assistance Program, which helps eligible* patients cover certain out-of-pocket treatment costs. OnePath can also provide assistance with navigating the health insurance process. To begin the enrollment process, a signed start form is required from you and your physician.

*At a minimum to be eligible for OnePath’s Co-Pay Assistance program, patients must be enrolled in OnePath and have commercial insurance. Other terms and conditions apply. Contact OnePath for more information.

What if I have a medical question or experience side effects?

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

Where can I turn if I have general questions about PI?

If you have a medical question, talk to your doctor. To learn more about primary immunodeficiency and connect with someone that 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

When was HyQvia approved in the US?

On September 12, 2014, the FDA approved HyQvia for the treatment of adult patients with PI.

Is HyQvia approved for adults?

Yes, HyQvia is approved to treat PI in adults. HyQvia is not approved to treat PI in children.

What is primary immunodeficiency (PI)?

What is primary immunodeficiency (PI)?

Primary immunodeficiency, commonly referred to as PI (also PIDD and primary immune deficiency), is a condition where part or all of your immune system is either missing or not working correctly. Most primary immunodeficiencies are genetic in nature – you or your loved one did not catch it. Primary immunodeficiency is an umbrella term that encompasses more than 350 different deficiencies of the immune system.

Today, the World Health Organization estimates that about 270,000 people or 1 in 1,200 in the United States have diagnosed PI. Nearly 100 times more Americans are living with PI than are currently diagnosed. Today, PI is more common than cystic fibrosis.

Is PI different from autoimmune diseases?

Yes. Though PI can be mistaken by people who have not heard of it before, they are different conditions. With autoimmune diseases, the immune system gets confused and attacks a part of the body. An example of an autoimmune disease is rheumatoid arthritis, where the immune system attacks the joints.

Although, the abnormalities in the immune system that result in PI can also sometimes lead to autoimmune diseases.

Is PI different from secondary immunodeficiency disease?

Yes. A secondary immunodeficiency is where an immune deficiency is caused by something other than the immune system itself and is not inherited. A secondary immunodeficiency is caused by other conditions, infections, or medications (like chemotherapy drugs), aging, or malnutrition.

The most well-known secondary immunodeficiency is acquired immunodeficiency syndrome (AIDS), which is caused by the human immunodeficiency virus (HIV).

Is PI different from PIDD?

No. PI and PIDD actually stand for the same thing - primary immunodeficiency.

What are signs of PI?

The Jeffrey Modell Foundation has developed 10 warning signs for primary immunodeficiency.

For adults they are:

  1. Two or more new ear infections within 1 year.
  2. Two or more new sinus infections within 1 year, in the absence of allergy.
  3. One pneumonia per year for more than 1 year.
  4. Chronic diarrhea with weight loss.
  5. Recurrent viral infections (colds, herpes, warts, condyloma).
  6. Recurrent need for intravenous antibiotics to clear infections.
  7. Recurrent, deep abscesses of the skin or internal organs.
  8. Persistent thrush or fungal infection on skin or elsewhere.
  9. Infection with normally harmless tuberculosis-like bacteria.
  10. A family history of PI.

You may want to speak to a physician about PI if you or someone you know is affected by two or more of the above warning signs.

How come I've only started to show signs of PI now?

Primary immunodeficiency can show itself in different ways and at different times throughout a person's life. Although PI was first identified in children, there has been a growing awareness that adults can be diagnosed with PI. Children born with apparently functioning immune systems can go on to develop a primary immunodeficiency disease later in adolescence or adulthood. Unfortunately, patients can go a long time between when they first develop symptoms of PI and when they get diagnosed. In fact, in 2007, the Immune Deficiency Foundation did a survey that showed that the average time from the onset of symptoms to diagnosis is 12.4 years in the United States.

Why does it take so long to diagnose PI?

Because many primary immunodeficiencies present as routine infections (ie sinus infections or pneumonia), PI can be difficult to diagnose and go undetected in multiple healthcare settings. PI is often mistaken for a variety of diseases/infections from skin rashes to diarrhea to noninfectious conditions such as allergies. Also, low awareness of PI and its treatment by both healthcare professionals and the general public further contributes to the delay in accurate diagnosis. The World Health Organization estimates that about 270,000 people or 1 in 1,200 in the United States have diagnosed PI. Nearly 100 times more Americans are living with PI than are currently diagnosed. Today, PI is more common than cystic fibrosis.

Who should be tested for PI?

In addition to the 10 warning signs for primary immunodeficiency from the Jeffrey Modell Foundation, the Immune Deficiency Foundation uses the S-P-U-R-R acronym to help identify those who should be tested for PI. S-P-U-R-R stands for Severe, Persistent, Unusual, Recurrent, and Runs in the family. Specifically, you should be suspicious of any of the following traits: infections that are severe, or infections that are persistent (won't go away), or infections that are sometimes unusual (caused by an uncommon organism), or infections that are recurrent (keep coming back). Finally, you should look for cases in which all these traits run in a family.

I think that I, or someone I know, may have PI. What should I do?

If you suspect that you or someone you know may have PI, you should speak with your doctor. If you need assistance locating a physician who has experience diagnosing and treating Primary Immunodeficiency, both the Immune Deficiency Foundation and Jeffrey Modell Foundation have resources available.

Resources

What kinds of financial resources are available to me?

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

Are there any foundations for patients with PI?

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

Are there any community events or conferences related to PI that I can attend?

The Immune Deficiency Foundation has a number of resources that are available for people living with PI. They have local events and every other year in June hold a national conference. The next national conference will be held in 2021 and has some of the leading experts in PI. In the off-years, they hold family retreat weekends. The Immune Deficiency Foundation is available to help in many ways – register with them on 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.

I’d like to speak to a person who has experience dealing with PI. Is there a number I can call?

Learn more about primary immunodeficiency 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.

Are there any places online where people living with PI can contact to support one another?

  1. The Immune Deficiency Foundation's discussion boards. More information can be found at idffriends.org
  2. The Jeffery Modell Foundation has a number of social media sites, such as Facebook, YouTube, Instagram, and Flickr, which can be found at jmfworld.com

What can be done to raise awareness of PI?

World PI Week aims to raise awareness and diagnosis of 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 of public awareness and physician education. Since then, they have continued to expand the reach of the campaign to help bring knowledge to both members of the PI community and the public. Learn more about the Jeffrey Modell Foundation's PSA campaign.

Insurance

What if I'm having problems with my insurance? Are there any resources I can use?

OnePath can provide assistance with navigating the health insurance process. OnePath is a free program that provides individualized treatment support to people who have been prescribed HyQvia.

To enroll in OnePath, your doctor must prescribe HyQvia in accordance with the approved indication and you and your doctor must sign the OnePath HyQvia Start Form. Your signature gives OnePath permission to help you with the insurance process or other issues that could arise when it comes to accessing HyQvia.

Also, The Immune Deficiency Foundation has a great handbook on how to handle insurance issues and questions. Search for the IDF Health Insurance Toolkit in the Patient Insurance Center.

How do I know if my insurance plan covers my treatment?

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 copays.

Once you and your healthcare provider have made the decision to begin therapy with HyQvia, eligible patients can receive product support through OnePath. OnePath can assist you with gaining access to HyQvia, including navigating insurance coverage. See above to learn if you are eligible for product support.

Can I change my brand within my insurance plan?

When it comes to immunoglobulin (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.

Once you and your healthcare provider have made the decision to begin therapy with HyQvia, eligible patients can receive product support through OnePath. OnePath can assist you with gaining access to HyQvia, including navigating insurance coverage. See above to learn if you are eligible for product support.

How should I talk to my doctor about my insurance restrictions?

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 your state of residence, 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.

Once you and your healthcare provider have made the decision to begin therapy with HyQvia, you may be eligible for Takeda's OnePath product support program. See above to learn if you are eligible for OnePath product support.

I have additional questions about my insurance. Are there any other resources I can read?

The Patient & Family Handbook for Primary Immunodeficiency Disorders, developed by the Immune Deficiency Foundation, devotes an entire chapter to health insurance. A copy of the 5th edition of the handbook can be downloaded here.

Once you and your healthcare provider have made the decision to begin therapy with HyQvia, you may be eligible for Takeda's OnePath product support program. See above to learn if you are eligible for OnePath product support.