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HyQvia is a liquid medicine that is given under the skin (subcutaneously) to treat primary immunodeficiency (PI) in people 2 years and older.

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IMPORTANT SAFETY INFORMATION and serious warnings regarding blood clots

What is HYQVIA?

HYQVIA is a liquid medicine that is given under the skin (subcutaneously) to treat primary immunodeficiency (PI) in people 2 years and older.

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.
Your HCP 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.

Who should not take HYQVIA?

Do not take HYQVIA if you:

Are allergic to IgG, hyaluronidase, other blood products, or any ingredient in HYQVIA.

What should I avoid while taking 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.

What should I tell my HCP before I start using or while using 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. It is not known whether HYQVIA can harm the unborn baby or breastfed infant.

What are the possible or reasonably likely side effects of HYQVIA?

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

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 hyaluronidase (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. 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.