omfort that worsens on deep breathing, unexplained rapid pulse, numbness or weakness on one side of the body.
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Your healthcare professional may perform blood tests regularly to check your IgG level.
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With your consent, your healthcare professional may provide blood samples to Baxalta US Inc. to test for antibodies that may form against the hyaluronidase part of HYQVIA.
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Do not infuse HYQVIA into or around an infected or red swollen area because it can cause infection to spread.
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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.
What should I tell my healthcare professional before I start using HYQVIA?
Before starting HYQVIA, tell your healthcare professional if you:
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Have or had any kidney, liver, or heart problems or history of blood clots because HYQVIA can make these problems worse.
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Have IgA deficiency or a history of severe allergic reactions to IgG or other blood products
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Are pregnant, trying to become pregnant or are breast feeding.
What is HYQVIA?
HYQVIA is a liquid medicine containing immune globulin and recombinant human hyaluronidase. HYQVIA contains IgG antibodies, collected from human plasma donated by healthy people. The antibodies help your body to fight off bacterial and viral infections. The hyaluronidase part of HYQVIA helps more of the immune globulin get absorbed into the body to fight infection.
Who should not take HYQVIA?
Do not take HYQVIA if you: Are allergic to IgG, hyaluronidase, or other blood products
Have IgA deficiency with antibodies to IgA
How should I take HYQVIA?
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HYQVIA is infused under the skin (subcutaneously) up to once every 4 weeks.
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You can get HYQVIA at your healthcare professional’s office, clinic, or hospital.
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You can use HYQVIA at home. You and your healthcare professional will decide if home self-infusion is right for you.
What are the possible or reasonably likely side effects of HYQVIA?
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 local reactions 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.
Mild or moderate pain
Redness
Swelling
Itching
The most common side effects of HYQVIA are:
Headache
Vomiting
Fatigue
Nausea
Fever
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.
Call your healthcare professional or go to your emergency department right away if you get:
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Hives, swelling in the mouth or throat, itching, trouble breathing, wheezing, fainting or dizziness. These could be signs of a serious allergic reaction.
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Bad headache with nausea, vomiting, stiff neck, fever, and sensitivity to light. These could be signs of swelling in your brain