Please expand for Indication and Important Safety Information.

IMPORTANT SAFETY INFORMATION

What is the most important information that I should know about CUVITRU, HYQVIA, GAMMAGARD LIQUID, and GAMMAGARD S/D?

CUVITRU, HYQVIA, GAMMAGARD LIQUID, and GAMMAGARD S/D can cause the following serious reactions:

• Severe allergic reactions causing difficulty in breathing or skin rashes
• Decreased kidney function or kidney failure
• Blood clots in the heart, brain, lungs, or elsewhere in the body
• Severe headache, drowsiness, fever, painful eye movements, or nausea and vomiting
• Dark colored urine, swelling, fatigue, or difficulty breathing

Additionally for HYQVIA:

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What are CUVITRU, HYQVIA, GAMMAGARD LIQUID, and GAMMAGARD S/D?

CUVITRU, HYQVIA, GAMMAGARD LIQUID, and GAMMAGARD S/D are medicines used to treat primary immunodeficiency (PI).

CUVITRU is for people 2 years and older and given under the skin (subcutaneously).

HYQVIA is for adults and given under the skin.

GAMMAGARD LIQUID is for people 2 years and older and given in a vein (intravenously) or under the skin.

GAMMAGARD S/D is for people 2 years and older and given in a vein.

IMPORTANT SAFETY INFORMATION

What is the most important information that I should know about CUVITRU, HYQVIA, GAMMAGARD LIQUID, and GAMMAGARD S/D?

CUVITRU, HYQVIA, GAMMAGARD LIQUID, and GAMMAGARD S/D can cause the following serious reactions:

• Severe allergic reactions causing difficulty in breathing or skin rashes
• Decreased kidney function or kidney failure
• Blood clots in the heart, brain, lungs, or elsewhere in the body
• Severe headache, drowsiness, fever, painful eye movements, or nausea and vomiting
• Dark colored urine, swelling, fatigue, or difficulty breathing

Additionally for HYQVIA:

• 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 antibodiesthat may form against the hyaluronidase part of HYQVIA.
• Do not infuse HYQVIA into or around an infected or red swollen area because it can causeinfection 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

Who should not use CUVITRU, HYQVIA, GAMMAGARD LIQUID, or GAMMAGARD S/D?

• Do not use CUVITRU or GAMMAGARD LIQUID if you have had a severe allergic reaction to immune globulin or other blood products, or have a condition called selective (or severe) immunoglobulin A (IgA) deficiency.
• Do not take HYQVIA if you are allergic to IgG, hyaluronidase, other blood products, or any ingredient in HYQVIA.
• Do not use GAMMAGARD S/D if you have had a severe allergic reaction to GAMMAGARD S/D.

What should I avoid while taking CUVITRU, HYQVIA, GAMMAGARD LIQUID, or GAMMAGARD S/D?

What should I tell my HCP before I start using CUVITRU, HYQVIA, GAMMAGARD LIQUID, or GAMMAGARD S/D?

• CUVITRU, HYQVIA, GAMMAGARD LIQUID, and GAMMAGARD S/D 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 any of these treatments.
• Tell your HCP if you are pregnant, trying to become pregnant, or nursing.
• 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.

What are the possible or reasonably likely side effects of CUVITRU, HYQVIA, GAMMAGARD LIQUID, and GAMMAGARD S/D?

CUVITRU, HYQVIA, GAMMAGARD LIQUID, and GAMMAGARD S/D can cause serious side effects. If any of the following problems occur after starting any of these treatments, 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, or blue lips or extremities. These could be signs of a serious heart or lung problem.
• Fever over 100ºF. This could be a sign of an infection.

For CUVITRU, the following one or more possible side effects may occur at the site of infusion. These generally go away within a few hours, and are less likely after the first few infusions.

• Mild or moderate pain
• Redness
• Itching

The most common side effects of CUVITRU are:

• Headache
• Nausea
• Fatigue
• Diarrhea
• Vomiting

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

The following one or more possible reactions may occur at the site of infusion of GAMMAGARD LIQUID for PI, generally go away within a few hours, and are less likely after the first few infusions:

• Mild or moderate pain
• Swelling
• Itching
• Redness
• Bruising
• Warmth

During the infusion of GAMMAGARD LIQUID for PI, look out for the first signs of the following common side effects:

• Headache
• Migraine
• Fever
• Fatigue
• Itching
• Rash/hives
• Cough
• Chest pain/tightness
• Chills/shaking chills
• Dizziness
• Nausea/vomiting
• Faster heart rate
• Upper abdominal pain
• Increased blood pressure
• Muscle cramps
• Sore throat

The most common side effects of GAMMAGARD S/D are:

• Headache
• Nausea
• Chills
• Fatigue
• Fever
• Upper abdominal pain
• Diarrhea
• Back pain
• Infusion site pain
• Sweating
• Flushing

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, including Warnings about Blood Clots, Decreased Kidney Function, and Kidney Failure, click for Information For Patients for CUVITRU, HYQVIA, GAMMAGARD LIQUID, and GAMMAGARD S/D, and discuss with your HCP.

You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch , or call 1-800-FDA-1088.

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