GAMMAGARD LIQUID Safety and
Side Effects

Demonstrated safety profile

We know that side effects and safety are important things to consider when starting a new medication. GAMMAGARD LIQUID has been studied for the treatment of primary immunodeficiency (PI), so your doctor can help you understand what to keep an eye out for. The studies show that most side effects for GAMMAGARD LIQUID were considered mild to moderate.

GAMMAGARD LIQUID IV side effects

Side effects may occur with IV treatment, and they are more likely to occur when you are being treated for the first time or receiving a new product. The most common side effects with IV infusions of GAMMAGARD LIQUID treatment, observed in ≥5% of the patients in the clinical trial, are shown below.

Most common side effects for GAMMAGARD LIQUID IV:

GAMMAGARD LIQUID can cause serious side effects. If any of the following problems occur after starting GAMMAGARD LIQUID, 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 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. 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 100°F. This could be a sign of an infection.

It's important to talk to your healthcare provider about what to expect with IV administration of GAMMAGARD LIQUID treatment. Your doctor, nurse, or other healthcare professional can help you prepare for treatment and tell you what can be done to manage possible side effects. Also, resources are available to help you understand your treatment.

GAMMAGARD LIQUID SubQ side effects

Side effects may occur with SubQ treatment. The most common side effects with SubQ infusions of GAMMAGARD LIQUID, observed in ≥5% of the patients in the clinical trial, are shown below.

Most common side effects for GAMMAGARD LIQUID SubQ:

GAMMAGARD LIQUID can cause serious side effects. If any of the following problems occur after starting GAMMAGARD LIQUID, 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 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. 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 100°F. This could be a sign of an infection.

Whenever giving yourself treatments at home, you should have another responsible person present to help treat side effects or get help if you have a serious adverse reaction occur. Ask your healthcare provider whether you should have rescue medications available, such as antihistamines or epinephrine.

It's important to talk to your healthcare provider about what to expect with SubQ administration of GAMMAGARD LIQUID treatment. Your doctor, nurse, or other healthcare professional can help you prepare for treatment and tell you what can be done to manage possible side effects. Also, resources are available to help you understand your treatment.

What should I avoid while taking GAMMAGARD LIQUID?

• GAMMAGARD LIQUID can make vaccines (like measles/mumps/rubella or chickenpox vaccines) not work as well for you. Before you get any vaccines, tell your healthcare provider (HCP) that you take GAMMAGARD LIQUID.
• Tell your HCP if you are pregnant, or plan to become pregnant, or if you are nursing.