What is GAMMAGARD LIQUID?

GAMMAGARD LIQUID is a ready-to-use liquid medicine that is given in a vein (intravenously) or under the skin (subcutaneously) to treat primary immunodeficiency (PI) in people 2 years and older.

What is the most important information that I should know about GAMMAGARD LIQUID?

GAMMAGARD LIQUID 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

Who should not use GAMMAGARD LIQUID?

Do not use GAMMAGARD LIQUID if you: Have had a severe allergic reaction to immune globulin or other blood products. Have a condition called selective (or severe) immunoglobulin A (IgA) deficiency.

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.

What are the possible or reasonably likely side effects of GAMMAGARD LIQUID?

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.

What to know about GAMMAGARD LIQUID

Effectiveness and
side effects with
subQ infusions

SubQ infusions: Study results

In the clinical study to look at the safety and effectiveness of GAMMAGARD LIQUID subQ, 47 patients with primary immunodeficiency (PI) were treated for about 1 year (54 weeks on average, with a range of 8 to 68 weeks overall). Patients receiving GAMMAGARD LIQUID showed protection against infection.

In the study, those taking GAMMAGARD LIQUID experienced the following per patient-year*:

There was <1 (0.067)
acute serious bacterial
infection† per year‡

0 hospitalizations
because of an infection

4.1 infections
of any kind

^*A patient-year is a patient experience in a clinical trial over the course of 1 year.

^†Validated acute serious bacterial infection (ASBI).

^‡3 patients had pneumonia, which didn’t need hospitalization.

What kind of side effects have people experienced?

98% of non-serious side effects in the subcutaneous (subQ) study were considered mild to moderate

Of the 348 non-serious side effects reported in patients treated with subQ GAMMAGARD LIQUID, 228 were considered mild and 112 moderate. The remaining 8 were severe.

2.4% rate of reactions on the body where the injection was given, per infusion

In 55 out of 2,294 infusions, side effects at the injection site were reported, including mild or moderate pain, swelling, itching, redness, bruising, and/or warmth.

Side effects may occur with a subQ treatment. The most common side effects in the trial with subQ infusions of GAMMAGARD LIQUID seen in ≥5% of patients were reactions at the infusion site, headache, fatigue, increased heart rate, fever, upper abdominal pain, nausea, vomiting, asthma, increased blood pressure, diarrhea, ear pain, canker sores, migraine, sore throat, and pain in the hands or feet.

99.8% of infusions were completed without reducing the infusion rate or stopping the infusion due to side effects or problems tolerating the infusion

Important reminders about subQ infusions at home*

When giving yourself infusions at home, you should have another responsible person present to help treat side effects or get help if a serious adverse reaction should occur. Ask your doctor whether you should have rescue medications on hand, like antihistamines or epinephrine, and what to expect with subQ infusions.

^*After a few training sessions with a nurse.

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Effectiveness & Side Effects With IV Infusions

Patient Stories

Effectiveness and side effects with subQ infusions