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.
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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.
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.
For additional support on your PI treatment
journey, stay connected with emails.
IMPORTANT SAFETY INFORMATION and serious warnings regarding blood clots, decreased kidney function or kidney failure
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.
INDICATION
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.
Important Safety Information
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?
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 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. 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.
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
- Rashes/hives
- Cough
- Chest pain/tightness
- Chills/shaking chills
- Dizziness
- Nausea/vomiting
- Faster heart rate
- Upper abdominal pain
- Increased blood pressure
- Muscle cramps
- Sore throat
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 Warning about Blood Clots, Decreased Kidney Function, and Kidney Failure, click for Information for Patientsopens in a new tab and discuss with your HCP.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatchopens in a new tab, or call 1-800-FDA-1088.