What to know about GAMMAGARD LIQUID

Effectiveness and
side effects with
IV infusions

IV infusions: Study results

There was a clinical study with IV infusions that 61 patients participated in. Of those PI (primary immunodeficiency) patients, GAMMAGARD LIQUID was shown to be effective at a dose of 300 to 600 mg/kg every 3 to 4 weeks for 12 months. 

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

Acute serious bacterial infection icon.

0 acute serious
bacterial infections†

Hospital icon.

0 hospitalizations
because of an infection

Bacteria icon.

4 validated other bacterial
infections reported‡

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

†Validated acute serious bacterial infections (ASBIs).

‡The validated other bacterial infections were urinary tract infection (1), gastroenteritis (sometimes called “stomach flu”) (1), and ear infection (2).

What kind of side effects have people experienced?

95% icon.

95% of the non-serious side effects were considered mild to moderate

381 of the 400 non-serious side effects reported in patients treated with GAMMAGARD LIQUID IV were considered mild (217) to moderate (164). The remaining 5% (19) were severe.

5.2% icon.

5.2% rate of headache per infusion

Headaches were the most common side effect (94 of 1,812 infusions).

Side effects may occur with an IV treatment, and they are more likely to occur when you are being treated for the first time or receiving a new medicine. In the clinical trial, the most common side effects with IV infusions of GAMMAGARD LIQUID seen in ≥5% of the patients were headache, fatigue, fever, nausea, chill/shaking chills, pain in the hands or feet, diarrhea, migraine, dizziness, vomiting, cough, hives, asthma, sore throat, rash, joint pain, muscle pain, swelling in the arms or legs, itching, and heart murmur.

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 Patients and discuss with your HCP.

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