Indication and Important Safety Information
GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% Solution
What is GAMMAGARD LIQUID?
- GAMMAGARD LIQUID is a ready-to-use, liquid medicine that contains immunoglobulin G (IgG) antibodies. GAMMAGARD LIQUID is used to treat adult patients with multifocal motor neuropathy (MMN).
- GAMMAGARD LIQUID is made from human plasma that is donated by healthy people.
- MMN is a rare disease that causes muscle weakness that worsens over time. It affects the strength of the lower parts of arms and hands more than the legs, usually without affecting the touch sensation.
- GAMMAGARD LIQUID is given into a vein (intravenously) every 2 to 4 weeks as ordered by your physician. Although it is possible to give yourself infusions into a vein at home, they are more often given in a hospital or infusion center by a nurse. Only use GAMMAGARD LIQUID by yourself after you have been instructed by your healthcare provider.
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 a known history of a severe allergic reaction to IgG or other blood products.
- Have selective (or severe) immunoglobulin A (IgA) deficiency with antibodies to IgA
GAMMAGARD LIQUID can cause serious side effects. Call your healthcare professional or go to the emergency department right away if you get:
- 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 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.
What are the possible or reasonably likely side effects of GAMMAGARD LIQUID?
The following is a list of common side effects seen in clinical trials of GAMMAGARD LIQUID administered intravenously for MMN: Headache, chest discomfort, muscle spasms, muscular weakness, nausea, sore throat, ear pain, and pain in extremity.
These are not all the possible side effects. Talk to your healthcare professional about any side effects that bother you or that don't go away.
You are encouraged to report suspected side effects by contacting FDA at 1-800-FDA-1088 or www.fda.gov/medwatch or Shire at 1-800-999-1785.
Please click here for the FDA-Approved Patient Product Labeling.