GamaSTAN (IGIM)

Immune globulin is a clean solution made from human plasma. It has antibodies that protect you from infections caused by different diseases.

Immune globulin intramuscular (IGIM, for injection into a muscle) is used to prevent infection with hepatitis A in people traveling to places where this disease is common. IGIM will not prevent hepatitis B.

IGIM is also used to help prevent infection after being exposed to measles, chickenpox (varicella), or rubella.

IGIM should not be used instead of routine vaccination against polio, varicella, mumps, or rubella.

Immune globulin may also be used for other reasons not mentioned in this medication guide.

GamaSTAN can lead to blood clots. The risk is greater for older adults or for those who have a history of blood clots, heart issues, or blood circulation problems. Blood clots are also more likely if you are on long-term bedrest, using birth control pills or hormone replacement therapy, or have a central intravenous (IV) catheter in place.

Contact your doctor immediately if you experience chest pain, difficulty breathing, rapid heartbeats, numbness or weakness, or swelling and warmth or discoloration in an arm or leg.

You should not use this medicine if:

• you have had an allergic reaction to an immune globulin or blood product; or
• you have immune globulin A (IgA) deficiency with antibody to IgA.

IGIM can cause blood clots, especially in older adults or people with certain conditions. Tell your doctor if you have ever had:

• heart problems, blood circulation problems, or "thick blood";
• a stroke or blood clot;
• kidney disease;
• diabetes;
• if you use estrogens (birth control pills or hormone replacement therapy);
• if you have been on long-term bedrest; or
• if you have a central intravenous (IV) catheter in place.

Tell your doctor if you are pregnant or breastfeeding.

Immune globulin is made from donated human plasma and may contain viruses or other infectious agents. Donated plasma is tested and treated to reduce the risk of contamination, but there is still a small possibility it could transmit disease. Ask your doctor about any possible risk.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor right away if you have signs of a blood clot such as:

• shortness of breath, chest pain with deep breathing;
• rapid heart rate;
• numbness or weakness on one side of the body; or
• swelling and warmth or discoloration in an arm or leg.

Common side effects of GamaSTAN may include:

• nausea;
• fever;
• headache;
• tiredness;
• pain or swelling where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

IGIM is injected into a muscle. A healthcare provider can teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Prepare an injection only when you are ready to give it. Do not use if the medicine is cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Do not inject IGIM into a vein or under the skin.

Your care provider will show you where on your body to inject IGIM.

You will need frequent blood tests. GamaSTAN can affect the results of certain other medical tests you may need. Tell any doctor who treats you that you are using immune globulin.

Store in the refrigerator, do not freeze. Throw away any IGIM not used before the expiration date on the medicine label.

Each vial (bottle) is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Call your doctor for guidance if you miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not receive a "live" vaccine while using immune globulin and for up to 6 months after your last dose. The vaccine may not work as well and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and nasal flu (influenza) vaccine.

Immune globulin can damage your kidneys, particularly if you are also taking certain medications for infections, cancer, osteoporosis, preventing organ transplant rejection, bowel disorders, high blood pressure, or pain and arthritis (including Advil, Motrin, and Aleve).

Other medications may interact with immune globulin, including both prescription and over-the-counter drugs, vitamins, and herbal products. Inform your doctor about all the medications you are currently taking and any new ones you begin or stop using.