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|BayGam

Immune Globulin (Human) Injection (IM)

BayGam is used for:

Providing antibodies to help prevent infection in certain patients who have a weakened immune system, or who have been exposed to measles, hepatitis A, or chickenpox. It may also be used for other conditions as determined by your doctor.

BayGam is an immune globulin. It works by providing antibodies, which fight infection.

Do NOT use BayGam if:

• you are allergic to any ingredient in BayGam
• you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to thimerosal, blood, or products that are produced from blood
• you have had an allergic reaction to gamma globulin or anti-immunoglobulin A (IgA) antibodies
• you have IgA deficiency or antibodies to IgA
• you have severely low blood platelet levels (thrombocytopenia) or other severe blood problems

Contact your doctor or health care provider right away if any of these apply to you.

Before using BayGam :

Some medical conditions may interact with BayGam . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have recently received any vaccinations
• if you have heart problems, low blood platelet levels, blood problems, or kidney problems

Some MEDICINES MAY INTERACT with BayGam . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Hydantoins (eg, phenytoin) because the risk of side effects may be increased
• Vaccinations (eg, measles, mumps, and rubella) because effectiveness may be decreased by BayGam

This may not be a complete list of all interactions that may occur. Ask your health care provider if BayGam may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use BayGam :

Use BayGam as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• BayGam is usually administered as an injection at your doctor"s office, hospital, or clinic. If you are using BayGam at home, carefully follow the injection procedures taught to you by your health care provider.
• If BayGam contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
• If you miss a dose of BayGam , contact your doctor for instructions.

Ask your health care provider any questions you may have about how to use BayGam .

Important safety information:

• Avoid vaccinations with live virus vaccines (eg, measles, mumps, oral polio) while you are using BayGam . Vaccinations may be less effective.
• Some of these products contain latex in the packaging. If you are allergic to latex, ask your doctor or pharmacist if your product contains latex.
• BayGam is made from human plasma. There is an extremely low risk of developing a viral infection or Creutzfeldt-Jakob disease (CJD) after using BayGam . Discuss any questions or concerns with your doctor.
• Use BayGam with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: It is unknown if BayGam can cause harm to the fetus. If you become pregnant while taking BayGam , discuss with your doctor the benefits and risks of using BayGam during pregnancy. It is unknown if BayGam is excreted in breast milk. If you are or will be breast-feeding while you are using BayGam , check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of BayGam :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Pain, swelling, tenderness, or redness at the injection site.

Severe allergic reactions (rash; itching; hives; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, hands, face, lips, eyes, throat, or tongue).

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

BayGam is usually handled and stored by a health care provider. If you are using BayGam at home, store BayGam as directed by your pharmacist or health care provider. Keep BayGam out of the reach of children and away from pets.

General information:

• If you have any questions about BayGam , please talk with your doctor, pharmacist, or other health care provider.
• BayGam is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about BayGam . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.