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|CytoGam

CytoGam

CytoGam is used for:

Reducing the risk of cytomegalovirus (CMV) disease associated with kidney, lung, liver, pancreas, and heart transplants. It may also be used for other conditions as determined by your doctor.

CytoGam is an intravenous immune globulin (IGIV) enriched in antibodies against CMV. It works by temporarily increasing the antibody concentration in the body.

Do NOT use CytoGam if:

• you are allergic to any ingredient in CytoGam
• you have selective immunoglobulin A (IgA) deficiency

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

Before using CytoGam :

Some medical conditions may interact with CytoGam . 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 kidney problems, diabetes, a blood infection, or low blood volume

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

• Live vaccines (eg, measles, mumps, rubella) because the effectiveness of the vaccine may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if CytoGam 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 CytoGam :

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

• CytoGam is usually administered as an injection at your doctor"s office, hospital, or clinic. If you are using CytoGam at home, carefully follow the injection procedures taught to you by your health care provider.
• If CytoGam contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it. Ask your health care provider any questions you may have about the proper use of CytoGam .
• The infusion should begin within 6 hours after entering the vial and should be complete within 12 hours of entering the vial. This product does not contain a preservative.
• Keep this product, as well as syringes and needles, out of the reach of children. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor, nurse, or pharmacist to explain local regulations for proper disposal.
• If you miss a dose of CytoGam , contact your doctor immediately.

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

Important safety information:

• Because CytoGam is obtained from human plasma, there is a risk that viruses can be passed on to patients who use CytoGam .
• Administration of live virus vaccines (eg, measles, mumps, rubella) should be delayed until approximately 3 months after receiving CytoGam .
• Contact your health care provider at once if any of the following occur: severe headache, stiff neck, drowsiness, fever, sensitivity to light, painful eye movements, nausea, vomiting.
• Local reactions to the injection site may occur (eg, tenderness, pain, hives, swelling). Apply a warm compress. If the symptoms persist, contact your health care provider.
• LAB TESTS, including liver and kidney function and immune globulin levels, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use CytoGam with caution in the ELDERLY because they may be more sensitive to its effects, such as kidney problems.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using CytoGam during pregnancy. It is unknown if CytoGam is excreted in breast milk. If you are or will be breast-feeding while you are using CytoGam , check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of CytoGam :

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:

Chills; fever; flushing; joint or back pain; muscle pain; nausea; pain, redness, or swelling at injection site; vomiting; wheezing.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); decreased urine output; drowsiness; eye pain; hoarseness; lightheadedness, especially upon standing; sensitivity to light; severe headache; shortness of breath; stiff neck; sudden weight gain.

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.

Store CytoGam in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. The product does not contain a preservative. The infusion should begin within 6 hours after entering the vial. Keep CytoGam out of the reach of children and away from pets.

General information:

• If you have any questions about CytoGam , please talk with your doctor, pharmacist, or other health care provider.
• CytoGam 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 CytoGam . 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.