Atgam

Treating rejection in kidney transplant patients. It is also used with other medicines to delay the onset of kidney transplant rejection. Atgam is also used to treat moderate to severe aplastic anemia in certain patients who cannot have a bone marrow transplant.

Atgam is a lymphocyte-selective immunosuppressant. It works by decreasing the action of certain types of blood cells (T lymphocytes), which are part of the body's immune system.

• you are allergic to Atgam , any ingredient in Atgam , or any other gamma globulin made from horse serum
• you have a severe decrease in white blood cell counts or severely decreased blood platelets

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

Some medical conditions may interact with Atgam . 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

Some MEDICINES MAY INTERACT with Atgam . However, no specific interactions with Atgam are known at this time.

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

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

• Atgam is usually administered as an injection at your doctor's office, hospital, or clinic.
• If Atgam 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. 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 Atgam , contact your doctor immediately.

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

• Atgam CONTAINS ALBUMIN, which comes from human blood. There is an extremely rare risk of developing a viral disease or a central nervous system disease called Creutzfeldt-Jakob disease. No cases of viral diseases or Creutzfeldt-Jakob disease from albumin have been identified.
• Atgam may cause dizziness or lightheadedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Atgam . Using Atgam alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• A skin test is normally performed before the first dose to check for possible allergy to horse serum.
• LAB TESTS, including blood cell counts, liver function tests, and kidney function tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Caution is advised when using Atgam in CHILDREN because they may be more sensitive to its effects.
• PREGNANCY and BREAST-FEEDING: It is unknown if Atgam can cause harm to the fetus. If you become pregnant while taking Atgam , discuss with your doctor the benefits and risks of using Atgam during pregnancy. It is unknown if Atgam is excreted in breast milk. If you are or will be breast-feeding while you are using Atgam , check with your doctor or pharmacist to discuss the risks to your baby.

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:

Diarrhea; headache; joint pain; nausea; night sweats; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back pain; chest pain; confusion or disorientation; decreased urination or dark urine; fast, slow, or irregular heartbeat; fever, chills, or sore throat; irritation or sores in the mouth; muscle pain; pain, redness, or swelling at the injection site; pain or swelling in the legs; pain or swelling in the neck or under the arms; red, swollen, or blistered skin; seizures; severe dizziness, lightheadedness, or headache; stomach pain; unusual bleeding or bruising; unusual skin sensations (eg, burning or tingling).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects atIf OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control centeror emergency room immediately.

Store Atgam in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Keep Atgam out of the reach of children and away from pets.

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

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