Lymphocyte immune globulin, anti-thymocyte equine

You will receive this medicine in a hospital or clinic setting to quickly treat any serious side effects that occur. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You should not receive lymphocyte immune globulin if you are allergic to it.

To make sure lymphocyte immune globulin is safe for you, tell your doctor if you have:

• liver or kidney disease; or

• if you have received a vaccine in the past 6 months.

It is not known whether lymphocyte immune globulin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether lymphocyte immune globulin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Lymphocyte immune globulin is made of certain blood products from horses and may contain viruses and other infectious agents. These blood components are tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

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

Tell your caregivers right away if you have:

• fast heartbeat, trouble breathing;

• a light-headed feeling, like you might pass out;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin, coughing up blood or vomit that looks like coffee grounds;

• seizure (convulsions); or

• low white blood cell counts--fever, swollen glands, skin sores, rash or itching, muscle or joint pain, feeling very weak or tired.

Common side effects may include:

• fever, chills, night sweats, or other signs of infection;

• blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;

• nausea, vomiting, diarrhea;

• pain where the medicine was injected;

• red or itching skin;

• abnormal liver or kidney function tests;

• dizziness, headache, confusion; or

• redness, swelling, warmth, irritation, or tenderness in the veins of your arms or legs.

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.

Usual Adult Dose for Aplastic Anemia:

10 to 20 mg/kg/day by IV infusion for 8 to 14 days. Additional alternating day therapy can be administered for up to a total of 21 doses.

Usual Adult Dose for Renal Transplant:

Delaying the Onset of Allograft Rejection:
15 mg/kg daily for 14 days, then every other day for 14 days for a total of 21 doses in 28 days. Administer the first dose within 24 hours before or after the transplant.

Rejection treatment:
10 to 15 mg/kg/day by IV infusion for 14 days. Additional alternating day therapy can be administered for up to 21 doses.

Usual Pediatric Dose for Aplastic Anemia:

Experience with children has been limited. Lymphocyte immune globulin has been administered safely to a small number of pediatric renal allograft recipients and pediatric aplastic anemia patients at dosage levels comparable to those in adults.

10 to 20 mg/kg/day for 8 to 14 days. Additional alternating day therapy can be administered for up to 21 doses in 28 days.

Usual Pediatric Dose for Renal Transplant:

Experience with children has been limited. Lymphocyte immune globulin has been administered safely to a small number of pediatric renal allograft recipients and pediatric aplastic anemia patients at dosage levels comparable to those in adults.

Induction therapy:
15 mg/kg/day by IV infusion for 14 days, followed by 15 mg/kg every other day for 14 days for a total of 21 doses in 28 days. Administer the first dose within 24 hours before or after the transplant.

Delaying the Onset of Allograft Rejection:
15 mg/kg daily for 14 days, then every other day for 14 days for a total of 21 doses in 28 days. Administer the Induction therapy: first dose within 24 hours before or after the transplant.

Rejection treatment:
10 to 15 mg/kg/day by IV infusion for 14 days. Additional alternating day therapy can be administered for up to 21 doses.

Other drugs may interact with lymphocyte immune globulin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.