Anti-thymocyte globulin is a sterilized solution made of the cells of rabbits that have been injected with white blood cells from humans.

Anti-thymocyte globulin lowers your body's immune system. The immune system helps your body fight infections. The immune system can also fight or "reject" a transplanted organ such as a liver or kidney. This is because the immune system treats the new organ as an invader.

Anti-thymocyte globulin is used together with other medicines to prevent your body from rejecting a kidney transplant.

Anti-thymocyte globulin may also be used for purposes not listed in this medication guide.

You should not use this medication if you are allergic to rabbit proteins, or if you have ever had an allergic reaction to anti-thymocyte globulin.

To make sure you can safely take anti-thymocyte globulin, tell your doctor if you have an active or chronic infection, or a serious infection called sepsis.

Serious and sometimes fatal infections may occur during treatment with anti-thymocyte globulin. Call your doctor right away if you have signs of infection such as: fever, chills, body aches, flu symptoms, mouth and throat ulcers, rapid heart rate, rapid and shallow breathing, weakness, tired feeling, or feeling like you might pass out.

Do not receive a "live" vaccine while using anti-thymocyte globulin. The vaccine may not work as well during this time, and may not fully protect you from disease.

Anti-thymocyte globulin is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Anti-thymocyte globulin must be given slowly, and the IV infusion can take 4 to 6 hours to complete.

You may be given other medications to help prevent serious side effects or allergic reaction.

Anti-thymocyte globulin can lower blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill. Your blood may need to be tested often. Visit your doctor regularly.

Usual Adult Dose for Renal Transplant:

-Prophylaxis of acute rejection: 1.5 mg/kg IV daily for 4 to 7 days with the first dose initiated prior to reperfusion of the donor kidney
-Treatment of acute rejection: 1.5 mg/kg IV daily for 7 to 14 days

Comments:
-Administer this drug with concomitant immunosuppressants.
-Administer the first dose over a minimum of 6 hours; administer doses on subsequent days over at least 4 hours.
-Premedication with corticosteroids, acetaminophen, and/or an antihistamine one hour prior to each infusion is recommended to reduce the incidence and intensity of infusion-related reactions.
-Administer prophylactic antifungal and antibacterial therapy if clinically indicated. Antiviral prophylactic therapy is recommended for patients who are seropositive for cytomegalovirus (CMV) at the time of transplant and for CMV-seronegative patients scheduled to receive a kidney from a CMV-seropositive donor.
-Monitor patients for adverse reactions during and after infusion.

Use: For the prophylaxis and treatment of acute rejection in patients receiving a kidney transplant; this drug is to be used in conjunction with concomitant immunosuppression

You should not use this medication if you are allergic to rabbit proteins, or if you have ever had an allergic reaction to anti-thymocyte globulin.

To make sure you can safely take anti-thymocyte globulin, tell your doctor if you have any of these other conditions:

• an active or chronic infection; or

• a serious infection called sepsis.

FDA pregnancy category C. It is not known whether anti-thymocyte globulin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether anti-thymocyte globulin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using anti-thymocyte globulin.

Using anti-thymocyte globulin may increase your risk of developing certain types of cancer, such as lymphoma (cancer of the lymph nodes). Talk with your doctor about your specific risk.

Call your doctor for instructions if you miss an appointment for your anti-thymocyte globulin injection.

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

Overdose symptoms may include some of the serious side effects listed in this medication guide.

Do not receive a "live" vaccine while using anti-thymocyte globulin. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.

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

Serious and sometimes fatal infections may occur during treatment with anti-thymocyte globulin. Stop using anti-thymocyte globulin and call your doctor right away if you have signs of infection such as:

• fever, chills, body aches, flu symptoms;

• mouth and throat ulcers;

• rapid heart rate, rapid and shallow breathing;

• weakness, tired feeling; or

• feeling like you might pass out.

Call your doctor at once if you have a serious side effect such as:

• white patches inside your mouth or on your lips;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• swollen glands, rash or itching, joint pain;

• pain or burning when you urinate;

• dry cough, wheezing, feeling short of breath;

• chest pain or heavy feeling, pain spreading to the arm or shoulder, sweating, general ill feeling; or

• high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling).

Less serious side effects may include:

• headache, dizziness;

• nausea, vomiting, diarrhea, stomach pain;

• swelling in your hands or feet; or

• pain, swelling, or redness where the injection was given.

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.

Tell your doctor about all other medicines you use, especially other drugs that weaken the immune system.

There may be other drugs that can interact with anti-thymocyte globulin (rabbit). Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.