Anti-thymocyte Globulin (Equine) Injection

IMPORTANT WARNING:

Anti-thymocyte globulin may cause a serious allergic reaction. Your doctor will probably do a skin test before beginning treatment to see if you are at risk for this reaction. Your doctor will monitor you during the infusion and for 24 hours afterwards. If you experience any of the following symptoms, tell your doctor immediately: rash, itching, hives, fast heartbeat, swelling of the throat or tongue, shortness of breath, and dizziness or fainting.

WHY is this medicine prescribed?

Anti-thymocyte globulin is used to prevent or treat kidney transplant rejection (attack of the transplanted organ by the immune system of the person receiving the organ). It is also used to treat aplastic anemia (condition in which the body does not make enough new blood cells). Anti-thymocyte globulin is in a class of medications called Immunosuppressants. It works by decreasing the activity of the immune system.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Anti-thymocyte globulin comes as a solution (liquid) to be given intravenously (into a vein). It is usually given once daily over at least 4 hours by a healthcare provider for up to 14 days. Your doctor may decide to give you additional doses every other day depending on your response.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before receiving anti-thymocyte globulin,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any otherdrugs, foods or substances. Tell your doctor or pharmacist about the allergy and whatsymptoms you had.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking anti-thymocyte globulin. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had kidney or liver disease.

• tell your doctor if you are pregnant or plan to become pregnant. You may be required to have a pregnancy test prior to receiving anti-thymocyte globulin. You should use birth control during and for 10 weeks after treatment with anti-thymocyte globulin. Talk to your doctor about what birth control is right for you. If your partner is capable of becoming pregnant, you should use birth control during and for 10 weeks after treatment with anti-thymocyte globulin. Talk to your doctor about what birth control would work best for you and your partner.

• tell your doctor if you are breast-feeding.

• do not have any vaccinations without talking to your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Anti-thymocyte globulin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea, vomiting, diarrhea

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• fever, chills, headache, chest pain, dizziness, fainting, shortness of breath, rapid breathing, and swelling
• rash, joint pain, fever, chills, and pain
• fever, chills, sweating, tiredness, muscle aches, cough, diarrhea, and other signs of infection
• unusual bleeding, bruising, rash of dark red spots under the skin,fever, sweating, chills, muscle aches, cough, shortness of breath, diarrhea, or stomachpain

Anti-thymocyte globulin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to anti-thymocyte globulin.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.