Thymoglobulin

Generic name: anti-thymocyte globulin (rabbit)
Drug class: Selective immunosuppressants

Medically reviewed by  A Ras MD.

What is Thymoglobulin used for?

Thymoglobulin is used after a kidney transplant to keep the body from rejecting the kidney. Thymoglobulin may be given to you for other reasons. Talk to your doctor.

Description

THYMOGLOBULIN® (anti-thymocyte globulin [rabbit]) is a purified, pasteurized, immunoglobulin G, obtained by immunization of rabbits with human thymocytes. This immunosuppressive product contains cytotoxic antibodies directed against antigens expressed on human T-lymphocytes.

THYMOGLOBULIN is a sterile, lyophilized powder for intravenous administration after reconstitution with sterile Water for Injection, USP (SWFI). Each single-dose 10 mL vial contains 25 mg of anti-thymocyte globulin (rabbit), 50 mg glycine, 10 mg sodium chloride, and 50 mg mannitol.

After reconstitution with 5 mL SWFI, each vial of reconstituted product contains approximately 5 mg/mL of THYMOGLOBULIN, of which >90% is rabbit gamma immune globulin (IgG). The reconstituted solution has a pH of 6.5 to 7.2.

Human red blood cells are used in the manufacturing process to deplete cross-reactive antibodies to non–T-cell antigens. The manufacturing process is validated to remove or inactivate potential exogenous viruses. All human red blood cells are from U.S.-registered or FDA-licensed blood banks. A virus removal step (nanofiltration, using a 20 nm filter) and a viral inactivation step (pasteurization, i.e., heat treatment of active ingredient at 60°C/10 hr) are performed for each lot. Each THYMOGLOBULIN lot is released following potency testing (lymphocytotoxicity and E-rosette inhibition assays), and cross-reactive antibody testing (hemagglutination, platelet agglutination, antiglomerular basement membrane antibody, and fibroblast toxicity assays on every lot).

Before taking Thymoglobulin, tell your doctor:

• If you are allergic to Thymoglobulin; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have an infection.
• If you are breast-feeding. Do not breast-feed while you take Thymoglobulin.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Thymoglobulin with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Thymoglobulin?

• Tell all of your health care providers that you take Thymoglobulin. This includes your doctors, nurses, pharmacists, and dentists.
• Some people have unsafe allergic effects or bad side effects during the infusion or within 24 hours of the infusion. Talk with the doctor.
• Very bad and sometimes deadly allergic side effects have rarely happened. Talk with your doctor.
• You may have more of a chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu. Some infections have been very bad and even deadly.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• The chance of cancer is higher after using Thymoglobulin. Talk with the doctor.
• You may have a chance of getting post-transplant lymphoproliferative disorder (PTLD). PTLD happens when your white blood cells grow out of control and can lead to cancer and death.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Thymoglobulin.
• Talk with your doctor before getting any vaccines. Use of some vaccines with Thymoglobulin may either raise the chance of an infection or make the vaccine not work as well.
• A very bad and sometimes deadly health problem called cytokine release syndrome (CRS) has happened in people getting Thymoglobulin. Call your doctor right away if you have chills, dizziness, feeling tired or weak, fever, headache, passing out, rash, swelling of the face, trouble breathing, upset stomach or throwing up, or wheezing.
• Use birth control to prevent pregnancy while taking Thymoglobulin and for 3 months after the last dose.
• If you get pregnant while taking Thymoglobulin or within 3 months after your last dose, call your doctor right away.

How is Thymoglobulin best taken?

Use Thymoglobulin as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion into a vein over a period of time.
• Other drugs may be given to help with infusion side effects.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of Thymoglobulin that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
• Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
• Signs of too much acid in the blood (acidosis) like confusion; fast breathing; fast heartbeat; a heartbeat that does not feel normal; very bad stomach pain, upset stomach, or throwing up; feeling very sleepy; shortness of breath; or feeling very tired or weak.
• Chest pain or pressure or a fast heartbeat.
• Any unexplained bruising or bleeding.
• Feeling very tired or weak.
• Swelling in the arms or legs.
• Shortness of breath.
• Anxiety.
• Feeling confused.
• Feeling agitated.
• Restlessness.

What are some other side effects of Thymoglobulin?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Upset stomach or throwing up.
• Stomach pain or diarrhea.
• Constipation.
• Not hungry.
• Feeling tired or weak.
• Muscle or joint pain.
• Trouble sleeping.
• Sweating a lot.
• Pimples (acne).
• Back pain.
• Signs of a common cold.
• Nose or throat irritation.
• Redness or swelling where the shot is given.
• Pain where the shot was given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Thymoglobulin?

• If you need to store Thymoglobulin at home, talk with your doctor, nurse, or pharmacist about how to store it.

Label

PRINCIPAL DISPLAY PANEL – 25 MG VIAL CARTON

 

• NDC 58468-0080-1
  Rx only
• Thymoglobulin®
  Anti-thymocyte Globulin (Rabbit)
• 25 mg per vial
• For Injection
  For Intravenous Infusion
• One single-dose vial
  Discard unused portion
• SANOFI GENZYME

SRC: NLM .