Patient Medication Information: uses, side effects, how to take - Thymoglobulin
Serious warnings and precautions box
What THYMOGLOBULIN is used for:
- treating acute kidney transplant rejection in conjunction with other medicines used to suppress the immune system.
- in the prevention of acute rejection in adult kidney transplant recipients.
How THYMOGLOBULIN works:
THYMOGLOBULIN is an immune globulin and works by suppressing the body’s immune system.
The ingredients in THYMOGLOBULIN are:
Medicinal ingredient(s): Anti-thymocyte Globulin [Rabbit]
Non-medicinal ingredients: D-Mannitol, Glycine, Sodium Chloride
THYMOGLOBULIN comes in the following dosage form(s):
THYMOGLOBULIN is supplied in a powder format that is mixed by a health care professional with Sterile Water for Injection prior to administration.
Do not use THYMOGLOBULIN if:
- you ever had an allergic reaction (for example rash, itchiness, or difficulty breathing) to rabbit products.
you ever had an allergic reaction to any ingredient in THYMOGLOBULIN.
THYMOGLOBULIN should only be used by physicians experienced in immunosuppressive therapy for the treatment of renal transplant patients.
In rare instances, serious immune-mediated reactions have been reported with the use of THYMOGLOBULIN and consist of anaphylaxis or severe cytokine release syndrome (CRS). CRS is a condition where the immune system releases too many substances called cytokines into the blood, which can cause serious symptoms requiring immediate medical attention.
- you have an active acute or chronic infection, which would contraindicate any additional immunosuppression.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take THYMOGLOBULIN. Talk about any health conditions or problems you may have, including if you:
plan to drive or operate machinery
- have an acute viral illness
- had severe or acute infections in the past
are pregnant or plan to become pregnant or are breast feeding
- plan to be vaccinated or have recently been vaccinated
- are taking other medications
Other warnings you should know about:
Medical surveillance is required during THYMOGLOBULIN infusion.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with THYMOGLOBULIN®:
- Live vaccines should not be administered when you are about to receive, receiving, or after treatment with THYMOGLOBULIN.
- The combination of THYMOGLOBULIN, heparin, and hydrocortisone in a dextrose infusion solution has been noted to precipitate and is not recommended.
How to take THYMOGLOBULIN:
THYMOGLOBULIN will normally be administered by a health care professional in hospital.
Usual dose:
The recommended dosage of THYMOGLOBULIN (Anti-thymocyte Globulin [Rabbit]) for treatment of acute renal graft rejection is 1.5 mg/kg of body weight administered daily for 7 to 14 days. For prophylaxis in adult renal transplant recipients the recommended dose is 1.5 mg/kg/day intravenously for at least seven days beginning intraoperatively, through a high-flow vein.
Overdose:
If you think you, or a person you are caring for, have taken too much THYMOGLOBULIN, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed dose:
If you missed a THYMOGLOBULIN dose, contact your doctor.
Possible side effects from using THYMOGLOBULIN:
These are not all the possible side effects you may have when taking THYMOGLOBULIN. If you experience any side effects not listed here, tell your healthcare professional.
These side effects may include:
- Fever
- Chills
- Low white blood cells
- Pain
- Headache
- Abdominal pain
- Diarrhea
- High blood pressure
- Nausea
- Bleeding
- Bruising
- Fatigue
- Tiredness
- Low platelets
- Swelling of your hands, ankles, feet, or legs
- Shortness of breath
- Unusual weakness
- High potassium levels in the blood
- Rapid heartbeat
- Infection
Other possible side effects include:
- Anemia (low red blood cells or hemoglobin)
- Hyperbilirubinemia (increased bilirubin levels in the blood).
- Damage to the smallest blood vessels known as thrombotic microangiopathy (TMA).
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | [Stop taking this drug and get immediate medical help] OR [Get immediate medical help] | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Common | |||
| Fever | ✓ | ||
| Shivering | ✓ | ||
Shortness of breath, difficulty ✓ breathing, wheezing or coughing | |||
| Feeling or being sick | ✓ | ||
| Dizzy or feeling faint | ✓ | ||
| Tiredness | ✓ | ||
| Muscle or joint pain | ✓ | ||
| Rash | ✓ | ||
| Headache ✓ | |||
| Bleeding or bruising more easily | ✓ | ||
| Irregular or fast heartbeat | ✓ | ||
| Symptoms of infection such as fever, chills, sore throat, mouth ulcers | ✓ | ||
| Diarrhea | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
You will not be asked to store your medicine. THYMOGLOBULIN will be stored in a refrigerator between +2°C and +8°C (36°F to 46°F). Protect from light. Do not freeze.
If you want more information about THYMOGLOBULIN:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.sanofi.com/en/canada, or by calling 1-800-265-7927.
Date of Authorization: 2026-01-22