Consumer Information for: THYMOGLOBULIN
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
What the medication is used for
Thymoglobulin® (Anti-thymocyte Globulin [Rabbit]) is used for treating acute kidney transplant rejection in conjunction with other medicines used to suppress the immune system. Thymoglobulin may also be used in the prevention of acute rejection in adult kidney transplant recipients.
What it does
Thymoglobulin is an immune globulin and works by suppressing the body’s immune system
When it should not be used
If you ever had an allergic reaction (for example rash, itchiness, or
difficulty breathing) to rabbit products.
If you ever had an allergic reaction to any ingredient in
Thymoglobulin.
If you have an active acute or chronic infection, which would
contraindicate any additional immunosuppression.
What the medicinal ingredient is
Anti-thymocyte Globulin [Rabbit]
What the non-medicinal ingredients are
D-Mannitol, Glycine, Sodium Chloride
For a full listing of nonmedicinal ingredients see Part 1 of the product monograph.
What dosage form it comes in
Thymoglobulin is supplied in a powder format that is mixed by a health care professional with Sterile Water for Injection prior to administration.
Warnings and precautions
Serious Warnings and Precautions
- Thymoglobulin (Anti-thymocyte Globulin [Rabbit]) should only be used by physicians experienced in immunosuppressive therapy for the treatment of renal transplant patients. (see General section)
- 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). (see Immune section)
BEFORE you use Thymoglobulin talk to your doctor or pharmacist
- If you plan to drive or operate machinery
- If you have an acute viral illness
- If you had severe or acute infections in the past
- If you are pregnant or plan to become pregnant or are breast feeding
- If you plan to be vaccinated or have recently been vaccinated
- If you are taking other medications
Medical surveillance is required during Thymoglobulin infusion.
Interactions with this medication
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.
Proper use of this medication
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
Missed Dose
If you missed a Thymoglobulin dose, contact your doctor
Thymoglobulin will normally be administered by a health care professional in hospital.
Side effects and what to do about them
Like all medicines, Thymglobulin can have side effects.
| Symptom / effect | Stop taking drug and talk with your doctor or pharmacist |
|---|---|
| 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 | ✔ |
| Diarrhoea | ✔ |
This is not a complete list of side effects. For any unexpected effects while taking Thymoglobulin, contact your doctor or pharmacist.
How to store
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.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for health professionals can be found at: www.sanofi.ca or by contacting the sponsor, sanofi-aventis Canada Inc., at: 1-800-265-7927.
This leaflet was prepared by sanofi-aventis Canada Inc.
Last revised: March 7, 2016
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