Thymoglobuline 25 mg powder for solution for infusion (anti-human T-lymphocyte immunoglobulin, rabbit) – against kidney and heart transplant rejection

Thymoglobuline contains anti-human T-lymphocyte immunoglobulin from rabbits – antibodies obtained by immunising rabbits with human thymus cells. It belongs to the group of immunosuppressants (anti-rejection medicines): the antibodies bind to certain immune cells, mainly T lymphocytes, and destroy them, so the body accepts the transplanted organ more easily.

It is used in patients with a transplanted kidney or heart, mainly in combination with other immunosuppressants. The medicine is a 25 mg powder for solution for infusion and is used exclusively in hospital, as an intravenous infusion lasting at least 6 hours.

What is Thymoglobuline used for and how is it given?

Basic information about the medicine

What is Thymoglobuline used for?

According to the leaflet and the summary of product characteristics, Thymoglobuline is intended for immunosuppression in solid organ transplantation:

• prophylaxis of rejection of a transplanted kidney;
• treatment of rejection of a transplanted kidney in case of corticosteroid resistance;
• prophylaxis of rejection of a transplanted heart.

It is mainly used in combination with other immunosuppressive medicines.

How is Thymoglobuline used and dosed?

The dose depends on body weight (in obese patients on ideal body weight), the indication and concomitant therapy. Dosing examples from the leaflet:

The powder is dissolved in 5 mL of water for injections, and the daily dose is diluted in 0.9% sodium chloride or 5% glucose (50–500 mL) and given as a slow infusion into a high-flow vein through a 0.22 micrometre in-line filter, over no less than 6 hours. Premedication with intravenous corticosteroids and antihistamines is recommended, and an antipyretic (e.g. paracetamol) may improve tolerance of the first infusion. The doctor may also give heparin. Treatment can be stopped without gradual dose reduction.

Special patient groups

• Children and adolescents: data are limited; the safety profile does not differ significantly from adults and no different doses are required. There are no data on treating kidney rejection in children.
• Elderly patients: dosing is the same as in adults.
• Kidney and liver impairment: no dose adjustment is needed; in liver disease special caution is required as existing clotting disorders may worsen (platelets and coagulation parameters are monitored).

Contraindications – when the medicine must not be used

• hypersensitivity to the active substance, rabbit proteins or the excipients;
• active acute or chronic infections in which any additional immunosuppression is contraindicated.

Precautions and warnings

• Before use it is checked whether the patient is allergic to rabbit proteins; equipment for emergency treatment of anaphylactic shock must be available.
• Serious infusion-related reactions (cytokine release syndrome) have rarely been accompanied by severe cardiorespiratory events; adherence to the dose, infusion duration and premedication reduce the risk.
• Infections (bacterial, fungal, viral, protozoal), cytomegalovirus reactivation and sepsis may occur, especially with several immunosuppressants.
• White blood cell and platelet counts are monitored before, during and after treatment; if they fall, the doctor reduces the dose or stops treatment.
• The medicine is manufactured using components of human blood; despite virus inactivation measures, transmission of infection cannot be completely ruled out.
• In the long term, an increased risk of infections and certain malignancies is possible.
• The medicine contains 4 mg sodium per vial.

Interactions with other medicines, food and drink

• Other immunosuppressants (e.g. azathioprine, corticosteroids): excessive immunosuppression increases the risk of serious infections and, in the long term, of malignancies.
• Vaccines: do not have vaccinations during or shortly after treatment without consulting your doctor – side effects or lack of vaccine response are possible.
• Food and drink: they are unlikely to affect the medicine.

Pregnancy and breastfeeding

• The medicine should not be given to pregnant women unless absolutely necessary, as its effects are unknown.
• Do not breastfeed while receiving the medicine – it may pass into breast milk.

Driving and using machines

• Do not drive or use machines while being treated with Thymoglobuline.

Possible side effects

Some side effects (fever, rash, headache, changes in pulse, blood pressure and breathing, allergic reactions) are more likely with the first or second dose.

• Very common (more than 1 in 10): low white blood cell and platelet counts, fever, infection, anaemia.
• Common (up to 1 in 10): diarrhoea, difficulty swallowing, nausea, vomiting, chills, febrile neutropenia, sepsis, muscle pain, growths (including malignant), shortness of breath, itching, rash, low blood pressure, raised liver enzymes.
• Uncommon (up to 1 in 100): serum sickness (rash, itching, hives, joint pain, kidney problems, swollen lymph nodes, 6–21 days after administration), malignant growth of lymphatic cells, liver failure.
• Not known: increased blood bilirubin.
• Delayed effects may occur months later – increased risk of infections and certain cancers, sometimes fatal.

Overdose, missed dose and stopping treatment

• Overdose: unlikely as the medicine is given by healthcare staff; a fall in platelets or white blood cells is possible, with fever, chills, sore throat, mouth ulcers and easier bleeding.
• Missed dose: if you think you did not receive a dose, tell your doctor – it is important to receive all prescribed doses.
• Stopping treatment: the doctor decides when to stop.

Related information

Immunosuppressive therapy after transplantation follows the transplant team's plan, with regular checks of blood count, transplanted organ function and monitoring for infections.

Composition, pack and manufacturer

• Active substance: anti-human T-lymphocyte immunoglobulin, rabbit – 25 mg per vial; after reconstitution in 5 mL sterile water, 1 mL contains 5 mg.
• Excipients: mannitol, glycine, sodium chloride; residues of polysorbate from the manufacturing process may be present.
• Appearance and pack: white to off-white/cream powder in a 10 mL glass vial with chlorobutyl rubber stopper and flip-off cap; 1 vial per carton.
• Marketing authorisation holder: Amicus SRB d.o.o., Milorada Jovanovića 9, Belgrade (transferred from Sanofi-Aventis d.o.o. Beograd according to the ALIMS 2022 transfer list). Manufacturers: Genzyme Polyclonals SAS, Lyon, France; Genzyme Ireland Limited, Waterford, Ireland. Authorisation 515-01-00053-21-002 of 07.12.2021.

Storage

• Store and transport refrigerated (2–8 °C); do not freeze. During transport, temperature excursions up to 25 °C for 3 days do not alter the product.
• Shelf life: 3 years. Use the solution immediately after preparation; if not used immediately, normally not longer than 24 hours at 2–8 °C unless prepared under controlled aseptic conditions.
• Keep out of the sight and reach of children.

Frequently asked questions

How long does a Thymoglobuline infusion take?

At least 6 hours, and the first dose may take longer. The medicine is given slowly into a high-flow vein while pulse, blood pressure, breathing and rash are monitored.

Why do I receive other medicines before the infusion?

Premedication with corticosteroids and antihistamines, and sometimes an antipyretic such as paracetamol, reduces the frequency and severity of infusion reactions. The doctor may also give heparin to reduce the risk of blood clots.

What is serum sickness?

It is a reaction to the antibodies in the medicine that occurs 6–21 days after administration: rash, itching, hives, joint pain, swollen lymph nodes and kidney problems. It is usually mild and resolves on its own or after a short course of corticosteroids.

May I be vaccinated after treatment?

Not without consulting your doctor. During and shortly after treatment a vaccine may cause side effects or not work because the immune system cannot respond.

Sources

• ALIMS – Patient information leaflet Thymoglobuline 25 mg (PIL)
• ALIMS – Summary of product characteristics Thymoglobuline 25 mg (SmPC)

Sources checked on: 25 October 2026.