Thymoglobuline 25 mg powder for solution for infusion

• Keep this leaflet. You may need to read it again.
• This medicine will be given to you by a doctor or nurse in hospital.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Thymoglobuline is and what it is used for
2. What you need to know before you are given Thymoglobuline
3. How Thymoglobuline is given
4. Possible side effects
5. How to store Thymoglobuline
6. Contents of the pack and other information

Thymoglobuline is used in patients who have had a kidney or heart transplant, to prevent the rejection of a kidney or a heart transplant. It is also used to treat the rejection of a kidney transplant in patients who are resistant to treatment with corticosteroids. Thymoglobuline is a type of drug known as an immunosuppressant (anti-rejection drug) and is usually used in combination with other immunosuppressants. When a patient receives an organ, the body’s natural defence system will try to get rid of it (reject it). Thymoglobuline modifies the body’s defence mechanism and helps it accept the transplanted organ.

• if you are allergic to anti–human thymocyte globulin, rabbits or any of the other ingredients of this medicine (listed in section 6).
• if you have a severe infection because Thymoglobuline decreases your body’s ability to fight infections.

Talk to your doctor or nurse before you are given Thymoglobuline. Thymoglobuline may not be suitable for you:

• if you have ever had an allergic reaction to animals or other medicines.
  Your doctor will monitor you closely and stop treatment if there are any signs of an allergic reaction to Thymoglobuline.
• if you have any blood disorders, such as lower than normal platelets in your blood (thrombocytopenia) or lower than normal white cells in your blood (leucopenia).The dose you will be given will depend on the number of white blood cells or platelets in your blood which will be checked before, during and after treatment.

During treatment with Thymoglobuline, your doctor will carry out regular blood tests and other tests to monitor your health. Because of the way this medicine works, it could affect your blood and other organs.

Human blood components are used in the manufacturing process for Thymoglobuline. When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/infections. Also during manufacturer of Thymoglobuline, steps have been included during processing of the blood that can inactivate or remove the viruses. Despite these measures, when medicines prepared from human blood components are administered, the possibility of passing on infection cannot be totally excluded.

This also applies to any unknown or emerging viruses or other types of infections.

The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus, hepatitis C virus and for the non-enveloped Hepatitis A and parvovirus B19 viruses.

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines or any other anti-rejection medicine (immunosuppressants), such as azathioprine or corticosteroids. This is because, if the body’s defense system is reduced too much, severe infections may occur. It may also increase the risk of developing cancer in the future.

Do not have any vaccination during or soon after treatment with Thymoglobuline without first discussing it with your doctor as it may cause side effects or may not work because your immune system cannot respond to it.

It is unlikely that eating and drinking will affect your medicine.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before taking this medicine. This is because Thymoglobuline should not be given to pregnant women unless it is absolutely necessary as the effects are unknown.

Do not breastfeed while you are being given Thymoglobuline.

This is because it may get into your breast milk and may affect the baby.

Do not drive or operate with machinery while being treated with Thymoglobuline.

This medicine contains 4 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 0.2% of the recommended maximum daily dietary intake of sodium for an adult.

Your doctor may give you some other medicines before, or at the same time as Thymoglobuline. These medicines are used to prevent, or treat possible side effects and could include:

• Antipyretics (like paracetamol) to reduce fever
• Corticosteroids (e.g. hydrocortisone) to prevent organ rejection and prevent side effects
• Antihistamines (e.g. cetirizine) to prevent an allergic response
• Heparin to reduce the risk of blood clots

It is unlikely you will be given more Thymoglobuline than you should, as you will be closely checked by your doctor or nurse during your treatment. If this does happen you may get a lower than normal platelet cell count (thrombocytopenia) or lower than normal white cell count (leucopenia). This can cause fever, chills, sore throat, mouth ulcers and bleeding or bruising more easily than normal.

• A raised itchy rash
• Difficulty in breathing
• Stomach pain
• Swelling of the face, tongue or throat

Sometimes, receiving a Thymoglobuline infusion may cause the following additional side effects. You should tell your doctor as soon as possible if you have any of the following:

• Difficulty breathing, wheezing or coughing
• Feeling or being sick
• Dizzy or feeling faint
• Tiredness
• Joint pain
• Headache
• Bleeding or bruising more easily than normal
• Irregular or fast heartbeat
• Symptoms of infection such as fever, chills, sore throat, mouth ulcers

During or after treatment with Thymoglobuline, some patients experience a temporary increase in certain liver function tests (laboratory tests which indicate how well your liver is functioning).

Generally, there are no symptoms and the liver function tests return to normal without treatment.

The side effects listed below were recorded during a clinical study. This does not necessarily mean that all were caused by Thymoglobuline.

Very common side effects (may affect more than 1 in 10 people):

• Low white blood cell count; low platelet count
• Fever
• Infection
• Low count of red blood cells (anaemia)

Common side effects (may affect more than 1 in 100 people):

• Diarrhoea, difficulty swallowing, nausea, vomiting
• Shivering
• Serum sickness, which is an illness caused by antibodies against Thymoglobuline causing rash, itching, urticaria (itchy, red welts), joint pains, kidney problems and swollen lymph nodes and which develops within 6-21 days. Serum sickness is usually mild and goes away without treatment or with a short course of corticosteroids
• Muscle pain
• Growths (including cancerous and non-cancerous)
• Shortness of breath
• Itchiness, rash
• Low blood pressure
• Increase in some liver enzymes in your blood

Uncommon side effects (may affect more than 1 in 1,000 people):

• Liver injury (liver failure)

These side effects may be mild and go away on treatment with other medicines. They may also be reduced by changing the dose of Thymoglobuline or increasing the period of time over which it is given.

Frequency not known (frequency cannot be estimated from the available data)

• Increased bilirubin in the blood (elevation of laboratory parameter)

Sometimes the effects of Thymoglobuline may not occur until months after it is used. These delayed effects may include an increased risk of infections and of certain types of cancer. These events have sometimes been associated with a fatal outcome.

If you are receiving Thymoglobuline with other medicines which suppress your immune system, you may be more susceptible to infections.

Talk to your doctor if you are concerned about any of these side effects or if there is anything you do not understand.

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed below. By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

or search for MHRA Yellow Card in the Google Play or Apple App Store.

Ireland

Malta

The active substance is: 25 mg of rabbit anti-human thymocyte immunoglobulin.

The other ingredients are: mannitol, glycine, sodium chloride (salt).

Thymoglobuline may also contain residues of polysorbate, from the manufacturing process.

Thymoglobuline is supplied in a glass vial containing a white powder.

Before it is used it is mixed with 5 millilitres (ml) of sterile water to make a liquid. Each millilitre (ml) contains 5 mg of rabbit anti-human thymocyte immunoglobulin. This liquid is then mixed with a sodium chloride or glucose solution so that it can be given slowly (infused) into your bloodstream through a plastic tube (catheter) in a large vein.

Marketing Authorisation Holder :

Manufacturer

Local representative:

Marketing Authorisation numbers:

UK: PL 12375/0021

Ireland: PA 611/3/1

Malta: MA 596/00201

This medicinal product is authorised in the Member States of the EEA under the following names:

Ireland: Thymoglobuline 25 mg powder for solution for infusion

Malta: Thymoglobuline 25 mg, powder for solution for infusion

Slovenia: Thymoglobuline 25 mg, powder for solution for infusion

UK: Thymoglobuline 25 mg powder for solution for infusion