Thymoglobuline
25 mg, powder for solution for infusion
Rabbit anti-human thymocyte immunoglobulin
Read all of this leaflet carefully before you are given this medicine.
- 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, please ask your doctor or nurse.
- If any of the side effects get serious or if you notice any side effects not listed in this leaflet, please tell your doctor.
In this leaflet:
- 1. What Thymoglobuline is and what it is used for
- 2. Before you are given Thymoglobuline
- 3. How Thymoglobuline is given
- 4. Possible side effects
- 5. How to store Thymoglobuline
- 6. Further information
What Thymoglobuline Is And What It Is Used For
Thymoglobuline belongs to a group of medicines called immunosuppressants (anti-rejection medicines). These medicines can help prevent the rejection of transplanted organs. They can also be used to treat other unwanted immune reactions.
Thymoglobuline is made by injecting human thymus cells into rabbits. It contains immunoglobulins (antibodies) which attach to and destroy some of the cells of your immune system in your body. These cells play a role in the rejection of transplanted organs or carry out other unwanted immune reactions.
Kidney and Heart Transplantation
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.
Before You Are Given Thymoglobuline
You should not be given Thymoglobuline
- if you are allergic (hypersensitive) to anti-human thymocyte globulin, rabbits , or any of the other ingredients of Thymoglobuline (see Section 6).
- if you have a severe infection because Thymoglobuline decreases your body’s ability to fight infections.
Take special care with Thymoglobuline
Tell your doctor 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.
- 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.
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 medicinal products 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.
Taking other medicines
Please tell your doctor if you are taking, or have recently taken any other medicines, including medicines taken without a prescription. It is especially important if you are taking:
- 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.
Vaccinations
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.
Using Thymoglobuline with food and drink
It is unlikely that eating and drinking will affect your medicine.
Pregnancy and breast-feeding
Please tell your doctor if you are or think that you may be pregnant. This is because Thymoglobuline should not be given to pregnant women unless it is absolutely necessary as the effects are unkown.
Do not breastfeed while you are being given Thymoglobuline. This is because it may get into your breast milk and may affect the baby.
Driving and using machines
Do not drive or operate with machinery while being treated with Thymoglobuline
How Thymoglobuline Is Given
Your medicine will be given to you by a doctor or nurse in a hospital. Thymoglobuline is given through a plastic tube (catheter) directly into your blood stream (intravenous infusion) over a period of at least 6 hours. The first dose may be given over a longer period of time.
The dose you will be given will depend on your weight (unless you are obese when it will depend on your ideal weight), which medical problem you are being treated for, and if you are being given any other medicines at the same time.
To prevent kidney rejection:
Between 1 and 1.5 mg of Thymoglobuline for every kilogram of weight every day for 3 to 9 days.
To prevent heart rejection:
Between 1 and 2.5 mg of Thymoglobuline for every kilogram of weight for 3 to 5 days.
To treat kidney rejection in patients resistant to corticosteroids:
1.5 mg of Thymoglobuline for every kilogram of weight every day for 7 to 14 days.
There are no data in children for rejection of kidney tranplantation.
Your doctor or nurse will check you regularly while you receive your first dose because this is when you are more likely to get side effects. They will check for rashes, check your pulse, blood pressure and breathing. From time to time your doctor may also want you to have a blood test to monitor your blood cell count. If your white blood cell count is low, your doctor may also administer medicines to prevent or treat infections; if your platelet counts are low, your doctor may give you a platelet transfusion.
The dose of Thymoglobuline may be changed by your doctor if you have any side effects.
Other medicines your doctor may give you
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
If you are given more Thymoglobuline than you should have
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.
Possible Side Effects
Like all medicines, Thymoglobuline can cause side effects, although not everybody gets them. Some side effects, such as fever, rash and headache, and others affecting your pulse rate, blood pressure and breathing, as well as some allergic reactions, are more likely to occur with your first or second dose of Thymoglobuline than with later doses.
Tell your doctor immediately if you notice:
- 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
The side effects listed below were recorded during a clinical study. This does not necessarily mean that all were caused by Thymoglobuline.
Very common (more than 1 in 10 patients) side effects include:
- Low white blood cell count; low platelet count
- Fever
- Infection
Common (up to 1 in 10 patients) include:
- Diarrhoea, difficulty swallowing, nausea, vomiting
- Shivering
- Serum sickness, which is an illness caused by antibodies against Thymoglobuline causing rash, itching, 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
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.
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.
If you are receiving Thymoglobuline with other medicines which suppress your immune system, you may be more susceptible to infections.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
How To Store Thymoglobuline
Your medicine will be stored in a hospital by a doctor or nurse, out of the sight and reach of children.
The unopened vials of Thymoglobuline will be stored in a refrigerator (2 – 8 °C).
The doctor or nurse will check that the product has not passed its expiry date before preparation.
Further Information
Thymoglobuline is a prescription only medicine (POM)
What Thymoglobuline contains
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.
What Thymoglobuline looks like and contents of the pack
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 and Manufacturer
The Marketing Authorisation Holder is:
The product is manufactured by:
Local representative:
UK and Ireland
Marketing Authorisation numbers:
UK: PL 12375/0021
Ireland: PA 611/3/1
Malta: MA 596/00201
For any information about Thymoglobuline, please contact the local representative or Marketing Authorisation Holder.
This leaflet was last approved in 11/2009
No comments:
Post a Comment