Simulect

How does it work?

Simulect injection contains the active ingredient basiliximab, which is a type of medicine called a monoclonal antibody. It belongs to a group of medicines called immunosupressants. These medicines reduce the body's immune response.

The immune system normally protects the body from foreign cells and infections by producing antibodies to fight them. A transplanted organ can be attacked by the immune system in a similar way, because it is recognised by the body as a foreign substance. This is known as "transplant rejection".

Basiliximab is used to help prevent the cells of the immune system from rejecting a transplanted kidney. When a kidney from another person is transplanted into the body, white blood cells called T lymphocytes recognise the new kidney as foreign material and become activated. The activated T- cells display a receptor on their surface, and a substance called interleukin-2 normally recognises and binds to these receptors.

Interleukin-2 is an important substance in the immune system. It causes the T-cells to multiply dramatically so that they can launch an attack on the foreign material and destroy it. Normally this type of immune response protects the body from foreign invadors, but in the case of a transplanted kidney, it causes the new organ to be rejected.

Basiliximab is used in kidney transplants to block this immune response. Basiliximab is designed to recognise and bind to the receptors displayed by the activated T-cells. This blocks interleukin-2 from binding to the T-cells and stimulating them to multiply. The result is to protect the transplanted kidney from being attacked by large numbers of T-cells, which gives the transplant a greater chance of being sucessful.

Basiliximab is given by injection or infusion (drip) into a vein. Only two doses are required, the first within two hours before the transplant surgery and the second four days after. This is to stop the body rejecting the new kidney during the first four to six weeks after the transplant. You will also be given other immunosuppressive medicines (usually ciclosporin and corticosteroids) to help prevent your body rejecting the transplant, and you will need to continue some of these after you leave hospital.

What is it used for?

Preventing rejection of kidney transplants (in combination with ciclosporin and corticosteroids)

Warning!

The first dose of this medicine must not be administered unless it is absolutely certain that the patient will receive the kidney transplant and other immunosuppressive medicines. The second dose will not be administered if the transplant is rejected within the first four days following the surgery, or if there was a severe allergic reaction to the first dose.

This medicine must not be used during pregnancy as it may be harmful to an unborn baby. Women who are receiving this medicine and could get pregnant should use an effective method of contraception to prevent pregnancy, and continue its use for at least 16 weeks after the last dose of this medicine.

Use with caution in

People over 65 years of age

People previously treated with this medicine for a transplant that either did not happen or was subsequently rejected.

Not to be used in

Pregnancy

Breastfeeding.

This medicine is not recommended for children aged under one year.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and Breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

This medicine must not be used during pregnancy as it may be harmful to an unborn baby. Women who are receiving this medicine and could get pregnant should use an effective method of contraception to prevent pregnancy, and continue its use for at least 16 weeks after the last dose of this medicine.

This medicine may pass into breast milk. As this could be harmful to a nursing infant, mothers should not breastfeed after receiving this medicine, and for at least 16 weeks after the last dose. Seek further medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Severe allergic reactions such as narrowing of the airways (bronchospasm), difficulty breathing, low blood pressure, itchy blistering rash, fluid in the lungs (pulmonary oedema), heart failure or anaphylactic shock

The side effects listed above may not include all of the side effects reported by the drug's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

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