Refludan

Blood clots normally only form to stop bleeding that has occurred as a result of injury to the tissues. Sometimes, however, a blood clot can form abnormally within the blood vessels. This is known as a thrombus. It can be dangerous because the clot may detach and travel in the bloodstream, where it becomes known as an embolus. The embolus may eventually get lodged in a blood vessel, thereby blocking the blood supply to a vital organ such as the heart, brain or lungs. This is known as a thromboembolism.

When blood begins to clot, a complicated cascade of chemicals is activated within the body. This results in the formation of a protein called thrombin. Thrombin is central to the complete process of blood clotting.

Lepirudin works by binding to thrombin and directly inhibiting its action, so interfering with the blood clotting.

Abnormal blood clots in the blood vessels are usually treated with an injectable anticoagulant medicine called heparin. Heparin is also used to prevent blood clots in people at risk, for example in people having orthopaedic surgery who are going to be immobile for a long period of time. However, in some people, heparin can cause the number of platelets in the blood to drop (a condition called heparin-associated thrombocytopenia). People who develop this condition cannot continue to have heparin treatment and lepirudin is used as an alternative.

Refludan is given as an injection or drip into a vein (intravenous infusion).

What is it used for?

- Preventing and treating abnormal blood clots in the blood vessels (such as deep vein thrombosis or pulmonary embolism, or in the management of heart attack) as an alternative to heparin in people who have developed a blood disorder to heparin (heparin-associated thrombocytopenia) but still require treatment with an injectable anticoagulant

Warning!

- During treatment daily blood tests are required to determine the blood clotting ability and the dose of medicine required.

Use with caution in

- People who have previously been treated with Refludan, other hirudins or hirudin analogues, eg bivalirudin (Angiox)
- Decreased kidney function
- Decreased liver function
- People who have had recent bleeding or major injury
- People at increased risk of bleeding, for example due to recent puncture of major blood vessels, organ biopsy or major surgery
- Bacterial infection of the heart valves and the lining surrounding the heart (bacterial endocarditis)
- Recent stroke
- Very high blood pressure

Not to be used in

- Pregnancy
- Breastfeeding

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.

- The manufacturer states not to use this medicine during pregnancy and breastfeeding as there is insufficient safety information available. Seek 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.

- Bleeding
- Fever
- Reactions at injection site
- Reduced levels of haemoglobin in the blood
- Allergic reactions such as skin rash, swelling of the lips, tongue and throat (angioedema), narrowing of the airways (bronchospasm) or anaphylaxis

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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