Idarucizumab - intravenous

Idarucizumab is used to reverse the effects of Dabigatran (a blood-thinning medicine) in your body.

This medicine is used in certain emergency situations where rapid inactivation of Dabigatran is required such as, if you need to undergo an emergency surgery or procedure, or when you are experiencing uncontrolled bleeding while taking Dabigatran.

Idarucizumab is to be given intravenously (into the vein) via injection or infusion. It is delivered directly into the bloodstream via the blood vessel.

Your doctor or nurse will administer the injection for you.

Let your doctor know if you are pregnant or breastfeeding.

Do not participate in activities in which you may fall or get injured, such as contact sports. Alert your doctor if you get any unusual bruising (large bruises or several bruises) or bleeding that takes a long time to stop (e.g. too much bleeding when you floss or brush your teeth).

After you have received Idarucizumab, you will need to have blood tests to check your body's response to the medicine.

• This blood test is called an INR (International Normalised Ratio). The INR measures how much time your blood takes to clot. Each person has his or her own target INR result. Your doctor will discuss with you about your target INR result.
• Coagulation parameters e.g. activated partial thromboplastin time (aPTT) or ecarin clotting time (ECT) should also be monitored and repeated every 2 hours then every 12 hours thereafter.

Idarucizumab may cause headache and constipation.

Some side effects may need immediate medical help. Alert your doctor quickly if you experience any of the following:

• rashes, breathlessness, swollen mouth or eyes (signs of an allergic reaction)
• unusual bleeding or bruising
• fast or irregular heartbeat
• shortness of breath and chest pain
• pain and swelling in your arms and legs
• cough
• fever

Inform your doctor if any of these side effects do not go away or are severe, or if you experience other side effects.

Always notify your doctor and pharmacist if you are taking any other medicines, including herbal tonics such as traditional Chinese medicines, supplements and medicines that you buy without a prescription.

Avoid alcohol.

Store in the refrigerator, between 2-8°C.

Do not allow to freeze. Protect from light.