Bivalirudin 250 mg Powder for solution for injection vial

• Keep this leaflet. You may need to read it again.
• If you have further questions, ask your doctor.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

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

• if you are allergic to bivalirudin or any of the other ingredients of this medicine (listed in section 6) or hirudins (other blood thinning medicines).
• if you have, or have recently had, any bleeding from your stomach, intestines, bladder or other organs, for example, if you have noticed abnormal blood in your stools or urine (except from menstrual bleeding).
• if you have, or have had, difficulty with your blood clotting (a low platelet count).
• if you have severe high blood pressure.
• if you have an infection of the heart tissue.
• if you have severe kidney problems or if you need kidney dialysis.

Check with the doctor if you are unsure.

Talk to your doctor before using Bivalirudin.

• if bleeding occurs (if this happens, treatment with Bivalirudin will be stopped). Throughout your treatment, the doctor will check you for any signs of bleeding.
• if you have been treated before with medicines similar to Bivalirudin (e.g. lepirudin).
• before the start of the injection or infusion, the doctor will tell you about the signs of allergic reaction. Such a reaction is uncommon (affects 1 to 10 users in 1,000).
• if you are having radiation treatment in the vessels that supply blood to the heart (treatment called beta or gamma brachytherapy).

After being treated with Bivalirudin for a cardiac event, you should stay in the hospital for at least 24 hours and you should be monitored for any symptoms or signs similar to the ones that remind you of your cardiac event and resulted in your hospitalization.

• if you are a child (less than 18 years of age), this medicine is not appropriate for you.

Tell your doctor

• if you are taking, have recently taken, or might take any other medicines.
• if you are taking blood thinners or medicines to prevent blood clots (anticoagulants or antithrombotics, e.g. warfarin, dabigatran, apixaban, rivaroxaban, acetylsalicylic acid, clopidogrel, prasugrel, ticagrelor).

These medicines may increase the risk of side effects such as bleeding when given at the same time as Bivalirudin. Your warfarin blood test result (INR test) may be affected by Bivalirudin.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Bivalirudin should not be used during pregnancy, unless clearly necessary. Your doctor will decide whether or not this treatment is appropriate for you. If you are breast-feeding, the doctor will decide whether Bivalirudin should be used.

The effects of this medicine are known to be short-term. Bivalirudin is only given when a patient is in hospital. It is, therefore, unlikely to affect your ability to drive or to use machines.

This medicine contains less than 23 mg of sodium per vial, which means that it is essentially “sodium free”.

For patients with acute coronary syndrome (ACS) who are treated medically the recommended starting dose is:

• 0.1 mg/kg body weight as an intravenous injection, followed by an infusion (drip) into vein of 0.25 mg/kg body weight per hour for up to 72 hours.

If, after this, you then need percutaneous coronary intervention (PCI) treatment, the dosage will be increased to:

• 0.5 mg/kg body weight for the intravenous injection, followed by an infusion into vein of 1.75 mg/kg body weight, per hour for at least the duration of the PCI. This intravenous infusion may continue for up to 4 hours.
• When this treatment is finished, the infusion may go back to 0.25 mg/kg body weight per hour.

If you need to have a coronary artery bypass graft operation, treatment with bivalirudin will either be stopped one hour before the operation or an additional dose of 0.5 mg/kg body weight will be given by injection followed by an infusion of 1.75 mg/kg body weight per hour.

For patients starting with percutaneous coronary intervention (PCI) the recommended dose is:

• 0.75 mg/kg body weight as an injection, followed immediately by an infusion of 1.75 mg/kg body weight, per hour (the intravenous infusion may continue for up to 4 hours).

If you have kidney problems, the dose of Bivalirudin Reig Jofre may need to be reduced.

In older people, if their kidney function is decreased, the dose may need to be reduced.

The doctor will decide for how long you should be treated.

Bivalirudin Reig Jofre is for injection, followed by infusion (drip), into a vein (never into a muscle). This is administered and supervised by a doctor experienced in caring for patients with heart disease.

Your doctor will decide how to treat you, including stopping the drug and monitoring for signs of ill effects.

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is bivalirudin.
• Each vial contains 250 mg bivalirudin.
• After reconstitution (addition of 5 ml water for injections to the vial to dissolve the powder), 1 ml contains 50 mg bivalirudin.
• After dilution (mixing 5 ml of the reconstituted solution into an infusion bag [total volume of 50 ml] of glucose solution or sodium chloride solution), 1 ml contains 5 mg bivalirudin. The other ingredients are mannitol and sodium hydroxide (for pH adjustment).

Bivalirudin is a powder for concentrate for solution for injection or infusion (powder for concentrate).

Bivalirudin is a white to off-white powder in a glass vial.

Bivalirudin is available in cartons containing 2 and 10 vials.

Marketing Authorisation Holder

Manufacturer

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

Denmark: Bivalirudin Reig Jofre 250 mg pulver til koncentrat til injektionsvæske eller infusionsvæske, opløsning

Spain: Bivalirudina Sala 250mg polvo para concentrado para solución inyectable o perfusión

Finland: Bivalirudin Reig Jofre 250 mg, kuiva-aine välikonsentraatiksi injektio-/infuusionestettä varten, liuos

Island: Bivalirudin Reig Jofre 250 mg stofn fyrir innrennslis- eða stungulyfsþykkni,

lausn Norway: Bivalirudin Reig Jofre 250 mg pulver til konsentrat til injeksjons- eller infusjonsvæske, oppløsning

Sweden: Bivalirudin Reig Jofre 250 mg pulver till koncentrat till injektions-/infusionsvätska, lösning

United Kingdom: Bivalirudin 250 mg powder for concentrate for solution for injection or infusion