250 mg powder for concentrate for solution for injection / infusion 
bivalirudin

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor, pharmacist, or nurse.

– If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

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

What Bivalirudin Accord is and what it is used for

Bivalirudin Accord contains a substance called bivalirudin, which is an antithrombotic agent. Antithrombotic agents are drugs that prevent the formation of blood clots ( thrombosis ).

Bivalirudin Accord is used to treat patients:

  • with chest pain due to heart disease ( acute coronary syndrome – AKS)
  • undergoing surgery to treat narrowed blood vessels (vascular surgery and/or percutaneous coronary intervention – PCI).

Bivalirudin contained in Bivalirudin Accord may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.

2. What you need to know before using Bivalirudin Accord

Do not use Bivalirudin Accord

  • if you are allergic to bivalirudin or any of the other ingredients of this medicine (listed in section 6) or hirudins (other blood thinners).
  • if you have or have recently had, bleeding from the stomach, intestines, bladder, or other organs, eg if you have detected abnormal blood in the stool or urine (with the exception of menstrual bleeding).
  • if you have or have had, problems with blood coagulation (low platelet count ).
  • if you have 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 your doctor if you are unsure.

Warnings and cautions

Talk to your doctor before using Bivalirudin Accord.

  • if bleeding occurs (if this happens, treatment with Bivalirudin Accord will be stopped). Your doctor will monitor you throughout the treatment period for signs of bleeding.
  • if you have previously been treated with medicines similar to Bivalirudin Accord (eg lepirudin).
  • Before starting an injection or infusion, your doctor will inform you about the signs of an allergic reaction. Such a reaction is less common (may affect 1 in 100 people).
  • if you receive radiation therapy to the blood vessels that supply the heart with blood (a procedure called beta- or gamma-brachytherapy).

After treatment with Bivalirudin Accord for heart problems, you should stay in the hospital for at least 24 hours. There, you should be monitored for symptoms or signs similar to those you experienced when you had heart problems that resulted in you being hospitalized.

Children and young people

  • if you are a child (under 18 years) this medicine is not suitable for you.

Other medicines and Bivalirudin Accord

Tell your doctor or pharmacist

  • if you are taking, have recently taken, or might take any other medicines.
  • if you are taking blood thinners or medicines that prevent blood clots (anticoagulants or antithrombotic agents, such as warfarin , dabigatran, apixaban, rivaroxaban, acetylsalicylic acid, clopidogrel, prasugrel, ticagrelor).

These drugs can increase the risk of side effects such as bleeding when co-administered with Bivalirudin Accord. The results of blood tests taken during warfarin treatment (INR test) may be affected by Bivalirudin Accord.

Pregnancy and breastfeeding

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

Bivalirudin Accord should not be used during pregnancy unless it is very important that you get it. Your doctor will decide if the treatment is right for you or not. If you are breast-feeding, your doctor will decide if you should use Bivalirudin Accord.

Driving and using machines

The effect of this drug is short-lived. Bivalirudin Accord is only given to patients in hospitals. It is therefore unlikely that your ability to drive or use machines will be affected.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Bivalirudin Accord contains sodium

This medicine contains less than 23 mg sodium per vial, ie is essential ‘sodium-free’.

How to use Bivalirudin Accord

Your treatment with Bivalirudin Accord will be monitored by a doctor. Your doctor will decide how much Bivalirudin Accord you are taking and prepare the medicine.

The dose one is given depends on your body weight and the type of treatment you are receiving.

Dosage

For patients with the acute coronary syndrome (ACS) who are receiving medical treatment, the recommended starting dose is:

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

If you subsequently need to undergo percutaneous coronary intervention therapy, dose one will be increased to:

  • 0.5 mg/kg body weight as an intravenous injection followed by an infusion into a vein of 1.75 mg/kg body weight per hour during the PCI
  • Once this treatment has been completed, you may return to an infusion of 0.25 mg/kg body weight per hour for a further 4 to 12 hours.

If you need to undergo bypass surgery on the coronary arteries of the heart, bivalirudin treatment will either be stopped 1 hour before the operation or an additional dose of 0.5 mg/kg body weight will be given as an injection followed by an infusion of 1.75 mg/kg body weight per hour.

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

  • 0.75 mg/kg body weight as an intravenous injection immediately followed by an infusion (drip) of 1.75 mg/kg body weight per hour for at least the duration of the PCI. The intravenous infusion can be continued for up to 4 hours after PCI and for STEMI patients (those with a severe type of myocardial infarction) it should be continued at this dose for up to 4 hours. Infusion one can be followed by an infusion with a lower dose of 0.25 mg/kg body weight for a further 4 to 12 hours.

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

In the elderly, the dose may need to be reduced if renal function is impaired.

Your doctor will decide how long you should be treated.

Bivalirudin Accord is given by injection followed by an infusion (drip) into a vein (never into a muscle). An injection is given and supervised by a physician experienced in the management of patients with heart disease.

If you take more Bivalirudin Accord than you should

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you get any of the following, possibly serious, side effects:

  • while you are in hospital: Tell your doctor or nurse immediately
  • after you leave the hospital: contact a doctor immediately or see the emergency department at the nearest hospital.

The most common (may affect up to 1 in 10 people) side effect of treatment with bivalirudin is major bleeding which may occur in the body (eg stomach, digestive system [including blood in vomit or feces], abdomen, lungs, groin, bladder, heart, eyes, ear, nose or brain)They can rarely result in stroke or be fatal. Swelling or pain in the groin or arm, back pain, bruising, headache, blood in the cough, pink or red urine, sweating, fainting, nausea, or dizziness due to low blood pressure may be a sign of internal bleeding. Bleeding is more likely to occur when bivalirudin is used in combination with other anticoagulants or antithrombotic agents (see section 2 “Other medicines and Bivalirudin Accord”).

  • Bleeding and bruising at the injection site (after PCI) can be painful. In rare cases, surgery may be needed to repair the blood vessel in the groin ( fistula, pseudoaneurysm) (may affect up to 1 in 1,000 users). A less common side effect(which may affect up to 1 in 100 people) is a low platelet count, which may aggravate any bleeding. Bleeding in the gums (less common, may affect up to 1 in 100 people) is usually not serious.
  • Allergic reactions are uncommon (may affect up to 1 in 100 people) and usually not serious but can in some cases be severe and in rare cases fatal due to low blood pressure ( shock ). They can start with limited symptoms such as itching, redness of the skin, rash, or small lumps on the skin. Sometimes the reactions can be more severe with itching in the throat, feeling of tightness in the throat, swelling of the tongue, face, eyes, or lips, wheezing during inhalation, difficulty breathing or exhaling (wheezing).
  • Thrombosis (blood clot) is a less common side effect (may affect up to 1 in 100 people) that can lead to serious or fatal complications such as a heart attack. Thrombosis includes thrombosis in the coronary artery (blood clot in the coronary artery s or in a stent which feels like a heart attack and can even be fatal) and/or thrombosis in the catheter. Both of these are rare (may affect up to 1 in 1,000 people).

If you get any of the following side effects (which may be less serious):

  • while you are in hospital: Tell your doctor or nurse immediately
  • after leaving the hospital: first consult a doctor. If you cannot reach the doctor, you should immediately go to the emergency department at the nearest hospital.

Very common side effects (may affect more than 1 user in 10):

  • Minor bleeding

Common side effects (may affect up to 1 in 10 people):

  • Anemia (low blood cell count )
  • Hematoma (bruising)

Uncommon side effects (may affect up to 1 in 100 people):

  • Nausea and/or vomiting

Rare side effects (may affect up to 1 in 1,000 people):

  • INR test (results from blood tests taken during warfarin treatment) increased (see section 2 “Other medicines and Bivalirudin Accord”)
  • Angina or chest pain
  • Slow heartbeat
  • Fast heartbeat
  • Respiratory distress
  • Reperfusion injury (no or slow reflow): impaired flow in the coronary artery’s when they have been reopened

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Bivalirudin Accord

Because Bivalirudin Accord is a hospital-only medicine, healthcare professionals are responsible for storing Bivalirudin Accord.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP and EXP. The expiration date is the last day of the specified month.

Prepared solution: Store in a refrigerator (2-8 ° C). Do not freeze.

Diluted solution: Do not store above 25 ° C. Store in a cold place. Do not freeze.

The solution should be a clear to slightly opalescent, colorless to light yellow solution.

The doctor will inspect the solution and discard it if it contains particles or is discolored.

6. Contents of the packaging and other information

Content declaration

  • The active substance is bivalirudin.
  • One vial contains 250 mg of bivalirudin.
  • After reconstitution (5 ml of water for injections added to the vial to dissolve the powder) 1 ml contains 50 mg of bivalirudin.
  • After dilution (a mixture of 5 ml of the reconstituted solution in an infusion bag[total volume 50 ml] glucose solution or sodium chloride solution) 1 ml contains 5 mg of bivalirudin.

The other ingredients are mannitol (E421) and sodium hydroxide (for pH adjustment).

What the medicine looks like and the contents of the pack

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

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

Bivalirudin Accord is supplied in cartons containing 1 vial, 5 vials, or 10 vials.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Accord Healthcare BV

Winthontlaan 200

3526 kV Utrecht

Netherlands

Manufacturer:

Laboratory Reig Jofré SA

C / Gran Capitán, 10, Sant Joan Despí,

08970 Barcelona

Spain

Accord Healthcare Limited

Sage House, 319 Pinner Road,

North Harrow, Middlesex, HA1 4HF,

UK

Muhammad Nadeem

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