Bivalirudin powder for solution for injection/infusion 250mg/vial
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Powder for concentrate for solution for infusion or injection of bivalirudin.
Drugs List
Therapeutic Indications
Uses
Adjunct in ACS patients planned for urgent/early intervention
Anticoagulant for patients undergoing percutaneous coronary intervention
Anticoagulant in adults undergoing percutaneous coronary intervention (PCI), including patients with ST-segment elevation MI (STEMI) undergoing primary PCI.
Treatment of adults with acute coronary syndrome (unstable angina/non-ST elevation myocardial infarction) planned for urgent or early intervention.
Bivalirudin should be used in combination with aspirin and clopidogrel.
Dosage
Adults
Patients undergoing PCI including primary PCI
Intravenous bolus of 0.75mg/kg body weight followed immediately by an intravenous infusion at a rate of 1.75mg/kg/hour for at least the duration of the procedure.
If required continue the infusion for up to 4 hours post-PCI.
A reduced infusion dose of 0.25mg/kg/hour may be continued for an additional 4 to 12 hours as necessary.
Activated clotting time (ACT) can be used to assess bivalirudin activity. Five minutes after bivalirudin bolus average ACT values are 365 plus or minus 100 seconds. If the activated clotting time is less than 225 seconds, five minutes after the bolus injection, a second bolus dose of 0.3mg/kg should be administered.
Patients with Acute Coronary Syndrome (ACS) (unstable angina and non ST-segment elevation myocardial infarction) planned for urgent or early intervention
Intravenous bolus of 0.1mg/kg body weight followed by an infusion of 0.25mg/kg/hour.
Medically managed patients may continue the infusion of 0.25mg/kg/hour for up to 72 hours.
Patients who proceed to PCI should receive an additional bolus of 0.5mg/kg before the procedure, and increase the infusion to 1.75mg/kg/hour for the duration of the procedure.
Following PCI, reduce the infusion rate to 0.25mg/kg/hour for 4 to 12 hours as clinically necessary.
Patients who proceed to coronary artery bypass graft (CABG) surgery off pump, should receive the 0.25mg/kg/hour infusion until the time of surgery. Just before the surgery they should receive a 0.5mg/kg bolus followed by an infusion of 1.75mg/kg/hour for the duration of the surgery.
Patients who proceed to CABG surgery on pump should receive the 0.25mg/kg/hour bivalirudin infusion until 1 hour before the surgery, after which, the infusion should be discontinued and the patient managed with unfractionated heparin.
Patients with Renal Impairment
Mild to moderate renal impairment:
The ACS dose (0.1mg/kg bolus followed by 0.25mg/kg/hour infusion) should not be adjusted.
Moderate renal impairment (GFR 30 to 59ml/minute) undergoing PCI:
Lower the infusion rate to 1.4mg/kg/hour. The bolus dose should not be changed.
If after 5 minutes the ACT is less than 225 seconds, administer a second bolus dose of 0.3mg/kg. Re-check the ACT 5 minutes after the second bolus dose.
Additional Dosage Information
In STEMI patients undergoing primary PCI, standard pre-hospital adjunctive therapy should include clopidogrel and may include the early administration of unfractionated heparin.
Bivalirudin can be used in combination with a GPIIb/IIIa inhibitor.
Bivalirudin can be initiated 30 minutes after the discontinuation of intravenous unfractionated heparin, or 8 hours after the discontinuation of subcutaneous low molecular weight heparin.
Administration
For intravenous injection or infusion via an intravenous line administration.
Contraindications
Children under 18 years
Conditions where bleeding would be hazardous
Haemorrhage
Risk of haemorrhage
Coagulopathy
Impaired haemostasis
Renal dialysis
Renal impairment - glomerular filtration rate below 30ml/minute
Subacute infective endocarditis
Uncontrolled severe hypertension
Precautions and Warnings
Brachytherapy
Breastfeeding
Pregnancy
Renal impairment - glomerular filtration rate 30-60ml/minute
Treatment to be initiated and supervised by a specialist
Monitor activated clotting time (ACT) in percutaneous coronary intervention
Monitor blood pressure regularly
Monitor for bleeding during treatment
Monitor for myocardial ischaemia post primary PCI
Monitor haematocrit values
Monitor haemoglobin levels
Advise patient to report symptoms of allergic type hypersensitivity
Advise patients to report bleeding episodes
Antibodies to ingredient may develop
Management of cases of shock should follow current medical standards
Discontinue if haemorrhage occurs
Discontinue if unexplained fall in blood pressure or haematocrit occurs
Patients should remain in a facility capable of managing ischaemic complications, particularly acute stent thrombosis for at least 24 hours.
Pregnancy and Lactation
Pregnancy
Use bivalirudin with caution in pregnancy.
At the time of writing there is limited data from the use of bivalirudin in human pregnancy. It is unknown whether bivalirudin crosses the human placenta. Briggs (2015) suggests that as bivalirudin should be used with aspirin, use during the third trimester when aspirin may be toxic is inadvisable. There is also a potential risk of maternal bleeding and neonatal bleeding if treatment occurred within 1 week of delivery.
Animal studies have shown a low risk.
Bivalirudin should only be used if maternal benefit outweighs the foetal risk.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Lactation
Use bivalirudin with caution in breastfeeding.
At the time of writing there is limited data from the use of bivalirudin in breastfeeding. It is unknown whether bivalirudin is excreted in human milk. Briggs (2015) advises waiting a minimum of 3 hours after the discontinuation of treatment before breastfeeding.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Side Effects
Abnormal INR
Allergic reaction
Anaemia
Anal bleeding
Anaphylactic reaction
Anaphylactic shock
Angina pectoris
Back pain
Bradycardia
Cardiac tamponade
Chest pain
Compartment syndrome
Contusion
Coronary artery thrombosis
Coronary stent thrombosis
Decrease in haemoglobin
Dyspnoea
Ear haemorrhage
Ecchymosis
Epistaxis
Gastrointestinal bleeding
Gingival bleeding
Groin pain
Haematemesis
Haematoma
Haematoma (injection site)
Haematuria
Haemoptysis
Haemorrhage
Haemorrhage (injection site)
Headache
Hypersensitivity reactions
Hypotension
Intracranial bleeding
Local pain (injection site)
Melaena
Myocardial infarction
Nausea
Ocular haemorrhage
Oesophageal haemorrhage
Pericardial haemorrhage
Peritoneal haemorrhage
Pharyngeal haemorrhage
Pulmonary haemorrhage
Rash
Reperfusion injury
Retroperitoneal bleeding
Thrombocytopenia
Thrombosis
Urticaria
Vascular disorders
Vascular pseudoaneurysm
Ventricular tachycardia
Vomiting
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: February 2018
Reference Sources
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Summary of Product Characteristics: Angiox 250mg powder for concentrate for solution for injection or infusion. The Medicines Company UK Ltd. Revised October 2016.
Summary of Product Characteristics: Bivalirudin 250mg powder for concentrate for solution for injection or infusion. Accord Healthcare Ltd. Revised May 2016.
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