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Bemiparin sodium parenteral

Updated 2 Feb 2023 | Parenteral anticoagulants

Presentation

Parenteral formulations containing bemiparin sodium.

Drugs List

  • bemiparin sodium 2500unit/0.2ml solution for injection pre-filled syringe
  • bemiparin sodium 3500unit/0.2ml solution for injection pre-filled syringe
  • ZIBOR 2500unit/0.2ml solution for injection pre-filled syringe
  • ZIBOR 3500unit/0.2ml solution for injection pre-filled syringe
  • Therapeutic Indications

    Uses

    Haemodialysis - prevention of clotting in extracorporeal circulation
    Venous thromboembolism in surgical patients: prophylaxis

    Dosage

    Adults

    General surgery with moderate risk of venous thromboembolism
    Day of surgical procedure
    2500units to be administered 2 hours before or 6 hours after surgery.

    Subsequent days after surgery
    2500units to be administered every 24 hours.

    Orthopaedic surgery with high risk of venous thromboembolism
    Day of surgical procedure
    3500units to be administered 2 hours before or 6 hours after surgery.

    Subsequent days after surgery
    3500units to be administered every 24 hours.

    Maintain prophylactic treatment for at least 7 to 10 days after the surgical procedure and until the risk of thromboembolic disease has decreased.

    Prevention of clotting in the extracorporeal circuit during haemodialysis
    Patients undergoing repeated haemodialysis of no longer than 4 hours in duration and with no risk of bleeding
    Patient weight over 60kg
    3500units as a single dose in the form of bolus into the arterial line at the beginning of the dialysis session.

    Patient weight below 60kg
    2500units as a single dose in the form of bolus into the arterial line at the beginning of the dialysis session.

    Patients with Renal Impairment

    Prevention of thromboembolic disease in patients undergoing general surgery
    Severe renal insufficiency (creatinine clearance less than 30ml/minute)
    No dose reduction required but consider measuring peak anti-Xa levels at 4 hours post dose.

    Prevention of thromboembolic disease in patients undergoing orthopaedic surgery
    Severe renal insufficiency (creatinine clearance less than 30ml/minute)
    A dose reduction up to 2500units once daily may be necessary. Consider measuring peak anti-Xa levels at 4 hours post dose.

    Administration

    For subcutaneous injection in patients undergoing surgery.

    For intra-arterial injection to prevent clotting in the extracorporeal circuit during haemodialysis.

    Contraindications

    Children under 18 years
    Haemorrhage
    Risk of haemorrhage
    Within 2 months of neurosurgery
    Acute bacterial endocarditis
    Breastfeeding
    Central nervous system trauma
    Disseminated intravascular coagulation
    Ear surgery
    Ear Trauma
    History of heparin-induced thrombocytopenia
    Ocular trauma
    Recent ocular surgery
    Severe hepatic impairment
    Severe pancreatic insufficiency

    Precautions and Warnings

    Lumbar puncture
    Spinal/epidural anaesthesia
    Calculus of lower urinary tract
    Chronic renal failure
    Diabetes mellitus
    Hepatic impairment
    History of peptic ulcer
    Hyperkalaemia
    Metabolic acidosis
    Nephrolithiasis
    Pregnancy
    Renal impairment - creatinine clearance 30-80ml/minute
    Thrombocytopenia
    Uncontrolled hypertension
    Vascular disorder

    Consider reducing dose if creatinine clearance is < or equal to 30ml/min
    Avoid switching to an alternative low molecular weight heparin
    Different low molecular weight heparins may not be equivalent
    Do not mix with other drugs or substances
    Do not use if any signs of precipitate or particulate matter apparent
    Monitor platelets before starting and during treatment
    Monitor serum electrolytes before and during treatment
    Monitor closely patient with pre-existing renal impairment
    Monitor neurological function in patients under anaesthesia
    Monitor plasma potassium in patients at risk of hyperkalaemia
    Monitor renal function in patients with renal impairment
    Adrenal suppression may occur leading to hyperkalaemia
    Discontinue if platelet count is significantly reduced
    Increased risk of hyperkalaemia with K+ suppl. and K+ sparing diuretic
    Spinal anaesthesia: tell patient-report symptoms of neurological impairment
    Discontinue if skin necrosis at injection site occurs
    Advise patient not to take NSAIDs unless advised by clinician
    Instruct patient not to rub or scratch test site

    Assess individual's bleeding and thrombotic risks prior to initiating bemiparin sodium.

    Treatment with bemiparin sodium can suppress adrenal secretion of aldosterone. This may lead to hyperkalaemia, especially in patients with diabetes mellitus, chronic renal failure, pre-existing metabolic acidosis, a raised plasma potassium or those taking potassium sparing drugs.

    Monitor platelet counts prior to treatment with bemiparin sodium, on the first day of therapy and then regularly 3 to 4 days and at the end of therapy.

    There is an increased risk of epidural or spinal haematoma, resulting in prolonged or permanent paralysis, by the use of an epidural or spinal catheter for anaesthesia, by concomitant use of drugs affecting haemostasis such as nonsteroidal anti-inflammatory drugs (NSAIDS), platelet inhibitors or anticoagulants, and by traumatic or repeated puncture.

    Pregnancy and Lactation

    Pregnancy

    Use bemiparin sodium with caution during pregnancy.

    The manufacturer advises caution if bemiparin sodium is used during pregnancy. At the time of writing there is limited published information regarding the use of bemiparin sodium during pregnancy. Potential risks are unknown.

    Lactation

    Bemiparin sodium is contraindicated during breastfeeding.

    The manufacturer does not recommend breastfeeding whilst taking bemiparin sodium. The presence of bemiparin sodium in human breast milk and its effect on exposed infants are unknown.

    Side Effects

    Anaemia
    Gastrointestinal bleeding
    Haematoma
    Haemorrhage
    Skin and mucosal bleeding
    Thrombocytopenia
    Thrombocytopenia (transient)
    Urogenital haemorrhage
    Wound complication

    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: June 2021

    Reference Sources

    Summary of Product Characteristics: Zibor 2,500IU anti Xa/0.2ml solution for injection in pre-filled syringes. ROVI Biotech Ltd. Revised May 2021.
    Summary of Product Characteristics: Zibor 3,500IU anti Xa/0.2ml solution for injection in pre-filled syringes. ROVI Biotech Ltd. Revised May 2021.

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 06 December 2022

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