Bemiparin sodium


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : SC Prophylaxis of venous thromboembolism during surgical procedures General surgery in moderate-risk patient: On the day of procedure, 2,500 IU anti-Xa given 2 hours before or 6 hours after surgery. On subsequent days, 2,500 IU anti-Xa given 24 hourly. Orthopaedic surgery in high-risk patient: On the day of procedure, 3,500 IU anti-Xa given 2 hours before or 6 hours after surgery. On subsequent days, 3,500 IU anti-Xa given 24 hourly. Continue prophylactic treatment for at least 7-10 days after the procedure and until the risk of thromboembolism is decreased or until the patient is fully ambulant. DVT 115 IU anti-Xa/kg once daily for 5-9 days. Refer to the detailed product guideline for further dosing instructions depending on the patient’s body weight. Haemodialysis Prophylaxis of clotting in the extracorporeal circulation during haemodialysis For patients undergoing repeated haemodialysis sessions of <4 hours and with no bleeding risk: <60 kg: 2,500 IU; >60 kg: 3,500 IU. Dose is to be given into the arterial side of the dialyser at the start of dialysis session, in a single dose.
Dosage Details
Hemodialysis
Prophylaxis of clotting in the extracorporeal circulation during haemodialysis
Adult: For patients undergoing repeated haemodialysis sessions of <4 hours and with no bleeding risk: <60 kg: 2,500 IU; >60 kg: 3,500 IU. Dose is to be given into the arterial side of the dialyser at the start of dialysis session, in a single dose.

Subcutaneous
Prophylaxis of venous thromboembolism during surgical procedures
Adult: General surgery in moderate-risk patient: On the day of procedure, 2,500 IU anti-Xa given 2 hours before or 6 hours after surgery. On subsequent days, 2,500 IU anti-Xa given 24 hourly. Orthopaedic surgery in high-risk patient: On the day of procedure, 3,500 IU anti-Xa given 2 hours before or 6 hours after surgery. On subsequent days, 3,500 IU anti-Xa given 24 hourly. Continue prophylactic treatment for at least 7-10 days after the procedure and until the risk of thromboembolism is decreased or until the patient is fully ambulant.

Subcutaneous
Deep vein thrombosis
Adult: Treatment of acute established DVT with or without pulmonary embolism: 115 IU anti-Xa/kg once daily for 5-9 days. Refer to the detailed product guideline for further dosing instructions depending on the patient’s body weight.
Renal Impairment
Prophylaxis of venous thromboembolism during surgical procedures:
CrCl (mL/min) Dosage
<30 General surgery in moderate-risk patient: Close monitoring is recommended; Orthopaedic surgery in high-risk patient: Dose adjustment may be necessary with close monitoring.

Deep vein thrombosis:
CrCl (mL/min) Dosage
<30 Dose adjustment may be necessary with close monitoring.
Hepatic Impairment
Severe: Contraindicated.
Contraindications
Hypersensitivity to bemiparin sodium, heparin, and substances of porcine origin. History of confirmed or suspected immunologically mediated heparin induced thrombocytopenia (HIT), active haemorrhage or increased risk of bleeding due to impaired haemostasis, severe pancreatic impairment, injuries to or operations on CNS, eyes, and ears (within the last 2 months); disseminated intravascular coagulation (DIC) associated with HIT, acute bacterial and slow endocarditis, organic lesions susceptible of bleeding (e.g. haemorrhagic stroke, active peptic ulcer, cerebral aneurysm or neoplasms). Severe hepatic impairment.
Special Precautions
Patient with uncontrolled arterial hypertension, history of gastro-duodenal ulcer disease, thrombocytopenia, nephrolithiasis or urethrolithiasis, choroid and retinal vascular disease; diabetes mellitus. Patient undergoing spinal or epidural anaesthesia and/or lumbar puncture. LMWHs are different and not necessarily equivalent; comply with the dosage regimen and specific method of use for each product. Hepatic and mild to moderate (CrCl 30-80 mL/min) renal impairment. Pregnancy and lactation.
Adverse Reactions
Significant: Severe bleeding, hyperkalaemia (reversible), cutaneous necrosis, mild and transient thrombocytopenia (type I). Rarely, antibody-mediated severe thrombocytopenia (type II).
Blood and lymphatic system disorders: Bleeding complications (e.g. skin, mucous membranes, wounds, gastrointestinal and urogenital tracts).
General disorders and administration site conditions: Ecchymosis, haematoma, and pain at inj site.
Hepatobiliary disorders: Mild and transient increase of AST, ALT, and gamma-glutamyl transferase levels.
Immune system disorders: Cutaneous allergic reactions (e.g. urticaria, pruritus). Rarely, anaphylactic reactions (e.g. fever, nausea, vomiting, dyspnoea, bronchospasm, glottis oedema, hypotension).
Musculoskeletal and connective tissue disorders: Osteoporosis (long-term use).
Potentially Fatal: For patient undergoing epidural/spinal anaesthesia or lumbar puncture: Rarely, epidural and spinal haematoma leading to neurological impairment (e.g. prolonged or permanent paralysis).
MonitoringParameters
Monitor serum electrolytes prior to therapy (in patient at risk of hyperkalaemia) and regularly thereafter in prolonged treatment; platelet counts prior to treatment, on the 1st day then regularly for 3-4 days, and at the end of therapy. Monitor for signs and symptoms of neurological impairment (e.g. back pain, numbness and weakness in lower limbs) and bowel or bladder dysfunction.
Overdosage
Symptoms: Bleeding. Management: Discontinue treatment depending on severity of haemorrhage and risk of thrombosis. Administration of protamine sulfate may be necessary for major haemorrhages.
Drug Interactions
Increased effects and risk of bleeding with vitamin K antagonists, other anticoagulants, aspirin, NSAIDs, ticlopidine, clopidogrel, other platelet inhibitors, systemic glucocorticoids, and dextran. May decrease the anticoagulant effect with glyceryl trinitrate. May increase the risk of hyperkalaemia with K-sparing diuretics.
Action
Description: Bemiparin sodium is a LMWH obtained by depolymerisation of heparin Na from porcine intestinal mucosa. Its anti-Xa activity ranges between 80-120 anti-Xa IU/mg and the anti-IIa activity ranges between 5-20 anti-IIa IU/mg. The anti-Xa/anti-IIa ratio is approx 8. Its high anti-Xa/IIa ratio may result to greater antithrombotic effect without increasing the bleeding risk.
Pharmacokinetics:
Absorption: Rapidly absorbed following SC inj. Bioavailability: Approx 96%. Time to peak plasma concentration: 2-4 hours.
Excretion: Elimination half-life: 5-6 hours.
Storage
Store below 30°C. Do not freeze.
ATC Classification
B01AB12 - bemiparin ; Belongs to the class of heparin group. Used in the treatment of thrombosis.
References
Chapman TM and Goa KL. Bemiparin: A Review of Its Use in the Prevention of Venous Thromboembolism and Treatment of Deep Vein Thrombosis. Drugs. 2003;63(21):2357-2377. doi: 10.2165/00003495-200363210-00009. Accessed 19/06/2020

Buckingham R (ed). Bemiparin Sodium. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/06/2020.

Hibor Pre-filled Syringes (Stada [Thailand] Co., Ltd). MIMS Thailand. http://www.mims.com/thailand. Accessed 05/06/2020.

Zibor 2,500 IU Anti-Xa/0.2 mL Solution for Injection in Pre-filled Syringes (Frosst Ibérica S.A.). MHRA. https://products.mhra.gov.uk/. Accessed 19/06/2020.

Zibor 25,000 IU Anti-Xa/mL Solution for Injection in Pre-filled Syringes (Frosst Ibérica S.A.). MHRA. https://products.mhra.gov.uk/. Accessed 05/06/2020.

Zibor 3,500 IU Anti-Xa/0.2 mL Solution for Injection in Pre-filled Syringes (Frosst Ibérica S.A.). MHRA. https://products.mhra.gov.uk/. Accessed 19/06/2020.

Disclaimer: This information is independently developed by MIMS based on Bemiparin sodium from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in