Bemiparin sodium

Hemodialysis
Prophylaxis of clotting in the extracorporeal circulation during haemodialysis

Subcutaneous
Prophylaxis of venous thromboembolism during surgical procedures

Subcutaneous
Deep vein thrombosis

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.

Severe: Contraindicated.

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.

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.

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).

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.

Symptoms: Bleeding. Management: Discontinue treatment depending on severity of haemorrhage and risk of thrombosis. Administration of protamine sulfate may be necessary for major haemorrhages.

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.

Description:
Mechanism of Action: 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.

Store below 30°C. Do not freeze.

Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)

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.