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Bemiparin | CAS No: 91449-79-5 | GMP-certified suppliers

A medication that prevents and treats venous thromboembolism, reducing blood clot risks after surgery, during hemodialysis, and in high-risk patients with deep vein thrombosis.

Therapeutic categories

Agents causing hyperkalemiaAnticoagulantsBlood and Blood Forming OrgansCarbohydratesGlycosaminoglycansHematologic Agents

Generic name

Bemiparin

Molecule type

small molecule

CAS number

91449-79-5

DrugBank ID

DB09258

Approval status

Approved drug, Investigational drug

ATC code

B01AB12

Primary indications

Bemiparin is indicated in the following cases: To prevent blood clots in the veins after general abdominal surgery in patients with a moderate risk of venous thromboembolism
In the prevention of the thromboembolic disease in non-surgical patients
Prevention of clotting in the extracorporeal circuit during hemodialysis
To prevent blood clots in the veins after a major orthopedic surgery in patients with high risk of venous thromboembolism

Product Snapshot

Bemiparin is a low molecular weight heparin formulated as an injectable solution for parenteral administration
It is primarily indicated for prevention and treatment of venous thromboembolism including postoperative clot prevention and hemodialysis circuit anticoagulation
Bemiparin is approved in key regulatory markets with both approved and investigational statuses

Clinical Overview

Bemiparin is a low molecular weight heparin (LMWH) classified as an ultra-LMWH due to its relatively low mean molecular mass of approximately 3600 daltons. It is utilized primarily for its antithrombotic properties in the prevention and treatment of venous thromboembolism (VTE). Clinical indications include prophylaxis of venous thrombosis following general abdominal surgery in patients at moderate risk, prevention of thromboembolic events in non-surgical patients, clot prevention during extracorporeal circulation in hemodialysis, prophylaxis after major orthopedic surgeries in high-risk patients, and secondary prevention as well as treatment of deep vein thrombosis (DVT).

Pharmacologically, bemiparin exerts its effect primarily through selective inhibition of coagulation factor Xa. By targeting factor Xa, it disrupts the conversion of prothrombin to thrombin, a critical amplification step in the coagulation cascade responsible for thrombus propagation. This selectivity results in a favorable safety profile with a reduced risk of bleeding when compared to heparins with higher antithrombin activity. Additionally, bemiparin exhibits a secondary mechanism involving binding to antithrombin III and factor IIa (thrombin), albeit with a lower anti-IIa activity relative to its potent anti-Xa effect. This is reflected in an anti-Xa to anti-IIa activity ratio of approximately 8:1.

Bemiparin’s pharmacokinetic profile includes a notable half-life of approximately 5.3 hours, allowing for sustained anticoagulant activity. Its second-generation classification is supported by its pharmacodynamic advantages, including long half-life and low molecular weight, facilitating use across various patient populations including pediatric, elderly, and those with renal impairment or congestive heart failure.

Safety considerations center on the typical risks associated with anticoagulants such as bleeding events. However, bemiparin demonstrates no significant prolongation of global clotting tests at therapeutic dosing. Ongoing research is exploring potential additional indications, including oncology and diabetic ulcer management.

In API sourcing and quality control, ensuring the molecular weight distribution and potency reflective of ultra-LMWH standards is critical. Suppliers should comply with pharmacopeial standards and maintain stringent quality assurance to uphold consistency in anti-Xa activity and impurity profiles to support clinical safety and efficacy.

Identification & chemistry

Generic name	Bemiparin
Molecule type	Small molecule
CAS	91449-79-5
UNII	PUE0TO3XDR
DrugBank ID	DB09258

Pharmacology

Summary	Bemiparin is a second-generation low molecular weight heparin that exerts anticoagulant effects primarily through selective inhibition of coagulation factor Xa, reducing thrombin generation and thrombus propagation. It also moderately inhibits factor IIa (thrombin) via binding to antithrombin III. Its pharmacodynamic profile is characterized by a high anti-Xa to anti-IIa activity ratio and prolonged half-life, supporting its use in preventing and treating venous thromboembolic events.
Mechanism of action	This drug is a second-generation low molecular weight heparin (LMWH). It has a very low mean molecular weight (3600 Dalton), a long half-life (5.3 hrs) and a large anti-Xa: anti-IIa ratio (8:1). The mechanism of action of bemiparin is inhibition of factor Xa, which is a necessary step in the clotting cascade. Factor-Xa is necessary for the propagation of a thrombus. Combined with various co-factors that bind to activated platelets, Factor-Xa increases coagulation by converting prothrombin to thrombin . Activated Factor-X, bound as part of the prothrombinase complex on the external surface of activated platelets, converts significant amounts of prothrombin to thrombin, promoting the so-called ‘thrombin burst’, referring to a burst of thrombin release . A secondary but less potent mechanism of action of this drug is binding to antithrombin III and activated factor II (Factor IIa), which further prevents the propagation of thrombi . Due to its excellent pharmacological profile-the second-generation LMWH with the lowest molecular weight, the longest half-life and the highest anti-Factor Xa/anti-Factor IIa activity ratio-it can be safely used in special categories of patients (children, elderly, patients with renal impairment and congestive heart failure). Several studies demonstrated its safety and efficacy, while cost analyses show the economic benefits of bemiparin treatment as compared to other heparins [A7866, A7867].
Pharmacodynamics	Bemiparin is an anticoagulant classified under the broad category of low molecular weight heparins. In humans, bemiparin has been proven to possess antithrombotic activity and, at therapeutic doses, does not significantly prolong global clotting laboratory tests .

Targets

Target	Organism	Actions
Coagulation factor X	Humans	antagonist
Antithrombin-III	Humans	antagonist
Heparin cofactor 2	Humans	antagonist

ADME / PK

Absorption	Hemiparin sodium is rapidly absorbed following its subcutaneous dose of injection, and the bioavailability is estimated to be 96% .
Half-life	Bemiparin, when administered in the dose range of 2,500 IU to 12,500 (therapeutic dosing), it has an approximate half-life of 5-6 hours .
Protein binding	There are currently no data available with regards to plasma protein binding, metabolism and excretion of bemiparin in humans .
Metabolism	In a study of healthy volunteers, bemiparin 3500 IU achieved more anti-Xa activity than enoxaparin 4000 IU, measured by the area under the curve. The peak of anti-Xa activity was reached at 3h post-administration, and there were anti-Xa measurable levels up to 16 h after subcutaneous injection .
Route of elimination	This drug is eliminated by the renal and hepatic routes. Elimination is prolonged in those with renal or hepatic impairment .
Volume of distribution	5.1 L .
Clearance	Elimination occurs in a linear fashion, with a mean clearance time of over 7 h and total clearance of 0.9 L/h .

Formulation & handling

Bemiparin is formulated as injectable solutions for intravenous, parenteral, and subcutaneous administration.
Handle with caution to avoid exposure to anticoagulant or antiplatelet herbs and supplements due to interaction risk.
As a small molecule anticoagulant, Bemiparin requires proper aseptic technique and storage conditions to maintain stability.

Regulatory status

Safety

Toxicity	Bemiparin, like other drugs in its class, may suppress adrenal secretion of aldosterone, leading to elevated potassium (hyperkalemia). This may occur more frequently in patients with conditions such as diabetes mellitus, chronic renal failure, metabolic acidosis, an increased plasma potassium, and those ingesting potassium sparing drugs. There is a linear relationship between duration of therapy and adverse effects, but this is usually reversible with cessation of treatment. Serum electrolytes should be measured in at-risk patients before starting bemiparin, and these patients should be monitored regularly thereafter particularly if treatment is prolonged beyond 1 week. In rare cases, mild transient thrombocytopenia (HIT type I) at the beginning of therapy with heparin with platelet counts between 100,000/mm3 and 150,000/mm3 due to temporary platelet activation has been noted in clinical studies. On rare occasions, antibody-mediated severe thrombocytopenia (HIT type II) with platelet counts clearly below 100,000/mm3 has been observed (see section 4.8). This effect usually occurs within 5-21 days after the initiation of treatment, although in patients with a history of heparin-induced thrombocytopenia this may occur more rapidly. Platelet count studies are recommended before the administration of bemiparin, on the first day of therapy and then every 3-4 days, in addition to repeating platelet studies at the end of therapy. Treatment must be discontinued immediately and an alternate therapy initiated if significant reductions in platelet counts are observed ( 30% decrease and above) . As with other heparin products, cases of cutaneous necrosis, often preceded by purpura or painful erythematous, ecchymose-like lesions have been reported with bemiparin. In these cases, treatment should cease immediately . Overdosage after subcutaneous or other routes of administration of bemiparin may lead to hemorrhagic complications. Neutralization can be obtained by slow intravenous of a suitable dose of the antidote protamine sulphate .

Toxicity

Bemiparin, like other drugs in its class, may suppress adrenal secretion of aldosterone, leading to elevated potassium (hyperkalemia). This may occur more frequently in patients with conditions such as diabetes mellitus, chronic renal failure, metabolic acidosis, an increased plasma potassium, and those ingesting potassium sparing drugs. There is a linear relationship between duration of therapy and adverse effects, but this is usually reversible with cessation of treatment. Serum electrolytes should be measured in at-risk patients before starting bemiparin, and these patients should be monitored regularly thereafter particularly if treatment is prolonged beyond 1 week. In rare cases, mild transient thrombocytopenia (HIT type I) at the beginning of therapy with heparin with platelet counts between 100,000/mm3 and 150,000/mm3 due to temporary platelet activation has been noted in clinical studies. On rare occasions, antibody-mediated severe thrombocytopenia (HIT type II) with platelet counts clearly below 100,000/mm3 has been observed (see section 4.8). This effect usually occurs within 5-21 days after the initiation of treatment, although in patients with a history of heparin-induced thrombocytopenia this may occur more rapidly. Platelet count studies are recommended before the administration of bemiparin, on the first day of therapy and then every 3-4 days, in addition to repeating platelet studies at the end of therapy. Treatment must be discontinued immediately and an alternate therapy initiated if significant reductions in platelet counts are observed ( 30% decrease and above) . As with other heparin products, cases of cutaneous necrosis, often preceded by purpura or painful erythematous, ecchymose-like lesions have been reported with bemiparin. In these cases, treatment should cease immediately . Overdosage after subcutaneous or other routes of administration of bemiparin may lead to hemorrhagic complications. Neutralization can be obtained by slow intravenous of a suitable dose of the antidote protamine sulphate .

High Level Warnings:

Monitor serum electrolytes for hyperkalemia risk, especially in patients with renal impairment or on potassium-sparing medications
Risk increases with treatment duration
Perform baseline and periodic platelet counts throughout therapy to detect heparin-induced thrombocytopenia