Overview
Dalteparin, a low molecular weight heparin (LMWH) prepared by nitrous acid degradation of unfractionated heparin of porcine intestinal mucosa origin, is an anticoagulant. It is composed of strongly acidic sulphated polysaccharide chains with an average molecular weight of 5000 and about 90% of the material within the range of 2000-9000. LMWHs have a more predictable response, a greater bioavailability, and a longer anti-Xa half life than unfractionated heparin. Dalteparin can also be safely used in most pregnant women. Low molecular weight heparins are less effective at inactivating factor IIa due to their shorter length compared to unfractionated heparin.
Indication
Dalteparin is used as a prophylaxis for deep-vein thrombosis and pulmonary embolisms in patients undergoing general surgery (e.g., abdominal, gynecologic, urologic), and in patients with acute medical conditions (e.g. cancer, bed rest, heart failure, severe lung disease). It is also used in patients who have severely restricted mobility, which poses a risk for thromboembolic complications. Dalteparin is also used concomitantly with aspirin and/or other therapy (e.g., nitrates, β-adrenergic blockers, clopidogrel, platelet glycoprotein [GP] IIb/IIIa-receptor inhibitors) to reduce the risk of acute cardiac ischemic events. The patients who undergo this treatment combination have unstable angina or non-ST-segment elevation/non-Q-wave myocardial infarction (i.e., non-ST-segment elevation acute coronary syndromes). It is also used in the prevention of clotting during hemodialysis and hemofiltration in connection with acute renal failure or chronic renal insufficiency.
Associated Conditions
- Cardiovascular Events
- Clotting
- Deep Vein Thrombosis
- Symptomatic Venous Thromboembolism
- Venous Thromboembolism
Research Report
Dalteparin Sodium (Fragmin®): A Comprehensive Pharmacological and Clinical Monograph
Introduction and Drug Identification
Overview of Dalteparin as a Low Molecular Weight Heparin (LMWH)
Dalteparin is a potent antithrombotic agent belonging to the class of low molecular weight heparins (LMWHs). It is a biological product derived from unfractionated heparin (UFH) of porcine intestinal mucosa origin through a controlled process of nitrous acid depolymerization.[1] This process yields a complex mixture of strongly acidic sulphated polysaccharide chains with an average molecular weight of approximately 5000 Daltons; about 90% of the material falls within the 2000 to 9000 Dalton range.[1] The resulting product, dalteparin sodium, functions as an anticoagulant, commonly referred to as a "blood thinner," and is clinically utilized for the prophylaxis and treatment of thromboembolic disorders, including deep vein thrombosis (DVT) and pulmonary embolism (PE).[3]
Marketed globally under the brand name Fragmin®, dalteparin holds a significant place in modern antithrombotic therapy.[3] Its development represented a substantial advancement over its parent compound, UFH. Dalteparin exhibits several key advantages, including a more predictable pharmacokinetic profile, superior bioavailability following subcutaneous administration, and a longer biological half-life. These properties permit reliable weight-based dosing, typically via self-administered subcutaneous injection, and reduce or eliminate the need for the intensive laboratory monitoring required for UFH therapy.[1] In recognition of its efficacy, safety, and critical role in healthcare, dalteparin is included on the World Health Organization's List of Essential Medicines.[3]
Key Identifiers and Chemical Properties
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/10/08 | Phase 3 | Not yet recruiting | |||
2024/04/17 | Phase 3 | Recruiting | |||
2023/12/01 | Phase 3 | Not yet recruiting | Western University, Canada | ||
2023/08/31 | Phase 4 | Recruiting | |||
2023/02/21 | Phase 4 | Recruiting | |||
2022/01/12 | Phase 2 | UNKNOWN | PharmaDiall Ltd. | ||
2021/12/28 | Phase 3 | Recruiting | |||
2021/10/05 | Phase 4 | UNKNOWN | |||
2021/04/20 | Phase 1 | Completed | |||
2020/07/23 | Phase 3 | Active, not recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Pfizer Laboratories Div Pfizer Inc | 0069-0220 | SUBCUTANEOUS | 12500 [iU] in 0.5 mL | 8/15/2022 | |
Pfizer Laboratories Div Pfizer Inc | 0069-0232 | SUBCUTANEOUS | 25000 [iU] in 1 mL | 8/15/2022 | |
Pfizer Laboratories Div Pfizer Inc | 0069-0253 | SUBCUTANEOUS | 2500 [iU] in 1 mL | 8/15/2022 | |
Pfizer Laboratories Div Pfizer Inc | 0069-0223 | SUBCUTANEOUS | 15000 [iU] in 0.6 mL | 8/15/2022 | |
Pfizer Laboratories Div Pfizer Inc | 0069-0228 | SUBCUTANEOUS | 18000 [iU] in 0.72 mL | 8/15/2022 | |
Pfizer Laboratories Div Pfizer Inc | 0069-0196 | SUBCUTANEOUS | 5000 [iU] in 0.2 mL | 8/15/2022 | |
Pfizer Laboratories Div Pfizer Inc | 0069-0195 | SUBCUTANEOUS | 2500 [iU] in 0.2 mL | 8/15/2022 | |
Pfizer Laboratories Div Pfizer Inc | 0069-0206 | SUBCUTANEOUS | 7500 [iU] in 0.3 mL | 8/15/2022 | |
Pfizer Laboratories Div Pfizer Inc | 0069-0217 | SUBCUTANEOUS | 10000 [iU] in 1 mL | 8/15/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
FRAGMIN INJECTION 2500 iu/ml | SIN05249P | INJECTION | 2500 iu/ml | 12/3/1990 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
FRAGMIN dalteparin sodium 5,000 Anti-Xa IU/0.2mL injection syringe | 25349 | Medicine | A | 10/21/1991 | |
FRAGMIN dalteparin sodium 12,500 anti-Xa IU/0.5mL injection syringe | 61939 | Medicine | A | 11/11/1997 | |
FRAGMIN dalteparin sodium 15,000 anti-Xa IU/0.6mL injection syringe | 61938 | Medicine | A | 11/11/1997 | |
FRAGMIN dalteparin sodium 7500 Anti-Xa IU/0.75mL injection syringe (graduated) | 66625 | Medicine | A | 11/23/1998 | |
FRAGMIN dalteparin sodium 2,500 Anti-Xa IU/0.2mL injection syringe | 25347 | Medicine | A | 10/21/1991 | |
FRAGMIN dalteparin sodium 10,000 Anti-XaIU/1mL injection syringe (graduated) | 66626 | Medicine | A | 11/23/1998 | |
FRAGMIN dalteparin sodium 18,000 anti-Xa IU/0.72mL injection syringe | 61937 | Medicine | A | 11/11/1997 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
FRAGMIN | 02494582 | Solution - Intravenous
,
Subcutaneous | 16500 UNIT / 0.66 ML | 6/8/2020 | |
FRAGMIN | 02352664 | Solution - Intravenous
,
Subcutaneous | 12500 UNIT / 0.5 ML | 2/1/2011 | |
FRAGMIN | 02132664 | Solution - Intravenous
,
Subcutaneous | 10000 UNIT / ML | 12/31/1995 | |
FRAGMIN | 02132648 | Solution - Subcutaneous
,
Intravenous | 5000 UNIT / 0.2 ML | 12/31/1995 | |
FRAGMIN | 02352672 | Solution - Subcutaneous
,
Intravenous | 15000 UNIT / 0.6 ML | 2/1/2011 | |
FRAGMIN | 02430789 | Solution - Intravenous
,
Subcutaneous | 3500 UNIT / 0.28 ML | 3/25/2015 | |
FRAGMIN | 02377454 | Solution - Subcutaneous
,
Intravenous | 2500 UNIT / ML | 7/25/2012 | |
FRAGMIN | 02132621 | Solution - Subcutaneous
,
Intravenous | 2500 UNIT / 0.2 ML | 12/31/1995 | |
FRAGMIN | 02352680 | Solution - Intravenous
,
Subcutaneous | 18000 UNIT / 0.72 ML | 2/1/2011 | |
FRAGMIN | 02231171 | Solution - Subcutaneous
,
Intravenous | 25000 UNIT / ML | 11/27/1997 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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