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.
Background
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
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 |
---|---|---|---|---|---|
Dalteparin Sodium Injection | 国药准字H20204000 | 化学药品 | 注射剂 | 10/23/2023 | |
Dalteparin Sodium Injection | 国药准字HJ20170037 | 化学药品 | 注射剂 | 7/1/2021 | |
Dalteparin Sodium Injection | 国药准字HJ20170043 | 化学药品 | 注射剂 | 7/1/2021 | |
Dalteparin Sodium Injection | 国药准字HJ20170042 | 化学药品 | 注射剂 | 7/1/2021 | |
Dalteparin Sodium Injection | 国药准字HJ20170040 | 化学药品 | 注射剂 | 7/1/2021 | |
Dalteparin Sodium Injection | 国药准字HJ20170044 | 化学药品 | 注射剂 | 7/1/2021 | |
Dalteparin Sodium Injection | 国药准字HJ20170041 | 化学药品 | 注射剂 | 7/1/2021 | |
Dalteparin Sodium Injection | 国药准字H20201000 | 化学药品 | 注射剂 | 5/26/2020 | |
Dalteparin Sodium Injection | 国药准字HJ20170045 | 化学药品 | 注射剂 | 7/1/2021 | |
Dalteparin Sodium Injection | 国药准字HJ20170038 | 化学药品 | 注射剂 | 7/1/2021 |
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 |