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Fragmin (Dalteparin Sodium)
Dalteparin enhances inhibition of Factor Xa and thrombin by antithrombin.
Dalteparin is a low molecular weight heparin indicated for prophylaxis of ischemic complications in unstable angina/non-Q-wave MI, DVT prophylaxis in surgical and medical patients, and extended VTE treatment in adult cancer patients and pediatric patients. The drug selectively inhibits Factor Xa while minimally affecting APTT, with rapid subcutaneous absorption and peak anti-Xa activity at approximately 4 hours. Major contraindications include active bleeding, HIT history, and concurrent epidural/neuraxial anesthesia; concurrent use with anticoagulants, antiplatelet agents, or thrombolytics increases bleeding risk. Dalteparin demonstrates favorable pharmacokinetics with 87% bioavailability and is not indicated for acute VTE treatment.
At a glance
| Generic name | Dalteparin Sodium |
|---|---|
| Sponsor | Pfizer Inc. |
| Drug class | Low molecular weight heparin (LMWH) |
| Target | Factor Xa and thrombin |
| Modality | Oligosaccharide |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
Dalteparin is a low molecular weight heparin with antithrombotic properties that acts by enhancing the inhibition of Factor Xa and thrombin by antithrombin. The drug potentiates preferentially the inhibition of coagulation Factor Xa, while only slightly affecting the activated partial thromboplastin time (APTT). This selective mechanism of action distinguishes dalteparin from unfractionated heparin.
Approved indications
- Prophylaxis of Ischemic Complications in Unstable Angina and Non-Q-Wave MI
- Prophylaxis of DVT in Abdominal Surgery
- Prophylaxis of DVT in Hip Replacement Surgery
- Prophylaxis of DVT in Medical Patients with Restricted Mobility
- Extended Treatment of Symptomatic VTE in Adult Patients with Cancer
- Treatment of Symptomatic VTE in Pediatric Patients
Boxed warnings
- WARNING: SPINAL/EPIDURAL HEMATOMAS Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: • Use of indwelling epidural catheters • Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants. • A history of traumatic or repeated epidural or spinal punctures • A history of spinal deformity or spinal surgery • Optimal timing between the administration of FRAGMIN and neuraxial procedures is not known Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis [see Warnings and Precautions (5.1) and Drug Interactions (7) ] . WARNING: SPINAL/EPIDURAL HEMATOMAS See full prescribing information for complete boxed warning. Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: • Use of indwelling epidural catheters • Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants. • A history of traumatic or repeated epidural or spinal punctures • A history of spinal deformity or spinal surgery • Optimal timing between the administration of FRAGMIN and neuraxial procedures is not known Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis ( 5.1 , 7 ).
Common side effects
- Epistaxis
- Deep vein thrombosis
- Anaemia
- Dyspnoea
Drug interactions
- Oral anticoagulants
- Platelet inhibitors
- Thrombolytic agents
Key clinical trials
- Effect of Anticoagulant Therapy on Endometrial Receptivity and Pregnancy Outcomes in Infertility
- Short-term Low-dose Low-molecular-weight Heparin to Prevent Postpartum Thrombosis (PHASE3)
- AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia (PHASE3)
- Dimolegin® (60 mg) Given Once Daily in Patients Undergoing Total Hip or Knee Replacement Compared to Enoxaparin (PHASE3)
- Two Different Regimens of Bemiparin as a Thromboprophylaxis in Morbidly Obese Surgical Patients (NA)
- Thromboprophylaxis in Lower Limb Immobilisation (PHASE3)
- Reduced-Dose Apixaban and Rivaroxaban Versus Low-Molecular-Weight Heparin in Patients With Hematologic Malignancies (NA)
- A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |