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)].
FRAGMIN Injection (dalteparin sodium injection) is a sterile, low molecular weight heparin.
Prophylaxis of Ischemic Complications in Unstable Angina and Non-Q-Wave Myocardial Infarction
FRAGMIN® Injection is indicated for the prophylaxis of ischemic complications in unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin therapy [see Clinical Studies (14.1) ].
Prophylaxis of Deep Vein Thrombosis
FRAGMIN is also indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE):
Extended Treatment of Symptomatic Venous Thromboembolism in Patients with Cancer
- In patients undergoing hip replacement surgery [see Clinical Studies (14.2) ];
- In patients undergoing abdominal surgery who are at risk for thromboembolic complications [see Clinical Studies (14.3) ];
- In medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness [see Clinical Studies (14.4) ].
FRAGMIN is also indicated for the extended treatment of symptomatic venous thromboembolism (VTE) (proximal DVT and/or PE), to reduce the recurrence of VTE in patients with cancer. In these patients, the FRAGMIN therapy begins with the initial VTE treatment and continues for six months [see Clinical Studies (14.5) ].
Limitations of Use
FRAGMIN is not indicated for the acute treatment of VTE.
Published Studies Related to Fragmin (Dalteparin)
PRODIGE: a randomized placebo-controlled trial of dalteparin low-molecular-weight heparin thromboprophylaxis in patients with newly diagnosed malignant glioma. [2010.09]
BACKGROUND AND OBJECTIVES: Venous thromboembolism (VTE) occurs in 20-30% of patients with malignant glioma per year of survival. We tested the efficacy of long-term dalteparin low-molecular-weight heparin (LMWH) for prevention of VTE in these patients... CONCLUSIONS: Trends suggesting reduced VTE and increased intracranial bleeding were seen in the LMWH thromboprophylaxis group. The role of long-term anticoagulant thromboprophylaxis in patients with brain tumors remains uncertain. (c) 2010 International Society on Thrombosis and Haemostasis.
Weight-adjusted dalteparin for prevention of vascular thromboembolism in advanced pancreatic cancer patients decreases serum tissue factor and serum-mediated induction of cancer cell invasion. [2010.07]
The aim of the present study was to assess the role of tissue factor and serum-induced cell invasion in patients with advanced pancreatic cancer (APC). A cohort of 39 patients with APC, without thrombosis, receiving chemotherapy, were entered in a randomized controlled trial (ISRCTN = 76464767) of thromboprevention with weight-adjusted dalteparin (WAD)...
PRODIGE: a randomized placebo-controlled trial of dalteparin low molecular weight heparin (LMWH) thromboprophylaxis in patients with newly diagnosed malignant glioma. [2010.06.28]
Summary Background and Objectives: Venous thromboembolism (VTE) occurs in 20-30% of patients with malignant glioma per year of survival. We tested the efficacy of long-term dalteparin low molecular weight heparin (LMWH) for prevention of VTE in these patients.The role of long-term anticoagulant thromboprophylaxis in patients with brain tumors remains uncertain.
Early and short-term acenocumarine or dalteparin for the prevention of central vein catheter-related thrombosis in cancer patients: a randomized controlled study based on serial venographies. [2009.12]
BACKGROUND: We evaluated efficacy and safety of early and short-term prophylaxis with acenocumarine or dalteparin in the prevention of non-occlusive or occlusive central vein catheter-related thrombosis (CVCrT)... CONCLUSIONS: In this study of early and short-term prophylaxis, acenocumarine was more effective than dalteparin on non-occlusive and asymptomatic CVCrT events. The first days following CVC insertion represent the highest risk for CVCrT.
Dalteparin for the prevention of recurrence of placental-mediated complications of pregnancy in women without thrombophilia: a pilot randomized controlled trial. [2009.01]
BACKGROUND: The role of anticoagulants for the prevention of placental-mediated pregnancy complications is uncertain. OBJECTIVES: Our aim was to investigate the effectiveness of dalteparin, a low-molecular-weight heparin, in preventing the recurrence of these complications in women without thrombophilia... CONCLUSION: In this pilot study, dalteparin is effective in decreasing the recurrence of placental-mediated complications in women without thrombophilia. Our results require confirmation in further randomized trials.
Clinical Trials Related to Fragmin (Dalteparin)
Efficacy of Low Molecular Weight Heparin in Superficial Vein Thrombosis [Active, not recruiting]
The aim of the study is to establish whether treatment of ST with low-molecular-weight
heparin in preventive or therapeutic doses prevents disease progression and thromboembolic
events (deep vein thrombosis and pulmonary embolism), whether efficacy of
low-molecular-weight heparin differs with regard to the dosage used (prevention, treatment),
and to recognize groups of patients in which treatment with heparin is most efficient, as
well as to determine factors that influence the efficacy of ST treatment with heparin.
Comparison of Low and Intermediate Dose Low-molecular-weight Heparin to Prevent Recurrent Venous Thromboembolism in Pregnancy [Recruiting]
This is a randomized-controlled open-label trial comparing two different doses of
low-molecular-weight heparin (LMWH) in pregnant patients with a history of previous venous
thromboembolism (VTE). Both doses are recommended doses in the 2012 guidelines of the
American College of Chest Physicians (ACCP), but it is not known which dose is more
efficacious in preventing recurrent venous thromboembolism in pregnancy.
Patients enter the study and will be randomized as soon as a home test confirms pregnancy.
LMWH will be administered until 6 weeks postpartum. Follow-up will continue until 3 months
postpartum. Patients will be recruited by their treating physician, either an obstetrician
Fragmin In The Treatment Of Acute Deep-Vein Thrombosis With Or Without Pulmonary Embolism In Cancer Patients [Completed]
To collect postmarketing data about Fragmin safety and efficacy in the treatment of deep
vein thrombosis with or without pulmonary embolism in cancer patients.
Dalteparin to Prevent Complications in Cancer Patients Receiving Chemotherapy Through a Catheter [Completed]
RATIONALE: The use of dalteparin may be able to prevent complications caused by the use of a
catheter to supply chemotherapy to cancer patients. It is not yet known if dalteparin is
effective in reducing these complications.
PURPOSE: Randomized phase III trial to determine the effectiveness of dalteparin in
preventing catheter-related complications in cancer patients who are receiving chemotherapy
through a catheter.
Dalteparin and Sunitinib Malate as First-Line Therapy in Treating Patients With Metastatic or Unresectable Kidney Cancer [Active, not recruiting]
This phase I trial is studying the side effects and best dose of dalteparin when given
together with sunitinib malate in treating patients with metastatic or unresectable kidney
cancer. Anticoagulants, such as dalteparin, help prevent blood clots and have been shown to
increase survival in patients with cancer. Anticoagulants may also prevent the formation of
new blood vessels. Sunitinib malate may stop the growth of tumor cells by blocking some of
the enzymes needed for cell growth and by inhibiting new blood vessels and blocking blood
flow to the tumor. Giving dalteparin together with sunitinib malate may starve tumors and
kill more tumor cells
Reports of Suspected Fragmin (Dalteparin) Side Effects
Pulmonary Embolism (15),
Liver Injury (9),
Cerebral Infarction (9),
Vascular Occlusion (8),
Drug Interaction (7),
Cerebral Haemorrhage (7),
Neoplasm Malignant (6), more >>
Page last updated: 2011-12-09