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
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, Hemorrhage, and PRECAUTIONS, Drug Interactions).
INNOHEP┬« is a sterile solution, containing tinzaparin sodium, a low molecular weight heparin.
INNOHEP┬« is indicated for the treatment of acute symptomatic deep vein thrombosis with or without pulmonary embolism when administered in conjunction with warfarin sodium. The safety and effectiveness of INNOHEP┬« were established in hospitalized patients.
Media Articles Related to Innohep (Tinzaparin)
Deep Vein Thrombosis (DVT, Blood Clot in the Legs)
Source: MedicineNet Antiphospholipid Syndrome Specialty [2016.09.16]
Title: Deep Vein Thrombosis (DVT, Blood Clot in the Legs)
Category: Diseases and Conditions
Created: 2/15/2000 12:00:00 AM
Last Editorial Review: 9/16/2016 12:00:00 AM
Published Studies Related to Innohep (Tinzaparin)
Safety profile of tinzaparin versus subcutaneous unfractionated heparin in elderly patients with impaired renal function treated for acute deep vein thrombosis: the Innohep(R) in Renal Insufficiency Study (IRIS). [2011.07]
INTRODUCTION: Trials comparing the use of full dose unfractionated heparin (UFH) or low molecular weight heparins (LMWHs) in very elderly patients with impaired renal function are lacking. IRIS aimed to assess whether LMWH is at least as safe as UFH in this population... CONCLUSION: The IRIS study was a challenging study involving patients (mean age 83 years) usually excluded from clinical studies, but its early termination has left questions unanswered. The mortality difference observed with tinzaparin vs. UFH in elderly, renally-impaired patients with DVT cannot be explained on the basis of bleedings or recurrent VTE, and may reflect an imbalance of mortality risk factors at baseline. Copyright (c) 2011. Published by Elsevier Ltd.
[Effect of tinzaparin on survival in non-small-cell lung cancer after surgery. TILT: tinzaparin in lung tumours]. [2011.05]
BACKGROUND: Experimental and clinical findings suggest that low molecular-weight heparins may improve overall survival in patients with cancer...
Relationship between baseline blood pressure parameters (including mean pressure, pulse pressure, and variability) and early outcome after stroke: data from the Tinzaparin in Acute Ischaemic Stroke Trial (TAIST). [2011.02]
BACKGROUND AND PURPOSE: High blood pressure (BP) in acute stroke is associated independently with a poor outcome. Recent evidence suggests that other hemodynamic parameters may also be associated with outcomes following stroke... CONCLUSIONS: Early death or neurologic deterioration, deterioration, and recurrent stroke are associated independently with high systolic BP, mean arterial pressure, pulse pressure, and BP variability. These measures offer potential therapeutic targets for improving early outcome after acute ischemic stroke.
Lipoprotein lipase responds similarly to tinzaparin as to conventional heparin during hemodialysis. [2010.12.06]
BACKGROUND: Low molecular weight (LMW) heparins are used for anticoagulation during hemodialysis (HD). Studies in animals have shown that LMW-heparins release lipoprotein lipase (LPL) as efficiently as unfractionated (UF) heparin, but are less able to retard hepatic uptake of the lipase. This raises a concern that the LPL system may become exhausted by LMW-heparin in patients on HD. We have explored this in the setting of clinical HD... CONCLUSION: Our data demonstrate that repeated HD with UF-heparin or tinzaparin does not exhaust the LPL-system.
Asymptomatic hemorrhagic transformation of infarction and its relationship with functional outcome and stroke subtype: assessment from the Tinzaparin in Acute Ischaemic Stroke Trial. [2010.12]
BACKGROUND AND PURPOSE: Asymptomatic hemorrhagic transformation of infarction (AHTI) is common, but its risk factors and relationship with functional outcome are poorly defined... CONCLUSIONS: AHTI is increased in ischemic stroke with cortical syndromes and of large vessel or cardioembolic etiology. Heparin does not increase AHTI. AHTI is not associated with functional outcome.
Clinical Trials Related to Innohep (Tinzaparin)
Tinzaparin in the Treatment of the Acute Pulmonary Embolism [Completed]
The purpose of this study is to evaluate the feasibility of the long-term treatment of
pulmonary embolism with tinzaparin compared to oral anticoagulants.
Long-Term Innohep« Treatment Versus a Vitamin K Antagonist (Warfarin) for the Treatment of Venous Thromboembolism (VTE) in Cancer [Completed]
The purpose of this study is to assess the efficacy and safety of Innohep┬« in preventing the
recurrence of VTE in patients with active cancer who have had an acute VTE episode.
Innohep for Prophylaxis of Venous Thromboembolism in Brain Tumor Patients [Completed]
To determine the safety of prophylaxis with Tinzaparin low molecular weight heparin in
primary brain tumor patients. 2. To determine the incidence of deep venous thrombosis or
pulmonary embolism in brain tumor patients who will be receiving Tinzaparin as primary
prophylaxis. 3. To determine the overall survival of patients with malignant glioma who
receive Tinzaparin. 4. To determine the bone density before and after prophylactic
A Comparison of Dalteparin and Tinzaparin for Prevention of Blood Clots in Hemodialysis Patients on Oral Anticoagulants Having Surgery [Completed]
The purpose of this study is to better understand if either dalteparin or tinzaparin is a
better drug to use in dialysis patients on blood thinners who are at high risk of developing
blood clots and need surgery.
Innohep« in Elderly Patients With Impaired Renal Function Treated for Acute Deep Vein Thrombosis [Completed]
The objective of the study is to compare the safety of innohep┬« and Unfractionated Heparin
(UFH) in terms of clinically relevant bleedings in elderly patients with impaired renal
function for initial treatment of acute Deep Venous Thrombosis (DVT).
The primary response criterion is the percentage of patients with clinically relevant
bleeding events prior to day 90 +/- 5.
Reports of Suspected Innohep (Tinzaparin) Side Effects
Pulmonary Embolism (28),
OFF Label USE (26),
Drug Ineffective (20),
Deep Vein Thrombosis (14),
Thrombosis in Device (13),
Incorrect Drug Administration Duration (13),
Maternal Exposure During Pregnancy (12),
Haemoglobin Decreased (11),
Haematoma (9), more >>
Page last updated: 2016-09-16