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Innohep (Tinzaparin Sodium) - Summary

 
 



SPINAL/EPIDURAL HEMATOMAS

When neuraxial anesthesia (epidural/spinal anesthesia) or spinal puncture is employed, patients anticoagulated or scheduled to be anticoagulated with low molecular weight heparins or heparinoids for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma which can result in long-term or permanent paralysis.

The risk of these events is increased by the use of indwelling epidural catheters for administration of analgesia or by the concomitant use of drugs affecting hemostasis such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, or other anticoagulants. The risk also appears to be increased by traumatic or repeated epidural or spinal puncture.

Patients should be frequently monitored for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.

The physician should consider the potential benefit versus risk before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis (see also WARNINGS, Hemorrhage, and PRECAUTIONS, Drug Interactions).

 

INNOHEP SUMMARY

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.


See all Innohep indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Innohep (Tinzaparin)

Deep Vein Thrombosis (DVT)
Source: MedicineNet Antiphospholipid Syndrome Specialty [2013.11.29]
Title: Deep Vein Thrombosis (DVT)
Category: Diseases and Conditions
Created: 2/15/2000 10:55:00 PM
Last Editorial Review: 11/29/2013 12:00:00 AM

'Increased risk of venous thromboembolism among NSAID users'
Source: Body Aches News From Medical News Today [2014.09.25]
Venous thromboembolism - the condition that includes both deep vein thrombosis and pulmonary embolism - has been linked to NSAID use in a new systematic review and meta-analysis.

more news >>

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.

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Clinical Trials Related to Innohep (Tinzaparin)

Long-Term Innohep´┐Ż Treatment Versus a Vitamin K Antagonist (Warfarin) for the Treatment of Venous Thromboembolism (VTE) in Cancer [Recruiting]
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.

Safety and Efficacy of Therapeutic Anticoagulation With Tinzaparin During Pregnancy Via Weight-based Dosing [Recruiting]
The purpose of this study is to evaluate the safety and efficacy of therapeutic anticoagulation with tinzaparin during pregnancy via weight-based dosing.

Tinzaparin in the Treatment of the Acute Pulmonary Embolism [Recruiting]
The purpose of this study is to evaluate the feasibility of the long-term treatment of pulmonary embolism with tinzaparin compared to oral anticoagulants.

A Comparison of Dalteparin and Tinzaparin for Prevention of Blood Clots in Hemodialysis Patients on Oral Anticoagulants Having Surgery [Recruiting]
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.

Effects of Tinzaparin on Cardio-Vascular Outcomes and on Blood Lipids in Diabetic Patients on Chronic Hemodialysis [Not yet recruiting]
Low molecular weight heparin (LMWH) provides a safe and effective alternative to UFH for hemodialysis anticoagulation. While unfractionated (UF) heparin has been implicated in hyper-lipidemia, the effect of LMWHs on the lipid profile in non-diabetic patients on chronic hemodialysis remains controversial. The effect of LMWH in diabetic patients, a high risk group for developing hyper-lipidemia and cardio-vascular disease, has not been studied.

The study intends to examine the long-term effects of the replacement of UFH by LMWH (tinzaparin sodium) on cardio-vascular outcomes and on lipoprotein profiles in a large group of diabetic patients stable on HD.

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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)Thrombosis (11)Haemoglobin Decreased (11)Haematoma (9)more >>


Page last updated: 2014-09-25

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