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Sclerosol (Talc Intrapleural) - Summary

 
 



SCLEROSOL SUMMARY

SCLEROSOL® INTRAPLEURAL AEROSOL
(sterile talc powder)
NDC No. 63256-100-30

Sclerosol® Intrapleural Aerosol (sterile talc powder 4 g) is a sclerosing agent for intrapleural administration supplied as a single-use, pressurized spray canister with two delivery tubes of 15 cm and 25 cm in length. Each canister contains 4.0 g of talc, either white or off-white to light grey, asbestos-free, and brucite-free grade of talc of controlled granulometry. The composition of the talc is ≥ 95% talc as hydrated magnesium silicate.

Sclerosol® Intrapleural Aerosol, administered by aerosol during thoracoscopy or open thoracotomy, is indicated to prevent recurrence of malignant pleural effusions in symptomatic patients.


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NEWS HIGHLIGHTS

Published Studies Related to Sclerosol (Talc Intrapleural)

Lung injury following thoracoscopic talc insufflation: experience of a single North American center. [2010.06]
BACKGROUND: Thoracoscopic talc insufflation (TTI) has been used to obliterate the pleural space and prevent recurrent pleural effusions or pneumothorax. Reports of acute pneumonitis and ARDS after the use of talc raised concern about its safety. Differences in particle size of various talc preparations may explain the variable occurrence of pneumonitis. We sought to determine the incidence of lung injury after TTI over a 13-year period at our institution... CONCLUSIONS: We report the occurrence of lung injury after TTI using the only talc approved by the US Food and Drug Administration. These results reinforce previous concerns regarding the talc used for pleurodesis in North America.

Acute inflammatory response secondary to intrapleural administration of two types of talc. [2010.02]
Intrapleural instillation of talc has been used in the treatment of recurrent pleural effusions but can, in rare instances, result in respiratory failure. Side-effects seem to be related to composition, size and inflammatory power of talc particles... In conclusion, talc with larger particles should be the preferred choice in clinical practice in order to induce safer pleurodesis.

A comparison of the effectiveness of talc, polidocanol and ethanol as pleural sclerosing agents in rabbits. [2009.03]
BACKGROUND: Aim of the study was to compare the pleurodesis results from the intrapleural injection of talc, polidocanol and ethanol into the rabbit pleura... CONCLUSION: The intrapleural injection of polidocanol produces better pleurodesis than does the intrapleural injection of talc or ethanol in rabbits. Because of the efficacy of polidocanol as a sclerosing agent, its use in humans should be considered after further animal studies.

Talc pleurodesis: evidence of systemic inflammatory response to small size talc particles. [2009.01]
The mechanisms of the systemic response associated with talc-induced pleurodesis are poorly understood. The aim of this study was to assess the acute inflammatory response and migration of talc of small size particles injected in the pleural space...

Pleural mesothelial cells mediate inflammatory and profibrotic responses in talc-induced pleurodesis. [2007.12]
Intrapleural talc is used to produce pleurodesis in malignant pleural effusions...

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Clinical Trials Related to Sclerosol (Talc Intrapleural)

Video-Assisted Surgery or Talc Pleurodesis in Treating Patients With Malignant Mesothelioma [Recruiting]
RATIONALE: Video-assisted surgery to remove part of the tissue layer covering the inside of the chest cavity may be effective in treating pleural effusion and cause less damage to normal tissue. Talc pleurodesis may keep fluid from building up in the chest cavity. It is not yet known which therapy is more effective in treating pleural effusion caused by malignant mesothelioma.

PURPOSE: This randomized phase III trial is studying video-assisted surgery to see how well it works compared with talc pleurodesis in treating patients with malignant mesothelioma.

Video-assisted Hyperthermic Pleural Chemoperfusion vs Talc Pleurodesis for Refractory Malignant Pleural Effusions. [Recruiting]
Aim of this study is to compare two methods of pleurodesis for refractory malignant pleural effusions, in terms of safety and efficacy.

Bleomycin, Doxycycline, or Talc in Treating Patients With Malignant Pleural Effusions [Active, not recruiting]
RATIONALE: Some drugs such as bleomycin or doxycycline, or other compounds like talc, may help to control fluid in the chest caused by cancer. It is not yet known if bleomycin, doxycycline, or talc is more effective in treating patients with malignant pleural effusions.

PURPOSE: Randomized phase III trial to compare the effectiveness of bleomycin, doxycycline, or talc in treating patients with malignant pleural effusions.

A Prospective Randomised Study of Efficacy, Safety and Costs of Talc Pleurodesis Under Medical Thoracoscopy and Pleurodesis Under Video-assisted Thoracoscopy Surgery for Recurrent Primary Spontaneous Pneumothorax [Recruiting]

Multicentre Study Comparing Indwelling Pleural Catheter With Talc Pleurodesis for Malignant Pleural Effusion Management [Recruiting]
Malignant pleural effusion (MPE) accounts for 50% of all pleural effusions and affects about 300,000 patients annually (UK and USA). Lung and breast cancers account for majority of malignant pleural effusions; 1 in 3 breast cancer, 1 in 4 lung cancer as well as > 90% of patients with mesothelioma develop pleural effusions. Breathlessness from MPE is disabling and impairs quality of life. Median survival ranges between 4-6 months. Although thoracentesis provides effective symptom relief, most effusions recur and pleurodesis is the standard of care. Pleurodesis can be performed via chest tube or applied during pleuroscopy, and talc is the most effective agent. For successful pleurodesis to occur the underlying lung must expand after fluid drainage and trapped lung due to metastatic disease occurs up to 30%. Symptomatic patients require hospitalization for these procedures which are likely to fail if trapped lungs are encountered, and pose significant burden to health services. Tunneled indwelling pleural catheter (IPC) is emerging as a viable alternative which provides access to the pleural space for fluid drainage when breathlessness arise. IPC can be performed at ambulatory setting without hospital admission. Case series have demonstrated long-term safety of IPC even in patients undergoing chemotherapy with acceptable complication rates. By keeping the pleural cavity free of fluid, IPC has led to spontaneous pleurodesis in 50% of patients, which allows its removal. Presently IPC is indicated for trapped lung or when talc pleurodesis has failed. A randomised comparative trial with talc pleurodesis is necessary to determine role of IPC as first-line therapy of MPE, if IPC leads to reduction in hospitalizations, adverse events and healthcare costs, and if it improves quality of life. The multicenter trial randomizes symptomatic patients 1: 1 to IPC or talc pleurodesis, and endpoints include hospitalization days till death or end of study, adverse events, quality of life, and healthcare costs.

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Page last updated: 2011-12-09

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