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For Intrapleural Administration Only
Shake Well Immediately Before Using
DESCRIPTION
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 nozzles of 15 cm and 25 cm in length. Each canister contains 4 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. The empirical formula is Mg3Si4O10(OH)2 with molecular weight of 379.3. Associated naturally occurring minerals include chlorite (hydrated aluminum and magnesium silicate), dolomite (calcium and magnesium carbonite), calcite (calcium carbonate) and quartz. Talc is practically insoluble in water, and in dilute solutions of acids and alkali hydroxides. The canister and delivery nozzles have been sterilized by gamma irradiation. The aerosol propellant contained in Sclerosol® Intrapleural Aerosol is 1,1,1,2-Tetrafluoroethane (HFA-134a) with 25 g present per canister. The canister delivers 1.2 g of talc per second through the valve and the product contains no other excipients.
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CLINICAL PHARMACOLOGY
Mechanism of Action:
The therapeutic action of talc instilled into the pleural cavity is thought to result from induction of an inflammatory reaction. This reaction promotes adherence of the visceral to the parietal pleura, obliterating the pleural space and preventing reaccumulation of pleural fluid. The extent of talc systemically absorbed after intrapleural administration has not been adequately studied. Systemic exposure could be affected by the integrity of the visceral pleura, and therefore could be increased if talc is administered immediately following lung resection or biopsy.
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CLINICAL STUDIES
The data demonstrating safety and efficacy of talc in the treatment of malignant pleural effusions are derived from the published medical literature. The following four trials were prospective, randomized studies of talc vs. a concurrent control, and provide sufficient detail for evaluation, including a clear, readily determined definition of response (no fluid reaccumulation by chest roentgenogram at one month or greater) and information allowing an analysis of all patients randomized. Talc was statistically significantly superior to the control arms in evaluable patients across the studies.
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*p values are two-sided
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REFERENCE
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TREATMENT
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TUMOR
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RESPONSE RATE IN EVALUABLE PTS
p value: Fisher's Exact*
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RESPONSE RATE IN
ALL PATIENTS
p value: Fisher's Exact*
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MINIMUM
DURATION OF RESPONSE
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Sorenson et al.
Eur J Respir Dis.
1984; 65:131
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Talc slurry
vs
Chest tube drainage
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Variety
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100% (9/9)
vs
58% (7/12)
p=0.022
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64% (9/14)
vs
41% (7/17)
p=0.285
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3 months
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Fentiman et al.
Eur J Cancer Clin Oncol 1986;
22:1079
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Talc poudrage
vs
Tetracycline solution
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Breast
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92% (11/12)
vs
48% (10/21)
p=0.022
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61% (11/18)
vs
43% (10/23)
p=0.345
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12 months
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Fentiman et al.
Cancer 1983;
52:737
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Talc poudrage
vs
Mustine solution
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Breast
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90% (18/20)
vs
53% (9/17)
p=0.023
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78% (18/23)
vs
39% (9/23)
p=0.016
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6 months
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Hamed et al.
Br. J. Surg
1989; 76:1266
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Talc poudrage
vs
Bleomycin solution
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Breast
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100% (10/10 procedures)
vs
33% (5/15 procedures)
p=0.001
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(unclear; results reported as
procedures, not patients)
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≥1 months
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In other studies, greater than 1000 patients with malignant pleural effusions have been reported (with varying degrees of detail and durations of response) to have had successful pleurodesis with talc.
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