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SCLEROSOL® INTRAPLEURAL AEROSOL
(sterile talc powder)
NDC No. 63256-100-30
Prescribing Information
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 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. The empirical formula is Mg3 Si4 O10 (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 tubes have been sterilized by gamma irradiation. The aerosol propellant contained in Sclerosol® Intrapleural Aerosol is dichlorodifluoromethane (CFC-12) with 26 g present per canister. The canister delivers 0.4 g of talc per second through the valve and the product contains no other excipients.
CLINICAL PHARMACOLOGY
Mechanism of Action:
The therapeutic action of talc instilled into the pleural cavity is believed 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.
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.
| REFERENCE | TREATMENT | TUMOR | RESPONSE RATE IN EVALUABLE PTS p value: Fisher's Exact* | RESPONSE RATE IN ALL PATIENTS p value: Fisher's Exact* | MINIMUM DURATION OF RESPONSE |
|---|---|---|---|---|---|
*p values are two-sided | |||||
| Sorenson et al. Eur J Respir Dis. 1984; 65:131 | Talc slurry vs Chest tube drainage | Variety | 100% (9/9) vs 58% (7/12) p=0.022 | 64% (9/14) vs 41% (7/17) p=0.285 | 3 months |
| Fentiman et al . Eur J Cancer Clin Oncol 1986; 22:1079 | Talc poudrage vs Tetracycline solution | Breast | 92% (11/12) vs 48% (10/21) p=0.022 | 61% (11/18) vs 43% (10/23) p=0.345 | 12 months |
| Fentiman et al . Cancer 1983; 52:737 | Talc poudrage vs Mustine solution | Breast | 90% (18/20) vs 53% (9/17) p=0.023 | 78% (18/23) vs 39% (9/23) p=0.016 | 6 months |
| Hamed et al . Br. J. Surg 1989; 76:1266 | Talc poudrage vs Bleomycin solution | Breast | 100% (10/10 procedures) vs 33% (5/15 procedures) p=0.001 | (unclear; results reported as procedures, not patients) | ≥1 months |
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.
INDICATIONS AND USAGE
Sclerosol® Intrapleural Aerosol, administered by aerosol during thoracoscopy or open thoracotomy, is indicated to prevent recurrence of malignant pleural effusions in symptomatic patients.
CONTRAINDICATIONS
None known.
WARNINGS
None.
PRECAUTIONS
General:
ADVERSE REACTIONS
Talc administration has been described in more than 1500 patients reported in the medical literature. Patients with malignant pleural effusions were treated with talc via poudrage or slurry. In general, with respect to reported adverse experiences, it is difficult to distinguish the effects of talc from the effects of the procedure(s) associated with its administration. The most reported common adverse experiences were fever and pain. Almost all of the cases of fever, and over half of the cases of pain, were in patients who received diagnostic biopsies at the time of talc administration.
OVERDOSAGE
Overdosages have not been reported. See PRECAUTIONS: 3) Potential pulmonary complications.
DOSAGE AND ADMINISTRATION
Sclerosol® Intrapleural Aerosol (sterile talc powder) is administered after adequate drainage of the effusion. It has been suggested that success of the pleurodesis is related to the completeness of the drainage of the pleural fluid, as well as full reexpansion of the lung, both of which will promote symphysis of the pleural surfaces.
The usual dosage of Sclerosol® Intrapleural Aerosol (sterile talc powder) is a single 4-8 g dose delivered intrapleurally from the spray canister (1-2 cans), which delivers talc at a rate of 0.4 g per second.
ADMINISTRATION PROCEDURE
Shake canister will before usage. Remove protective cap and securely attach actuator button with its delivery tube (either 15 cm or 25 cm) to the valve stem of canister.
Insert delivery tube through pleural trocar, taking care not to place the distal end of the delivery tube adjacent to the lung parenchyma or directly against the chest wall. While firmly holding the delivery tube and pleural trocar together in one hand, gently apply pressure to the actuator button on the canister. Sclerosol Intrapleural Aerosol® is not delivered by metered dose, but depends on the extent and duration of manual compression of the actuator button on the canister. The distal end of the delivery tube should be pointed in several different directions, while short bursts are administered in order to distribute the talc powder equally and extensively on all visceral and parietal pleural surfaces. For optimal distribution, always maintain the Sclerosol Intrapleural Aerosol® (sterile talc powder) canister in the upright position. After application, discard the canister and delivery tube. The duration of chest tube drainage following talc sclerosis is dictated by the clinical situation.