Sclerosol

Specific Drugs

• Following intrapleural administration, talc induces inflammation that results in fibrosis and adherence of visceral to parietal pleura (pleurodesis), thereby obliterating the pleural space and reducing the chance of fluid reaccumulation.1 2 18 19 20

For Intrapleural Administration Only

Shake Well Immediately Before Using

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

None known.

General:

1) Future procedures. The possibility of future diagnostic and therapeutic procedures involving the hemithorax to be treated must be considered prior to administering Sclerosol® Intrapleural Aerosol. Sclerosis of the pleural space may preclude subsequent diagnostic procedures of the pleura on the treated side. Talc sclerosis may complicate or preclude future ipsilateral lung resective surgery, including pneumonectomy for transplantation purposes.

2) Use in potentially curable disease. Talc has no known antineoplastic activity and should not be used for potentially curable malignancies where systemic therapy would be more appropriate, e.g., a malignant effusion secondary to a potentially curable lymphoma.

3) Potential pulmonary complications. Acute pneumonitis or acute respiratory distress syndrome (ARDS) have rarely been reported in association with intrapleural talc administration. Whether these were causally related to talc is unclear. In none of the reported cases was talc applied thoracoscopically or by insufflation. Three of four case reports of ARDS have occurred after treatment with 10 g of talc administered via intrapleural chest tube instillation. One patient died one month post treatment and two patients recovered without further sequelae.

Intravenous administration of talc is a well-recognized cause of pulmonary hypertension and pulmonary lung parenchymal disease, but these complications have not been reported after intrapleural administration. Pulmonary diseases, e.g., silicosis or asbestosis-like diseases, chronic bronchitis, bronchogenic carcinoma, and pleural plaques have been reported in association with inhaled talc.

4) Contents under pressure. The contents of the Sclerosol® Intrapleural Aerosol (sterile talc powder) canister are under pressure. The canister must not be punctured and should not be used or stored near heat or open flame.

Drug Interactions: It is not known whether the effectiveness of a second sclerosing agent after prior talc pleurodesis would be diminished by the absorptive properties of talc.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies on the carcinogenicity of talc have been performed using non-standard designs in which talc and its asbestos content were not fully characterized, preventing firm conclusions on its carcinogenicity. Tumor incidence in rats was not increased following either a single 20 mg injection with a 6 month recovery period or weekly injections of 25 mg for 4 weeks with an 84-week recovery period. Genotoxicity was assessed in cultures of rat pleural mesothelial cells (RPMC), as unscheduled DNA syntheses (UDS) and sister chromatid exchanges (SCEs). Asbestos-free talc was negative for genotoxicity under the conditions tested. No information is available on impairment of fertility in animals by talc.

Pregnancy: Pregnancy category B. An oral administration study has been performed in the rabbit at 900 mg/kg, approximately 5-fold higher than the human dose on mg/m² basis, and has revealed no evidence of teratogenicity due to talc. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should not be used during pregnancy unless it is clearly needed.

Pediatric Use: The safety and efficacy of Sclerosol Intrapleural Aerosol® (sterile talc powder) in pediatric patients have not been established.

Geriatric Use: The mean and median ages of patients treated with talc in the clinical studies table were 50-62 years. No analyses to specifically evaluate the safety and efficacy in the geriatric population have been reported.

NDC 63256-100-30: Sclerosol® Intrapleural Aerosol (sterile talc powder) contains 4 g of talc suspended in 25 g of inert propellant in a single-use aluminum canister. The canister is fitted with a continuous spray valve which delivers approximately 1.2 g of talc per second. This canister, attached to an actuator button, and two delivery nozzles of 15 cm and 25 cm length, are supplied in a sterile, flexible plastic peel pack.

STORAGE: Warning: Contents under pressure. Do not puncture or incinerate container. Store between 20°C - 25°C (68°F - 77°F); excursions permitted between 15°C - 30°C (59°F - 86°F) (see USP Controlled Room Temperature). Protect against sunlight and do not expose to a temperature above 49° C (120° F), or the canister may rupture. Avoid freezing. Shake well before using.

DISTRIBUTED BY: Bryan Corporation, Woburn MA 01801

October 2012

Principal Display Panel – Pouch Label

Sclerosol® Intrapleural Aerosol
(Sterile Talc Powder)

NDC 63256-100-30 Reorder No. 1680

Description: Spray can containing 4 g of asbestos-free talc.
Precisely measured & uniform particle size.
Supplied sterile with two nozzles (15 cm and 25 cm)

Lot# XXXXX Expires XXXX
Bryan Corporation 800-343-7711 or 781-935-0004
CONTENTS STERILE
SHAKE WELL IMMEDIATELY BEFORE USING

Principal Display Panel – Canister Label

Sclerosol®

INTRAPLEURAL AEROSOL
(STERILE TALC POWDER)

NDC 63256-100-30

CAT. No: 1680

DESTROY AFTER ONE USE
Please read instructions before use.
Spray canister containing 4 grams of asbestos-free & brucite-free talc.
Precisely measured, uniform particle size, supplied sterile with two nozzles (15 cm and 25 cm).
Net Weight: 30g
Content: Talc 4 grams
1,1,1,2-Tetrafluoroethane (HFA-134a/P) with 25 grams per canister
Delivers approximately 1.2 g of talc/second