Sterile Talc

Recommended Dose

The recommended dose is 5 g, suspended in 50 ml to 100 ml 0.9% Sodium Chloride Injection, USP

Preparation

Prepare the talc suspension using aseptic technique in an appropriate laminar flow hood as follows:

Step 1. Using a 16 gauge needle attached to a 60-ml LuerLok syringe, draw up 50 ml of 0.9 % Sodium Chloride injection, USP. Vent the talc bottle using a needle. Slowly inject the 50 ml of 0.9% Sodium Chloride Injection, USP into the bottle.

Step 2. Swirl the bottle to disperse the talc powder.

Step 3. Divide the contents of the bottle equally into two 60 ml LuerLok syringes, each attached with a 16 gauge needle, by withdrawing 25 ml of the suspension into each syringe with continuous swirling. Add 0.9% Sodium Chloride Injection, USP to a total volume of 50 ml in each syringe. Draw 10 ml of air into each syringe to the 60 ml mark to serve as a headspace for mixing prior to administration. Each syringe should contain 2.5 g of Sterile Talc Powder in 50 ml of 0.9% Sodium Chloride Injection, USP with an air headspace of 10 ml.

Step 4. Label the syringes with the talc concentration, the expiration date and time, the identity of the patient intended to receive the material, and the following statements:

“SHAKE SYRINGE WELL to resuspend before administration”

“FOR PLEURODESIS ONLY – not for intravenous administration”

Step 5. If not used immediately, store prepared suspension in refrigerator. Discard the prepared suspension if not used within 12 hours.

Administration

Prior to administration, continuously agitate the syringes to evenly redisperse the talc and avoid settlement. Immediately prior to administration, vent the 10 ml air headspace from each syringe. Administer the talc suspension through the chest tube according to standard procedures.

Pregnancy

Pregnancy Category B.

Risk Summary

A reproduction study performed in rabbits at doses up to approximately 5 times the human dose revealed no evidence of teratogenicity. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Animal Data

Rabbits were administered talc by oral gavage daily during the period of organogenesis at doses of up to 900 mg/kg (approximately 5 times the human dose on a mg/m2 basis). No significant dose-related toxicity was reported except at maternally toxic doses. In multiple animal studies, intrapleurally administered talc was not absorbed systemically.

Pediatric Use

Safety and effectiveness have not been established in pediatric patients.

Sterile Talc POWDER is a sclerosing agent for intrapleural administration. Sterile Talc POWDER is white or off-white to light gray, asbestos-free and brucite-free Sterile Talc powder of controlled particle size. The powder is ≥ 95% hydrated magnesium silicate [Mg3Si4O10 (OH)2, molecular weight 379.3]; associated minerals include chlorite (hydrated aluminum and magnesium silicate), dolomite (calcium and magnesium carbonate), calcite (calcium carbonate), and quartz. Talc is insoluble in water.

Mechanism of Action

Talc instilled into the pleural cavity is thought to result in an inflammatory reaction. This reaction can promote adherence of the visceral and parietal pleura, which may prevent reaccumulation of pleural fluid.

Sterile Talc POWDER is supplied in a single use 100 ml brown glass bottle, sealed with a gray, 20 mm stopper and covered with a flip-off seal.

NDC 63256-200-05: 5 gram individual bottle packaged in a pouch.

NDC 63256-200-10: Carton of ten (10) 5-gram bottles.

Store the powder at 25°C (77°F); excursions permitted between15°C to 30°C (59°F - 86°F) [see USP Controlled Room Temperature]. Protect against sunlight.

The U.S. Food and Drug Administration has approved Sterile Talc Powder (5 g, 100 ml vial) administered intrapleurally via chest tube, as sclerosing agent to decrease the recurrence of malignant pleural effusions in symptomatic patients.

Sterile Talc Powder (Product #1690), is a natural, asbestos- free product, supplied sterile in a single use 100 ml amber glass vial. The recommended dose is 5 g, dissolved in 50-100 ml sodium chloride administered slowly through the chest tube. Each 5 g dosage is sterilized via gamma irradiation and is of a controlled particle size.

This product, joins the only other licensed form of talc, Sclerosol Intrapleural Aerosol, also manufactured and marketed by Bryan Corporation. Sclerosol Intrapleural Aerosol is packaged with a chlorofluorocarbon (CFC) propellant for direct insufflation into the pleural cavity intraoperatively or during thoracoscopy. Both of these talc products are made exclusively by Bryan Corporation, and are covered by an Orphan Drug designation held by Bryan Corporation.

For further information, please visit www.bryancorp.com

Source: Bryan Corporation