Sclerosol

Generic Name: Talc
Class: Sclerosing Agents
CAS Number: 14807-96-6

Introduction

Sclerosing agent.1 2

Uses for Sclerosol

Pleural Effusions

Sclerosis of pleural serosal surfaces (pleurodesis) to prevent recurrence of malignant pleural effusions in symptomatic patients.1 2 3 4 5 6 7 8 9 10

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Intrapleural talc has resulted in absence of reaccumulation of effusions (determined by clinical examination or chest radiograph) in about 93% of patients with recurrent, symptomatic malignant pleural effusions.3 14

Sclerosol Dosage and Administration

Administration

Administer intrapleurally as an aerosol during thoracoscopy or open thoracotomy2 or as a slurry instilled via a chest tube.1 Do not administer IV.1

Prior to intrapleural administration as an aerosol or slurry, adequately drain the effusion from pleural cavity.1 2 Success of talc pleurodesis apparently is related to completeness of pleural fluid drainage and full lung reexpansion.1 2

Intrapleural Administration as an Aerosol

For intrapleural administration as an aerosol, commercially available in single-use aluminum spray canisters containing 4 g of talc suspended in 25 g of inert propellant (1,1,1,2-tetrafluoroethane [HFA-134a]).2

Administration Procedure

Shake aerosol canister well before use; securely attach actuator button with delivery tube (15 or 25 cm) to canister valve stem.2

Insert delivery tube through the pleural trocar; avoid placing distal end of the tube adjacent to lung parenchyma or directly against chest wall.2

For optimal distribution, always maintain canister in an upright position.2

Firmly hold delivery tube and pleural trocar together in one hand; gently press actuator button on the canister.2

While pointing distal end of delivery tube in several different directions, administer short bursts to distribute talc equally and extensively on all visceral and parietal pleural surfaces.2

Discard canister and delivery tube after administration.2

Duration of chest tube drainage following sclerosis is dictated by the clinical situation.2

Rate of Administration

Commercially available single-use canister is fitted with a continuous spray valve that delivers talc at a rate of approximately 1.2 g per second, but is not considered to be a metered-dose delivery system.2 Dose delivered depends on extent and duration of manual compression of the actuator button.2

Intrapleural Administration as a Slurry

For intrapleural administration as a slurry, commercially available in single-use 100-mL bottles containing 5 g of talc powder for extemporaneous preparation of slurry.1

Preparation of Slurry

Prepare slurry in a laminar flow hood using aseptic technique.1

Attach 16-gauge needle to a 60-mL Leur-Lok syringe and draw up 50 mL of 0.9% sodium chloride injection into the syringe.1

Vent bottle containing 5 g of talc with a needle and slowly inject syringe contents into the bottle.1 Swirl bottle to disperse talc powder; continue swirling to keep powder from settling.1

Divide the slurry into two 60-mL irrigation syringes by withdrawing 25 mL of slurry into each syringe with continuous swirling.1 Draw up additional 0.9% sodium chloride injection so that total volume in each syringe is 50 mL.1 Draw air into each syringe to the 60-mL mark to provide 10 mL of space for mixing prior to administration.1

After mixing, each irrigation syringe will contain slurry consisting of 2.5 g of talc in 50 mL of 0.9% sodium chloride injection with 10 mL of air space.1

Appropriately label each syringe, including expiration date and time, identity of patient to receive the preparation, and the cautionary statements “For Pleurodesis Only–NOT FOR IV ADMINISTRATION” and “Shake Well Before Use.“ 1

Use slurry within 12 hours of preparation.1

Administration Procedure

Immediately prior to intrapleural administration, completely and continuously agitate irrigation syringes containing talc slurry (to evenly redisperse talc and avoid settlement) and vent the 10 mL of air (provided for mixing).1

Attach adapter and place a syringe tip on adapter; maintain continuous agitation of the syringe.1

Empty syringe contents through the chest tube into chest cavity by applying gentle pressure to syringe plunger.1

Chest tube may be flushed with 10–25 mL of 0.9% sodium chloride solution to ensure complete dose delivery; clamp drainage tube.1

Have patient move from supine to alternating decubitus positions at 20- to 30-minute intervals over a period of about 2 hours to distribute the talc within the chest cavity;1 however, recent evidence suggests that this step may not be necessary.1

At end of this period, unclamp chest drainage tube and remove excess saline by routine continual external suction on the tube.1

Dosage

Adults

Pleural Effusions
Intrapleural Aerosol

Usually 4–8 g (from 1–2 spray canisters) as a single dose.2

Spray canister delivers talc at a rate of approximately 1.2 g per second;2 dose of talc delivered depends on extent and duration of manual compression of actuator button on the canister.2 (See Intrapleural Administration as an Aerosol under Dosage and Administration.)

Intrapleural Slurry

5 g as slurry dispersed in 50–100 mL of 0.9% sodium chloride injection.1 (See Intrapleural Administration as a Slurry under Dosage and Administration.)

Optimal dose is unknown; 5 g was dose most frequently reported in published literature.1

Special Populations

No special population dosage recommendations at this time.1 2

Cautions for Sclerosol

Contraindications

  • No known contraindications.1 2

Warnings/Precautions

General Precautions

Potentially Curable Malignancies

Talc has no known antineoplastic activity; do not use alone for potentially curable malignancies when systemic antineoplastic therapy would be more appropriate (e.g., malignant effusion secondary to a potentially curable lymphoma).1 2

Future Procedures

Prior to intrapleural administration of talc, consider the possible need for future diagnostic and therapeutic procedures involving the hemithorax.1 2

Sclerosis of pleural space may preclude subsequent diagnostic procedures of the pleura on the treated side and may complicate or preclude future ipsilateral lung resective surgery, including pneumonectomy for transplantation purposes.1 2

Pulmonary Complications

Acute pneumonitis and ARDS reported in association with intrapleural talc;1 2 causal relationship not established.2 In 3 of 4 case reports, ARDS occurred following relatively large talc dose (10 g) administered intrapleurally via chest tube.1 2 No reported cases involved talc administered thoracoscopically or by insufflation.2

IV administration of talc causes pulmonary hypertension and lung parenchymal disease; not reported following intrapleural administration.2

Inhaled talc associated with pulmonary diseases (e.g., silicosis or asbestos-like disease, chronic bronchitis, bronchogenic carcinoma, pleural plaques).2

Aerosol Canister Pressure

Contents of the aerosol canisters are under pressure; do not puncture and do not store or use near heat or open flame.2 (See Aerosol under Stability.)

Specific Populations

Pregnancy

Category B.1 2

Do not use during pregnancy unless benefits outweigh risks.1 2

Pediatric Use

Safety and efficacy not established in pediatric patients.1 2

Geriatric Use

Safety and efficacy in geriatric patients not specifically evaluated.1 2

Estimated mean and median ages of patients receiving intrapleural talc slurry via chest tube in clinical studies were 60 and 62 years, respectively.1 In other clinical studies, mean and median ages of patients receiving intrapleural talc ranged between 50 and 62 years.2

Common Adverse Effects

Fever, pain.1 2

Interactions for Sclerosol

Specific Drugs

Drug

Comments

Sclerosing agents

Unknown whether talc’s absorptive properties would diminish effectiveness of subsequent therapy with a second sclerosing agent1 2

Sclerosol Pharmacokinetics

Absorption

Bioavailability

Extent of absorption after intrapleural administration not determined; integrity of pleural surface may affect systemic exposure.1 2

Special Populations

Systemic exposure may be increased when administered immediately following lung resection or biopsy.1 2

Stability

Storage

Intrapleural

Aerosol

20–25°C; may be exposed to 15–30°C.2 Avoid freezing.2

Contents under pressure and may rupture.2 Do not expose to temperatures >49°C, protect from sunlight, do not puncture or incinerate.2

Powder

18–25°C.1 Protect from sunlight.1

Use slurry within 12 hours of preparation;1 discard if not used within 12 hours.1

Actions

  • 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

Advice to Patients

  • Importance of describing the intrapleural procedure to patients prior to administration of talc.

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.1 2

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 2

  • Importance of informing patients of other important precautionary information.1 2 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Talc

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Intrapleural

Aerosol

4 g

Sclerosol Intrapleural Aerosol (with 1,1,1,2-Tetrafluoroethane [HFA-134a] propellant)

Bryan

Powder

5 g

Sterile Talc Powder

Bryan

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions May 30, 2013. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Bryan Corporation. Sterile talc powder for intrapleural administration only prescribing information. Woburn, MA; 2003 Sep.

2. Bryan Corporation. Sclerosol intrapleural aerosol (sterile talc powder) prescribing information. Woburn, MA; 2012 Oct.

3. American Thoracic Society. Management of malignant pleural effusions. Am J Respir Crit Care Med. 2000; 162:1987-2001. [PubMed 11069845]

4. Sorensen PG, Svendsen TL, Enk B. Treatment of malignant pleural effusion with drainage, with and without instillation of talc. Eur J Respir Dis. 1984; 65:131-5. [PubMed 6365578]

5. Aelony Y, King R, Boutin C. Thoracoscopic talc poudrage pleurodesis for chronic recurrent pleural effusions. Ann Intern Med. 1991; 115:778-82. [IDIS 288492] [PubMed 1929026]

6. Hamed H, Fentiman IS, Chaudary MA et al. Comparison of intracavitary bleomycin and talc for control of pleural effusions secondary to carcinoma of the breast. Br J Surg. 1989; 76:1266-7. [PubMed 2481558]

7. Ong KC, Indumathi V, Raghuram J et.al. A comparative study of pleurodesis using talc slurry and bleomycin in the management of malignant pleural effusions. Respirology. 2000; 5:99-103. [PubMed 10894097]

8. Zimmer PW, Hill M, Casey K et al. Prospective randomized trial of talc slurry vs bleomycin in pleurodesis for symptomatic malignant pleural effusions. Chest. 1997; 112:430-4. [IDIS 392697] [PubMed 9266880]

9. Noppen M, Degreve J, Mignolet M et al. A prospective, randomised study comparing the efficacy of talc slurry and bleomycin in the treatment of malignant pleural effusions. Acta Clin Belg. 1997; 52:258-62. [PubMed 9489119]

10. Fentiman IS, Rubens RD, Hayward JL. A comparison of intracavitary talc and tetracycline for the control of pleural effusions secondary to breast cancer. Eur J Cancer Clin Oncol. 1986; 22:1079-81. [PubMed 3536525]

11. Fentiman IS, Rubens RD, Hayward JL. Control of pleural effusions in patients with breast cancer. A randomized trial. Cancer. 1983; 52:737-9. [IDIS 173650] [PubMed 6190551]

12. Kuzdzal J, Sladek K, Wasowski D et al. Talc powder vs doxycycline in the control of malignant pleural effusion: a prospective, randomized trial. Med Sci Monit. 2003; 9:PI72-9. [PubMed 12824959]

13. Yim AP, Chan AT, Lee TW et al. Thoracoscopic talc insufflation versus talc slurry for symptomatic malignant pleural effusion. Ann Thorac Surg. 1996; 62:1655-8. [IDIS 377654] [PubMed 8957368]

14. Walker-Renard PB, Vaughan LM, Sahn SA. Chemical pleurodesis for malignant pleural effusions. Ann Intern Med. 1994; 120:56-64. [IDIS 323067] [PubMed 8250457]

15. Noppen M, Degreve J, Mignolet M et al. A prospective, randomised study comparing the efficacy of talc slurry and bleomycin in the treatment of malignant pleural effusions. Acta Clin Belg. 1997; 52:258-62. [PubMed 9489119]

16. Zimmer PW, Hill M, Casey K et al. Prospective randomized trial of talc slurry vs bleomycin in pleurodesis for symptomatic malignant pleural effusions. Chest. 1997; 112:430-4. [IDIS 392697] [PubMed 9266880]

17. Hamed H, Fentiman IS, Chaudary MA et al. Comparison of intracavitary bleomycin and talc for control of pleural effusions secondary to carcinoma of the breast. Br J Surg. 1989; 76:1266-7. [PubMed 2481558]

18. Ruckdeschel JC. Management of malignant pleural effusion: an overview. Semin Oncol. 1988; 15(Suppl 3):24-8. [PubMed 3293215]

19. Andrews CO, Gora ML. Pleural effusions: pathophysiology and management. Ann Pharmacother. 1994; 28:894-903. [IDIS 334463] [PubMed 7524816]

20. Hausheer FH, Yarbro JW. Diagnosis and treatment of malignant pleural effusion. Semin Oncol. 1985; 12:54-75. [PubMed 2579439]

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