Sclerosol

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

Introduction

Sclerosing agent;^{1 2} sterile, asbestos- and brucite-free, controlled-granule-size talc powder.¹

Uses for Sclerosol

Pleural Effusions

Sclerosis of pleural serosal surfaces (pleurodesis) to decrease the risk of malignant pleural effusion recurrence in symptomatic patients with advanced stages of metastatic tumors.^{1 2 3 4 5 6 7 8 9 10}

Safety and efficacy based on data from published literature.^{1 2 3 14}

Absence of reaccumulation of the effusion (determined by clinical examination or chest radiograph) reported in about 93% of patients with recurrent, symptomatic malignant pleural effusions.^{3 14}

Similar success rates with talc slurry or aerosol powder.³

May be at least as effective as intrapleural bleomycin,^{1 2 6 7 8 9 15 16 17} doxycycline,¹² mustine,^{2 11} or tetracycline^{2 10} (no longer commercially available as a parenteral formulation in the US) and more effective than therapeutic thoracentesis.^{1 2 4 11}

Sclerosol Dosage and Administration

Administration

Administer intrapleurally as a slurry instilled via a chest tube¹ or by aerosol during thoracoscopy or open thoracotomy.²

Intrapleural Instillation via Chest Tube

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 vial containing 5 g of talc with a needle; slowly inject syringe contents into the vial and swirl to disperse.¹

Continue swirling vial to prevent settling; draw up 25 mL of slurry into each of 2 60-mL syringes.¹

Draw up sufficient 0.9% sodium chloride injection into each syringe to total 50 mL; each syringe will contain a slurry of 2.5 g of talc per 50 mL of 0.9% sodium chloride injection.¹

Draw air into each syringe to the 60-mL mark to provide 10 mL of space for mixing prior to administration.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

Prior to administration, adequately drain the effusion from the pleural cavity.^{1 2} Success of treatment apparently is related to the completeness of pleural fluid drainage and to full reexpansion of the lung.^{1 2}

Completely and continuously agitate the slurry-containing syringes to disperse and avoid settlement of the talc.¹

Immediately prior to administration, vent the 10 mL of air (provided for mixing) from each syringe.¹

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

Apply gentle pressure to syringe plunger to empty syringe contents through the chest tube into the chest cavity.¹

Flush the chest tube with 10–25 mL of 0.9% sodium chloride solution to ensure complete dose delivery; clamp the drainage tube.¹

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

Intrapleural Aerosol

Administration Procedure

Prior to administration, adequately drain the effusion from the pleural cavity.^{1 2} Success of treatment apparently is related to the completeness of pleural fluid drainage and to full reexpansion of the lung.^{1 2}

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 the distal end of the tube adjacent to lung parenchyma or directly against the chest wall.²

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

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

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

Discard the canister and delivery tube after application.²

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

Rate of Administration

Commercially available spray canister delivers talc at a rate of 0.4 g per second but is not considered to be a metered-dose delivery system; dose delivered depends on the extent and duration of manual compression of the actuator button.²

Dosage

Adults

Pleural Effusions

Intrapleural Instillation

5 g as slurry dispersed in 50–100 mL of 0.9% sodium chloride injection.¹

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

Intrapleural Aerosol

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

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

Future Procedures

Prior to administration, 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}

Potentially Curable Malignancies

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

Pulmonary Complications

Acute pneumonitis and ARDS reported; 3 of 4 reports of ARDS occurred following relatively large dose (10 g) instilled intrapleurally via chest tube.^{1 2}

IV administration 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

The contents of the aerosol canister are under pressure; do not puncture or use near heat or open flame.²

Specific Populations

Pregnancy

Category B.^{1 2}

Pediatric Use

Safety and efficacy not established in children <18 years of age.^{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 in clinical studies were 60 and 62 years, respectively.¹ Mean and median ages of patients receiving talc intrapleural aerosol were 50–62 years.²

Common Adverse Effects

Fever, pain.^{1 2}

Interactions for Sclerosol

Specific Drugs

Drug	Comments
Sclerosing agents	Unknown whether talc’s absorptive properties may diminish the effectiveness of subsequent therapy with a second sclerosing agent1 2

Sclerosol Pharmacokinetics

Absorption

Bioavailability

Extent of absorption after intrapleural administration not determined; integrity of the 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

Powder

18–25°C.¹ Protect from sunlight.¹

Use slurry within 12 hours following preparation.¹

Aerosol

15–30°C.² Do not expose to temperatures >49°C (canister may rupture).² Avoid freezing.² Protect from sunlight.²

ActionsActions

• 
  

  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 patients of other important precautionary information. (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 dichlorodifluoromethane [CFC-12] propellants)	Bryan
	Powder	5 g	Sterile Talc Powder	Bryan

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 2005. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Bryan Corporation. Sterile talc powder prescribing information. Woburn, MA; undated.

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

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]

More Sclerosol resources

• Sclerosol Side Effects (in more detail)
• Sclerosol Support Group
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• Sclerosol Prescribing Information (FDA)


• Sterile Talc Prescribing Information (FDA)