Products Affected - Description

• • Sclerosol intrapleural aerosol powder, Lymol, 4 gram, can, 1 count, NDC 63256-0100-30 - discontinued
  • Sterile Talc intrapleural powder, Lymol, 5 gram, bottle, 1 count, NDC 63256-0200-05 - discontinued

Reason for the Shortage

• • Lymol discontinued Sclerosol and talc powder due to issues with obtaining raw materials. Lymol does not plan to manufacture these products in the future.[1]
  • Novatech SA has all Steritalc products available.[2]

Available Products

• • Steritalc intrapleural powder, Novatech SA, 2 grams, 50 mL single dose vial, NDC 62327-0222-02
  • Steritalc intrapleural powder, Novatech SA, 3 grams, 10 mL single dose vial, NDC 62327-0333-03
  • Steritalc intrapleural powder, Novatech SA, 4 grams, 50 mL single dose vial, NDC 62327-0444-04

• • Before sterile talc powder became commercially available, extemporaneous formulations of asbestos-free talc, USP, were used for pleural effusions.[3] Large containers of the commercial grade talc are available in 100 gram and 500 gram sizes and institutions repackaged and sterilized these products in 5 gram quantities. The powder can be sterilized by exposure to ethylene gas for 3.5 hours, followed by aeration for 12 hours.[3] Alternatively, talc powder can be sterilized by irradiation or exposure to a dry-heat oven.[4] When dry heat is used, the necessary exposure time varies inversely with temperature.
  • Dilute sterilized talc powder 5 gram in 0.9% sodium chloride injection 100 mL to form a slurry prior to instillation.[5]
  • Stability studies have not been conducted with extemporaneously compounded talc slurry. The slurry is preservative free

• • One concern regarding talc is the development of respiratory complications such as adult respiratory distress syndrome and acute pneumonitis. The mechanism is unknown, however it appears to be related to the grade of talc used. Graded talc (particle size 5-70 microns) is less likely to cause respiratory complications compared with non-graded or small particle talc (particle size <5 microns).[5-6]

• • Talc is considered a highly effective pleurodesis agent. Alternative agents used for pleurodesis include bleomycin, doxycycline, iodine, and minocycline.[3,5-12] The decision on use of each agent will depend on the indication, availability of the products, and healthcare professional knowledge and preference.

• 1. Lymol Medical (personal communication). August 31, September 6, November 8, 2016; January 9, February 10, April 25, August 8, November 9, 2017; January 17, July 9, October 9, 2018; January 16, April 8, June 11, August 14, and December 18, 2019; March 18, 2022.
  2. Novatech SA (personal communication). May 24, September 13, October 5, November 10, 2017; April 11, July 9, October 9, 2018; January 16, April 8, June 11, August 14, October 17, December 18, 2019; February 19, May 22, July 8, August 20, and October 16, 2020; January 14, May 7, August 26, and November 30, 2021; March 18, 2022.
  3. Schafers SJ, Dresler CM. Update on talc, bleomycin, and the tetracyclines in the treatment of malignant pleural effusions. Pharmacotherapy. 1995;15(2):228-235.
  4. Eselin J, Thompson DF. Talc in the treatment of malignant pleural effusion. DICP. 1991;25(11):1187-1189.
  5. Devita VTJ, Lawrence TS, Rosenberg SA, eds. Cancer: Principles & Practice of Oncology. 9th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2011.
  6. Roberts ME, Neville E, Berrisford RG, Antunes G, Ali NJ. Management of a malignant pleural effusion: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010;65 Suppl 2:ii32-40.
  7. Chen JS, Chan WK, Tsai KT, et al. Simple aspiration and drainage and intrapleural minocycline pleurodesis versus simple aspiration and drainage for the initial treatment of primary spontaneous pneumothorax: an open-label, parallel-group, prospective, randomised, controlled trial. Lancet. 2013;381(9874):1277-1282.
  8. Clive AO, Jones HE, Bhatnagar R, Preston NJ, Maskell N. Interventions for the management of malignant pleural effusions: a network meta-analysis. Cochrane Database Syst Rev. 2016(5):CD010529.
  9. Hallifax RJ, Yousuf A, Jones HE, Corcoran JP, Psallidas I, Rahman NM. Effectiveness of chemical pleurodesis in spontaneous pneumothorax recurrence prevention: a systematic review. Thorax. 2016.
  10. Jablonski S, Kordiak J, Wcislo S, et al. Outcome of pleurodesis using different agents in management prolonged air leakage following lung resection. Clin Respir J. 2016.
  11. Rafiei R, Yazdani B, Ranjbar SM, et al. Long-term results of pleurodesis in malignant pleural effusions: Doxycycline vs Bleomycin. Adv Biomed Res. 2014;3:149.
  12. Yankulov AD. A study of the pleurodesis potential of talc, iodpovidone, doxacycline and silver nitrate in experimental and clinical conditions in patients with malignant pleural effusions. Folia Med (Plovdiv). 2013;55(2):82-83.