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10/22/2019

Sterile Talc

Products Affected - Description

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

Reason for the Shortage

    • Lymol has Sclerosol and talc powder on shortage due to manufacturing delays.[1]
    • Novatech SA has Steritalc 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

Estimated Resupply Dates

    • Lymol has Sclerosol and talc powder on long-term back order and the company cannot estimate a release date.[1]

Implications for Patient Care

    • 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.

Safety

    • 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]

Alternative Agents & Management

    • 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.

References

    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, and August 14, 2019.
    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, and October 17, 2019.
    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.

Updated

Updated October 22, 2019 by Michelle Wheeler, PharmD, Drug Information Specialist. Created August 31, 2016 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2019, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Vizient to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Vizient, ASHP, and the University of Utah 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, which respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither Vizient, ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this bulletin. Neither Vizient, ASHP nor University of Utah endorses or recommends the use of any drug.

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