(talc) powder, for intrapleural use, indicated to decrease recurrence of malignant pleural effusions and pneumothorax

• Granulometrically controlled talc
• Sterile
• Asbestos-free
• Endotoxin-free

STERITALC^® has been the standard of care for decades. Thousands of patients worldwide have been successfully treated with STERITALC^®.

It is the only talc-based pleurodesis product with a well-documented and proven track record of safety and efficacy.

21 clinical studies from16 countries involving 2486 patients over a period of  25 years

„Es gilt als gesichert, dass es beim französischen Luzenac-Talk (… Steritalc^®, Novatech) zu keiner systemischen Talkumdissemination kommt.“
“It is accepted as certain that the French Luzenac talc (… STERITALC^®, NOVATECH) does not result in a systemic talc dissemination.”
_{Schnyder / Tschopp: Behandlung des Pneumothorax mittels internistisch-thorakoskopischer Talkumpleurodese. Der Pneumologe 2010. 7: 357-363}

“The most important clinical implication of our study is that large-particle talc can safely be used for pleurodesis. Other talc preparations should not be used for this indication.”
_{Janssen et al.: Safety of pleurodesis with talc poudrage in malignant pleural effusion:a prospective cohort study. Lancet 2007; 369: 1535-1539}

Excerpt from the US Prescribing Information for STERITALC^®:

There are published reports of two large, prospective trials conducted to evaluate the safety of STERITALC^® administered intrapleurally. One trial evaluated 558 patients treated with STERITALC^® 4 g by poudrage for MPE. The second trial evaluated 418 patients with recurrent primary spontaneous pneumothorax treated with STERITALC^® 2 g by poudrage.
No cases of ARDS or talc-related lung injury were reported.

Preventing systemic spread – preventing ARDS.

STERITALC^® consists of talcum which is mined in France and is specifically processed for medical use (talcum pleurodesis).

STERITALC^® is intended for treatment of malignant pleural effusion by insufflation of medical grade talc following drainage of pleural effusion. It is non-soluble and induces permanent pleurodesis. Compared with tetracyclines, talcum is more effective^1,2.

For malignant indications 2 to 5 g are used, for treatment of pneumothorax 1 to 2 g are used.

A critical side effect of talcum pleurodesis can be ARDS (Acute Respiratory Distress Syndrome). A possible cause of ARDS may be the systemic dissemination of talcum. In some cases, after application in the pleural cavity, talcum was found even in other organs (kidneys, spleen, liver)^3,4.

The literature assumes that there is a relation between the talcum particle size and the systemic dissemination of talcum: smaller talcum particles appear to disseminate more than larger ones⁵.

The clinical picture also shows the effect of different particle sizes: talcum with a mean particle size below 15 μm induced stronger systemic and pulmonary inflammation reactions than talcum with a mean particle size of 25 μm⁶.

STERITALC^®, produced by Novatech SA, France, is specifically calibrated in order to avoid systemic dissemination. Animal⁷ and clinical studies⁸ show the lesser systemic dissemination.

A multi-center study showed that STERITALC^® with its calibrated particle size can be safely used for pleurodesis of malignant pleural effusions. None of more than 550 patients developed ARDS⁹. The authors recommend to use no other talcum.

Another cause of ARDS may be a sepsis due to unsterile talcum, or talcum containing endotoxines¹⁰. STERITALC^® is free of endotoxines and comes sterile.

^{1 Noppen et al 1997, Acta Clin Belg. 1997; 52(5): 258-62
2 Hamed et al 1989, Br. J. Surg. 1989; Vol. 76, December 1266-1267
3 Fraticelli et al 2002, Chest 2002; 122: 1737-1741
4 Ferrer et al 2002, Chest 2002; 122: 1018-1027
5 Ferrer et al 2002, Chest 2002; 122: 1018-1027
6 Maskell, Am .J. Respir. Crit. Care Med. 2004; 170: 377-382
7 Fraticelli et al 2002, Chest 2002; 122: 1737-1741
8 Maskell, Am. J. Respir. Crit. Care Med. 2004; 170: 377-382
9 Janssen, Lancet 2007; 369: 1535-1539
10 Antony, Eur. Respir. J. 2001; 18: 402-419}

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205555s000lbl.pdf