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Talc (sterile): Drug information

Talc (sterile): Drug information
(For additional information see "Talc (sterile): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Sclerosol Intrapleural;
  • Sterile Talc Powder;
  • Steritalc
Pharmacologic Category
  • Sclerosing Agent
Dosing: Adult
Pleural effusion, malignant

Pleural effusion, malignant:

Aerosol: Intrapleural: 4 to 8 g (1 to 2 cans) as a single dose.

Suspension:

Sterile Talc Powder: Intrapleural: 5 g as a single dose.

Steritalc: Intrapleural: 2 to 5 g as a single dose (based on patient diagnosis and condition other doses may be used); maximum cumulative dose: 10 g.

Pneumothorax

Pneumothorax: Steritalc: Intrapleural: 2 g as a single dose (based on patient diagnosis and condition other doses may be used); maximum cumulative dose: 10 g.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions are derived from product labeling unless otherwise specified.

Postmarketing:

Cardiovascular: Acute myocardial infarction, cardiac arrhythmia, hypotension, pulmonary embolism, tachycardia

Endocrine & metabolic: Hypovolemia

Nervous system: Pain

Respiratory: Acute respiratory distress syndrome, bronchopleural fistula, dyspnea, empyema of pleura, hemoptysis, pneumonia, pneumonitis (including interstitial pneumonitis) (Griffo 2009), respiratory failure (Griffo 2009)

Miscellaneous: Fever

Contraindications

Steritalc: Pregnancy.

Sclerosol, Sterile Talc Powder: There are no contraindications listed in the manufacturer's labeling.

Warnings/Precautions

Concerns related to adverse effects:

• Pulmonary effects: Acute pneumonitis and acute respiratory distress syndrome (ARDS), including fatalities have been reported with intrapleural sterile talc; most cases of ARDS occurred with talc doses of 10 g via a chest tube. Systemic sterile talc exposure may be affected by the visceral pleura integrity and may be increased if sterile talc is administered following mechanical pleura abrasion or biopsy. Talc particle size distribution may correlate with the risk of toxicities. Products are for intrapleural use only; IV administration (not recommended) is associated with pulmonary hypertension and lung parenchymal disease. Silicosis or asbestosis-like conditions (chronic bronchitis, bronchogenic carcinoma, and pleural plaques) are associated with inhaled talc.

Dosage form specific issues:

• Sclerosol: Contents under pressure and should be kept away from any heat source or open flame; do not puncture canister.

• Steritalc: Lead exposure: Steritalc contains lead (as an impurity). The primary target organ for lead toxicity is the central nervous system, although lead exposure may also have an impact on blood pressure, renal function, and anemia. The threshold for minimum risk exposure levels has not been fully established in humans. Pediatric patients are more sensitive to lead toxicity (than adults); a safe blood level has not been established in children. Cognitive and neurobehavioral deficits are observed in children exposed to lead.

Other warnings/precautions:

• Appropriate use: Should not be used for potentially curable malignancies where systemic therapy would be more appropriate (sterile talc does not have antineoplastic activity). Clinicians should evaluate need for future diagnostic or surgical procedures before use; sclerosis of pleural space may preclude or complicate subsequent ipsilateral surgery and diagnostic procedures (eg, pneumonectomy for transplantation).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Aerosol Powder, Intrapleural:

Sclerosol Intrapleural: 4 g (30 g) [contains dichlorodifluoromethane]

Powder, Intrapleural:

Steritalc: 2 g (1 ea); 3 g (1 ea); 4 g (1 ea)

Suspension Reconstituted, Intrapleural:

Sterile Talc Powder: 5 g (1 ea)

Generic Equivalent Available: US

No

Pricing: US

Aerosol powder (Sclerosol Intrapleural Intrapleural)

4 g (per gram): $4.20

Powder (Steritalc Intrapleural)

2 g (per each): $142.50

3 g (per each): $183.00

4 g (per each): $204.00

Suspension (reconstituted) (Sterile Talc Powder Intrapleural)

5 g (per each): $97.50

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

For intrapleural (pleurodesis) administration only; not for IV administration. Administer after adequate drainage of the effusion or air.

Sclerosol Intrapleural Aerosol: Shake well and attach delivery tube. Insert delivery tube through pleural trocar, manually press on actuator button of canister to release; point in several different directions to distribute to all pleural surfaces. Keep canister in an upright position for optimal distribution. Rate of delivery is 1.2 g per second.

Sterile Talc Powder: Administer as a suspension. Shake well before instillation. Vent the10 mL air headspace and empty contents of each syringe into chest cavity through the chest tube by gently applying pressure to syringe plunger. After administration, clamp the chest tube for 1 to 2 hours and then drain the pleural fluid; the chest tube can be removed when drainage is <100 to 150 mL/24 hours (Ref).

Steritalc:

Slurry for tube thoracostomy: Shake syringe well prior to administration to redisperse talc and avoid settling. Immediately prior to administration, vent the 10 mL air headspace from each syringe and administer talc suspension through the chest tube (follow standard procedures). Inject slurry through pleural drainage into pleural cavity; clamp pleural drainage and retain negative pressure in the pleural cavity. With slurry in cavity, re-position patient regularly to achieve even slurry distribution. Aspirate slurry through pleural drainage.

Insufflation/poudrage: Perform procedure with a tube thoracoscopy. Follow device instructions for insufflation or poudrage. After use, some talc may remain in the vial (discard unused portion).

2 or 4 g vials: Introduce cannula into trocar, distribute talc evenly in pleural cavity by spraying several times and changing cannula direction every few sprays.

3 g vial: Keep product upright during use; avoid contact between the cannula tip and tissue or body fluids (may result in blocked cannula; if blockage occurs, shorten cannula with a scalpel, cutting perpendicular to cannula and ensuring the cut edge is straight and smooth). Proceed with intervention by introducing cannula into the trocar, distribute the talc evenly in the pleural cavity by pressing insufflation bulb carefully and at regular intervals. After spraying a few times, change the cannula direction.

Use: Labeled Indications

Pleural effusion, malignant: Sclerosing agent to decrease or prevent the recurrence of malignant pleural effusion in symptomatic patients (following maximal drainage of pleural effusion).

Pneumothorax: Sclerosing agent to decrease the recurrence of pneumothorax.

Medication Safety Issues
High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs that have a heightened risk of causing significant patient harm when used in error.

Reproductive Considerations

Patients who could become pregnant should use effective contraception during Steritalc treatment and for 5 months following the final dose. Steritalc may impair fertility in males (decreased sperm production).

Pregnancy Considerations

Steritalc is contraindicated in pregnancy; Steritalc contains lead (as an impurity); lead exposure during pregnancy may result in miscarriage, premature birth, low birth weights, and slow/impaired mental childhood development. When used at the highest recommended dose (10 grams), Steritalc may deliver ≤40 mcg of lead.

Pneumothorax during pregnancy is rare; however, pregnancy and the birth process may increase the risk. The individual risks of various treatments to the mother and fetus should be considered in consultation with a multidisciplinary health care team (MacDuff 2010; Schnell 2019).

Breastfeeding Considerations

It is not known if sterile talc is present in breast milk.

Steritalc contains lead (as an impurity), which is known to have an adverse effect on health and development in neonates, infants, and children. Due to the potential for serious adverse reactions resulting from lead exposure in the breastfed infant, lactating patients should avoid breastfeeding during Steritalc treatment and for 5 months following the final dose.

Mechanism of Action

Sterile talc instilled into the pleural cavity induces an inflammatory reaction, promoting adherence of the visceral and parietal pleura, therefore, preventing reaccumulation of pleural air or fluid.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Not well studied; systemic exposure may be influenced by integrity of visceral pleura

  1. Dresler CM, Olak J, Herndon JE, et al, “Phase III Intergroup Study of Talc Poudrage Vs Talc Slurry Sclerosis for Malignant Pleural Effusion,” Chest, 2005, 127(3):909-15. [PubMed 15764775]
  2. Griffo S, Musumeci A, De Luca G, Saccenti A, Grande LM, Stassano P. Talc-induced interstitial pneumonitis with respiratory failure. Anaesth Intensive Care. 2009;37(1):127-129. doi:10.1177/0310057X0903700114 [PubMed 19157360]
  3. Kvale PA, Seleecky PA, and Prakash UB, “Palliative Care in Lung Cancer: ACCP Evidence-Based Clinical Practice Guidelines (2nd Edition),” Chest, 2007, 132(3 Suppl):368-403. [PubMed 17873181]
  4. MacDuff A, Arnold A, Harvey J; BTS Pleural Disease Guideline Group. Management of spontaneous pneumothorax: British Thoracic Society pleural disease guideline 2010. Thorax. 2010;65(suppl 2):ii18-31. doi: 10.1136/thx.2010.136986. [PubMed 20696690]
  5. Schnell J, Beer M, Eggeling S, et al. Management of spontaneous pneumothorax and post-interventional pneumothorax: German S3 guideline. Respiration. 2019;97(4):370-402. doi: 10.1159/000490179. [PubMed 30041191]
  6. Sclerosol intrapleural aerosol (sterile talc) [prescribing information]. Woburn, MA: Bryan Corporation; October 2012.
  7. Sterile Talc Powder (sterile talc powder) [prescribing information]. Woburn, MA: Bryan Corporation; June 2014.
  8. Steritalc (sterile talc powder) [prescribing information]. La Ciotat Cedex, France: Novatech SA; received January 2023.
Topic 9496 Version 105.0

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