Dosage Forms
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)
Pharmacology
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/Pharmacodynamics
Absorption
Not well studied; systemic exposure may be influenced by integrity of visceral pleura.
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.
Contraindications
Steritalc: Pregnancy.
Sclerosol, Sterile Talc Powder: There are no contraindications listed in the manufacturer's labeling.
Dosage and Administration
Dosing: Adult
Pleural effusion, malignant:
Intrapleural aerosol: 4 to 8 g (1 to 2 cans) as a single dose
Intrapleural suspension:
Sterile Talc Powder: 5 g
Steritalc: 2 to 5 g (based on patient condition other doses may be used); maximum cumulative dose: 10 g
Pneumothorax: Intrapleural: Steritalc: 2 g (based on patient condition other doses may be used); maximum cumulative dose: 10 g
Reconstitution
Sclerosol Intrapleural Aerosol: Shake well.
Sterile Talc Powder: Vent bottle with needle; slowly add NS 50 mL to bottle using aseptic technique. Swirl the bottle to disperse talc and avoid settling. Divide the contents of bottle into two 60 mL syringes (25 mL of talc suspension in each). Add an additional NS 25 mL to each syringe for a total of 50 mL (2.5 g/50 mL). Draw syringe back to add 10 mL air to facilitate mixing prior to administration. Shake well to resuspend prior to use. If not used immediately, label “For pleurodesis only; NOT for IV administration.”
Steritalc:
Slurry for tube thoracostomy (2 g or 4 g dosage forms): Do not prepare the slurry in advance; use slurry immediately after preparation. Prepare the talc suspension using aseptic technique in an appropriate laminar flow hood. Fully bend or remove the flap into the direction of the arrow; puncture top to mix slurry. Using a 16-gauge needle attached to a 60-mL Luer Lok syringe, draw up 50 mL NS, vent the talc bottle with a needle and slowly inject the 50 mL NS into the glass vial; swirl glass vial to disperse talc powder. Divide the contents of the glass vial equally into two 60-mL Luer Lok syringes (with a 16-gauge needle on each syringe) by withdrawing 25 mL of the suspension into each syringe while continuously swirling. Add NS to a total volume of 50 mL in each syringe. Draw back to the 60 mL mark on each syringe to add 10 mL air to serve as a headspace for mixing prior to administration. When preparing from a 2 g vial, each syringe contains 1 g sterile talc in 50 mL NS with an air headspace of 10 mL and when preparing from a 4 g vial, each syringe contains 2 g sterile talc in 50 mL NS with an air headspace of 10 mL. Label “For pleurodesis only; NOT for IV administration.” Shake syringe well prior to administration to re-suspend.
Insufflation/poudrage (2, 3, or 4 g dosage forms):
2 or 4 g vials: Use a device approved or cleared for Steritalc insufflation/poudrage. Fully remove top from vial; fill vial content into the applicator for insufflation/poudrage and follow the selected device manufacturer's instructions for insufflation/poudrage.
3 g vial: The 3 g vial is designed for use/sterile talc administration in combination with a compatible approved/cleared device (eg, Novatech TALCAIR) intended for manual insufflation of medical grade talc into the pleural cavity during pleurodesis. Remove the aluminum tear-off cap from the vial; remove vial stopper; close vial with the vial coupling, firmly press vial coupling onto the vial until lid clicks onto the vial top by placing the vial on a firm/level base. Connect the insufflation bulb to the vial coupling using the Luer lock connector and ensure that all components are firmly connected with each other.
Administration
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 (Dresler 2005; Kvale 2007).
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.
Storage
Sclerosol Intrapleural Aerosol: Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F); do not expose to temperatures above 49°C (120°F). Do not freeze. Protect from sunlight.
Sterile Talc Powder: Store at 25°C (77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Protect from sunlight. If not used immediately after mixing, refrigerate and use within 12 hours of preparation.
Steritalc: Store intact product at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Protect from light. Following preparation for pleurodesis, if not used immediately, store suspension refrigerated; discard prepared suspension if not used within 12 hours.
Adverse Reactions
Frequency not defined.
Cardiovascular: Cardiac arrhythmia, hypotension, myocardial infarction, pulmonary embolism, tachycardia
Central nervous system: Pain
Endocrine & metabolic: Hypovolemia
Respiratory: Acute respiratory distress syndrome, bronchopleural fistula, dyspnea, empyema of pleura, hemoptysis, pneumonia, pneumonitis
Miscellaneous: Fever
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, anemia, and male fertility. 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. Lead exposure during pregnancy may also cause adverse events.
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).
Pregnancy
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).
Women of reproductive potential should use effective contraception during Steritalc treatment and for 5 months following the final dose. Steritalc may impair fertility in males (decreased sperm production).
Patient Education
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience application site irritation. Have patient report immediately to prescriber signs of a severe pulmonary disorder (lung or breathing problems like difficulty breathing, shortness of breath, or a cough that is new or worse) or abnormal heartbeat (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
