CLASSES

Sclerosing Agents

DEA CLASS

Rx

DESCRIPTION

Sterile intrapleural agent containing 95% or more of magnesium silicate; do not confuse sterile talc with 'talcum powder' which is a lay term that refers to various types of dusting powder
Primarily used to decrease the recurrence of malignant pleural effusions in symptomatic adults following maximal drainage of the pleural effusion; also used in adults to to decrease the recurrence of pneumothorax
Lead is present in sterile talc as an impurity and the product is contraindicated for use during pregnancy due to the potential for fetal harm and potential loss of pregnancy

COMMON BRAND NAMES

Sclerosol, STERITALC

HOW SUPPLIED

Sclerosol Intrapleural Aer: 4g
STERITALC/Talc Intrapleural Pwd: 2g, 3g, 4g

DOSAGE & INDICATIONS

MAXIMUM DOSAGE

Do not exceed 10 grams intrapleurally per procedure.

Do not exceed 10 grams intrapleurally per procedure.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

DOSING CONSIDERATIONS

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

ADMINISTRATION

Intrapleural Administration
Sterile talc powder is indicated for pleurodesis only and is administered intrapleurally; it is NOT for IV administration.
Administer after adequate drainage of the pleural effusion or air.
Follow the manufacuturer's "Instructions for preparation and administration", depending on clinical indication for use.

STORAGE

Generic:
- Protect from direct sunlight
- Store at 77 degrees F; excursions permitted to 59-86 degrees F
Sclerosol:
- Do Not Store at Temperatures Above 120 degrees F (49 degrees C)
- Protect from direct sunlight
- Protect from freezing
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
STERITALC:
- Protect from light
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F

CONTRAINDICATIONS / PRECAUTIONS

Sclerosis of the pleural space with talc may preclude or complicate subsequent ipsilateral surgery and diagnostic procedures. Consider the possible effects of the intrapleural use of sterile talc on future diagnostic and therapeutic procedures prior to administration. Acute pneumonitis and acute respiratory distress syndrome (ARDS), including fatal cases, have been reported with intrapleural use of various talc products. Systemic exposure of talc could be affected by the integrity of the visceral pleura and could be increased if talc is administered immediately after mechanical abrasion or biopsy of the pleura. The literature also suggests a possible correlation between talc particle size distribution and risk of toxicity. There are published reports of two large, prospective trials conducted to evaluate the safety of the SteriTalc product administered intrapleurally. One trial evaluated 558 patients treated with 4 grams sterile talc by poudrage. The second trial evaluated 418 patients treated with sterile talc 2 grams by poudrage. No cases of ARDS or talc-related lung injury were reported.

Sterile talc intrapleural instillation is contraindicated for use in pregnant women because it contains lead, which can cause fetal harm and potential loss of pregnancy. Exposure of a pregnant woman to lead may cause miscarriage, premature birth, lower birth weights and slow or impaired mental development in the child. Administration of the SteriTalc product at the highest recommended dose of 10 grams may deliver up to 40 mcg of lead.

Use of sterile talc may pose a reproductive risk. Advise females of reproductive potential to follow recommended contraception requirements and to use effective contraception during treatment and for 5 months following the final dose. Sterile talc products such as SteriTalc contain lead, which may impair fertility (cause infertility or reduce fertility) in males of reproductive potential.

Breast-feeding should be avoided during treatment with sterile talc and for 5 months after the final intrapleural dose. There is no information regarding the presence of sterile talc in human milk, the effects on the breastfed infant, or the effects on milk production following intrapleural instillation of the drug. SteriTalc contains lead, which is known to have adverse effects on health and development in exposed pediatric patients.

The safety and efficacy of talc, magnesium silicate have not been established in neonates, infants, children, or adolescents. Lead is present in talc as an impurity. The main target organ for lead toxicity is the nervous system, but effects of lead exposure also include increased blood pressure, anemia, decreased sperm production, and damage to the kidneys in children and adults. Minimal risk levels of lead have not been derived for humans because clear thresholds for effects have not been identified. Children are more sensitive to lead toxicity than adults, and no safe blood level has been determined in children. Cognitive and neurobehavioral deficits are observed in children exposed to lead. Administration of the SteriTalc product at the highest recommended dose of 10 grams may deliver up to 40 mcg of lead.

ADVERSE REACTIONS

acute respiratory distress syndrome (ARDS) / Early / Incidence not known

dyspnea / Early / 5.0-10.0
costovertebral pain / Delayed / 10.0
bleeding / Early / Incidence not known
pneumonitis / Delayed / Incidence not known

fever / Early / 10.0
infection / Delayed / Incidence not known

DRUG INTERACTIONS

There are no drug interactions associated with Talc, Magnesium Silicate products.

PREGNANCY AND LACTATION

Sterile talc intrapleural instillation is contraindicated for use in pregnant women because it contains lead, which can cause fetal harm and potential loss of pregnancy. Exposure of a pregnant woman to lead may cause miscarriage, premature birth, lower birth weights and slow or impaired mental development in the child. Administration of the SteriTalc product at the highest recommended dose of 10 grams may deliver up to 40 mcg of lead.

Breast-feeding should be avoided during treatment with sterile talc and for 5 months after the final intrapleural dose. There is no information regarding the presence of sterile talc in human milk, the effects on the breastfed infant, or the effects on milk production following intrapleural instillation of the drug. SteriTalc contains lead, which is known to have adverse effects on health and development in exposed pediatric patients.

MECHANISM OF ACTION

Talc instilled into the pleural cavity is thought to result in an inflammatory reaction. This reaction promotes adherence of the visceral and parietal pleura to prevent reaccumulation of pleural air or fluid.

PHARMACOKINETICS

Talc, magnesium silicate is administered intrapleurally. The amount of systemic absorption after intrapleural administration is not known; however, the systemic exposure of talc could be affected by the integrity of the visceral pleura and could be increased if administered immediately following biopsy or lung resection. Data from animals indicated that the use of specific, size-calibrated talc products seems to correlate with the likeliness of systemic talc exposure and its potential risks; larger-size talc particles are less likely to induce systemic reactions. Additional pharmacokinetic data are not available.