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  • 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

    HOW SUPPLIED

    Sclerosol Intrapleural Aer: 4g
    Talc Intrapleural Pwd

    DOSAGE & INDICATIONS

    To decrease the recurrence of malignant pleural effusion in symptomatic patients following maximal drainage of the pleural effusion.
    NOTE: Administer talc after adequate drainage of the effusion.
    Intrapleural dosage (SteriTalc)
    Adults

    The recommended dose is 2 to 5 grams administered intrapleurally. Do not exceed a total cumulative dosage of 10 grams per procedure.

    For use in adult patients to decrease the recurrence of pneumothorax.
    Intrapleural dosage (SteriTalc)
    Adults

    The recommended dose is 2 grams administered intrapleurally. According to physician's discretion and in consideration of diagnosis and patient's condition, different dosages may be applied, but a cumulative dosage of 10 grams should not be exceeded.

    MAXIMUM DOSAGE

    Adults

    Do not exceed 10 grams intrapleurally per procedure.

    Geriatric

    Do not exceed 10 grams intrapleurally per procedure.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

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

    Renal Impairment

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

    ADMINISTRATION

    Other Administration Route(s)

    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

    CONTRAINDICATIONS / PRECAUTIONS

    Pneumonitis

    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.

    Pregnancy

    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.

    Contraception requirements, infertility, reproductive risk

    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

    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.

    Children, infants, neonates

    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

    Severe

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

    Moderate

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

    Mild

    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

    Pregnancy

    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.