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TESTOLACTONE

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Classification   |    Detailed evidence-based information

Substances Included Synonyms

Therapeutic Toxic Class

    A) Testolactone, a synthetic testosterone derivative, is an aromatase inhibitor which blocks the peripheral aromatization of androgens into estrogens, but does not have significant androgenic activity.

Specific Substances

    1) D-Homo-17a-oxaandrosta-1,4-diene-3,17-dione
    2) 1-Dehydrotestololactone
    3) NSC-23759
    4) SQ-9538
    5) CAS 968-93-4
    1.2.1) MOLECULAR FORMULA
    1) C19-H24-O3 (Sweetman, 2007)

Available Forms Sources

    A) FORMS
    1) Testolactone is available in 50 mg tablets (Prod Info TESLAC(R) oral tablets, 2004).
    B) USES
    1) Testolactone is indicated as adjunctive palliative therapy in postmenopausal women with advanced or disseminated breast cancer. Testolactone can also be used in women who were diagnosed with disseminated breast cancer when premenopausal and who do not have functional ovaries (Prod Info TESLAC(R) oral tablets, 2004).

Overview

Life Support

    A) This overview assumes that basic life support measures have been instituted.

Clinical Effects

    0.2.1) SUMMARY OF EXPOSURE
    A) WITH THERAPEUTIC USE
    1) Maculopapular erythema, hypertension, paresthesia, malaise, aching pain, edema of the extremities, glossitis, anorexia, nausea and vomiting have been reported. Alopecia and/or nail growth disturbance have also been reported rarely.
    B) WITH POISONING/EXPOSURE
    1) Limited overdose data. Effects are expected to be an extension of adverse effects reported with therapeutic use.
    0.2.20) REPRODUCTIVE
    A) Testolactone has been classified as FDA pregnancy category C.

Laboratory Monitoring

    A) Monitor vital signs following ingestion. Increases in blood pressure have been reported.
    B) Monitor fluid and electrolyte status in patients with significant vomiting.

Treatment Overview

    0.4.2) ORAL/PARENTERAL EXPOSURE
    A) Treatment is symptomatic and supportive.
    B) Decontamination is generally not necessary; consider activated charcoal after very large ingestions or if more toxic coingestants involved.
    C) ACTIVATED CHARCOAL: Administer charcoal as a slurry (240 mL water/30 g charcoal). Usual dose: 25 to 100 g in adults/adolescents, 25 to 50 g in children (1 to 12 years), and 1 g/kg in infants less than 1 year old.

Range Of Toxicity

    A) A specific toxic dose has not been delineated. There have been no reports of testolactone overdose at the time of this review.

Clinical Effects

Summary Of Exposure

    A) WITH THERAPEUTIC USE
    1) Maculopapular erythema, hypertension, paresthesia, malaise, aching pain, edema of the extremities, glossitis, anorexia, nausea and vomiting have been reported. Alopecia and/or nail growth disturbance have also been reported rarely.
    B) WITH POISONING/EXPOSURE
    1) Limited overdose data. Effects are expected to be an extension of adverse effects reported with therapeutic use.

Heent

    3.4.2) HEAD
    A) WITH THERAPEUTIC USE
    1) GLOSSITIS has occurred following therapeutic administration of testolactone (Prod Info TESLAC(R) oral tablets, 2004).

Cardiovascular

    3.5.2) CLINICAL EFFECTS
    A) HYPERTENSIVE DISORDER
    1) WITH THERAPEUTIC USE
    a) Increased blood pressure has been associated with testolactone administration (Prod Info TESLAC(R) oral tablets, 2004).

Neurologic

    3.7.2) CLINICAL EFFECTS
    A) PARESTHESIA
    1) WITH THERAPEUTIC USE
    a) Paresthesias have been reported following testolactone administration (Prod Info TESLAC(R) oral tablets, 2004).
    B) MALAISE
    1) WITH THERAPEUTIC USE
    a) Malaise has occurred in association with testolactone administration (Prod Info TESLAC(R) oral tablets, 2004).

Gastrointestinal

    3.8.2) CLINICAL EFFECTS
    A) NAUSEA AND VOMITING
    1) WITH THERAPEUTIC USE
    a) Nausea and vomiting have occurred following testolactone administration (Prod Info TESLAC(R) oral tablets, 2004).
    B) LOSS OF APPETITE
    1) WITH THERAPEUTIC USE
    a) Anorexia has been reported with testolactone therapy (Prod Info TESLAC(R) oral tablets, 2004).

Dermatologic

    3.14.2) CLINICAL EFFECTS
    A) MACULOPAPULAR ERUPTION
    1) WITH THERAPEUTIC USE
    a) Maculopapular erythema has occurred in association with testolactone administration (Prod Info TESLAC(R) oral tablets, 2004).
    B) ALOPECIA
    1) WITH THERAPEUTIC USE
    a) Alopecia, with and without associated nail growth disturbances, has been rarely reported with testolactone administration, and appeared to spontaneously resolve without treatment interruption (Prod Info TESLAC(R) oral tablets, 2004).

Musculoskeletal

    3.15.2) CLINICAL EFFECTS
    A) PAIN
    1) WITH THERAPEUTIC USE
    a) Aching pain has been associated with testolactone administration (Prod Info TESLAC(R) oral tablets, 2004).

Reproductive

    3.20.1) SUMMARY
    A) Testolactone has been classified as FDA pregnancy category C.
    3.20.2) TERATOGENICITY
    A) ANIMAL STUDIES
    1) LACK OF EFFECT - Teratogenic effects were not observed in rabbits who were given doses 2.5 to 7.5 times the recommended human dose (Prod Info TESLAC(R) oral tablets, 2004).
    3.20.3) EFFECTS IN PREGNANCY
    A) PREGNANCY CATEGORY
    1) Testolactone has been classified by the manufacturer as FDA pregnancy category C (Prod Info TESLAC(R) oral tablets, 2004).
    B) ANIMAL STUDIES
    1) Increased fetal mortality, increased abnormal fetal development, and increased mortality in growing pups were reported in rats who were given testolactone doses 5 to 15 times the recommended human dose (Prod Info TESLAC(R) oral tablets, 2004).
    3.20.4) EFFECTS DURING BREAST-FEEDING
    A) LACK OF INFORMATION
    1) It is unknown whether testolactone is excreted in human breast milk (Prod Info TESLAC(R) oral tablets, 2004).
    3.20.5) FERTILITY
    A) ANIMAL STUDIES
    1) LACK OF EFFECT - Testolactone did not affect fertility in male or female rats (Prod Info TESLAC(R) oral tablets, 2004).

Carcinogenicity

    3.21.1) IARC CATEGORY
    A) IARC Carcinogenicity Ratings for CAS938-93-4 (International Agency for Research on Cancer (IARC), 2016; International Agency for Research on Cancer, 2015; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010a; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2008; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2007; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2006; IARC, 2004):
    1) Not Listed

Laboratory Monitoring

Monitoring Parameters Levels

    4.1.1) SUMMARY
    A) Monitor vital signs following ingestion. Increases in blood pressure have been reported.
    B) Monitor fluid and electrolyte status in patients with significant vomiting.

Methods

    A) CHROMATOGRAPHY
    1) High-performance liquid chromatography was used for quantitation of testolactone and its metabolite, 4,5-dihydrotestolactone, in human plasma and urine. Sensitivity of this method was 20 ng/mL for testolactone and 4,5-dihydrotestolactone after using 0.5 mL of the sample (Pascucci et al, 1983).

Treatment

Life Support

    A) Support respiratory and cardiovascular function.

Monitoring

    A) Monitor vital signs following ingestion. Increases in blood pressure have been reported.
    B) Monitor fluid and electrolyte status in patients with significant vomiting.

Oral Exposure

    6.5.1) PREVENTION OF ABSORPTION/PREHOSPITAL
    A) Decontamination is generally not necessary; consider activated charcoal after very large ingestions or if more toxic coingestants involved.
    6.5.2) PREVENTION OF ABSORPTION
    A) ACTIVATED CHARCOAL
    1) CHARCOAL ADMINISTRATION
    a) Consider administration of activated charcoal after a potentially toxic ingestion (Chyka et al, 2005). Administer charcoal as an aqueous slurry; most effective when administered within one hour of ingestion.
    2) CHARCOAL DOSE
    a) Use a minimum of 240 milliliters of water per 30 grams charcoal (FDA, 1985). Optimum dose not established; usual dose is 25 to 100 grams in adults and adolescents; 25 to 50 grams in children aged 1 to 12 years (or 0.5 to 1 gram/kilogram body weight) ; and 0.5 to 1 gram/kilogram in infants up to 1 year old (Chyka et al, 2005).
    1) Routine use of a cathartic with activated charcoal is NOT recommended as there is no evidence that cathartics reduce drug absorption and cathartics are known to cause adverse effects such as nausea, vomiting, abdominal cramps, electrolyte imbalances and occasionally hypotension (None Listed, 2004).
    b) ADVERSE EFFECTS/CONTRAINDICATIONS
    1) Complications: emesis, aspiration (Chyka et al, 2005). Aspiration may be complicated by acute respiratory failure, ARDS, bronchiolitis obliterans or chronic lung disease (Golej et al, 2001; Graff et al, 2002; Pollack et al, 1981; Harris & Filandrinos, 1993; Elliot et al, 1989; Rau et al, 1988; Golej et al, 2001; Graff et al, 2002). Refer to the ACTIVATED CHARCOAL/TREATMENT management for further information.
    2) Contraindications: unprotected airway (increases risk/severity of aspiration) , nonfunctioning gastrointestinal tract, uncontrolled vomiting, and ingestion of most hydrocarbons (Chyka et al, 2005).
    6.5.3) TREATMENT
    A) SUPPORT
    1) Treatment is symptomatic and supportive.
    B) MONITORING OF PATIENT
    1) Monitor vital signs following ingestion. Increases in blood pressure have been reported.
    2) Monitor fluid and electrolyte status in patients with significant vomiting.

Range Of Toxicity

Summary

    A) A specific toxic dose has not been delineated. There have been no reports of testolactone overdose at the time of this review.

Therapeutic Dose

    7.2.1) ADULT
    A) The recommended adult dose of testolactone is 250 milligrams orally four times daily (Prod Info TESLAC(R) oral tablets, 2004).
    7.2.2) PEDIATRIC
    A) Safety and efficacy in pediatric patients have not been established (Prod Info TESLAC(R) oral tablets, 2004).

Maximum Tolerated Exposure

    A) A specific toxic dose has not been delineated.

Workplace Standards

    A) ACGIH TLV Values for CAS938-93-4 (American Conference of Governmental Industrial Hygienists, 2010):
    1) Not Listed

    B) NIOSH REL and IDLH Values for CAS938-93-4 (National Institute for Occupational Safety and Health, 2007):
    1) Not Listed

    C) Carcinogenicity Ratings for CAS938-93-4 :
    1) ACGIH (American Conference of Governmental Industrial Hygienists, 2010): Not Listed
    2) EPA (U.S. Environmental Protection Agency, 2011): Not Listed
    3) IARC (International Agency for Research on Cancer (IARC), 2016; International Agency for Research on Cancer, 2015; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010a; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2008; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2007; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2006; IARC, 2004): Not Listed
    4) NIOSH (National Institute for Occupational Safety and Health, 2007): Not Listed
    5) MAK (DFG, 2002): Not Listed
    6) NTP (U.S. Department of Health and Human Services, Public Health Service, National Toxicology Project ): Not Listed

    D) OSHA PEL Values for CAS938-93-4 (U.S. Occupational Safety, and Health Administration (OSHA), 2010):
    1) Not Listed

Pharmacology Toxicology

Pharmacologic Mechanism

    A) Testolactone is a synthetic testosterone derivative without significant androgen activity. The drug inhibits steroid aromatase activity, thereby blocking the production of estradiol and estrone from androgen precursors such as testosterone and androstenedione (Prod Info TESLAC(R) oral tablets, 2004; Sciarra, 1988).

Physicochemical

Physical Characteristics

    A) Testolactone is a white to off-white, odorless, crystalline powder, that is soluble in ethanol and slightly soluble in water (Prod Info TESLAC(R) oral tablets, 2004; Sweetman, 2007).

Molecular Weight

    A) 300.4 (Sweetman, 2007)

References

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