BNF for Children 2011-2012

380 6.4.2 Male sex hormones and antagonists BNFC 2011–20126 Endocrine systemVirormone c (Nordic) LInjection, testosterone propionate 50 mg/mL, netprice 2-mL amp = £4.50DoseDelayed puberty in males. By intramuscular injection50 mg once weeklyImplantTestosterone (Organon) LImplant, testosterone 100 mg, net price = £7.40;200 mg = £13.79DoseMaintenance of sexual maturation in malesChild over 16 years 100–600 mg; 600 mg usually maintainsplasma-testosterone concentration within the normalrange for 4–5 monthsCreamTestosterone LCream, testosterone 5% (other strengths available)Available from ‘special-order’ manufacturers or specialistimporting companies, see p. 809Anti-androgens and precociouspubertyThe gonadorelin stimulation test (section 6.5.1) is usedto distinguish between gonadotrophin-dependent (central)precocious puberty and gonadotrophin-independentprecocious puberty. Treatment requires specialistmanagement.Gonadorelin analogues, used in the management ofgonadotrophin-dependent precocious puberty, delaydevelopment of secondary sexual characteristics andgrowth velocity.Testolactone and cyproterone are used in the managementof gonadotrophin-independent precociouspuberty, resulting from McCune-Albright syndrome,familial male precocious puberty (testotoxicosis), hormone-secretingtumours, and ovarian and testicular disorders.Testolactone inhibits the aromatisation of testosterone,the rate limiting step in oestrogen synthesis.Cyproterone is a progestogen with anti-androgen properties.Spironolactone (section 2.2.3) is sometimes used incombination with testolactone because it has someandrogen receptor blocking properties.High blood concentration of sex hormones may activaterelease of gonadotrophin releasing hormone, leading todevelopment of secondary, central gonadotrophindependentprecocious puberty. This may require theaddition of gonadorelin analogues to prevent progressionof pubertal development and skeletal maturation.CYPROTERONE ACETATECautions blood counts initially and throughout treatment;monitor adrenocortical function regularly; diabetesmellitus (see also Contra-indications)Skilled tasks Fatigue and lassitude may impair performanceof skilled tasks (e.g. driving)Contra-indications severe diabetes (with vascularchanges), sickle-cell anaemia, liver disease includingDubin-Johnson and Rotor syndromes, previous orexisting liver tumours, malignant or wasting diseases,meningioma or history of meningioma, severedepression, history of thromboembolic disordersHepatic impairment monitor hepatic function regularly—dose-relatedtoxicity, see Side-effects belowSide-effects fatigue and lassitude, breathlessness,weight changes, reduced sebum production (mayclear acne), changes in hair pattern, gynaecomastia(rarely leading to galactorrhoea and benign breastnodules); rarely hypersensitivity reactions, rash andosteoporosis; inhibition of spermatogenesis (see notesabove); hepatotoxicity reported (including jaundice,hepatitis and hepatic failure)Hepatotoxicity Direct hepatic toxicity including jaundice,hepatitis and hepatic failure have been reported (usually afterseveral months) with cyproterone acetate 200–300 mg daily.Liver function tests should be performed before treatmentand whenever symptoms suggestive of hepatotoxicityoccur—if confirmed cyproterone should normally be withdrawnunless the hepatotoxicity can be explained by anothercause such as metastatic disease (in which case cyproteroneshould be continued only if the perceived benefit exceeds therisk)Licensed use unlicensed for use in childrenIndication and doseGonadotrophin-independent precociouspuberty) (specialist use only; see also notes above). By mouthInitially 25 mg twice daily, adjusted according toresponseCyproterone Acetate (Non-proprietary) ATablets, cyproterone acetate 50 mg, net price 56-tabpack = £31.54. Label: 21, counselling, drivingNote 10 mg tablets available from ‘special-order’ manufacturersor specialist-importing companies, see p. 809Androcur c (Bayer Schering) ATablets, scored, cyproterone acetate 50 mg, net price56-tab pack = £24.41. Label: 21, counselling, drivingTESTOLACTONECautions interactions: Appendix 1 (testolactone)Pregnancy avoidBreast-feeding no information availableSide-effects nausea, vomiting, anorexia, diarrhoea;hypertension; peripheral neuropathy; weight changes;changes in hair pattern; rarely hypersensitivity reactions,rashIndication and doseGonadotrophin-independent precociouspuberty (specialist use only; see also notes above). By mouth5 mg/kg 3–4 times daily; up to 10 mg/kg 4 timesdaily may be requiredTestolactone ATablets, testolactone 50 mgAvailable from ‘special-order’ manufacturers or specialistimporting companies, see p. 809GOSERELINCautions monitor bone mineral densityContra-indications undiagnosed vaginal bleedingPregnancy avoidBreast-feeding avoidSide-effects changes in blood pressure, headache,mood changes including depression, hypersensitivityreactions including urticaria, pruritus, rash, asthma