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Precautions Interactions Pharmacokinetics Profile Profile 2310 Sex Hormones and their Modulators group of 28 028 who had used tibolone for an average of ment. Final results showed that after a median follow-up USP 36: (Trenbolone Acetate). Store in airtight containers at about 3 years. The risk of endometrial cancer was increased of about 3 years, there was an increased risk of cancer a temperature of 2 degrees to 8 degrees. to 1.79 (95% confidence interval l.43 to 2.25) in those who recurrence in those given tibolone, compared with place­ had used tibolone, compared with women who had never bo. Profile used HRT, and the risk was higher with more than 3 years of For reports of the incidence of breast and endometrial use compared with shorter durations. In contrast, a smaller cancers in women given tibolone, see Carcinogenicity, Trenbolone acetate has been used as an anabolic agent in veterinary practice. The hexahydrobenzylcarbonate has also randomised study' comparing tibolone with combined HRT p. 2309.3. been used for its anabolic properties. recorded no cases of endometrial hyperplasia or carcinoma 1. Dimitrakakis C, et al. Clinical effects of tibolone in postmenopausal WHO specifies an acceptable daily intake of trenbolone in 1317 women given tibolone for up to 2 years. women after 5 years of tamoxifen therapy for breast cancer. Climacteric 2005; 8: 342-5 1. acetate as a residue in foods, and recommends maximum I. von Dadelszen P, et a!. Endometrial hyperplasia and adenocarcinoma 2. Goutzioulis M, et a!. Tibolone therapy in breast cancer survivors: a during tibolone (Livial) therapy. Br J Obstet Gynaeco! I994; 101: 158-61. residue limits in various animal tissues. 1 However, it should retrospective study. J Obstet Gynaecol Res 2007; 33: 68-73. 2. Ginsburg J, Prelcvic Cause of vaginal bleeding in postmenopausal be noted that, in the EU the use of trenbolone acetate and GM. 3. Lee K-B, eta!. Endometrial cancer patients and tibolone: a matched case­ women taking tibolone. Maturitas 1996; 24: 107-10. control study. Maturitas 2006; 55: 264--9. other anabolic steroids is restricted to certain therapeutic 3. Yazigi R. et al. Carcinoma of the endometrium in patients treated with 4. Lee K-B, eta!. The safety of tibolone in epithelial ovarian cancer patients. indications in non-food producing animals and their use as tibolone. Gynecol Oncol 2004; 93: 568-70. Maturitas 2006; 55: 156-61. 4. Prys Davies A, Oram D. Exacerbation of adenomyosis in a growth promotors is banned. 5. Velthuis-te Wierik EJM, et a!. Preferential prescribing of tibolone and postmenopausal woman taking tibolone associated with an elevation l. FAO/WHO. Evaluation of certain veterinary drug residues in food: combined estrogen plus progestogen therapy in postmenopausal in serum CA 125. Br J Obstet Gynaecol 1994; 101: 632�3. thirty-fourth report of the joint FAO/WHO expert committee on food women. Menopause 2007; 14: 518-2 7. 5. de Vries CS, et a!. Tibolone and endometrial cancer: a cohort and nested additives. WHO Tech Rep Ser 788 1989. Also available at: http://libdoc. 6. Kenemans P, et al. LIBERATE Study Group. Safety and efficacy of case-control study in the UK. Drng Safety 2005; 28: 241�9. who.int/trs/WHO�TRS_788.pdf (accessed 13/11/07) tibolone in breast-cancer patients with vasomotor symptoms: a double­ 6. Million Women Study Collaborators. Endometrial cancer and hormone­ blind, randomised, non-inferiority trial. Lancet Oncol 2009; 10: 135-46. replacement therapy in the Million Women Study. Lancet 2005; 365: 1543-51. 7. Archer DF, et a!. Endometrial effects of tibolone. J Clin Endocrinol Metab Porphyria. The Drug Database for Acute Porphyria, com­ Trimegestone (BAN, USAN, r!NNJ · 2007; 92: 911-18. piled by the Norwegian Porphyria Centre (NAPOS) and . f\V-219�7;. Jrlr\1;eg'est()h; Triin�g�stgh� . TiirB�9estone; the Porphyria Centre Sweden, classifies tibolone as prob­ _ . Effects on thecardiovascular system. A study' of tibolone ably porphyrinogenic; it should be prescribed only for Trimogestoni;Tri.me.gestonum; Jpr1MerecJoH. _ •. <. 1. 7�;f&[- La�CtC>yl�l7-met.t'lyt\)stra-4,9cd!en�;H;ne: 17�[(5)-2� in the treatment of osteoporosis in postmenopausal compelling reasons and precautions should be considered · women aged between 60 and 85 years found tbat in all patients.1 H)ldroxypropiqnyll-l..7""metriylestrilc4;9·d)enc3"one, ·· although it reduced the risk of fracture, breast cancer, and l. The Drug Database for Acute Porphyria. Available at: http://www. CziH3fl0.,,:>42.5 possibly colon cancer, there was an increased risk of drugs-porphyria.org (accessed 06/10/ll) qA s.�74:5 t�-d2-$, stroke. The authors therefore concluded that tibolone UNII ...-..46S8KOH!(8fi¥ should not be used in elderly women and women with Interactions risk factors for stroke. Compounds that induce liver enzymes, such as phenytoin, Profile I. Cummings SR, et a!. LIFT Trial Investigators. The effects of tibolone in older postmenopausal women. N Eng! J Med 2008; 359: 697-708. carbamazepine, and rifampicin, might theoretically Trimegestone is a progestogen (see Progesterone, p. 2300.2) enhance the metabolism of tibolone and thus reduce its used as the progestogenic component of menopausal HRT activity. (see p. 2244. 1). It is given orally in daily doses of 250 or Precautions For reference to the effect of tibolone on the activity of 500 micrograms in a cyclical regimen, or 12 5 micrograms in Tibolone is contra -indicated in women with breast cancer or oral anticoagulants, see Sex Hormones under Warfarin, a continuous regimen. Trimegestone is also under oestrogen-dependent tumours, cardiovascular or cerebro­ p. 1535.1. investigation as a component of a combined oral vascular disorders including arterial or venous thromboem­ contraceptive. bolism, or a history of these conditions, undiagnosed Pharmacokinetics Reviews. vaginal bleeding, untreated endometrial hyperplasia, and 1. Grubb G, et a!. Clinical experience with trimegestone as a new progestin acute liver disorders. It should not be given to pregnant or Tibolone is rapidly and extensively absorbed after oral doses in HRT. Steroids 2003; 68: 921-6. breast-feeding women and is not intended for use in and quickly metabolised into three active metabolites, two 2. Sitruk-Ware R. et al. Preclinical and clinical properties of trimegestone: a potent and selective progestin. Gynecol Endocrinol 2007; 23: 310-19. premenopausal women, except those being treated with a of which have mainly oestrogenic activity while the third, like the parent compound, has progestogenic and gonadorelin analogue. Porphyria. The Drug Database for Acute Porphyria, com­ androgenic activity. Peak concentrations of tibolone and Use of tibolone within 12 months of a natural piled by the Norwegian Porphyria Centre (NAPOS) and its metabolites occur after about I to 1.5 hours, and the two menopause is not recommended because irregular vaginal the Porphyria Centre Sweden, classifies trimegestone and main metabolites have an elimination half-life of about 7 bleeding is likely. Breakthrough bleeding and spotting may oestrogen combinations as probably porphyrinogenic; it hours. Metabolites are excreted in the bile and eliminated in occur in the first few months of therapy, but should be should be prescribed oniy for compelling reasons and pre­ the faeces. About 30% of a dose is excreted in the urine. investigated if it persists beyond 6 months, starts after that cautions should be considered in all patients.1 time, or continues after tibolone has been stopped. Missing a l. The Drug Database for Acute Porphyria. Available at: http://www. I. Timmer CJ, Doorstam DP. Effect of renal impairment on the dose may increase the likelihood of bleeding and spotting. drugs-porphyria.org (accessed 04/IO/ll) Care should be taken when giving tibolone to patients pharmacokinetics of a single oral dose of tibolone 2.5 mg in early postmenopausal women. Pharmacotherapy 2002; 22: 148-53. with uterine fibroids, endometriosis, liver disease, gall­ 2. Timmer CJ, Huisman JA. Effect of a standardized meal on the Preparations stones, disorders that may be exacerbated by fluid retention bioavailability of a single oral dose of tibolone 2.5 mg in healthy ............................. such as cardiac or renal dysfunction, hypertension, epilepsy, postmenopausal women. Phannacotherapy 2002; 22: 310--15. ProprietaryPreparations (details are given in Volume B) 3. Timmer CJ, et a!. Pharmacokinetics of tibolone in early and late or migraine, or with a history of these conditions. It should Arg.: Totelle Ciclico; Totelle Con­ postmenopausal women. Br J Clin Phannacol 2002; 54: 101-6. Mul�·ingredient Prepara�ons, also be given with caution to patients with dyslipidaemia or 4. Verheul HAM, et a!. Pharmacokinetic parameters of sulfated tibolone tinuo; Braz.: Totelle Cicio; Totelle; Chile: Ginotex; Lavelle Cicli­ diabetes mellitus. Patients with risk factors for thromboem­ metabolites in postmenopausal women after single and multiple doses of co; Lavelle Continuo; Totelle Ciclico; Totelle Continuo; Mex. : bolic disorders or oestrogen -dependent tumours, or a tibolone. Clin Pharmacal Ther 2007; 81: 573-9. Totelle Continuo; Totelle Secuencial; Venez.: Totelle Ciclico; history of endometrial hyperplasia, should be closely Totelle Continuo. monitored. Tibolone should be stopped if there are signs of thromboembolism, a significant increase in blood pressure, ProprietaryPreparations (details are given in Volume B) new onset of migraine-type headache, or if abnormal liver Triptorelin (BAN, USAN, r!NNJ ® function tests or cholestatic jaundice occur. Consideration Arg. : Cervictal; Climalonat; Cli­ Single-ingredient Prepara�ons. B!<l-520l4; ··.•cL-1J$.5$'2; should be given to stopping tibolone 4 to 6 weeks before matix; Discretal; Paraclim; Senalina; Tiboclim; Tibofem; Tiro­ f'Y�25650;. El!M;2100�; · [6,o·TI)-pts:­ elective surgery when prolonged immobilisation after varina; Tocline; Austral.: Livial; Xyvion; Austria: Liviel; Belg.: p(lanJ MeJnTsing .·hor�norye-r�leasi[lg _factpr;. tr!pt(jf�li.�a: . · . Heria; Livial; Braz.: Klimater; Libiam; Livial; Livolon; Reduclim; .
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