Hormone Therapy Products Available in Canada for Treatment of Menopausal Symptoms Physician Desk Reference

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1 Hormone Therapy Products Available in Canada for Treatment of Menopausal Symptoms Physician Desk Reference A clinical resource provided to you by

2 Prescribing Hormone Therapy Physicians today have a wide selection of hormone therapies to choose from if HT is deemed necessary for the management of troublesome menopausal symptoms. This guide was developed to assist busy physicians in optimizing treatment decisions by summarizing some of the key information about all of the hormone therapies currently available in Canada. For complete information about the individual treatments reviewed in this guide, please consult the respective product monographs. For more information about menopause, please consult the SOGC Clinical Guideline, Menopause and Osteoporosis Update 2009, available online at sogc.org. Clinical Guidance 1 These are general recommendations that must be modified according to individual clinical situations and desires of the woman after she has been fully assessed and informed of all the available treatment options. Contraindications to estrogen and progestin use Unexplained vaginal bleeding prior to investigation Known or suspected breast carcinoma Undiagnosed vaginal bleeding Acute liver disease Active thromboembolic disease (estrogen only) Pregnancy Use estrogen with caution History of cardiovascular disease and hypertriglyceridemia Risk of recurrence of breast cancer is unknown Use progestin with caution History of thromboembolic disorders Reference: 1 Reid RL, Blake J, Khan A, Abramson B, Fortier M, Senikas V. Menopause and Osteoporosis Update J Obstet Gynaecol Can 2009 Jan;31(1)(Suppl 1).

3 Oral (Tablets)* ESTRACE Shire Canada Inc. Derived from soybeans 17β-Estradiol Dosage / Strength 0.5 mg 1 mg 2 mg Prevention of PREMARIN Wyeth Canada Equine Conjugated estrogens 0.3 mg mg 0.9 mg 1.25 mg Prevention of Atrophic vaginitis Vulvar atrophy C.E.S. Generic Derived from plant sterols Conjugated estrogens 0.3 mg mg 0.9 mg 1.25 mg Prevention and treatment of Atrophic vaginitis * No progestin required in hysterectomized women. Oral Progestins PROMETRIUM Schering-Plough Progestin Synthetic Progestin Micronized progesterone Dosage / Strength 100 mg For women with an intact uterus as an adjunct to postmenopausal estrogen replacement therapy to significantly reduce the risk of endometrial hyperplasia and carcinoma PROVERA/ PROVERA PAK Pfizer Canada Inc. Derived from soybeans Medroxyprogesterone acetate Tablets: 2.5 mg 5 mg 10 mg Provera PAK: 5 mg x 14 tablets 10 mg x 10 tablets To oppose the effects of estrogen on the endrometrium and significantly reduce the risk of hyperplasia and carcinoma -1-

4 Oral Combination Products ACTIVELLE Novo Nordisk Synthetic Estradiol (as hemihydrate) Norethindrone acetate (NETA) Dosage / Strength 1 mg Estradiol mg NETA Vulvar or vaginal atrophy associated with menopause ACTIVELLE LD Novo Nordisk Synthetic Estradiol (as hemihydrate) Norethindrone acetate (NETA) 0.5 mg Estradiol mg NETA ANGELIQ Bayer Inc. Synthetic 17β-Estradiol Drospirenone (DRSP) 1 mg Estradiol + 1 mg DRSP Vulvar and vaginal dryness associated with menopause FemHRT Warner Chilcott Company, Inc. Synthetic Ethinyl estradiol (EE) Norethindrone acetate (NETA) 2.5 µg EE mg NETA (1 tablet) 5 µg EE + 1 mg NETA (1 tablet) Vulvar and vaginal atrophy associated with menopause Prevention of PREMPLUS/ PREMPLUS CYCLE Wyeth Canada Equine Conjugated estrogens (CE) Medroxyprogesterone acetate (MPA) Continuous therapy: mg CE + 2.5mg MPA (2 tablets) 0.625mg + 5 mg MPA (2 tablets) Vulvar and vaginal atrophy associated with menopause Prevention of Cyclic therapy: mg CE + 10 mg MPA (2 tablets) -2-

5 Transdermal (Patches and Gel)* CLIMARA Bayer Inc. Synthetic 17β-Estradiol Patch: mg 0.05 mg mg 0.1 mg (Weekly) Dosage, Strength and Administration Prevention of ESTRADERM Novartis Pharmaceuticals ESTRADOT Novartis Pharmaceuticals ESTROGEL Schering-Plough Synthetic 17β-Estradiol Patch: mg 0.05 mg 0.1 mg (Twice weekly) Synthetic 17β-Estradiol Patch: mg mg 0.05 mg mg 0.1 mg (Twice weekly) Synthetic 17β-Estradiol Gel: 0.06% 2.5 g/2 pumps daily from day 1 to 25 of each calendar month or from day 1 to 21 of a 28-day cycle (Daily) Prevention of Prevention of OESCLIM Triton Pharma Inc. Synthetic 17β-Estradiol Patch: mg mg 0.05 mg mg 0.1 mg (Twice weekly) * No progestin required in hysterectomized women. -3-

6 Transdermal Combination Products* CLIMARA PRO (matrix patch) Bayer Inc. ESTALIS Novartis Pharmaceuticals ESTRING (silastic ring) Bayer Inc. Synthetic 17β-Estradiol Levornogestrel (LNG) Synthetic 17β-Estradiol Norethindrone acetate (NETA) Dosage, Strength and Administration 45 µg Estradiol + 15 µg LNG (Once weekly) 50 µg Estradiol µg NETA 50 µg Estradiol µg NETA (Twice Weekly) Dosage / Strength Vulvar and vaginal atrophy * Recommended only in patients with an intact uterus since the regimen includes a progestin whose role is to prevent endometrial hyperplasia. Vaginal ** Synthetic 17β-Estradiol 2.0 mg/ring Atrophic vaginitis with or without pruritus vulvae Dyspareunia Dysuria Urinary urgency (atrophic mucosa in the urethra and trigonum) PREMARIN (cream) Wyeth Canada Equine Conjugated estrogens mg/g g/applicator Supplied in tubes of 14 g Atrophic vaginitis Dyspareunia Kraurosis vulvae VAGIFEM (tablet) Novartis Pharmaceuticals Synthetic 17β-Estradiol mg Initial dose: 1 tablet/d for 2 weeks Maintenance dose: 1 tablet twice weekly with 3-4 day interval **Addition of a progestin is not required. -4- Atrophic vaginitis

7 Unsupported Therapies Custom-Compounded Bioidenticals Custom-compounded bioidenticals are not regulated by Health Canada SOGC does NOT support the use of custom-compounded bioidenticals. SOGC DOES support the North American Menopause Society statement on Bioidentical Hormone Therapy: Concern arises with the bioidentical hormone medications that are customcompounded (custom-mixed) recipes prepared by a pharmacist following an individual prescriber s order for a specific treatment. These medications do not have [HEALTH CANADA] approval because individually mixed recipes have not been tested to prove that the active ingredients are absorbed appropriately or provide predictable levels in blood and tissue. Further, there is no scientific evidence about the effects of these compounded medications on the body both good and bad. Examples of custom-compounded bioidenticals: Bi-est cream Tri-est cream Estriol cream Progesterone cream DHEA (dehydroepiandrosterone) tablets -5-

8 For more information on women s health issues consult: sogc.org menopauseandu.ca sexualityandu.ca endometriosisinfo.ca hpvinfo.ca laughingwithoutleaking.ca menopause.org.ca powderroom.ca thebigow.ca womenshealthmatters.ca the society of obstetricians and gynaecologists of canada la société des obstétriciens et gynécologues du canada 780 promenade Echo Drive, Ottawa, Ontario K1S 5R7 Tel/Tél. : or/ou (613) Fax/Téléc. : (613) SOGC, September Unless otherwise specifically indicated, the naming of any organization, product or therapy, does not imply SOGC endorsement. Reproduction of this document in whole, or in part is strictly prohibited.

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