Berkshire West Integrated Care System Representing Berkshire West Clinical Commisioning Group Royal Berkshire NHS Foundation Trust Berkshire Healthcare NHS Foundation Trust Berkshire West Primary Care Alliance HRT formulary and treatment guidance [APC ClinDoc 010) For the latest information on interactions and adverse effects, always consult the latest version of the Summary of Product Characteristics (SPC), which can be found at: http://www.medicines.org.uk/ Approval and Authorisation Approved by Job Title Date Area Prescribing APC Chair January 2016 Committee Change History Version Date Author Reason v.1.0 09/2018 - Updated APC Category This prescribing guideline remains open to review considering any new evidence This guideline should only be viewed online and will no longer be valid if printed off or saved locally Author - Date of production: January 2016 Job Title - Review Date May 2019 Protocol Lead - Version v 1.0 Berkshire West CCGs HRT formulary and treatment guidance Contents ñ Formulary Oral or transdermal HRT—ofer choice but avoid oral if ñ Diagnosing menopause and need for treatment ñ VTE risks or personal /frst degree relatve with history ñ Initatng and managing HRT Patent assessment ñ Poor symptom control with oral Choice of HRT route ñ Bowel disorder /absorpton problems /gastric banding Types of treatment regimes ñ Lactose intolerance Topical oestrogen ñ History of migraines Dose, duraton and weaning of HRT ñ Tibolone Stroke risks e.g. BMI>30/smoker/sedentary ñ Contraindicatons, cautons and risks of HRT ñ History of or concerns of gall stones ñ Consideratons associated with HRT ñ On hepatc enzyme inducing agent including OTC preparatons Bleeding paterns Lack of efcacy Side efects Contracepton, IUS and HRT First treatment opton ñ Premature ovarian insufciency/premature menopause ñ When to refer Second line treatment optons ñ Resources and references Oestrogen only Hysterectomy, 1 prescripton charge HRT Product Oestrogen Delivery Dose Indicaton for use Elleste solo Oestradiol Oral tablets 1 mg, 2mg First line oral treatment opton daily Premarin Conjugated equine Oral tablets 300mcg, Consider if previously well on conjugated oestrogen 0.625mg, 1.25mg equine oestrogen. daily Evorel Oestradiol Transdermal 25,50,75,100 mcg First line transdermal opton patches twice weekly Elleste Solo Mx Oestradiol Transdermal 40, 80mcg twice Skin allergy /poor absorpton with Evorel, patches weekly alternatve adhesives Estradot Oestradiol Transdermal 25, 37.5, 50, 75, Smaller sized patches consider for higher patches 100mcg twice doses and pette women weekly Sandrena Oestradiol Transdermal gel 0.5, 1, 1.5 mg/g Patent preference, skin allergy to patches daily or side efects Sequental/cyclical combined HRT Uterus present, perimenopausal women, 2 prescripton charges, monthly bleed HRT Product Oestrogen/progestogen Delivery Dose Indicaton for use Oestrogen/ progestogen Elleste duet Oestradiol /norethisterone Oral tablets 1mg/1mg First line oral treatment opton Femoston Oestradiol/dydrogesterone Oral tablets 1mg/10mg If cyclical side efects to norethisterone or other progestogen Prempak C Conjugated equine Oral tablets 0.625mg/150mcg Consider if previously well on conjugated 1.25mg/150mcg equine oestrogen. oestrogen/norgestrel daily Evorel Sequi Oestradiol/norethisterone Transdermal 50mcg/170mcg First line transdermal treatment opton patches FemSeven Sequi Oestradiol/levonorgestrel Transdermal 50mcg/10mcg Skin allergy /poor absorpton with Evorel, patches alternatve adhesives Oestradiol tablet/ Oestradiol plus proges- Side efects with other progestogens, patch/gel as above togen/progesterone of bleeding problems, contraceptve needs plus adjunctve choice (see table below) progestogen/ progesterone 1 Contnuous combined HRT Uterus present, postmenopausal women, 1 prescripton charge, cycle free HRT Product Oestrogen/progestogen Delivery Dose Indicatons for use Oestrogen/ progestogen Kliovance Oestradiol/norethisterone Oral tablets 1mg/0.5mg First line oral treatment opton Femoston Cont Oestradiol/dydrogesterone Oral tablets 1mg/5mg If side efects to other progesto- 0.5mg/2.5mg gen Premique low dose Conjugated equine oes- Oral tablets 0.3mg/1.5mg Consider if previously well on con- trogen/ jugated equine oestrogen. medroxyprogesterone acetate Indivina Oestradiol/ Oral tablets 1mg/5mg Contnued irregular bleeding with Medroxyprogesterone ace- other oral contnuous combined tate HRT with no uterine pathology Angeliq Oestradiol/drospirenone Oral tablets 1mg/2mg Bloatng, breast tenderness, acne with other progestogens Tibolone Tibolone (synthetc molecule Oral tablets 2.5mg Low libido (also consider post hys- with oestrogen, progestogen terectomy and/or BSO if libido and androgenic propertes) low) Evorel Cont Oestradiol/norethisterone Transdermal 50mcg/170mcg First line transdermal treatment patches twice weekly opton FemSeven Cont Oestradiol/levonorgestrel Transdermal 50mcg/10mcg Skin allergy /poor absorpton with patches once weekly Evorel, alternatve adhesives Oestradiol only tablet/ Oestradiol plus progestogen/ Side efects with other progesto- patch/gel (see page 1) progesterone of choice (see gens or bleeding problems plus adjunctve proges- table below) togen/progesterone Topical vaginal oestrogen HRT product Oestrogen Delivery Dose Indicatons for use Vagifem Oestradiol Vaginal tablet 10mcg as First line topical treatment opton directed Gynest/Estriol 0.01% Oestriol Vaginal cream Using applicator Patent or clinician preference as directed Estring Oestradiol Vaginal ring 7.5mcg daily over Allergies to other topical prod- 90 days ucts, dexterity problems with ap- plicators, patent preference Adjunctve progestogen in HRT—use alongside either oral or transdermal oestrogen for women with uterus to pro- vide endometrial protecton. Intrauterine system (Mirena) - NB Licensed for 4 years for HRT use Medroxyprogesterone acetate (provera) tablets ñ cyclical regime—10mg for 12 days each 28 day cycle ñ contnuous combined HRT—2.5-5mg daily contnuously Utrogestan (micronized progesterone) capsules ñ Cyclical regime—200mg orally at bedtme for 12 days each 28 day cycle ñ Contnuous combined HRT—100mg orally daily contnuously at bedtme 2 Treatment guidance Adopt an individualised approach to diagnosis, investgaton and management of menopause Diagnosing menopause and need for treatment—both short and long term ñ Diagnosis of menopause should be based on the woman’s symptoms and age ñ Healthy women > 45 years with menopausal symptoms, diagnose without laboratory tests if the woman has vasomotor symptoms and irregular periods. the woman has not had a period for at least 12 months. or based on symptoms in woman without a uterus. ñ Consider using FSH if the woman is between 40–45 years with menopausal symptoms, including a change in menstrual cycle. the woman is younger than 40 years in whom premature menopause is suspected. ñ A pelvic examinaton should be performed only if clinically indicated and to exclude other possible causes of symptoms. ñ FSH level over 30 IU/L is diagnostc of ovarian decline. Fluctuatons of FSH in perimenopause limit its value. FSH should not be done if taking combined oestrogen and progestogen contracepton or high dose progestogen. ñ Consider HRT to manage menopause symptoms including vasomotor symptoms, psychological symptoms (including low mood that arises as result of menopause), altered sexual functon and urogenital atrophy. ñ The benefts of HRT are likely to outweigh the risks for women with disruptve symptoms below the age of 60 years or with- in 10 years of menopause. ñ In women with premature ovarian insufciency (premature menopause), systemic HRT is recommended, if not contraindi- cated, untl at least the average age of natural menopause (51-52 years) to prevent the early onset of osteoporosis, CVD, Alzheimer’s disease, Parkinsonism and cognitve decline. ñ HRT may be appropriate for preventon of osteoporosis related fractures in women below the age of 60 years or within 10 years of menopause in symptomatc women or if other bone protecton medicaton is contraindicated. ñ There is no clear evidence that SSRIs or SNRIs ease low mood in menopausal women who have not been diagnosed with depression. Initatng and managing HRT ñ The opton of taking HRT is an individual decision made afer a consultaton with the woman that addresses quality of life, health priorites, risks (including age and tme since menopause), benefts and her personal preference. ñ Consider HRT, if not contraindicated, for treatment of vasomotor symptoms, low mood in menopausal women, uro- genital atrophy (either topical alone or alongside systemic) and altered sexual functon. It will also provide osteoporo- sis protecton. ñ Discuss efectveness of HRT, risks, benefts, bleeding paterns, side efects. ñ Patent assessment includes History of menopause and other symptoms Menstrual history Contraceptve needs (HRT is not contraceptve) Personal and family medical problems, patent risk factors cancer—breast, bowel, ovarian osteoporosis venous thromboembolism, CV risks other medical problems including migraine Concomitant medicaton including alternatve/OTC therapies Patent preference for treatment Check blood pressure, height, weight, BMI ñ Choice of route Ofer patent choice of oral or transdermal. Avoid oral if ñ VTE risks or personal /frst degree relatve with history of VTE (both provoked and unprovoked) ñ Poor symptom control with oral ñ Bowel disorder /absorpton problems /gastric banding, ñ Lactose intolerance ñ History of migraines ñ Stroke risks e.g. BMI>30/smoker/sedentary