MyWay HRT Range Overview and Stock Availability

With multiple products for mono, sequential and continuous combined needs,
view the MyWay HRT range AND availability below

Last updated: 10/08/2021

Stock Status Key

In Stock

Current Stock Constraint

MONO FORMULATION OPTIONS (17ß ESTRADIOL)
Elleste logo Elleste™ Solo
Doses:
  • 1mg estradiol
  • 2mg estradiol
Elleste Solo™ MX
Doses:
  • 40mcg transdermal estradiol  Discontinued
  • 80mcg transdermal estradiol  Discontinued
Zumenon logo Zumenon®
Doses:
  • 1mg estradiol
  • 2mg estradiol
SEQUENTIAL COMBINED FORMULATION OPTIONS
(17ß ESTRADIOL + PROGESTIN)
Elleste logo Elleste Duet™
Doses:
  • 1mg estradiol + 1mg norethisterone acetate
  • 2mg estradiol + 1mg norethisterone acetate
Femoston logo Femoston®
Doses:
  • 1mg estradiol + 10mg dydrogesterone
  • 2mg estradiol + 10mg dydrogesterone
CONTINUOUS COMBINED FORMULATION OPTIONS
(17ß ESTRADIOL + PROGESTIN)
Elleste logo Elleste Duet™ Conti
Doses:
  • 2mg estradiol + 1mg norethisterone acetate
Femoston conti logo Femoston® conti
Doses:
  • 0.5mg estradiol + 2.5mg
    dydrogesterone
  • 1mg estradiol + 5mg
    dydrogesterone
Elleste logo Femoston logo Femoston conti logo Zumenon logo
Formulation options

Mono Formulations
17ß Estradiol only

Elleste Solo Doses:
  • 1mg estradiol
  • 2mg estradiol
Elleste Solo MX Doses:
  • 40mcg transdermal
    estradiol  Discontinued
  • 80mcg transdermal
    estradiol  Discontinued
Zumenon® Doses:
  • 1mg estradiol
  • 2mg estradiol

Sequential Combined
Formulations

17ß Estradiol+progestin

Elleste Duet Doses:
  • 1mg estradiol + 1mg norethisterone acetate
  • 2mg estradiol + 1mg norethisterone acetate
Femoston® Doses:
  • 1mg estradiol + 10mg dydrogesterone
  • 2mg estradiol + 10mg dydrogesterone

Continuous Combined
Formulations

17ß Estradiol + progestin

Elleste Duet Conti Doses:
  • 2mg estradiol + 1mg norethisterone acetate
Femoston®-conti Doses:
  • 0.5mg estradiol + 2.5mg
    dydrogesterone
  • 1mg estradiol + 5mg
    dydrogesterone

ELL-2021-0049, August 2021

Mylan

Dear Healthcare Professional,

Earlier this year, Mylan informed you that our third-party manufacturing partner was experiencing an interruption in the production of Elleste, which included; Elleste Solo (1mg & 2mg), Elleste Duet (1mg & 2mg) and Elleste Duet Conti (2mg).

At that time, we anticipated a temporary interruption and for stock levels to resume during the middle of 2019. To minimise disruption to patients and to support pharmacies, societies and healthcare professionals (HCPs) across the country we took several proactive steps, including:

  1. • sending two Elleste stock constraint mailers to 50,000+ HCPs;
  2. • informing the British Menopause Society;
  3. • continuously communicating with the National Pharmacy Association; and
  4. • creating a MyWay Pharmacist leaflet for our salesforce to use when visiting pharmacists across the country.

In addition, we created a new promotional page on our dedicated HCP website, called MyWay HRT Overview and Stock Availability. This page provides details of our range of HRT products, stock availability and options to switch patients to alternative products where appropriate.

To ensure the stable supply of Elleste Oral Tablets in the future, Mylan will be transferring the production of Elleste to a Mylan owned and operated facility.

The site transfer is in progress and we anticipate production to resume by second half of 2020. In the meantime, any stock of Elleste Oral Tablets in the market, is available to order and prescribe. Once that supply has been depleted, the replenishment of Elleste Oral Tablets will not be available until the site transfer process has been completed.

We will continue to support pharmacies, societies and healthcare professionals by providing updates to our materials and communications including updates to stock availability, timing for resolution and information about Mylan’s other HRT products.

Please note that this does not affect the transdermal patches; Elleste Solo™ MX (40 and 80mcg).

Information for Prescribers

Mylan is unable to make any specific treatment recommendations to healthcare professionals or individual patients. We would like to highlight that there are other Hormone Replacement Therapy products in our portfolio which are available, please visit mywayhub.co.uk/en-gb/range or www.mylanconnects.co.uk for more information. Please note these are promotional websites and contain information on Mylan’s products.

For enquiries in relation to availability of a product, please contact our Customer Service team on, +44 (0)1707 853 100 or mguk_customer.service@mylan.co.uk. For medical information enquiries, please contact Mylan medical information team on +44 (0)1707 853000 (option 1) or info.uk@mylan.co.uk.

Yours Sincerely,

Dr Ken Tam
Senior Medical Advisor

About Elleste
Elleste is a hormone replacement therapy (HRT) for oestrogen deficiency symptoms in post and peri-menopausal women.

Resources
Elleste Solo 1mg – Patient Information Leaflet and SmPC
Elleste Solo 2mg – Patient Information Leaflet and SmPC
Elleste Duet 1mg – Patient Information Leaflet and SmPC
Elleste Duet 2mg – Patient Information Leaflet and SmPC
Elleste Duet Conti 2mg – Patient Information Leaflet and SmPC

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Mylan by phone: 0800 121 8267 or email: ukpharmacovigilance@mylan.com

ELL-2019-0050

Date of preparation: August 2019

For Medical Information please e-mail info.uk@viatris.com
For Customer Service please e-mail productenquiries@viatris.com

Considerations

Why 17ß estradiol?

  • Non-equine
  • Body-identical 17ß estradiol

Why Dydrogesterone?

  • The Femoston® range of products contain both 17ß estradiol and
    dydrogesterone
  • The Femoston® range offers both sequential and continuous combined options
  • Dydrogesterone’s molecular structure and shape makes it a highly selective
    progestogen, binding almost exclusively to the progestogen receptors1
  • In comparison to progesterone, dydrogesterone has increased bioavailability and has some progestogenic metabolites meaning that a dose of 10-20 times lower is adequate for endometrial proliferation1

Progestogenic Side Effect Profiles1

Progestogen
Progestogenic
Estrogenic
Androgenic
Anti-androgenic
Glucocorticoid
Anti-
mineralo-corticoid
Progesterone + ± + +
Dydrogesterone + ± ±
Drospirenone + + +
MPA* + ± +
Norethisterone + + +
Levonorgestrel + +

+ Effective; ± Weakly effective; – Not effective
*MPA: medroxyprogesterone acetate

Receptor side effects2,3,4

Receptors Common side effects by stimulation of receptors
Estrogenic Breast tenderness, enlargement, leg cramps, bloating, nausea, headache
Progestogenic PMS type symptoms, mood changes
Androgenic Oily skin, acne, hirsutism
Glucocorticoid Dosage and duration dependent: oedema, fluid retention, weight gain
Mineralcorticoid3 Oedema, weight gain, bloating and migraine

Why go low?

Dose comparison

Estrogen Ultra Low Low Standard High
Conjugated equine
estrogens (mg)
0.3 0.625 1.25
Micronized
17ß-estradiol (mg)
0.5 1 2 4
Estradiol
valerate (mg)
1 2
Transdermal
17ß-estradiol (μg)
25 50 100

Table adapted from Maturitas, 40, Gambacciani M. Hormone replacement therapy: the benefits
in tailoring the regimen and dose. 195-201, Copyright (2001), with permission from Elsevier.

  • The benefits of Femoston® conti in a low dose

    Lowest available
    oral dose on the market9

    Femoston logo
  • Both the International Menopause Society (IMS) and the British Menopause Society (BMS) recommended that women should be placed on the lowest effective doses5,7,8
  • Some benefits of going low.6-8
    • Provide adequate symptom relief
    • Higher rates of amenorrhoea and better tolerability profile
    • Ultra-low dose continuous combined estradiol and progestogen regimens (e.g. 0.5mg estradiol in combination with dydrogesterone 2.5 mg) appear to maintain the benefits of higher dose regimens whilst allowing minimal use of progestogen to reduce side-effects
  • References

    1. 1) Schindler AE, Campagnoli C, Druckmann R, et al. Classification and pharmacology of progestins. Maturitas. 2008;61(1–2):171–80.
    2. 2) Menopause matters, URL: https://www.menopausematters.co.uk/sideeffects.php.
    3. 3) Jones EE. Androgenic effects of oral contraceptives: implications for patient compliance. Am J Med.1995;16;98(1A):116S-119S. doi: 10.1016/s0002-9343(99)80069-2.
    4. 4) Panay N, et al. Progestogen intolerance and compliance withhormone replacement therapy in menopausal women. Human Reproduction Update. 1997;3(2):159-171.
    5. 5) Baber RJ, Panay N, Fenton AT. 2016 IMS Recommendations on women’s midlife health and menopause hormone therapy. Climacteric.16 Mar;19(2):109-50.
    6. 6) Stevenson J, et al.Oral ultra-low dose continuous combined hormone replacement therapy with 0.5 mg 17β-oestradiol and 2.5 mg dydrogesterone for the treatment of vasomotor symptoms: results from a double-blind, controlled study. Maturitas. 2010 Nov;67(3):227-32.
    7. 7) Panay N, et al. on behalf of the British Menopause Society (BMS) and Women’s Health Concern (WHC). Menopause International. 2013; 19(2): 59-68.
    8. 8) Hamoda H, et al. The British Menopause Society & Women's Health Concern 2020 recommendations on hormone replacement therapy in menopausal women. Post Reprod Health. 2020;26(4):181-209.
    9. 9) Mylan data on file 2021.

HCP Disclaimer

This website is intended for UK healthcare professionals only.

hcp popup title

Viatris Connect is an online platform for UK healthcare professionals.

Across the website you will find news, blogs and product information.

FREE Menopause and HRT webinars available to watch by registering to Viatris Connect today

Please note that the website contains promotional and non-promotional material including educational content and resources to help you and your patients.

REGISTER NOW