Individual Women, Individual HRT


A combined portfolio of HRT treatment options

MyWay HRT Range
Overview and
Stock Availability

Important Information about the Elleste™ Oral Range (estradiol +/- norethisterone)

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

Last updated: 21st October 2019

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
  • 80mcg transdermal estradiol
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
Femoston logo Femoston® conti
Doses:
  • 0.5mg estradiol + 2.5mg
    dydrogesterone
  • 1mg estradiol + 5mg
    dydrogesterone
Elleste logo Femoston logo Femoston conti logo Zumenon logo
Forulaton options

Mono Formulations
17ß Estradiol only

Elleste™ Solo
Doses:
  • 1mg estradiol
  • 2mg estradiol
Elleste Solo™ MX
Doses:
  • 40mcg transdermal
    estradiol
  • 80mcg transdermal
    estradiol
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
Femoston® conti
Doses:
  • 0.5mg estradiol + 2.5mg
    dydrogesterone
  • 1mg estradiol + 5mg
    dydrogesterone

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

Considerations

Why 17ß estradiol?

Non-equine
Body-identical 17ß estradiol

Why Dydrogesterone?

  • The Femoston® range of products contain both 17ß estrodiol and
    dydrogesterone
  • The Femoston® range offers both sequential and continuous combined options
  • Dydrogesterone’s molecular structure and shape makes it a highly selective
    progestin, 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
Oestrogenic
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
Oestrogenic 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?

  • Both the International Menopause Society (IMS) and the British Menopause Society (BMS) recommended that women should be placed on the lowest effective doses5,7
  • Some benefits of going low.6,7
    • Provide adequate symptom relief
    • Higher rates of amenorrhoea and better tolerability profile
    • Less side effects and risk associated reduced progestogen required
    • Patients to be more compliant, realising the benefits of HRT
    • Can be used in new starters (if postmenopausal), ≥12 months since last period, long-term users and women who are considering weaning off

Dose comparison

Oestrogen Ultra Low Low Standard High
Conjugated equine
oestrogens (mg)
0.3 0.625 1.25
Micronized
17ß-oestradiol (mg)
0.5 1 2 4
Oestradiol
valerate (mg)
1 2
Transdermal
17ß-oestradiol (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.

References
  1. Schindler AE. Maturitas 2003; 46(Suppl. 1): 7-16.
  2. Menopause matters, URL: https://www.menopausematters.co.uk/sideeffects.php.
  3. Jones EE. Am J Med 1995; 98(1A): 116S-9S.
  4. Panay N, et al. Human Reproduction Update 1997; 3( 2): 159-71.
  5. Baber RJ, et al. Climacteric 2016; 19(2): 109-50.
  6. Stevenson J, et al. Maturitas 2010; 67: 227-32.
  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.

HCP Disclaimer

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