Duavive

oestrogens conjugated / bazedoxifene

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This is a summary of the European public assessment report (EPAR) for Duavive. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Duavive.

For practical information about using Duavive, patients should read the package leaflet or contact their doctor or pharmacist.

What is Duavive and what is it used for?

Duavive is a medicine used for the treatment of symptoms (such as hot flushes) caused by low blood levels of the female hormone oestrogen in women who have been through the menopause. It is used in women who still have their uterus (womb) and who cannot be treated with progestogen-containing medicines (medicines derived from the hormone called progesterone).

Duavive contains two active substances: conjugated oestrogens and bazedoxifene.

How is Duavive used?

Duavive can only be obtained with a prescription. It is available as modified release tablets (containing 0.45 mg conjugated oestrogens and 20 mg bazedoxifene) which release bazedoxifene immediately and conjugated oestrogens over a longer period of time.

The recommended dose of Duavive is one tablet once a day. Treatment should be for the shortest duration possible as long as benefits outweigh risks.

How does Duavive work?

One of the active substances in Duavive, conjugated oestrogens, works as hormone replacement therapy. It replaces the oestrogen hormones that are no longer produced naturally in women who have been through the menopause, thereby alleviating symptoms such as hot flushes.

However, oestrogens used alone can cause hyperplasia (growth) of the endometrium (lining of the womb) which could lead to endometrial cancer. Duavive therefore also contains the active substance bazedoxifene, which blocks the effects of oestrogens on the womb and so reduces the risk of endometrial cancer.

Both active substances have been available in the European Union (EU) for a number of years. Conjugated oestrogens have been available for many years as hormone replacement therapy and bazedoxifene has been authorised in 2009 for the treatment of osteoporosis (a disease that makes bones fragile) in women who have been through the menopause.

What benefits of Duavive have been shown in studies?

Duavive was compared with placebo (a dummy treatment) in two main studies in 996 women who have been through the menopause, investigating the effects on either hot flushes or vulvovaginal atrophy (dryness, irritation and soreness around the genital area). An additional study also looked at the effects of Duavive on osteoporosis.

In the study investigating the effects on hot flushes, treatment with Duavive (conjugated oestrogen 0.45 mg and bazedoxifene 20 mg) over 12 weeks reduced the average daily number of moderate and severe hot flushes by 7.6 compared with 4.9 for placebo. Treatment with Duavive also led to a greater average fall in the daily severity score of hot flushes than placebo treatment: 0.9 versus 0.3. Similar results were seen with a higher strength of conjugated oestrogen (0.625 mg) plus bazedoxifene 20 mg when compared with placebo.

The study looking at the effects of Duavive on vulvovaginal atrophy found an improvement in some of the signs of vaginal atrophy but not in the most bothersome symptoms when compared with placebo.

Because studies with the higher strength combination did not sufficiently show that this strength was more effective than the approved strength of Duavive, the company withdrew its application for the former. One of the studies also looked at the effects of Duavive on osteoporosis; however, as there was no benefit of Duavive over the individual components the company withdrew its application for Duavive in the treatment of osteoporosis.

What are the risks associated with Duavive?

The most common side effect with Duavive (which may affect more than 1 in 10 people) is abdominal pain (stomach ache).

Some women must not use Duavive including those who have had problems with venous thromboembolism (blood clots in the veins) such as deep-vein thrombosis (DVT), pulmonary embolism (a blood clot in the lungs) and retinal-vein thrombosis (a blood clot at the back of the eye), or are at an increased risk of such problems. It must not be used in women who have had a stroke or heart attack. It must also not be used in women who have, are likely to have or have had breast cancer or other cancers that are known to be oestrogen-dependent. Duavive is only for use in women who have been through the menopause, so it must not be used in women who could become pregnant.

For the full list of all side effects and restrictions with Duavive, see the package leaflet.

Why is Duavive approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Duavive’s benefits are greater than its risks and recommended that it be approved for use in the EU. Duavive was shown to improve the symptoms caused by lack of oestrogen in postmenopausal women when compared with placebo. Because the observed treatment effects were smaller than what is seen with alternative treatments (progestogen-containing treatments) the CHMP therefore concluded that Duavive should be reserved for women who cannot take these alternative medicines.

Regarding safety, the long-term risk of endometrial hyperplasia has not been fully investigated and the CHMP recommended further studies to be carried out. The CHMP also noted that long-term use of Duavive is associated with a risk of stroke and venous thromboembolism which is similar to the risk with conjugated oestrogens and bazedoxifene when used alone.

What measures are being taken to ensure the safe and effective use of Duavive?

A risk management plan has been developed to ensure that Duavive is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Duavive, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Duavive

The European Commission granted a marketing authorisation valid throughout the European Union for Duavive on 16 December 2014.

For more information about treatment with Duavive, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Duavive : EPAR - Summary for the public BG = bălgarski 30/01/2015  
Duavive : EPAR - Summary for the public ES = español 30/01/2015  
Duavive : EPAR - Summary for the public CS = čeština 30/01/2015  
Duavive : EPAR - Summary for the public DA = dansk 30/01/2015  
Duavive : EPAR - Summary for the public DE = Deutsch 30/01/2015  
Duavive : EPAR - Summary for the public ET = eesti keel 30/01/2015  
Duavive : EPAR - Summary for the public EL = elliniká 30/01/2015  
Duavive : EPAR - Summary for the public EN = English 30/01/2015  
Duavive : EPAR - Summary for the public FR = français 30/01/2015  
Duavive : EPAR - Summary for the public IT = italiano 30/01/2015  
Duavive : EPAR - Summary for the public LV = latviešu valoda 30/01/2015  
Duavive : EPAR - Summary for the public LT = lietuvių kalba 30/01/2015  
Duavive : EPAR - Summary for the public HU = magyar 30/01/2015  
Duavive : EPAR - Summary for the public MT = Malti 30/01/2015  
Duavive : EPAR - Summary for the public NL = Nederlands 30/01/2015  
Duavive : EPAR - Summary for the public PL = polski 30/01/2015  
Duavive : EPAR - Summary for the public PT = português 30/01/2015  
Duavive : EPAR - Summary for the public RO = română 30/01/2015  
Duavive : EPAR - Summary for the public SK = slovenčina 30/01/2015  
Duavive : EPAR - Summary for the public SL = slovenščina 30/01/2015  
Duavive : EPAR - Summary for the public FI = suomi 30/01/2015  
Duavive : EPAR - Summary for the public SV = svenska 30/01/2015  
Duavive : EPAR - Summary for the public HR = Hrvatski 30/01/2015  
Name Language First published Last updated
Duavive : EPAR - Risk-management-plan summary (English only) 30/01/2015  

This EPAR was last updated on 13/05/2016 .

Authorisation details

Product details

Product details for Duavive
NameDuavive
Agency product numberEMEA/H/C/002314
Active substance

oestrogens conjugated / bazedoxifene

International non-proprietary name (INN) or common name

oestrogens conjugated / bazedoxifene

Therapeutic area Osteoporosis
Anatomical therapeutic chemical (ATC) code G03CX

Publication details

Publication details for Duavive
Marketing-authorisation holder

Pfizer Limited

Revision5
Date of issue of marketing authorisation valid throughout the European Union16/12/2014

Contact address:

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Product information

Product information

19/04/2016  Duavive -EMEA/H/C/002314 -IA/0011

Name Language First published Last updated
Duavive : EPAR - Product Information EN = English 30/01/2015 13/05/2016
Duavive : EPAR - Product Information EN = English 30/01/2015 13/05/2016
Duavive : EPAR - Product Information EN = English 30/01/2015 13/05/2016
Duavive : EPAR - Product Information EN = English 30/01/2015 13/05/2016
Duavive : EPAR - Product Information EN = English 30/01/2015 13/05/2016
Duavive : EPAR - Product Information EN = English 30/01/2015 13/05/2016
Duavive : EPAR - Product Information EN = English 30/01/2015 13/05/2016
Duavive : EPAR - Product Information EN = English 30/01/2015 13/05/2016
Duavive : EPAR - Product Information EN = English 30/01/2015 13/05/2016
Duavive : EPAR - Product Information EN = English 30/01/2015 13/05/2016
Duavive : EPAR - Product Information EN = English 30/01/2015 13/05/2016
Duavive : EPAR - Product Information EN = English 30/01/2015 13/05/2016
Duavive : EPAR - Product Information EN = English 30/01/2015 13/05/2016
Duavive : EPAR - Product Information EN = English 30/01/2015 13/05/2016
Duavive : EPAR - Product Information EN = English 30/01/2015 13/05/2016
Duavive : EPAR - Product Information EN = English 30/01/2015 13/05/2016
Duavive : EPAR - Product Information EN = English 30/01/2015 13/05/2016
Duavive : EPAR - Product Information EN = English 30/01/2015 13/05/2016
Duavive : EPAR - Product Information EN = English 30/01/2015 13/05/2016
Duavive : EPAR - Product Information EN = English 30/01/2015 13/05/2016
Duavive : EPAR - Product Information EN = English 30/01/2015 13/05/2016
Duavive : EPAR - Product Information EN = English 30/01/2015 13/05/2016
Duavive : EPAR - Product Information EN = English 30/01/2015 13/05/2016
Duavive : EPAR - Product Information EN = English 30/01/2015 13/05/2016
Duavive : EPAR - Product Information EN = English 30/01/2015 13/05/2016

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Duavive : EPAR - All Authorised presentations EN = English 30/01/2015  
Duavive : EPAR - All Authorised presentations EN = English 30/01/2015  
Duavive : EPAR - All Authorised presentations EN = English 30/01/2015  
Duavive : EPAR - All Authorised presentations EN = English 30/01/2015  
Duavive : EPAR - All Authorised presentations EN = English 30/01/2015  
Duavive : EPAR - All Authorised presentations EN = English 30/01/2015  
Duavive : EPAR - All Authorised presentations EN = English 30/01/2015  
Duavive : EPAR - All Authorised presentations EN = English 30/01/2015  
Duavive : EPAR - All Authorised presentations EN = English 30/01/2015  
Duavive : EPAR - All Authorised presentations EN = English 30/01/2015  
Duavive : EPAR - All Authorised presentations EN = English 30/01/2015  
Duavive : EPAR - All Authorised presentations EN = English 30/01/2015  
Duavive : EPAR - All Authorised presentations EN = English 30/01/2015  
Duavive : EPAR - All Authorised presentations EN = English 30/01/2015  
Duavive : EPAR - All Authorised presentations EN = English 30/01/2015  
Duavive : EPAR - All Authorised presentations EN = English 30/01/2015  
Duavive : EPAR - All Authorised presentations EN = English 30/01/2015  
Duavive : EPAR - All Authorised presentations EN = English 30/01/2015  
Duavive : EPAR - All Authorised presentations EN = English 30/01/2015  
Duavive : EPAR - All Authorised presentations EN = English 30/01/2015  
Duavive : EPAR - All Authorised presentations EN = English 30/01/2015  
Duavive : EPAR - All Authorised presentations EN = English 30/01/2015  
Duavive : EPAR - All Authorised presentations EN = English 30/01/2015  
Duavive : EPAR - All Authorised presentations EN = English 30/01/2015  
Duavive : EPAR - All Authorised presentations EN = English 30/01/2015  

Pharmacotherapeutic group

Sex hormones and modulators of the genital system

Therapeutic indication

Duavive is indicated for:

Treatment of oestrogen deficiency symptoms in postmenopausal women with a uterus (with at least 12 months since the last menses) for whom treatment with progestin-containing therapy is not appropriate. 

The experience treating women older than 65 years is limited.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Duavive : EPAR - Procedural steps taken and scientific information after authorisation EN = English 22/07/2015 13/05/2016

Initial marketing-authorisation documents

Name Language First published Last updated
Duavive : EPAR - Public assessment report EN = English 30/01/2015  
CHMP summary of positive opinion for Duavive EN = English 24/10/2014  

Authorised

This medicine is approved for use in the European Union