Duavive
Authorised
This medicine is authorised for use in the European Union
oestrogens conjugated / bazedoxifene
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
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.
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.
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.
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.
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.
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.
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.
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 Duavive : EPAR - Risk-management-plan summary.
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.
Product information
Latest procedure affecting product information:
II/0036
24/07/2023
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Duavive
- Active substance
- oestrogens conjugated
- bazedoxifene
- International non-proprietary name (INN) or common name
- oestrogens conjugated
- bazedoxifene
- Therapeutic area (MeSH)
- Postmenopause
- Anatomical therapeutic chemical (ATC) code
- G03CC07
Pharmacotherapeutic group
conjugated estrogens and bazedoxifeneTherapeutic 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.
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