Duavive (Conjugated Estrogens/Bazedoxifene)

Duavive general information

What is Duavive used for?

Duavive tablets 0.45mg/20mg are a combination hormone replacement therapy (HRT) for women with an intact uterus, who have not had a period for at least 12 months, and are used to substitute for a lack of oestrogen production by the ovaries that happens during menopause.  This combination therapy is used for women where a combination containing a progestin is not suitable.  Duavive tablets help relieve symptoms of menopause caused by oestrogen deficiency, such as hot flushes, night sweats, sleeplessness, vaginal dryness, headaches, mood swings, lack of concentration and loss of energy; while at the same time protecting against endometrial (lining of the uterus) cancer.  They may also be used to help prevent postmenopausal bone loss (osteoporosis) and reduce risk of fracture. 

How does Duavive work?

Duavive tablets 0.45mg/20mg are a modified-release tablet containing a hormone component of conjugated oestrogens, which is a mixture of natural oestrogen in different forms, including estrone, equilin, 17α-estradiol and 17β-estradiol; also a non-hormone component bazedoxifene, which is belongs to a group of drugs known as selective estrogen receptor modulators (SERMs).  These two components in Duavive tablets are used in combination for hormone replacement therapy (HRT) to relieve symptoms of menopause.  Oestrogen is the female steroid hormone produced by the ovaries that binds to specific receptors inside oestrogen-responsive cells and stimulates them to make proteins involved in several aspects of female secondary characteristics including regulating the menstrual cycle.  Oestrogen also has several other actions in various metabolic processes including maintaining bone mass and lipid (fat) metabolism.  Conjugated oestrogens in Duavive tablets substitute for lack of endogenous oestrogen (produced by the ovaries) and bind to the oestrogen receptor in various tissues where they demonstrate tissue selective oestrogen receptor agonist activity to alleviate symptoms of menopause.  They also bind to oestrogen receptors in the endometrium (lining of the uterus) where they stimulate growth of the endometrium.  However, unopposed oestrogen actions can increase the risk of endometrial hyperplasia and cancer.  Bazedoxifene in Duavive tablets acts as an oestrogen antagonist, by binding to the oestrogen receptor in the uterus and this counteracts the effects of oestrogen on endometrial cell growth, which reduces the risk of endometrial cancer. The combination of an oestrogen agonist and antagonist works to relieve the various symptoms of menopause and provides selective protection against endometrial cancer.

What does Duavive contain?

Duavive tablets contain the active ingredients conjugated oestrogens (0.45mg) and bazedoxifene acetate equivalent to 20 mg of bazedoxifene that are used in combination for hormone replacement therapy (HRT) to relieve symptoms of menopause.  Conjugated oestrogens are a mixture of sodium estrone sulfate, sodium equilin sulfate, sodium sulfate conjugates, 17α-dihydroequilin, 17α-estradiol, and 17β-dihydroequilin, obtained exclusively from natural sources and blended to simulate pregnant mares’ urine. Duavive tablets also contain lactose monohydrate, microcrystalline cellulose, powdered cellulose, hypromellose, magnesium stearate, calcium phosphate, sucrose, hyprolose, macrogol 400, sucrose palmitate, ascorbic acid, OpadryPink, Opaglos 2 Clear, Opacode black ink.

Duavive for hormone replacement therapy (HRT)

Duavive tablets 0.45mg/20mg contain a hormone component, comprising conjugated oestrogens, and a non-hormone component bazedoxifene, a selective estrogen receptor modulator (SERM) that are used in combination for hormone replacement therapy (HRT) for women with intact uterus.  Conjugated oestrogens in Duavive tablets substitute for a lack of oestrogen production by the ovaries that happens during menopause, to relieve moderate symptoms of menopause caused by oestrogen deficiency, such as hot flushes, night sweats, sleeplessness, vaginal dryness, headaches, mood swings, lack of concentration and loss of energy.  Oestrogen also has several other beneficial actions in various metabolic processes including bone turnover and helps prevent postmenopausal bone loss (osteoporosis) and reduce risk of fracture.  Conjugated oestrogens in Duavive tablets also bind to oestrogen receptors in the endometrium (lining of the uterus) where they stimulate growth of the endometrium, which can increase the risk of endometrial hyperplasia and cancer.  Bazedoxifene in Duavive tablets acts as an oestrogen antagonist, by binding to the oestrogen receptor in the uterus and this counteracts the effects of oestrogen on endometrial cell growth, which reduces the risk of endometrial cancer. The combination of an oestrogen agonist and antagonist works to relieve the various symptoms of menopause and provides selective protection against endometrial cancer.

What are the side effects of Duavive?

The most commonly reported side effects when taking Duavive tablets include vulvovaginal candidiasis (yeast infection) abdominal pain, constipation; diarrhoea, nausea, muscle spasms.

When should Duavive not be used?

You should not use Duavive tablets if you:

• are allergic to conjugated oestrogens or bazedoxifene or any ingredients in Duavive
• are of childbearing age as Duavive tablets are only for use in postmenopausal women
• have liver disease
• have a past or family history of carcinoma of the breast, endometrial carcinoma, untreated endometrial hyperplasia
• have a history of thrombosis (blood clots), heart attack or stroke
• have abnormal vaginal bleeding of unknown cause
• have leiomyoma (uterine fibroids) or endometriosis
• have high blood pressure that is not well controlled
• have Porphyria (an inherited condition affecting the skin and nervous system)
• have diabetes mellitus with or without vascular involvement, cholelithiasis (gall stones) migraine or (severe) headache, systemic lupus erythematosus (an autoimmune disease), seizures (epilepsy), asthma, a disease affecting the eardrum and hearing (otosclerosis), without discussion with your doctor
• are taking medicines that interact with Duavive including anticonvulsants like phenytoin and carbamazepin, anti-infectives like rifampicin, cimetidine, the antibiotic erythromycin, the immunosuppressant cyclosporin, and the antifungal ketoconazole, and herbal medicines containing St John's wort.

How should Duavive be taken?

You should take one tablet of your Duavive tablets0.45mg/20mg swallowed whole with a glass of water once daily, with or without food and at the same time each day.  You should continue to take your Duavive tablets for as long as recommend by your doctor.

How long should you take Duavive?

You should continue to take your Duavive tablets for as long as recommend by your doctor.

Missed dose of Duavive

If you miss a dose of Duavive tablets 0.45mg/20mg take it as soon as you remember, unless it is time to take the next dose, then skip the missed dose.  Do not take a double dose.

How should Duavive be stored?

You should store your Duavive tablets 0.45mg/20mg below 25°C in a cool dry place.