INFORMATION FOR HEALTH CARE PROFESSIONALS

THE INNOVATIVE NEW TREATMENT TO HELP RELIEVE THE SYMPTOMS OF MENOPAUSE

Introducing Duavive®. A novel pairing of conjugated estrogens (CE) with the selective estrogen receptor modulator (SERM) bazedoxifene (BZA).1

 

Duavive Key patient benefits:

  • Significant reduction in the frequency and severity of moderate to severe hot flushes.2
  • The BZA component as an alternative to progesterone to help protect the uterine lining.2
  • Effects on breast density similar to placebo at one year.3
  • Increase in bone mass compared to placebo at two years.4
  • Low incidence of endometrial hyperplasia at one year.5
  • An improved QOL in symptomatic postmenopausal women.6

 

Duavive can offer an alternative treatment option for post menopausal women with a uterus for whom treatment with progesterone-containing therapy is not appropriate.

 

References

  1. Kharode, Y, Bodine PVN, Miller CP, Lyttle R, Komm BS. The pairing of a selective receptor modulator, bazedoxifene, with conjugated estrogens as a new paradigm for the treatment of menopausal symptoms osteoporosis prevention. Endocrinology. 2008;149(12):6084-6091
  2. Pinkerton JV, Utian WH, Constantine GD, Oliver S, Pickar HJ. Relief of vasomotor symptoms with the tissue-selective estrogen complex containing bazedoxifene/conjugated estrogens: a randomised, controlled trial. Menopause. 2009;16(6):1116-1124
  3. Pinkerton JV, Harvey JA, Lindsay R et al. Breast effects of bazedoxifene - conjugated estrogens: a randomised controlled trial. Obstet Gynecol 2013;121(5):959-96
  4. Lindsay R, Gallagher JC, Kagan R, Pickar JH, Constantine G. Efficacy of tissue selective estrogen completex of bazedoxifene/conjugated estrogens of osteoporosis prevention in at risk post-menopausal women. Fertil Steril. 2009;92(3):1045-1052
  5. Pickar JH, Yehl, Bachmann GA, Speroff L. Endometrial effects of a tissue selective estrogen complex containing bazedoxifene/conjugated estrogens as a menopausal therapy. Fertil Steril. 2009;92(3):1018-1024
  6. Utian W, Holly Y, Bobula J, Mirkin S, Olivier S, Pickar JH. Bazedoxifene/conjugated estrogens and quality of life in post menopausal women. Maturitas 2009; 63: 329 - 335.

Duavive Mode of Action Video

Duavive Mode of Action Video Discussion: Dr. Barry Komm

RESOURCES

Menopause Practicioners Website & Toolkit.  Click Here to View

Presentation Slides - "A New Approach to Menopause Hormone Therapy", Dr. Anna Fenton.  Click Here to View

Presentation Slides - "Menopause Management", Dr. Anna Fenton.  Click Here to View

 

DUAVIVE MATERIALS

Duavive One Page Summary.  Click Here to View

Duavive Core Clinical Data Booklet.  Click Here to View

Duavive Overview.  Click Here to View

DUAVIVE®

Conjugated Estrogens/Bazedoxifene

0.45 mg/20 mg Modified-Release Tablets

INDICATIONS

Treatment of estrogen 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.

DUAVIVE®

Hypersensitivity to conjugated estrogens, bazedoxifene or excipients; known, suspected or history of breast cancer, estrogen-dependent malignant tumours; undiagnosed genital bleeding; untreated endometrial hyperplasia; active or history of VTE, arterial thromboembolic disease; thrombophilic disorders; impaired liver function; porphyria; not to be taken by women of childbearing potential. See Data Sheet for details.

PRECAUTIONS

Not to be given with concomitant progestins, additional estrogens or other SERMs.

Full medical examination before initiation and follow up, especially of breast health; conditions requiring supervision: leiomyoma or endometriosis, risk factors for thromboembolic disorders or estrogen-dependent tumours, hypertension, coronary artery disease and stroke, liver disorders (liver function), diabetes mellitus, cholelithiasis, migraine, systemic lupus erythematosus, endometrial hyperplasia history, epilepsy, asthma, otosclerosis; risk of endometrial hyperplasia and carcinoma; risk of VTE; cholecystitis reported; monitor patients with hypertriglyceridaemia; may cause fluid retention; estrogens increase thyroid binding globulin; use in pregnancy Category D; minor influence on ability to drive and use machines. See Data Sheet for details.

ADVERSE EFFECTS

Abdominal pain; vulvovaginal candidiasis; constipation; diarrhoea; nausea; muscle spasms; blood trigylcerides increased; VTE; breast tenderness; hot flushes. See Data Sheet for details.

DOSAGE AND ADMINISTRATION

Recommended: CE 0.45 mg/bazedoxifene 20 mg taken as a single oral tablet, once daily. Version: pfmpnduavt20316 Supersedes: pfmpnduavt10316 Based on the Data Sheet of 10 March 2016 Page 2 of 2

Use DUAVIVE for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.

MEDICINES CLASSIFICATION

Prescription Medicine; DUAVIVE is an unfunded medicine – a prescription charge will apply.

Before prescribing, review Data Sheet available from Medsafe (www.medsafe.govt.nz) or Pfizer New Zealand Limited, Auckland (www.pfizer.co.nz) or call 0800 736 363.

V11116 Duavive® is a registered trademark. TAPSPP9133 PP-DUA-NZL0020 © Pfizer 2016.