How vulvar and vaginal atrophy (VVA) affects your patients’ quality of life VVA is an undertreated medical condition1

How vulvar and vaginal atrophy (VVA) affects your patients’ quality of life VVA is an undertreated medical condition1

Vaginal dryness and dyspareunia are two of the most common bothersome symptoms of menopause1,2

The Women’s EMPOWER Survey found that two of the most common bothersome menopause symptoms reported by women with VVA are:2

  Vaginal dryness: 79% | Dyspareunia: 59%

Both conditions are components of Genitourinary Syndrome of Menopause (GSM), caused by significant changes to vaginal tissues, including:,3,4,5

Prior to menopause
  • Vaginal lining is moist and thick with rugal folds
  • Vaginal mucosa is well vascularized
  • Adequate vaginal secretions
  • Adequate lubrication produced during sexual stimulation
After menopause
  • Vagina becomes shorter and narrower
  • Vaginal lining becomes thinner and less elastic, with fewer rugal folds
  • Diminished blood flow
  • Diminished vaginal secretions
  • Reduced lubrication during sexual stimulation

Vulvar and vaginal atrophy: An undertreated medical condition1

VVA is a chronic medical condition,1 so women need a treatment they can adhere to.

Impact of VVA on women’s health

VVA symptoms, including vaginal dryness and dyspareunia, have a negative impact on women’s:

  • quality of life3
  • psychosocial wellbeing6
  • sexual function6

VVA symptoms are often underdiagnosed and undertreated1,2,3,5

Despite the impact of their symptoms, many women suffer with vaginal dryness/dyspareunia because:

  • they mistakenly believe these symptoms are an unavoidable part of aging
  • they think VVA symptoms will go away on their own like hot flashes and night sweats
  • they find vaginal dryness and/or dyspareunia too embarrassing to discuss

Existing treatment options are unappealing to many women.

Adherence and persistence with existing treatments are inconsistent due to:1,2,5

  • concerns about exposure to hormones (estrogen)
  • inconvenience of creams, inserts, rings, etc. that may stain undergarments and/or interfere with sexual spontaneity
  • discomfort with vaginal application

55% of women surveyed expressed a preference for an oral product instead of a topical one.1

As the first and only non-hormonal, oral therapy for the two most common bothersome symptoms of VVA, Osphena® could be the solution.1,7

Osphena® is an estrogen agonist/antagonist indicated for the treatment of moderate to severe dyspareunia and/or vaginal dryness, symptoms of vulvar and vaginal atrophy, due to menopause.7

  1. Kingsberg SA, Wysocki S, Magnus L, et al. Vulvar and vaginal atrophy in postmenopausal women: findings from the REVIVE (REal Women’s VIews of Treatment Options for Menopausal Vaginal ChangEs) survey. J Sex Med. 2013;10:1790–1799.
  2. Kingsberg SA, Krychman M, et al. The Women’s EMPOWER Survey: Identifying Women’s Perceptions on Vulvar and Vaginal Atrophy and its Treatment. J Sex Med 2017; 14: 413-424.
  3. North American Menopause Society. Management of symptomatic vulvovaginal atrophy 2013 position statement of the North American Menopause Society. Menopause. 2013;20(9):888-902.
  4. Portman DJ, Gass ML et al. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women's Sexual Health and the North American Menopause Society. J Sex Med. 2014;11(12):2865-72.
  5. MacBride MB, Rhodes DJ, Shuster LT. Vulvovaginal Atrophy. Mayo Clin Proc 2010; 85(1): 87-94.
  6. Parish SJ, Nappi RE, Krychman ML, Kellogg-Spadt S, Simon JA, Goldstein JA, Kingsberg SA. Impact of vulvovaginal health on postmenopausal women: a review of surveys on symptoms of vulvovaginal atrophy. Int J Womens Health. 2013 Jul 29;5:437-47.
  7. Osphena Prescribing Information. January 2019.

Indication and Important Safety Information including Boxed Warning

INDICATIONS:

OSPHENA (ospemifene) is indicated for:

  • The treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.
  • The treatment of moderate to severe vaginal dryness, a symptom of vulvar and vaginal atrophy, due to menopause.

Important Safety Information for OSPHENA

WARNING: ENDOMETRIAL CANCER and CARDIOVASCULAR DISORDERS

Endometrial Cancer

OSPHENA is an estrogen agonist/antagonist with tissue selective effects. In the endometrium, OSPHENA has estrogen agonistic effects. There is a potential increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adequate diagnostic measures, including directed and random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.

Cardiovascular Disorders

In clinical trials for OSPHENA (duration of treatment up to 15 months), the incidence rates of thromboembolic and hemorrhagic stroke were 1.13 and 3.39 per thousand women years, respectively, in the OSPHENA 60 mg treatment group and 3.15 and 0 with placebo. The incidence of DVT was 2.26 per thousand women years (2 reported cases) in the OSPHENA 60 mg treatment group and 3.15 per thousand women years (1 reported case) with placebo. OSPHENA should be prescribed for the shortest duration consistent with treatment goals and risks for the individual woman.

There is a reported increased risk of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) who received daily oral conjugated estrogens (CE) [0.625 mg]-alone therapy over 7.1 years as part of the Women’s Health Initiative (WHI).

CONTRAINDICATIONS

  • Undiagnosed abnormal genital bleeding
  • Known or suspected estrogen-dependent neoplasia
  • Active deep vein thrombosis (DVT), pulmonary embolism (PE) or a history of these conditions
  • Active arterial thromboembolic disease (e.g., stroke and myocardial infarction) or a history of these conditions
  • Hypersensitivity (for example, angioedema, urticaria, rash, pruritus) to OSPHENA or any of its ingredients
  • OSPHENA is contraindicated in women who are or may become pregnant. OSPHENA may cause fetal harm when administered to a pregnant woman. Ospemifene was embryo-fetal lethal with labor difficulties and increased pup deaths in rats at doses below clinical exposures, and embryo-fetal lethal in rabbits at 10 times the clinical exposure based on mg/m. If this drug is used during pregnancy, or if a woman becomes pregnant while taking this drug, she should be apprised of the potential hazard to a fetus.

WARNINGS AND PRECAUTIONS

Cardiovascular Disorders

In the clinical trials for OSPHENA (duration of treatment up to 15 months), the incidence rates of thromboembolic and hemorrhagic stroke were 1.13 and 3.39 per thousand women years, respectively in OSPHENA 60 mg treatment group and 3.15 and 0 per thousand women years in placebo. Should thromboembolic or hemorrhagic stroke occur or be suspected, OSPHENA should be discontinued immediately.

In the OSPHENA clinical trials, two cases of myocardial infarctions (MI) occurred in women receiving 60 mg of ospemifene.

In the OSPHENA clinical trials, two cases of DVT occurred in women receiving OSPHENA 60 mg. Should a VTE occur or be suspected, OSPHENA should be discontinued immediately.

If feasible, OSPHENA should be discontinued at least 4 to 6 weeks before surgery of the type associated with an increased risk of thromboembolism or during periods of prolonged immobilization.

Malignant Neoplasms

OSPHENA is an estrogen agonist/antagonist with tissue selective effects. In the endometrium, OSPHENA has agonistic effects. In the OSPHENA clinical trials (60 mg treatment group), no cases of endometrial cancer were seen with exposure up to 52 weeks. There was a single case of simple hyperplasia without atypia. Endometrial thickening equal to 5 mm or greater was seen in the OSPHENA up to 52 weeks treatment groups at a rate of 101.4 per thousand women vs. 20.9 per thousand women for placebo. The incidence of any type of proliferative (weakly plus active plus disordered) endometrium was 26.3 per thousand women in the OSPHENA up to 52 weeks treatment groups vs. 0 per thousand women for placebo. Uterine polyps occurred at an incidence of 19.6 per thousand women in the OSPHENA up to 52 weeks treatment groups vs. 8.3 per thousand women for placebo.

An increased risk of endometrial cancer has been reported with the use of unopposed estrogen therapy in a woman with a uterus. The greatest risk appears to be associated with prolonged use and estrogen dose. Adding a progestin to postmenopausal estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. There are, however, possible risks that may be associated with the use of progestins with estrogens compared to estrogen-alone regimens. These include an increased risk of breast cancer. The use of with OSPHENA therapy was not evaluated in the clinical trials.

OSPHENA 60 mg has not been adequately studied in women with breast cancer; therefore, it should not be used in women with known or suspected breast cancer.

Severe Hepatic Impairment

OSPHENA should not be used in women with severe hepatic impairment.

In clinical trials, the more commonly reported adverse reactions in ≥1 percent of patients treated with OSPHENA 60 mg compared to placebo were:

  1. In 12-week, double blind, placebo-controlled clinical trials were hot flush (6.5% vs. 2.6%), vaginal discharge (3.8% vs. 0.4%), muscle spasms (1.8% vs. 0.6%) and hyperhidrosis (1.1% vs. 0.2%)
  2. In all clinical trials up to 52-weeks (safety population) were headaches (2.8% vs. 2.4%), hot flush (12.2% vs. 4.2%), muscle spasms (4.5% vs. 2.4%), hyperhidrosis (2.5% vs. 1.8%), night sweats (1.2% vs. 0.0%), vaginal discharge (6.00% vs. 0.6%) and vaginal hemorrhage (1.3% vs. 0.0%).

The following adverse reactions have been identified during post-approval use of ospemifene:

  • Neoplasms Benign, Malignant and Unspecified (including cysts and polyps); endometrial hyperplasia, endometrial cancer.
  • Immune System Disorders: allergic conditions including hypersensitivity, angioedema
  • Nervous System Disorders: headache
  • Vascular Disorders: deep vein thrombosis, thrombosis, pulmonary embolism
  • Skin and Subcutaneous Tissue Disorders: rash, rash erythematous, rash generalized, pruritus, urticaria

Drug interactions: OSPHENA is primarily metabolized by CYP3A4 and CYP2C9. CYP2C19 and other pathways contribute to the metabolism of ospemifene. Do not use estrogens or estrogen agonists/antagonists, fluconazole, ketoconazole or rifampin concomitantly with OSPHENA. Co-administration of OSPHENA with drugs that inhibit CYP3A4 and CYP2C9 may increase the risk of OSPHENA-related adverse reactions. OSPHENA is highly protein bound. Use cautiously with highly protein bound drugs as use with other highly protein-bound drugs may lead to increase exposure of that drug or ospemifene.

Please see Full Prescribing Information for OSPHENA (ospemifene) tablets, including Boxed Warning, regarding Endometrial Cancer and Cardiovascular Disorders, and Patient Information at osphena.com/hcp.

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION:

OSPHENA (ospemifene) is indicated for:

  • The treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause
  • The treatment of moderate to severe vaginal dryness, a symptom of vulvar and vaginal atrophy, due to menopause

Important Safety Information for OSPHENA

WARNING: ENDOMETRIAL CANCER and CARDIOVASCULAR DISORDERS

Endometrial Cancer

OSPHENA is an estrogen agonist/antagonist with tissue selective effects. In the endometrium, OSPHENA has estrogen agonistic effects. There is a potential increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adequate diagnostic measures, including directed and random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.

Cardiovascular Disorders

In clinical trials for OSPHENA (duration of treatment up to 15 months), the incidence rates of thromboembolic and hemorrhagic stroke were 1.13 and 3.39 per thousand women years, respectively, in the OSPHENA 60 mg treatment group and 3.15 and 0 with placebo. The incidence of DVT was 2.26 per thousand women years (2 reported cases) in the OSPHENA 60 mg treatment group and 3.15 per thousand women years (1 reported case) with placebo. OSPHENA should be prescribed for the shortest duration consistent with treatment goals and risks for the individual woman.

There is a reported increased risk of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) who received daily oral conjugated estrogens (CE) [0.625 mg]-alone therapy over 7.1 years as part of the Women’s Health Initiative (WHI).

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION:

OSPHENA (ospemifene) is indicated for:

  • The treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause
  • The treatment of moderate to severe vaginal dryness, a symptom of vulvar and vaginal atrophy, due to menopause

Important Safety Information for OSPHENA

WARNING: ENDOMETRIAL CANCER and CARDIOVASCULAR DISORDERS

Endometrial Cancer

OSPHENA is an estrogen agonist/antagonist with tissue selective effects. In the endometrium, OSPHENA has estrogen agonistic effects. There is a potential increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adequate diagnostic measures, including directed and random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.

Cardiovascular Disorders

In clinical trials for OSPHENA (duration of treatment up to 15 months), the incidence rates of thromboembolic and hemorrhagic stroke were 1.13 and 3.39 per thousand women years, respectively, in the OSPHENA 60 mg treatment group and 3.15 and 0 with placebo. The incidence of DVT was 2.26 per thousand women years (2 reported cases) in the OSPHENA 60 mg treatment group and 3.15 per thousand women years (1 reported case) with placebo. OSPHENA should be prescribed for the shortest duration consistent with treatment goals and risks for the individual woman.

There is a reported increased risk of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) who received daily oral conjugated estrogens (CE) [0.625 mg]-alone therapy over 7.1 years as part of the Women’s Health Initiative (WHI).