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Cenestin is the first and only FDA approved, plant-derived, “synthetic conjugated estrogens, A” tablet indicated for the treatment of moderate-to-severe vasomotor symptoms (VMS) and vulvar and vaginal atrophy (VVA) due to menopause.1

“Synthetic” means that Cenestin is synthesized from soybean and yam plant.
“A” signifies the first of its kind. Cenestin does not contain any animal precursors.2

In the United States, approximately 40 to 50 million women experience hot flashes during menopause.3 And, as many as 32 million women may experience VVA symptoms.4 If this sounds like you, or the women you treat, learn more from the Cenestin “Now Approved” press release.

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Cenestin is expected to be available in retail pharmacies nationwide by early June 2024. To review the Full Prescribing Information, including BOXED WARNING, click below.

Cenestin is expected to be available in retail pharmacies nationwide by early June 2024.

To review the Full Prescribing Information, including BOXED WARNING, click below.

FULL PRESCRIBING INFORMATION white arrow

IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING & INDICATIONS

WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA and BREAST CANCER See full prescribing information for complete BOXED WARNING.

Estrogen-Alone Therapy

  • There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens like CENESTIN.
  • Do not use estrogen-alone therapy like CENESTIN for the prevention of cardiovascular disease or dementia.
  • The Women’s Health Initiative (WHI) estrogen-alone sub study reported increased risks of stroke and deep vein thrombosis (DVT).
  • The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older.

Estrogen Plus Progestin Therapy

  • Do not use estrogen plus progestin therapy for the prevention of cardiovascular disease or dementia.
  • The WHI estrogen plus progestin sub study reported increased risks of DVT, pulmonary embolism (PE), stroke and myocardial infarction (MI).
  • The WHI estrogen plus progestin study reported increased risks of invasive breast cancer.
  • The WHIMS estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older.

Prescribe estrogens with or without progestins at the lowest effective doses and for shortest duration consistent with treatment goals and risk for individual women.

  • CENESTIN is contraindicated in patients with undiagnosed abnormal genital bleeding.
  • CENESTIN is contraindicated in patients with breast cancer or a history of breast cancer. One large meta-analysis of prospective cohort studies reported increased risks that were dependent upon duration of use and could last up to > 10 years after discontinuation of estrogen plus progestin therapy and estrogen-alone therapy. Extension of the WHI trials also demonstrated increased breast cancer risk associated with estrogen plus progestin therapy.
  • CENESTIN is contraindicated in patients with estrogen-dependent neoplasia.
  • CENESTIN is contraindicated in patients with active deep vein thrombosis, pulmonary embolism, or a history of these medical conditions.
  • CENESTIN is contraindicated in patients with active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions.
  • CENESTIN is contraindicated in patients with known anaphylactic reaction or angioedema or hypersensitivity to CENESTIN.
  • CENESTIN is contraindicated in patients with hepatic impairment or disease.
  • CENESTIN is contraindicated in patients with protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.
  • Use of estrogens including CENESTIN increases the risk of gallbladder disease.
  • Estrogens may cause some degree of fluid retention. Monitor use of CENESTIN in patients with a condition(s) that might predispose to fluid retention, such as cardiac or renal impairment.
  • Discontinue estrogen including CENESTIN if severe hypercalcemia, loss of vision, severe hypertriglyceridemia or cholestatic jaundice occurs.
  • Monitor thyroid function in patients on thyroid replacement therapy. Patients dependent on thyroid hormone replacement therapy who are also receiving estrogens like CENESTIN may require increased doses of their thyroid replacement therapy.
  • Few cases of malignant transformation of residual endometrial implants have been reported in women treated post-hysterectomy with estrogen-alone therapy. Consider the addition of a progestin for women known to have residual endometriosis post-hysterectomy.
  • The most common adverse reactions (> 10%) with CENESTIN are: headache, paresthesia, breast pain, abdominal pain, endometrial thickening, metrorrhagia, dizziness, pain, leg cramps, dyspepsia, leukorrhea, vaginitis and nausea.

DRUG INTERACTIONS

Medications belonging to class of inducers and/or inhibitors of CYP3A4 may affect estrogen drug metabolism and decrease or increase the estrogen plasma concentration.

Inducers of CYP3A4 such as St. John’s wort (hypericum perforatum) preparations, phenobarbital, carbamazepine, and rifampin may reduce plasma concentrations of estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile. Inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice may increase plasma concentrations of estrogens and may result in adverse reactions.

OVERDOSAGE

Overdosage of estrogen may cause nausea and vomiting, breast tenderness, abdominal pain, drowsiness and fatigue, and withdrawal bleeding may occur in women. Discontinue CENESTIN therapy and institute appropriate symptomatic care.

INDICATIONS

CENESTIN is used for treatment of moderate to severe vasomotor symptoms due to menopause.

CENESTIN is used for treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. Limitations for use – Use of topical vaginal products to be considered first before prescribing CENESTIN solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy.

You may report side effects to ASPEN Pharmaceuticals, LLC at 1-201-406-7955, or to the FDA at 1-800-FDA-1088.

Please click here for Full Prescribing Information, including BOXED WARNING.

References: 1. Cenestin® (synthetic conjugated estrogens, A) tablets package insert. Avion Pharmaceuticals, LLC; 2023. 2. R.E. Stevens, P. Roy, and K.V. Phelps. Clin Pharmacol. 2002. 3. Utian WH; Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: A comprehensive review. Health and Quality of Life Outcomes. 2005; doi:10.1186/1477-7525-3-4  4. Wysocki S, Kingberg S, Krychman M. Management of Vaginal Atrophy: Implications from the REVIVE Survey. Clin Med Insights Reprod Health. 2014;8:23-30.

WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA and BREAST CANCER See full prescribing information for complete BOXED WARNING.

Estrogen-Alone Therapy

  • There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens like CENESTIN.
  • Do not use estrogen-alone therapy like CENESTIN for the prevention of cardiovascular disease or dementia.
  • The Women’s Health Initiative (WHI) estrogen-alone sub study reported increased risks of stroke and DVT.
  • The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older.

Estrogen Plus Progestin Therapy

  • Do not use estrogen plus progestin therapy for the prevention of cardiovascular disease or dementia.
  • The WHI estrogen plus progestin sub study reported increased risks of DVT, pulmonary embolism (PE), stroke and myocardial infarction (MI).
  • The WHI estrogen plus progestin study reported increased risks of invasive breast cancer.
  • The WHIMS estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older.

Prescribe estrogens with or without progestins at the lowest effective doses and for shortest duration consistent with treatment goals and risk for individual women.

  • CENESTIN is contraindicated in patients with undiagnosed abnormal genital bleeding.
  • CENESTIN is contraindicated in patients with breast cancer or a history of breast cancer. One large meta-analysis of prospective cohort studies reported increased risks that were dependent upon duration of use and could last up to > 10 years after discontinuation of estrogen plus progestin therapy and estrogen-alone therapy. Extension of the WHI trials also demonstrated increased breast cancer risk associated with estrogen plus progestin therapy.
  • CENESTIN is contraindicated in patients with estrogen-dependent neoplasia.
  • CENESTIN is contraindicated in patients with active deep vein thrombosis, pulmonary embolism, or a history of these medical conditions.
  • CENESTIN is contraindicated in patients with active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions.
  • CENESTIN is contraindicated in patients with known anaphylactic reaction or angioedema or hypersensitivity to CENESTIN.
  • CENESTIN is contraindicated in patients with hepatic impairment or disease.
  • CENESTIN is contraindicated in patients with protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.
  • Use of estrogens including CENESTIN increases the risk of gallbladder disease.
  • Estrogens may cause some degree of fluid retention. Monitor use of CENESTIN in patients with a condition(s) that might predispose to fluid retention, such as cardiac or renal impairment.
  • Discontinue estrogen including CENESTIN if severe hypercalcemia, loss of vision, severe hypertriglyceridemia or cholestatic jaundice occurs.
  • Monitor thyroid function in patients on thyroid replacement therapy. Patients dependent on thyroid hormone replacement therapy who are also receiving estrogens like CENESTIN may require increased doses of their thyroid replacement therapy.
  • Few cases of malignant transformation of residual endometrial implants have been reported in women treated post-hysterectomy with estrogen-alone therapy. Consider the addition of a progestin for women known to have residual endometriosis post-hysterectomy.
  • The most common adverse reactions (> 10%) with CENESTIN are: headache, paresthesia, breast pain, abdominal pain, endometrial thickening, metrorrhagia, dizziness, pain, leg cramps, dyspepsia, leukorrhea, vaginitis and nausea.

DRUG INTERACTIONS

Medications belonging to class of inducers and/or inhibitors of CYP3A4 may affect estrogen drug metabolism and decrease or increase the estrogen plasma concentration.

Inducers of CYP3A4 such as St. John’s wort (hypericum perforatum) preparations, phenobarbital, carbamazepine, and rifampin may reduce plasma concentrations of estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile. Inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice may increase plasma concentrations of estrogens and may result in adverse reactions.

OVERDOSAGE

Overdosage of estrogen may cause nausea and vomiting, breast tenderness, abdominal pain, drowsiness and fatigue, and withdrawal bleeding may occur in women. Discontinue CENESTIN therapy and institute appropriate symptomatic care.

INDICATIONS

CENESTIN is used for treatment of moderate to severe vasomotor symptoms due to menopause.

CENESTIN is used for treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. Limitations for use – Use of topical vaginal products to be considered first before prescribing CENESTIN solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy.

You may report side effects to ASPEN Pharmaceuticals, LLC at 1-201-406-7955, or to the FDA at 1-800-FDA-1088.

Please click here for Full Prescribing Information, including BOXED WARNING.

References: 1. Cenestin® (synthetic conjugated estrogens, A) tablets package insert. Vertical Pharmaceuticals, 2023. 2. R.E. Stevens, P. Roy, and K.V. Phelps. Clin Pharmacol. 2002. 3. Utian WH; Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: A comprehensive review. Health and Quality of Life Outcomes. 2005; doi:10.1186/1477-7525-3-4  4. Wysocki S, Kingberg S, Krychman M. Management of Vaginal Atrophy: Implications from the REVIVE Survey. Clin Med Insights Reprod Health. 2014;8:23-30.