What are the contraindications of Femoston (Estradiol/Dydrogesterone) in Hormone Replacement Therapy (HRT)?

Contraindications of Femoston in Hormone Replacement Therapy

Femoston (estradiol/dydrogesterone) is absolutely contraindicated in women with undiagnosed abnormal genital bleeding, known or suspected breast cancer, estrogen-dependent neoplasia, active or recent thromboembolic disease (DVT, PE, stroke, MI within past year), active liver disease, known hypersensitivity to ingredients, and pregnancy. 1

Absolute Contraindications

Malignancy-Related Contraindications

• Known, suspected, or history of breast cancer (except in appropriately selected patients being treated for metastatic disease) 2, 1
• Known or suspected estrogen-dependent neoplasia, including:
  • Low-grade serous epithelial ovarian cancer 3
  • Granulosa cell tumors 3
  • Certain types of sarcoma (leiomyosarcoma and stromal sarcoma) 3
  • Advanced endometrioid uterine adenocarcinoma 3
• Undiagnosed abnormal genital bleeding 2, 1

Cardiovascular and Thromboembolic Contraindications

• Active deep vein thrombosis or pulmonary embolism, or history of these conditions 1
• Active or recent arterial thromboembolic disease (within the past year), including stroke and myocardial infarction 1
• History of venous thromboembolism or stroke 2
• Antiphospholipid syndrome 2

Hepatic Contraindications

• Active liver dysfunction or disease 2, 1

Other Absolute Contraindications

• Known hypersensitivity to estradiol or dydrogesterone 1
• Known or suspected pregnancy (no indication for use; Femoston should not be used in pregnancy) 1

Age and Timing Considerations for Risk Assessment

High-Risk Populations

• Women ≥60 years of age or more than 10 years after natural menopause are at elevated risk for stroke with oral estrogen-containing HRT, and this excess risk must be weighed against clinical benefits 3
• Women at elevated baseline risk for cardiovascular disease or stroke face increased hazard with oral estrogen therapy 3

Optimal Candidate Profile

The benefit-risk profile is most favorable for women who are:

• <60 years of age 3
• Within 10 years of menopause onset 3
• Without elevated cardiovascular disease, stroke, or breast cancer risk 3

Critical Assessment Requirements Before Prescribing

Mandatory Screening Checklist

Before initiating Femoston, assess for the following contraindications 3:

• History of breast cancer
• Liver disease
• History of myocardial infarction
• Known or suspected estrogen-dependent neoplasia
• History of deep vein thrombosis
• Thrombophilic disorders

Important Clinical Pitfalls

Endometrial Protection Requirement

• Using estrogen without progestin in women with an intact uterus increases endometrial cancer risk and is contraindicated 2
• Femoston contains dydrogesterone specifically to provide endometrial protection in women with an intact uterus 4, 5

Inappropriate Indications

• Initiating HRT solely for prevention of chronic conditions (rather than symptom management) is not recommended 2
• The FDA indication is limited to short-term treatment of menopausal symptoms and prevention of osteoporosis, not primary prevention of cardiovascular disease 3

Drug Interactions in Cancer Patients

• If a patient were taking tamoxifen for breast cancer (which itself contraindicates HRT), paroxetine or fluoxetine should not be used as alternatives for vasomotor symptoms 3, 2

Special Populations with Relative Contraindications

Gynecologic Cancer Survivors

While not absolute contraindications for all gynecologic cancers, HRT including Femoston is contraindicated in survivors of 3:

• Low-grade serous epithelial ovarian cancer
• Granulosa cell tumors
• Leiomyosarcoma and stromal sarcoma
• Advanced endometrioid uterine adenocarcinoma

HRT is NOT contraindicated in survivors of cervical, vaginal, or vulvar cancers (non-hormone-dependent tumors) 3