Femring

ESTRADIOL ACETATE

Manufacturer: Millicent US, Inc.

Score: 148.0

Quick Summary

Femring is an estrogen indicated for the treatment of moderate to severe vasomotor symptoms due to menopause and moderate to severe vulvar and vaginal atrophy due to menopause. The drug is contraindicated in women with undiagnosed abnormal genital bleeding, known or suspected breast cancer, and active DVT or PE, among other conditions. The recommended dose is one ring inserted into the vagina for 3 months, with patients started at the lowest dose of 0.05 mg/day. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

Treatment of moderate to severe vasomotor symptoms due to menopause
Treatment of moderate to severe vulvar and vaginal atrophy due to menopause

Important Safety Information

Warning

WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA

Contraindications

Undiagnosed abnormal genital bleeding
Known, suspected, or history of breast cancer
Known or suspected estrogen-dependent neoplasia
Active DVT, PE, or history of these conditions
Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions

Adverse Reactions

Vaginal bleeding
Breast tenderness
Headache
Intermenstrual bleeding
Vaginal candidiasis

Dosing Recommendations

General Guidance

Dosage adjustment should be guided by the clinical response. Therapy should be started at the lowest effective dose and the shortest duration consistent with treatment goals.

Moderate to severe vasomotor symptoms due to menopause

Adult Dose

0.05 mg/day

Pediatric Dose

Not indicated for pediatric use

Moderate to severe vulvar and vaginal atrophy due to menopause

Adult Dose

0.05 mg/day

Pediatric Dose

Not indicated for pediatric use

Special Population Considerations

Pregnancy

Femring should not be used during pregnancy

Nursing Mothers

Femring should not be used during lactation

Pediatric Use

Femring is not indicated in children

Geriatric Use

There have not been sufficient numbers of geriatric women involved in clinical studies utilizing Femring to determine whether those over 65 years of age differ from younger subjects in their response to Femring