ETHINYL ESTRADIOL/ SEGESTERONE RING,VAG

Clinical Criteria Summary

• Prevention of pregnancy in females of reproductive potential
• Not adequately studied in females with a body mass index (BMI) greater than 29 kg/m²

• High risk of arterial or venous thrombotic disease
• Current or history of breast cancer or other estrogen- or progestin-sensitive cancer
• Liver tumors, acute hepatitis, or severe (decompensated) cirrhosis
• Undiagnosed abnormal uterine bleeding
• Hypersensitivity to ingredients
• Use of hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir

• Risk of venous thromboembolic events (VTE) and arterial events (e.g., stroke, myocardial infarction)
• Liver enzyme elevations
• Hypertension
• Potential for gall bladder disease
• Abnormal uterine bleeding
• Depression
• Toxic shock syndrome (TSS)
• Vaginal and cervical erosion and/or ulceration
• Risk of vaginal infection with prolonged use

• Patient-inserted into vagina; must remain continuously for 3 weeks (21 days) followed by a 1-week (7-day) ring-free interval
• Reusable ring stored in provided case during the ring-free interval
• Provides contraception for 13 cycles (1 year)
• Must be cleaned with mild soap and water before storage and prior to re-insertion

• Pregnancy: No indication for use
• Lactation: Hormones and metabolites are found in human milk and may reduce milk production; alternative contraception recommended for breastfeeding females
• Does not protect against sexually transmitted infections including HIV
• Oil-based (including silicone-based) vaginal lubricants and medications will alter the vaginal system/exposure and should not be used
• Compatible with water-based vaginal lubricants/creams and male condoms

• Considered when a 12-month product is preferred due to clinical or patient-specific needs (e.g., extended travel or deployment, limited or no access to refrigeration, history of or potential difficulties with obtaining timely refills)
• Not studied for indications other than pregnancy prevention or dosing regimens outside the product label

Monophasic pills with 30 mcg EE and desogestrel 0.15 mg: 21 active pills; 7 inert pills

Nuisance side effects associated with combination hormonal contraceptives may be managed by adjusting the estrogen/progestin content or ratio
Progestin-only products may be considered in patients with contraindications or a desire to avoid estrogen (general class guidance)

Listed on the VA National Formulary as generic components to allow for substitution of the least expensive equivalent product
Product availability varies and the listed products are not comprehensive