drospirenone and estetrol
Drug Details
- Generic Name
- drospirenone and estetrol
- Brand Names
- Nextstellis
- Application Number
- NDA214154
- Sponsor
- Mayne Pharma
- NDC Codes
- 1
- Dosage Forms
- KIT
- Routes
- N/A
- Active Ingredients
- N/A
Indications and Usage
1 INDICATIONS AND USAGE NEXTSTELLIS is indicated for use by females of reproductive potential to prevent pregnancy. NEXTSTELLIS is a combination of drospirenone, a progestin, and estetrol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 ) Limitations of Use NEXTSTELLIS may be less effective in females with a BMI ≥ 30 kg/m 2 . In females with BMI ≥ 30 kg/m 2 , decreasing effectiveness may be associated with increasing BMI ( 14 ). Limitations of Use NEXTSTELLIS may be less effective in females with a BMI ≥ 30 kg/m 2 . In females with BMI ≥ 30 kg/m 2 , decreasing effectiveness may be associated with increasing BMI [see Clinical Studies (14) ].