If you would like more information, or have any questions, about NEXTSTELLIS, then please submit a request: for example, on our product availability, savings program and our pre-activated Savings Cards, sampling or for details on our patient support services.
NEXTSTELLIS® and the Silhouette logo are owned by and licensed from ESTETRA SRL © 2023 Mayne Pharma. All rights reserved. 3301 Benson Drive, Raleigh NC 27609. PM-US-NEX-0320 6/23
IMPORTANT SAFETY INFORMATION FOR NEXTSTELLIS® (drospirenone and estetrol tablets 3 mg/14.2 mg)
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
See full prescribing information for complete boxed warning.
- Females over 35 years old who smoke should not use NEXTSTELLIS
- Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use.
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use NEXTSTELLIS safely and effectively. See full prescribing information for NEXTSTELLIS.
NEXTSTELLIS (drospirenone and estetrol tablets), for oral use
Initial U.S. Approval: 2021
INDICATIONS AND USAGE
NEXTSTELLIS is a combination of drospirenone, a progestin, and estetrol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy.
LIMITATIONS OF USE
NEXTSTELLIS may be less effective in females with a BMI ≥30 kg/m2. In females with BMI ≥30 kg/m2, decreasing effectiveness may be associated with increasing BMI.
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
NEXTSTELLIS consists of 28 tablets in the following order:
WARNINGS AND PRECAUTIONS
Most common adverse reactions (≥2%): Bleeding irregularities, mood disturbance, headache, breast symptoms, dysmenorrhea, acne, weight increased, and libido decreased
USE IN SPECIFIC POPULATIONS
To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
BMI=body mass index; COC=combined oral contraceptive; EU=European Union; HDL=high-density lipoprotein; LDL=low-density lipoprotein; LNG=levonorgestrel.