Estetrol (1 brand name, 1 dosage form, 1 route)
Available dosage forms: TABLET.
Routes of administration: ORAL.
Brand Names
- NEXTSTELLIS
Boxed Warning
Cigarette smoking increases the risk of serious cardiovascular events from combined hormonal contraceptive (CHC) use. This risk increases with age, particularly in females over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs, including NEXTSTELLIS, are contraindicated in females who are over 35 years of age and smoke. [See Contraindications (4) and Warnings and Precautions (5.1)]
Indications and Usage
NEXTSTELLIS is indicated for use by females of reproductive potential to prevent pregnancy.
Contraindications
NEXTSTELLIS is contraindicated in females who are known to have or develop the following conditions: A history of, increased risk for, or current arterial or venous thrombotic/thromboembolic diseases. Examples include females who are known to: -Smoke, if 35 years of age and older [see Boxed Warning and Warnings and Precautions (5.1)] -Have current or history of deep vein thrombosis or pulmonary embolism [see Warnings and Precautions (5.1)] -Have cerebrovascular disease [see Warnings and Precautions (5.1)] -Have coronary artery disease [see Warnings and Precautions (5.1)] -Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1)] -Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)] -Have uncontrolled hypertension or hypertension with vascular disease [see Warnings and Precautions (5.1)] -Have diabetes mellitus with hypertension or end-organ damage; or diabetes mellitus of > 20 years duration [see Warnings and Precautions (5.9)] -Have migraine headaches with aura [see Warnings and Precautions (5.4)] Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see Warnings and Precautions (5.5)] Hepatic adenoma, hepatocellular carcinoma, acute hepatitis, or severe (decompensated) cirrhosis [see Warnings and Precautions (5.6)] Use of hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [see Warnings and Precautions (5.7)] Abnormal uterine bleeding that has an undiagnosed etiology [see Warnings and Precautions (5.5)] Renal Impairment [see Warnings and Precautions (5.2)] Adrenal insufficiency [see Warnings and Precautions (5.2)]
Adverse Reactions
The following clinically significant adverse reactions with the use of COCs are discussed elsewhere in labeling: Serious cardiovascular events including venous and arterial thromboembolism [see Boxed Warning and Warnings and Precautions (5.1)] Hyperkalemia [see Warnings and Precautions (5.2)] Liver disease [see Warnings and Precautions (5.5)]
Mechanism of Action
CHCs prevent pregnancy primarily by suppressing ovulation.
Overdosage
Overdosage of CHCs may cause nausea, vomiting, and severe headaches. Individual reports of thromboembolic complications and vaginal bleeding have occurred from overdosage. Pediatric patients with unintended CHC ingestion have reported nausea and vomiting and some developed irritability and drowsiness; rare reports described vaginal bleeding.