Segesterone Acetate (1 brand name, 1 dosage form, 1 route)
Available dosage forms: RING.
Routes of administration: VAGINAL.
Brand Names
- ANNOVERA
Boxed Warning
Cigarette smoking increases the risk of serious cardiovascular events from combination 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, CHC should not be used by females who are over 35 years of age and smoke. [See Contraindications (4) and Warnings and Precautions (5.5)].
Indications and Usage
ANNOVERA is indicated for use by females of reproductive potential to prevent pregnancy.
Contraindications
ANNOVERA is contraindicated in females who are known to have or develop the following conditions: A high risk of arterial or venous thrombotic diseases. Examples include females who are known to: -Smoke, if over age 35 [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 (5.4)]. -Have diabetes mellitus and are over age 35, diabetes mellitus with hypertension or vascular disease, or other end-organ damage, or diabetes mellitus of >20 years duration [see Warnings and Precautions (5.5), (5.7)]. -Have headaches with focal neurological symptoms, migraine headaches with aura, or are over age 35 with any migraine headaches [see Warnings and Precautions (5.8)]. Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see Warnings and Precautions (5.11)]. Liver tumors, acute hepatitis, or severe (decompensated) cirrhosis [see Warnings and Precautions (5.2) and Use in Specific Populations (8.6)]. Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.9)]. Hypersensitivity to any of the components of ANNOVERA. Hypersensitivity reactions reported include: throat constriction, facial edema, urticaria, hives, and wheezing [see Adverse Reactions (6.1)]. Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alanine transaminase (ALT)
Adverse Reactions
The following adverse reactions are described elsewhere in other sections of the labeling: Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions (5.1)] Vascular events [see Warnings and Precautions (5.1)] Liver disease [see Warnings and Precautions (5.2)]
Drug Interactions
The sections below provide information on substances for which data on drug interactions with CHCs are available. There is little information available about the clinical effect of most drug interactions that may affect ANNOVERA. However, based on the known pharmacokinetic effects of these drugs, clinical strategies to minimize any potential adverse effect on contraceptive effectiveness or safety are suggested. Consult the approved product labeling of all concurrently used drugs to obtain further information about interactions with ANNOVERA or the potential for metabolic enzyme or transporter system alterations.
Mechanism of Action
CHCs lower the risk of becoming pregnant primarily by suppressing ovulation.
Overdosage
There have been no reports of serious ill effects from overdose of CHCs. Overdosage may cause withdrawal bleeding in females and nausea. In case of suspected overdose, all ANNOVERA vaginal systems should be removed and symptomatic treatment given.