Norelgestromin (4 brand names, 1 dosage form, 1 route)
Available dosage forms: FILM, EXTENDED RELEASE.
Routes of administration: TRANSDERMAL.
Brand Names
- ETHINYL ESTRADIOL AND NORELGESTROMIN
- ONSURA
- ORTHO EVRA
- XULANE
Boxed Warning
• Cigarette Smoking and Serious Cardiovascular Events Cigarette smoking increases the risk of serious cardiovascular events from hormonal contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs, including Xulane, are contraindicated in women who are over 35 years of age and smoke [see Contraindications (4) and Warnings and Precautions (5.1)]. • Contraindicated in Women with a BMI ≥ 30 kg/m2 Xulane is contraindicated in women with a BMI ≥ 30 kg/m2. The risk of VTE may be greater with Xulane in women with a BMI > 30 kg/m2 compared to women with a lower BMI. [see Contraindications (4) and Warnings and Precautions (5.1)].
Indications and Usage
Xulane is indicated for the prevention of pregnancy in women with a body mass index (BMI) < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate. Limitations of Use: Xulane may be less effective in preventing pregnancy in women who weigh 198 lbs. (90 kg) or more. Xulane is contraindicated for use in women with BMI ≥ 30 kg/m2 [see Contraindications (4), Warnings and Precautions (5.1) and Clinical Studies (14)].
Dosage and Administration
To achieve maximum contraceptive effectiveness, Xulane must be used exactly as directed. Complete instructions to facilitate patient counseling on proper system usage may be found in the FDA-Approved Patient Labeling.
Contraindications
Xulane is contraindicated in females who are known to have or develop the following conditions: •At high risk of arterial or venous thromboembolic events. Examples include women who: oSmoke, if over age 35 [see Boxed Warning, and Warnings and Precautions (5.1)] oHave deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1)] oHave inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)] oHave cerebrovascular disease [see Warnings and Precautions (5.1)] oHave coronary artery disease [see Warnings and Precautions (5.1)] oHave 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)] oHave uncontrolled hypertension [see Warnings and Precautions (5.5)] oHave diabetes mellitus with vascular disease [see Warnings and Precautions (5.7)] oHave headaches with focal neurological symptoms or have migraine headaches with aura ▪Women over age 35 with any migraine headaches [see Warnings and Precautions (5.8)] •Body Mass Index ≥ 30 kg/m2 [see Warnings and Precautions (5.1)] •Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions (5.3) , Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)] •Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.9)] •Pregnancy, because there is no reason to use hormonal contraceptives during pregnancy [see Warnings and Precautions (5.10) and Use in Specific Populations (8.1)] •Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [See Warnings and Precautions (5.12) ] •Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alanine aminotransferase (ALT) elevations [see Warnings and Precautions (5.4)]
Adverse Reactions
The following serious adverse reactions with the use of combination hormonal contraceptives, including Xulane, are discussed elsewhere in the labeling: •Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions (5.1)] •Vascular events, including venous and arterial thromboembolic events [see Warnings and Precautions (5.1)] •Liver disease [see Warnings and Precautions (5.3)] Adverse reactions commonly reported by users of combination hormonal contraceptives are: •Irregular uterine bleeding •Nausea •Breast tenderness •Headache
Drug Interactions
Consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.
Mechanism of Action
NGMN is the active progestin largely responsible for the progestational activity that occurs in women following application of norelgestromin and ethinyl estradiol transdermal system. NGMN is also the primary active metabolite produced following oral administration of NGM, the progestin component of some oral contraceptive products. Combination hormonal contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation).
Overdosage
Overdosage may cause nausea and vomiting, and withdrawal bleeding may occur in women. In case of suspected overdose, all Xulane patches should be removed and symptomatic treatment given.