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Nextstellis Generic Name & Formulations
Legal Class
Rx
General Description
Drospirenone 3mg, estetrol 14.2mg (24 tabs); inert (4 tabs).
Pharmacological Class
Progestin + estrogen.
How Supplied
Blister card (28 tabs)—1
Manufacturer
Generic Availability
NO
Nextstellis Indications
Indications
Oral contraception.
Limitations of Use
May be less effective in females with a BMI ≥30kg/m2.
Nextstellis Dosage and Administration
Adult
1 tab daily for 28 days; repeat.
Children
Pre-menarche: not applicable.
Nextstellis Contraindications
Contraindications
High risk of arterial or venous thrombotic disease (eg, smokers over age 35, history of DVT or PE, cerebrovascular or coronary artery disease, thrombogenic valvular disease, atrial fibrillation, subacute bacterial endocarditis, hypercoagulopathies, uncontrolled hypertension, hypertension with vascular disease, diabetes with hypertension or end-organ damage, diabetes of >20 years duration, migraineurs with aura). Hormonally-sensitive malignancy (eg, breast cancer). Hepatic adenoma, hepatocellular carcinoma, acute hepatitis, severe cirrhosis. Concomitant ombitasvir/paritaprevir/ritonavir with or without dasabuvir. Undiagnosed abnormal uterine bleeding. Renal impairment. Adrenal insufficiency.
Nextstellis Boxed Warnings
Boxed Warning
Cigarette smoking and serious cardiovascular events.
Nextstellis Warnings/Precautions
Warnings/Precautions
Increased risk of cardiovascular events esp. in cigarette smokers >35yrs of age or use of other nicotine-containing products. Discontinue if thrombotic event, unexplained visual changes occur, or during prolonged immobilization. Start at least 4 weeks after delivery in females who are not breastfeeding. Discontinue if new migraines develop, or if increased frequency or severity of migraines during use. Hyperkalemia or risk thereof. Prediabetes. Diabetes. Hypertriglyceridemia. Gallbladder disease. Pregnancy-related cholestasis. History of depression. Hereditary angioedema, history of chloasma gravidarum, increased sun sensitivity, UV radiation exposure; avoid. Monitor BP; discontinue if significant rise occurs. May need nonhormonal contraception if not starting on 1st day of menses, postpartum use, after abortion/miscarriage (see full labeling). BMI ≥35kg/m2: not evaluated. Pregnancy: discontinue if occurs. Postmenopausal women: not indicated. Nursing mothers: use alternative contraception.
Nextstellis Pharmacokinetics
See Literature
Nextstellis Interactions
Interactions
See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Nextstellis prior to starting HCV regimen and restart 2wks after completion. Monitor serum K+ during 1st cycle with drugs that increase potassium; consider monitoring in high-risk patients taking concomitant long-term strong CYP3A4 inhibitors (eg, ketoconazole). May be antagonized by CYP3A inducers (eg, rifampin); avoid; use backup or alternative contraception if unavoidable. May be antagonized by bile acid sequestrants; separate dosing of Nextstellis and the concomitant drug (refer to respective drug labeling). May antagonize antidiabetic drugs, lamotrigine; adjust dose. May potentiate certain systemic corticosteroids. May need dose adjustment of thyroid hormones.
Nextstellis Adverse Reactions
Adverse Reactions
Bleeding irregularities, mood disturbance, headache, breast symptoms, dysmenorrhea, acne, increased weight, decreased libido; serious thromboembolic events, elevated liver enzymes (discontinue if persistent or significant), amenorrhea, oligomenorrhea.
Nextstellis Clinical Trials
See Literature
Nextstellis Note
Not Applicable
Nextstellis Patient Counseling
See Literature
