Contraception:

Indications for: NEXTSTELLIS

Oral contraception.

Limitations of Use:

May be less effective in females with a BMI ≥30kg/m2.

Adult Dosage:

1 tab daily for 28 days; repeat.

Children Dosage:

Pre-menarche: not applicable.

NEXTSTELLIS 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.

Boxed Warning:

Cigarette smoking and serious cardiovascular events.

NEXTSTELLIS 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 Classification:

Progestin + estrogen.

NEXTSTELLIS 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.

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.

Generic Drug Availability:

NO

How Supplied:

Blister card (28 tabs)—1