Contraception:
Indications for: LOSEASONIQUE
Oral contraception.
Adult Dosage:
1 tab daily for 91 days; repeat. Take at the same time daily. Use Sunday start for 1st cycle; use backup method until orange tabs are taken for 7 consecutive days. Allow at least 4 weeks postpartum, if not breastfeeding, to begin cycle. Use backup method if 2 consecutive orange tabs are missed (see full labeling).
Children Dosage:
Pre-menarchal: not recommended.
LOSEASONIQUE Contraindications:
High risk of arterial or venous thrombotic disease (eg, smokers or migraineurs over age 35, DVT or PE, cerebrovascular or coronary artery disease, thrombogenic valvular disease, atrial fibrillation, subacute bacterial endocarditis, hypercoagulopathies, uncontrolled hypertension, hypertension with vascular disease, diabetes over age 35, diabetes with hypertension or vascular disease or other end-organ damage, diabetes of >20yrs duration, headaches with focal neurologic symptoms). Undiagnosed abnormal uterine bleeding. Breast or other estrogen- or progestin-sensitive neoplasms. Hepatic tumors, acute viral hepatitis, or severe (decompensated) cirrhosis. Concomitant ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
LOSEASONIQUE Warnings/Precautions:
Increased risk of cardiovascular and cerebrovascular events esp. women over age 35, smokers, and females with hypertension, dyslipidemia, diabetes, or obesity. Evaluate any medical or family history of thrombotic or thromboembolic disorders prior to initiation. Discontinue if thrombotic event, unexplained visual changes, or jaundice occurs, and at least 4 weeks before through 2 weeks after surgery associated with increased risk of thromboembolism. Gallbladder disease. Pregnancy-related cholestasis. Diabetes. Prediabetes. Uncontrolled dyslipidemia. Hypertriglyceridemia. Depression. Hereditary angioedema. Evaluate significant changes in headaches, irregular uterine bleeding, amenorrhea. Cholasma gravidarum. Monitor blood pressure; discontinue if significant hypertension occurs. Do regular complete physical exams. Hepatic impairment: not studied. Pregnancy: discontinue if occurs. Nursing mothers: use other methods of contraception until breastfeeding is discontinued.
LOSEASONIQUE Classification:
Progestin + estrogen.
LOSEASONIQUE Interactions:
See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Loseasonique prior to starting HCV regimen and restart 2wks after completion. Concomitant glecaprevir/pibrentasvir: not recommended. May be antagonized by CPY3A4 or other enzyme inducers (eg, aprepitant, barbiturates, bosentan, carbamazepine, efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, rifabutin, rufinamide, St. John’s wort, topiramate, certain protease inhibitors); use backup contraception. May be affected by protease inhibitors. May antagonize lamotrigine. May affect lab tests (eg, coagulation factors, lipids, glucose tolerance, binding proteins). May need dose adjustment of thyroid hormones.
Adverse Reactions:
Irregular uterine bleeding, nausea, breast tenderness, headache, dysmenorrhea, vomiting, back pain, acne, weight gain; pulmonary embolus, breakthrough bleeding, amenorrhea, oligomenorrhea, chloasma, liver disease.
Drug Elimination:
Levonorgestrel: renal (~45%), fecal (~32%). Ethinyl estradiol: renal, fecal. Half-life: ~34 hours (levonorgestrel); ~18 hours (ethinyl estradiol).
How Supplied:
Dispensers—2 (2 X 91 day cycles)
