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Twirla Generic Name & Formulations
Legal Class
Rx
General Description
Levonorgestrel 120mcg/day, ethinyl estradiol 30mcg/day; transdermal patch.
Pharmacological Class
Progestin + estrogen.
How Supplied
Patches—1, 3
Manufacturer
Generic Availability
NO
Twirla Indications
Indications
Transdermal contraception.
Limitations of Use
Consider the reduced effectiveness in women with BMI ≥25-<30kg/m2 before prescribing.
Twirla Dosage and Administration
Adult
Apply to abdomen, buttock, or upper torso; with each new patch, rotate application site. Apply 1 patch once weekly for 3 weeks, then 1 patch-free week; repeat.
Children
Premenarchal: not applicable.
Twirla Contraindications
Contraindications
High risk for arterial or venous thrombotic events (eg, smokers or migraineurs over age 35, history of DVT or PE, cerebrovascular or coronary artery disease, thrombogenic valvular disease, atrial fibrillation, subacute bacterial endocarditis, hypercoagulopathies, uncontrolled hypertension, diabetes with vascular disease). Headaches with focal neurologic symptoms or migraines with aura. BMI ≥30kg/m2. Undiagnosed abnormal uterine bleeding. Breast or other estrogen- or progestin-sensitive neoplasms. Hepatic disease or tumors. Pregnancy. Concomitant ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
Twirla Boxed Warnings
Boxed Warning
Cigarette smoking. Serious cardiovascular events. Contraindicated in women with a BMI ≥30kg/m2.
Twirla Warnings/Precautions
Warnings/Precautions
Increased risk of cardiovascular events (eg, stroke, MI) esp. in cigarette smokers >35yrs of age. 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, and during and after prolonged immobilization. Gallbladder disease. History of pregnancy-related cholestasis. Diabetes. Uncontrolled dyslipidemia. Hypertriglyceridemia; increased risk of pancreatitis. Obesity. Depression. Hereditary angioedema. Cholasma gravidarum. Evaluate significant changes in headaches, irregular uterine bleeding, amenorrhea. Monitor BP; discontinue if significant rise occurs. Do regular complete physical exams. Nursing mothers: not recommended (use alternative method).
Twirla Pharmacokinetics
See Literature
Twirla Interactions
Interactions
See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Twirla prior to starting HCV regimen and restart 2wks after completion. Antagonized by hepatic enzyme inducing drugs (eg, aprepitant, barbiturates, bosentan, carbamazepine, efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, rifabutin, rufinamide, topiramate, St. John's Wort), others. May antagonize lamotrigine; consider dosage adjustment. May be affected by HIV protease inhibitors (eg, nelfinavir, ritonavir, darunavir/ritonavir), HCV protease inhibitors (eg, boceprevir, telaprevir), NNRTIs (eg, nevirapine, etravirine). Concomitant colesevelam; give 4hrs apart. May be potentiated by acetaminophen, ascorbic acid, atorvastatin, rosuvastatin, and CYP3A4 inhibitors (eg, itraconazole, ketoconazole, voriconazole, fluconazole, grapefruit juice). May potentiate cyclosporine, prednisolone, theophylline, tizanidine, voriconazole. May antagonize acetaminophen, morphine, salicyclic acid, temazepam. May affect measurement of coagulation factors, thyroid binding globulin, sex hormone binding globulin, lipids, glucose tolerance, other serum binding proteins.
Twirla Adverse Reactions
Adverse Reactions
Application site disorders, nausea, headache, dysmenorrhea, increased weight; hypertension, amenorrhea, oligomenorrhea, possible venous thromboembolism; ectopic pregnancy, others (see full labeling).
Twirla Clinical Trials
See Literature
Twirla Note
Not Applicable
Twirla Patient Counseling
See Literature
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