Levonorgestrel / ethinyl estradiol

JOLESSA ® is indicated for use by females of reproductive potential to prevent pregnancy. JOLESSA is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy.

COCs prevent pregnancy primarily by suppressing ovulation.

Take one tablet daily by mouth at the same time every day for 91 days. Take tablets in the order directed on the Extended-Cycle Tablet Dispenser.

JOLESSA is contraindicated in females who are known to have or develop the following conditions: A high risk of arterial or venous thrombotic diseases. Examples include females who are known to: Smoke, if over age 35. Have current or history of deep vein thrombosis or pulmonary embolism. Have cerebrovascular disease. Have coronary artery disease. Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation). Have inherited or acquired hypercoagulopathies. Have uncontrolled hypertension or hypertension with vascular disease.

Boxed warning (cigarette smoking and serious cardiovascular events): Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including JOLESSA, are contraindicated in women who are over 35 years of age and smoke. Vascular risks: Stop if a thrombotic or thromboembolic event occurs. Stop at least 4 weeks before and through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding. Consider cardiovascular risk factors before initiating in all females, particularly those over 35 years. Liver disease: Discontinue if jaundice occurs.

The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: Serious cardiovascular events and stroke Vascular events Liver disease The most common adverse reactions (≥2%) reported during clinical trials were headache, menorrhagia, nausea, dysmenorrhea, acne, migraine, breast tenderness, weight increased, and depression.

The sections below provide information on substances for which data on drug interactions with COCs are available. There is little information available about the clinical effect of most drug interactions that may affect COCs. However, based on the known pharmacokinetic effects of these drugs, clinical strategies to minimize any potential adverse effect on contraceptive effectiveness or safety are suggested. Consult the approved product labeling of all concurrently used drugs to obtain further information about interactions with COCs or the potential for metabolic enzyme or transporter system alterations. No drug-drug interaction studies were conducted with JOLESSA. Enzyme inducers (e.g. CYP3A4): May decrease the effectiveness of JOLESSA or increase breakthrough bleeding. Counsel patients to use a backup or alternative method of contraception when enzyme inducers are used with JOLESSA.

Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF). Protect from light.