INDICATIONS AND USAGE
Lo Loestrin® Fe is an estrogen/progestin combination oral contraceptive (COC) indicated for use by women to prevent pregnancy. The efficacy of Lo Loestrin Fe in women with a body mass index (BMI) of >35 kg/m2 has not been evaluated.
IMPORTANT SAFETY INFORMATION
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 should not be used by women who are over 35 years of age and smoke.
Lo Loestrin Fe is contraindicated in pregnant patients, in women with a high risk of arterial or venous thrombotic diseases, liver tumors (benign or malignant) or liver disease, undiagnosed abnormal uterine bleeding, or breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past, and in women using Hepatitis C drugs containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
Warnings and Precautions
Discontinue Lo Loestrin Fe if a thrombotic event occurs, and at least 4 weeks before and through 2 weeks after major surgery. Lo Loestrin Fe should not be started any earlier than 4 weeks after delivery, in women who are not breastfeeding. If jaundice occurs, treatment should be discontinued.
Lo Loestrin Fe should not be prescribed for women with uncontrolled hypertension or hypertension with vascular disease. Women who are pre-diabetic or diabetic should be monitored while using Lo Loestrin Fe. Alternate contraceptive methods should be considered for women with uncontrolled dyslipidemia. Patients using Lo Loestrin Fe who have a significant change in headaches or irregular bleeding or amenorrhea should be evaluated.
In the clinical trial for Lo Loestrin Fe, serious adverse reactions included deep vein thrombosis, ovarian vein thrombosis, and cholecystitis. The most common adverse reactions (incidence ≥2%) were nausea/vomiting, headache, bleeding irregularities, dysmenorrhea, weight fluctuation, breast tenderness, acne, abdominal pain, anxiety, and depression.
Patients should be counseled that COCs do not protect against HIV infection (AIDS) and other sexually transmitted diseases.
full Prescribing Information, including Boxed Warning, for Lo Loestrin Fe.