IMPORTANT SAFETY INFORMATION
Indication and Usage of Aubra®
Aubra is a combined oral contraceptive (COC) indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
Selected Safety Information
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with the extent of smoking (in epidemiologic studies, 15 or more cigarettes per day was associated with a significantly increased risk) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.
BRIEF SUMMARY: Consult the Package Insert for Complete Prescribing Information for Aubra
- Thrombophlebitis or thromboembolic disorders
- A history of deep vein thrombophlebitis or thromboembolic disorders
- Cerebrovascular or coronary artery disease (current or past)
- Valvular heart disease with thrombogenic complications
- Thrombogenic rhythm disorders
- Hereditary or acquired thrombophilias
- Major surgery with prolonged immobilization
- Uncontrolled hypertension
- Diabetes with vascular involvement
- Known or suspected carcinoma of the breast or personal history of breast cancer
- Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
- Undiagnosed abnormal genital bleeding
- Hepatic adenoma or carcinoma, or active liver disease
- Cholestatic jaundice of pregnancy or jaundice with prior contraceptive pill use
- Known or suspected pregnancy
- Hypersensitivity to any of the components of Aubra
WARNINGS AND PRECAUTIONS
- Thrombotic and other vascular events- Stop Aubra if an arterial or venous thrombotic event occurs, 4 weeks before and 2 weeks after major surgeries or surgeries known to have an elevated risk of thromboembolism, or if there is an unexplained loss or change of vision (Evaluate for retinal thrombosis immediately.). Combined oral contraceptives should be used with caution in women with cardiovascular risk factors.
- Carcinoma of the breast- Women with current or past history of breast cancer should not use Aubra.
- Liver Disease- Discontinue Aubra if jaundice develops. Hepatic adenomas and very rare hepatocellular carcinoma (> 8 years use) are associated with COC use.
- High Blood pressure- Women with well-controlled hypertension should be monitored closely. Women with uncontrolled hypertension should not use Aubra.
- Other warnings and precautions include gall bladder disease, carbohydrate and lipid metabolic effects, headache, bleeding irregularities including amenorrhea, COC use before and during pregnancy, depression, and interference with laboratory tests.
ADVERSE REACTIONS / SIDE EFFECTS
The most serious reactions are discussed above and include serious cardiovascular events and smoking, vascular events and liver disease. Commonly reported adverse reactions include irregular uterine bleeding, nausea, breast tenderness and headache.
Patients should be counseled that Aubra does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Reference: Aubra® prescribing information. Charleston, SC: Afaxys, Inc. August 2015.
Please see full prescribing information
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report via the FDA MedWatch Program at www.fda.gov/medwatch