IMPORTANT SAFETY INFORMATION
INDICATION and USAGE OF TRI-VYLIBRA®
Tri-VyLibra is an estrogen/progestin combined oral contraceptive (COC) indicated for use by women to prevent pregnancy. Tri-VyLibra is also indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-VyLibra should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.
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, particularly in women over 35 years of age, and with the number of
cigarettes smoked. For this reason, combination oral contraceptives, including Tri-VyLibra, should not be used by women who are over 35 years of age and smoke.
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- A high risk of arterial or venous thrombotic diseases. Examples include women who are known to smoke, if over age 35, have deep vein thrombosis or pulmonary embolism, now or in the past, have inherited or acquired hypercoagulopathies, 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 uncontrolled hypertension, have diabetes mellitus with vascular disease
- Have headaches with focal neurological symptoms or migraine headaches with aura or women over age 35 with any migraine headaches
- Liver tumors, benign or malignant, or liver disease
- Undiagnosed abnormal uterine bleeding
- Pregnancy, because there is no reason to use COCs during pregnancy
- Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past
- Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations
WARNINGS AND PRECAUTIONS
- Thrombotic and other vascular events — Stop combined oral contraceptives 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 and cervix — Women with current or past history of breast cancer should not use COCs.
- Liver Disease — Discontinue COCs if jaundice develops. Hepatic adenomas and very rare hepatocellular carcinoma (> 8 years use) are associated with COC use. Do not use in women receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations.
- High Blood pressure — Women with well-controlled hypertension should be monitored closely. Women with uncontrolled hypertension should not use COCs.
- 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.
The most serious reactions are discussed elsewhere in the labeling 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 Tri-VyLibra does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Tri-VyLibra® [prescribing information]. Charleston, SC: Afaxys Pharma, LLC; November 2017.
Please see full Prescribing Information .
To report SUSPECTED ADVERSE REACTIONS, call 1-855-888-2467 or report via the FDA MedWatch Program at
www.fda.gov/medwatch or 1-800-FDA-1088.