IMPORTANT SAFETY INFORMATION for Tri-VyLibra® Lo (norgestimate and ethinyl estradiol tablets, USP 0.180 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.250 mg/0.025 mg)
INDICATIONS
Tri-VyLibra Lo (norgestimate and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy.
Consult the Package Insert or click here for Complete Prescribing Information.
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CONTRAINDICATIONS
Tri-VyLibra Lo 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 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, 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 combined oral contraceptives during pregnancy)
- Current diagnosis of, or history of, breast cancer, which may be hormone sensitive
- Use 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 problems—Stop combined oral contraceptives (COCs) if an arterial or venous thrombotic event occurs, or 4 weeks before through 2 weeks after major surgery 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). Start Tri-VyLibra Lo no earlier than 4 weeks after delivery, in women who are not breastfeeding. COCs should be used with caution in women with cardiovascular risk factors.
- Malignant neoplasms—Women with current or past history of breast cancer should not use COCs because breast cancer may be hormonally sensitive.
- Liver disease—Discontinue COCs if jaundice develops. Hepatic adenomas and very rare hepatocellular carcinomas are associated with long-term (>8 years) COC use.
- 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 gallbladder disease, carbohydrate and lipid metabolic effects, headache, bleeding irregularities, COC use before and during pregnancy, depression, interference with laboratory tests, hereditary angioedema, and chloasma.
ADVERSE REACTIONS
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The most serious reactions are discussed elsewhere in the labeling and include serious cardiovascular events, 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 Lo does not protect against HIV infection (AIDS) and other sexually transmitted infections (STIs).
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