IMPORTANT SAFETY INFORMATION
Tarina Fe 1/20 EQ™ 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.
Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.
Consult the Package Insert for Complete Prescribing Information
- Thrombophlebitis or thromboembolic disorders
- A past history of deep-vein thrombophlebitis or thromboembolic disorders
- Cerebrovascular or coronary artery disease
- Known or suspected carcinoma of the breast
- Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
- Undiagnosed abnormal genital bleeding
- Hepatic adenoma or carcinoma
- Cholestatic jaundice of pregnancy or jaundice with prior contraceptive pill use
- Known or suspected pregnancy
- Hypersensitivity to any of the components of Tarina Fe 1/20 EQ™
- 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 Tarina Fe 1/20 EQ™ 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 Tarina Fe 1/20 EQ™.
- Liver disease—Discontinue Tarina Fe 1/20 EQ™ 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 Tarina Fe 1/20 EQ™.
- 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 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 Tarina Fe 1/20 EQ™ does not protect against HIV
infection (AIDS) and other sexually transmitted diseases.
Tarina Fe 1/20 EQ™ [prescribing information]. Charleston, SC: Afaxys Pharma, LLC; May 2018.
Please see full Prescribing Information
To report SUSPECTED ADVERSE REACTIONS, call
report via the FDA MedWatch Program at www.fda.gov/medwatch or 1-800-FDA-1088.