IMPORTANT SAFETY INFORMATION
Indication and Usage of Tarina Fe 1/20
Tarina Fe 1/20 is a combined oral contraceptive (COC) indicated for the prevention of
pregnancy in women who elect to use oral contraceptives as a method of
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 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
Consult the Package Insert for Complete Prescribing Information
- Thrombophlebitis or thromboembolic disorders,
- A past history of deep vein thrombophlebitis or thromboembolic disorders,
- Cerebral vascular or coronary artery disease,
- Known or suspected carcinoma of the breast
- Carcinoma of the endometrium or other known or suspected estrogen-dependent
- 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
- 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 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.
- Liver Disease - Discontinue Tarina Fe 1/20 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
- 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 does not protect against HIV
infection (AIDS) and other sexually transmitted diseases.
Reference: Tarina® Fe 1/20 [prescribing information]. Charleston, SC: Afaxys, Inc.; November 2017.
To report a Suspected Adverse Reaction to Tarina Fe 1/20, please contact the
Afaxys Health and Safety team at 1-855-888-2467.
Please see full Prescribing Information