Important Safety Information
Cyred EQ™ is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
WARNINGS: CARDIOVASCULAR RISK ASSOCIATED WITH SMOKING
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 Cyred EQ™, should not be used by women over 35
years of age who smoke.
Consult the Package Insert for
Complete Prescribing Information
- A high risk of arterial or venous thrombotic disease including women who are known to smoke if over age 35, have a current or past history of deep vein thrombosis, pulmonary embolism, thrombophlebitis, thrombophilic conditions or thromboembolic disorders, have cerebrovascular or coronary artery disease (current or history), have valvular heart disease with complications, have persistent blood pressure values of greater than or equal to 160 mm Hg systolic or greater than or equal to 100 mm Hg diastolic, have headache with focal neurologic symptoms, or have diabetes with vascular involvement
- Major surgery with prolonged immobilization
- Known or suspected carcinoma of breast or personal history of breast cancer; carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
- Undiagnosed abnormal genital bleeding
- Acute or chronic hepatocellular disease with abnormal liver function, hepatic adenomas or carcinomas
- Cholestatic jaundice of pregnancy or jaundice with prior contraceptive pill use
- Known or suspected pregnancy
- Hypersensitivity to any of the components of the oral contraceptive pills
- 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 Cyred EQ™ does
not protect against HIV infection (AIDS) and other
sexually transmitted diseases.
Cyred 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