Important Safety Information
Indication and Usage of Cyred®
Cyred is indicated for the prevention of pregnancy in women who elect to use oral
contraceptives as a method of contraception.
Selected Safety Information about Cyred
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
Cigarette smoking increases the risk of serious cardiovascular events from
combination 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, should not
be used by women over 35 years of age and smoke.
BRIEF SUMMARY: 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
- 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
- Undiagnosed abnormal genital bleeding
- Acute or chronic hepatocellular disease with abnormal liver function, hepatic
adenomas or carcinoma
- 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
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
- 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.
ADVERSE REACTIONS / SIDE EFFECTS
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
Reference: Cyred<® prescribing information. Charleston, SC: Afaxys, Inc. January 2016.
Please see full prescribing information
To report SUSPECTED ADVERSE REACTIONS, call
report via the FDA MedWatch Program at www.fda.gov/medwatch