Indicated for:

Oral Contraceptive:

• Use by women to prevent pregnancy.

Premenstrual Dysphoric Disorder (PMDD):

• The treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception. The effectiveness of Yaz for PMDD when used for more than three menstrual cycles has not been evaluated. Yaz has not been evaluated for the treatment of premenstrual syndrome (PMS).

Acne:

• For the treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Yaz should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke.

Do not prescribe Yaz to women who are known to have the following:

• Renal impairment
• Adrenal insufficiency
• 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 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 inherited or acquired hypercoagulopathies, have uncontrolled hypertension, have diabetes mellitus with vascular disease, have headaches with focal neurological symptoms or have migraine headaches ·with or without aura if over age 35
• Undiagnosed abnormal uterine bleeding
• Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive
• Liver tumors, benign or malignant, or liver disease
• Pregnancy, because there is no reason to use COCs during pregnancy
• Use of Hepatitis C drug combinations containing ombitasvir, paritaprevir/ritonavir, with or without dasabuvir due to the potential for ALT elevations

Studies suggest a small increased relative risk of developing gallbladder disease among COC users.

Consider alternative contraception for women with uncontrolled dyslipidemias.

Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs.

Carefully monitor prediabetic and diabetic women who are taking Yaz. COCs may decrease glucose intolerance in a dose-related fashion.

Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while taking COCs.

Women with a history of depression should be carefully observed and Yaz discontinued if depression recurs to a serious degree.

If a woman taking Yaz develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue Yaz if indicated. An increase in frequency or severity of migraine during COC use (which may be prodromal of a cerebrovascular event) may be a reason for immediate discontinuation of the COC.

Unscheduled (breakthrough or intracyclic) bleeding and spotting sometimes occur in patients on COCs, especially during the first three months of use. If bleeding persists or occurs after previously regular cycles, check for causes such as pregnancy or malignancy.

Medications that may increase serum potassium concentration include ACE inhibitors, angiotensin-II receptor antagonists, potassium-sparing diuretics, potassium supplementation, heparin, aldosterone antagonists, and NSAIDS. Consider monitoring serum potassium concentration in high-risk patients who take a strong CYP3A4 inhibitor long-term and concomitantly.

Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampin, topiramate and products containing St. John’s wort.

Consider monitoring serum potassium concentration in high-risk patients who take a strong CYP3A4 inhibitor long-term and concomitantly. Strong CYP3A4 inhibitors include azole antifungals (e.g. ketoconazole, itraconazole, voriconazole), HIV/HCV protease inhibitors (e.g., indinavir, boceprevir), and clarithromycin.

Ascorbic acid and acetaminophen may increase plasma EE concentrations, possibly by inhibition of conjugation.

COCs have been shown to significantly decrease plasma concentrations of lamotrigine, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.

Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because serum concentration of thyroid-binding globulin increases with use of COCs.

The use of COCs may change the results of some laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins.

For postpartum women who do not breastfeed or after a second trimester abortion, start Yaz no earlier than 4 weeks postpartum due to the increased risk of thromboembolism. If the patient starts on Yaz postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken Yaz for 7 consecutive days.

When possible, advise the nursing mother to use other forms of contraception until she has weaned her child. Estrogen-containing COCs can reduce milk production in breastfeeding mothers. Small amounts of oral contraceptive steroids and/or metabolites are present in breast milk. 

GoToSource

• Heavy menstrual bleeding. GoToSource

• Premenstrual syndrome. GoToSource

Hyperkalemia (high blood potassium level). GoToSource

Weight gain, migraines, depression, insulin resistance and increased triglycerides and HDL cholesterol. GoToSource

Myocardial infarction and ischemic stroke. GoToSource

Kidney damage, liver dysfunction and adrenal insufficiency. GoToSource

Increased risk of breast cancer. GoToSource

Venous thromboembolism. GoToSource

Gallbladder disease. GoToSource

Lawsuits filed for strokes, blood clots, breast cancer and heart attacks.