Natazia

• Estradiol Valerate and Estradiol Valerate/Dienogest is an estrogen/progestin COC indicated for use by women to prevent pregnancy. ( 1 )
• Treatment of heavy menstrual bleeding in women without organic pathology who choose to use an oral contraceptive as their method of contraception. ( 1.2 )
• The efficacy of Estradiol Valerate and Estradiol Valerate/Dienogest in women with a body mass index (BMI) of >30 kg/m 2 has not been evaluated. ( 1 , 8.8 )

1.1Oral Contraception Estradiol Valerate and Estradiol

Valerate/Dienogest is indicated for use by women to prevent pregnancy. The efficacy of Estradiol Valerate and Estradiol Valerate/Dienogest in women with a body mass index (BMI) of > 30 kg/m 2 has not been evaluated.

1.2Heavy Menstrual Bleeding Estradiol Valerate and Estradiol

Valerate/Dienogest is also indicated for the treatment of heavy menstrual bleeding in women without organic pathology who choose to use an oral contraceptive as their method of contraception [see Clinical Studies ( 14.2 )].

Do not prescribe Estradiol Valerate and Estradiol Valerate/Dienogest to women who are known to have the following:

• A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:
• Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions ( 5.1 )]
• Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions ( 5.1 )]
• Have cerebrovascular disease [see Warnings and Precautions ( 5.1 )]
• Have coronary artery disease [see Warnings and Precautions ( 5.1 )]
• Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions ( 5.1 )]
• Have inherited or acquired hypercoagulopathies [see Warnings and Precautions ( 5.1 )]
• Have uncontrolled hypertension [see Warnings and Precautions ( 5.4 )]
• Have diabetes mellitus with vascular disease [see Warnings and Precautions ( 5.6 )]
• Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see Warnings and Precautions ( 5.7 )]
• Undiagnosed abnormal uterine bleeding [see Warnings and Precautions ( 5.8 )]