Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate

Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14) ] . The efficacy of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets in women with a body mass index (BMI) of more than 35 kg/m 2 has not been evaluated.

• Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are an estrogen/progestin COC indicated for use by women to prevent pregnancy ( 1 )
• The efficacy in women with a body mass index of more than 35 kg/m 2 has not been evaluated ( 1 , 8.8 )

Do not prescribe norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets to women who are known to have the following conditions:

• A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: o Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1) ] o Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1) ] o Have cerebrovascular disease [see Warnings and Precautions (5.1) ] o Have coronary artery disease [see Warnings and Precautions (5.1) ] o 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) ] o Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1) ] o Have uncontrolled hypertension [see Warnings and Precautions (5.3) ] o Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.5) ] o Have headaches with focal neurological symptoms or have migraine headaches with aura
• All women over age 35 with migraine headache [see Warnings and Precautions (5.6) ]
• Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions (5.2) ]
• Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.7) ]
• Pregnancy, because there is no reason to use COCs during pregnancy [see Warnings and Precautions (5.8) and Use in Specific Populations (8.1) ]