Aurovela Fe

Aurovela 24 Fe is indicated for use by women to prevent pregnancy [see Clinical Studies (14)].

The efficacy of Aurovela 24 Fe in women with a body mass index (BMI) of greater than 35 kg/m2 has not been evaluated.

Do not prescribe Aurovela 24 Fe 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:

• 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 inherited or acquired hypercoagulopathies [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 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 aura [see Warnings and Precautions (5.7)]

• Women over age 35 with any migraine headaches [see Warnings and Precautions (5.7)]
• Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions (5.2)]
• Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.8)]
• Pregnancy, because there is no reason to use COCs during pregnancy [see Warnings and Precautions (5.9) and Use in Specific Populations (8.1)]
• Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past [see Warnings and Precautions (5.11)]
• Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [see Warnings and Precautions (5.3)]

Pregnancy

There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to low dose COCs prior to conception or during early pregnancy.

Do not administer COCs to induce withdrawal bleeding as a test for pregnancy. Do not use COCs during pregnancy to treat threatened or habitual abortion.

Women who do not breastfeed should not start COCs earlier than 4 weeks postpartum.

Nursing Mothers

Advise the nursing mother to use another contraceptive method, when possible, until she has weaned her child. COCs can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. Small amounts of oral contraceptive steroids and/or metabolites are present in breast milk.

Pediatric Use

Safety and efficacy of Aurovela 24 Fe have been established in women of reproductive age. Efficacy is expected to be the same in postpubertal adolescents under the age of 18 years as for users 18 years and older. Use of this product before menarche is not indicated.

Geriatric Use

Aurovela 24 Fe has not been studied in postmenopausal women and is not indicated in this population.

Hepatic Impairment

The pharmacokinetics of Aurovela 24 Fe has not been studied in subjects with hepatic impairment. However, steroid hormones may be poorly metabolized in patients with hepatic impairment. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded [see Contraindications (4) and Warnings and Precautions (5.2)].

Renal Impairment

The pharmacokinetics of Aurovela 24 Fe has not been studied in women with renal impairment.

Body Mass Index

The safety and efficacy of Aurovela 24 Fe in women with a body mass index (BMI) greater than 35 kg/m2 has not been evaluated [see Clinical Studies (14)].

NDC 65862-934-58
28 Day Regimen

AurovelaTM 24 Fe provides
24 days of active therapy

AurovelaTM 24 Fe
(Norethindrone Acetate and Ethinyl Estradiol
Tablets USP and Ferrous Fumarate Tablets)
1 mg/20 mcg

This product (like all oral contraceptives) is intended to prevent pregnancy. It does not
protect against HIV infection (AIDS) and other sexually transmitted diseases.

                                                This carton contains 5 pouches.
Rx only              Each pouch contains 1 blister card of 28 tablets.

Contraception:
Ethinyl estradiol-norethindrone products are packaged in 21 or 28 day dosage preparations.
Regardless of the number of tablets in a package, the cycle length for oral contraceptives is generally considered to be 28 days. (The first day of menstrual bleeding is counted as day 1.)

Initiation of Oral Contraceptive Therapy
This product can be administered in two ways:

When initiating a Sunday start regimen, the first tablet may be taken on the first Sunday after menstruation begins. If a period begins on a Sunday, the first tablet may be taken on that day. When initiating a Sunday start regimen, another contraceptive method should be used until after the first 7 consecutive days of administration. For a 28 day package, one tablet is taken daily for 28 days and a new package begun on the following day. For a 21 day package, one tablet is taken daily for 21 days followed by 7 days with no medication. A new package of contraceptives is begun on the following day.

When initiating a Day 1 start regimen, the first tablet is taken on the first day on menstruation. Such initiation may increase the risk of spotting and breakthrough bleeding but decrease the risk of early ovulation and pregnancy. For a 28 day package, one tablet is taken daily for 28 days and a new package begun on the following day. For a 21 day package, one tablet is taken daily for 21 days followed by 7 days with no medication. A new package of contraceptives is begun on the following day.

Many clinicians recommend that additional contraceptive methods be used during the first cycle of hormonal therapy in order to reduce the risk of unintended pregnancy.

Missed Doses:
If a woman misses one dose of active tablets, the missed dose should be taken as soon as it is remembered and the normal schedule should be resumed.

If a woman misses two doses in week 1 or week 2 of the cycle, 2 tablets may be taken as soon as they are remembered and 2 tablets taken the next day and the normal schedule may be resumed. (Additional contraceptive methods should be used for 7 days.)

If a woman misses two doses in week 3 or three doses at any time in the cycle, Day 1 starters should discard the current package and begin a new package that same day. Sunday starters should take 1 tablet daily from the current package until Sunday, when the current package is discarded and a new package begun. (Additional contraceptive methods should be used until the woman has taken at least 7 days of hormonal therapy from the new package.)

Acne:
-Use Estrostep Fe (R) for the treatment of acne only if the patient desires an oral contraceptive for birth control and plans to stay on it for at least 6 months.
-The timing and initiation of dosing with Estrostep FE (R) should follow the guidelines for use as an oral contraceptive.