BLISOVI FE 1.5/30

INDICATIONS AND USAGE Blisovi Fe 1.5/30 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TABLE I: LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD Adapted from RA Hatcher et al, Reference 7. % of Women Experiencing an Unintended Pregnancy in the First Year of Continuous Use Method Lowest Expected The authors' best guess of the percentage of women expected to experience an accidental pregnancy among couples who initiate a method (not necessarily for the first time) and who use it consistently and correctly during the first year if they do not stop for any other reason. Typical This term represents "typical" couples who initiate use of a method (not necessarily for the first time), who experience an accidental pregnancy during the first year if they do not stop use for any other reason. (No contraception) (85) (85) Oral contraceptives 3 Combined 0.1 N/A N/A--Data not available Progestin only 0.5 N/A Diaphragm with spermicidal cream or jelly 6 20 Spermicides alone (foam, creams, gels, vaginal suppositories, and vaginal film) 6 26 Vaginal Sponge Nulliparous 9 20 Parous 20 40 Implant 0.05 0.05 Injection:depot medroxyprogesterone acetate 0.3 0.3 IUD Progesterone T 1.5 2.0 Copper T 380A 0.6 0.8 LNg 20 0.1 0.1 Condom without spermicides Female 5 21 Male 3 14 Cervical Cap with spermicidal Cream of jelly Nulliparous 9 20 Parous 26 40 Periodic abstinence (all methods) 1 to 9 25 Withdrawal 4 19 Female sterilization 0.5 0.5 Male sterilization 0.10 0.15

DOSAGE AND ADMINISTRATION The blister has been designed to make oral contraceptive dosing as easy and as convenient as possible. The tablets are arranged in four rows of seven tablets each, with the days of the week appearing on the blister above the first row of tablets. Note: Each blister has been preprinted with the days of the week, starting with Sunday, to facilitate a Sunday-Start regimen. Six different day labels strips have been provided with the Detailed Patient & Brief Summary Patient Package Insert in order to accommodate a Day-1 Start regimen. If the patient is using the Day-1 Start regimen, she should place the self-adhesive day label strip that corresponds to her starting day over the preprinted days. Important: The patient should be instructed to use an additional method of protection until after the first week of administration in the initial cycle when utilizing the Sunday-Start regimen. The possibility of ovulation and conception prior to initiation of use should be considered. Dosage and Administration for 28-Day Dosage Regimen To achieve maximum contraceptive effectiveness, Blisovi Fe 1.5/30 should be taken exactly as directed and at intervals not exceeding 24 hours. Blisovi Fe 1.5/30 provides a continuous administration regimen consisting of 21 pink tablets of Blisovi Fe 1.5/30 and 7 brown non-hormone containing tablets of ferrous fumarate. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen and do not serve any therapeutic purpose. There is no need for the patient to count days between cycles because there are no "off-tablet days." 1. Sunday-Start Regimen: The patient begins taking the first pink tablet from the top row of the blister (labeled Sunday) on the first Sunday after menstrual flow begins. When menstrual flow begins on Sunday, the first pink tablet is taken on the same day. The patient takes one pink tablet daily for 21 days. The last pink tablet in the blister will be taken on a Saturday. Upon completion of all 21 pink tablets, and without interruption, the patient takes one brown tablet daily for 7 days. Upon completion of this first course of tablets, the patient begins a second course of 28-tablets, without interruption, the next day (Sunday), starting with the Sunday pink tablet in the top row. Adhering to this regimen of one pink tablet daily for 21 days, followed without interruption by one brown tablet daily for seven days, the patient will start all subsequent cycles on a Sunday. 2. Day-1 Start Regimen: The first day of menstrual flow is Day 1. The patient places the self-adhesive day label strip that corresponds to her starting day over the preprinted days on the blister. She starts taking one pink tablet daily, beginning with the first pink tablet in the top row. After the last pink tablet (at the end of the third row) has been taken, the patient will then take the brown tablets for a week (7 days). For all subsequent cycles, the patient begins a new 28 tablet regimen on the eighth day after taking her last pink tablet, again starting with the first tablet in the top row after placing the appropriate day label strip over the preprinted days on the blister. Following this regimen of 21 pink tablets and 7 brown tablets, the patient will start all subsequent cycles on the same day of the week as the first course. Tablets should be taken regularly with a meal or at bedtime. It should be stressed that efficacy of medication depends on strict adherence to the dosage schedule. Special Notes on Administration Menstruation usually begins two or three days, but may begin as late as the fourth or fifth day, after the brown tablets have been started. In any event, the next course of tablets should be started without interruption. If spotting occurs while the patient is taking pink tablets, continue medication without interruption. If the patient forgets to take one or more pink tablets, the following is suggested: One tablet is missed take table …

CONTRAINDICATIONS Oral contraceptives are contraindicated in women who currently have the following conditions: Thrombophlebitis or thromboembolic disorders A past history of deep vein thrombophlebitis or thromboembolic disorders Cerebral vascular or coronary artery disease Current diagnosis of, or history of, breast cancer, which may be hormone sensitive Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia Undiagnosed abnormal genital bleeding Cholestatic jaundice of pregnancy or jaundice with prior pill use Hepatic adenomas or carcinomas Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see WARNINGS, RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT ) .

ADVERSE REACTIONS An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS section) : Thrombophlebitis Arterial thromboembolism Pulmonary embolism Myocardial infarction Cerebral hemorrhage Cerebral thrombosis Hypertension Gallbladder disease Hepatic adenomas or benign liver tumors Post Marketing Experience Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 to 1.12 (Figure 1) (70-74). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 1) (70, 73, 75). One of these studies reported no association between breast cancer risk and COC use. The other two studies found an increased relative risk of 1.19 to 1.33 with current or recent use. Both of these studies found an increased risk of breast cancer with current use of longer duration, with relative risks ranging from 1.03 with less than one year of COC use to approximately 1.4 with more than 8 to 10 years of COC use. FIGURE 1: RELEVANT STUDIES OF RISK OF BREAST CANCER WITH COMBINED ORAL CONTRACEPTIVES There is evidence of an association between the following conditions and the use of oral contraceptives, although additional confirmatory studies are needed: Mesenteric thrombosis Retinal thrombosis The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related: Nausea Vomiting Gastrointestinal symptoms (such as abdominal cramps and bloating) Breakthrough bleeding Spotting Change in menstrual flow Amenorrhea Temporary infertility after discontinuation of treatment Edema Melasma which may persist Breast changes: tenderness, enlargement, secretion Change in weight (increase or decrease) Change in cervical erosion and secretion Diminution in lactation when given immediately postpartum Cholestatic jaundice Migraine Rash (allergic) Depression Reduced tolerance to carbohydrates Vaginal candidiasis Change in corneal curvature (steepening) Intolerance to contact lenses The following adverse reactions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted: Pre-menstrual syndrome Cataracts Changes in appetite Cystitis-like syndrome Headache Nervousness Dizziness Hirsutism Loss of scalp hair Erythema multiforme Erythema nodosum Hemorrhagic eruption Vaginitis Porphyria Impaired renal function Hemolytic uremic syndrome Budd-Chiari syndrome Acne Changes in libido Colitis FIGURE 1: RELEVANT STUDIES OF RISK OF BREAST CANCER WITH COMBINED ORAL CONTRACEPTIVES

DESCRIPTION Blisovi Fe 1.5/30 is progestogen-estrogen combination. Blisovi Fe 1.5/30 provides a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each pink tablet contains norethindrone acetate (17α-ethinyl-19-nortestosterone acetate), 1.5 mg; ethinyl estradiol (17α-ethinyl-1,3,5(10)-estratriene-3,17β-diol), 30 mcg. Each pink tablet contains the following inactive ingredients: acacia, confectioner's sugar, corn starch, FD & C red no. 40, lactose monohydrate, magnesium stearate and talc. Each brown placebo tablet contains ferrous fumarate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and sucrose. The ferrous fumarate tablets do not serve any therapeutic purpose. Norethindrone Acetate USP Ethinyl Estradiol USP

OVERDOSAGE Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea, and withdrawal bleeding may occur in females.

OVERDOSAGE Serious ill effects have not been reported following ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea and withdrawal bleeding in females. In case of overdosage, contact your health care provider or pharmacist.

HOW SUPPLIED Blisovi Fe 1.5/30 (28 Tablets) (norethindrone acetate and ethinyl estradiol tablets USP, 1.5 mg/0.03 mg; and ferrous fumarate tablets) are available in a blister (NDC 68180-866-71) containing 28 tablets packed in a pouch (NDC 68180-866-71). Such three pouches are packaged in a carton (NDC 68180-866-73). Each blister contains 28 tablets, as follows: 21 pink coloured, round flat face beveled edged tablets, each containing 1.5 mg norethindrone acetate and 0.03 mg ethinyl estradiol, debossed with "LU" on one side and "K24" on the other side. 7 brown mottled, round, flat face beveled edged tablets debossed with "LU" on one side and "M22" on the other side. Each brown tablet contains 75 mg ferrous fumarate. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].