SETLAKIN Levonorgestrel and Ethinyl Estradiol Kit, 3 pouches — NDC 16714-366-03 (Billing 16714-0366-03)

1 INDICATIONS AND USAGE SETLAKIN is indicated for use by females of reproductive potential to prevent pregnancy. SETLAKIN is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 )

2 DOSAGE AND ADMINISTRATION Take one tablet daily by mouth at the same time every day for 91 days. ( 2.1 ) Take tablets in the order directed on the Extended-Cycle Tablet Dispenser. ( 2.2 )

2.1How to Start and Take SETLAKIN SETLAKIN is dispensed in an Extended-Cycle Tablet Dispenser [see How Supplied/Storage and Handling (16)]. SETLAKIN should be started on a Sunday (see Table 1 ). For the first cycle of a Sunday Start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration.

Table 1: Instructions for Administration of SETLAKIN Starting SETLAKIN in females with no current use of hormonal contraception (Sunday Start) Important: Consider the possibility of ovulation and conception prior to initiation of this product. Tablet Color: SETLAKIN active tablets are pink (Day 1 to Day 84). SETLAKIN inactive tablets are white (Day 85 to Day 91).

Sunday Start: For each 91-day course, take in the following order: Take the first pink tablet (0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol) on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, take the tablet on that day. Due to the potential risk of becoming pregnant, use additional non-hormonal contraception (such as condoms or spermicide) for the first 7 days of treatment.

Take subsequent pink tablets once daily at the same time each day for a total of 84 days. Take one white tablet (inert) daily for the following 7 days and at the same time of day that active tablets were taken. A scheduled period should occur during the 7 days that the white tablets are taken.

Begin the next and all subsequent 91-day courses of SETLAKIN without interruption on the same day of the week (Sunday) on which the patient began her first dose. Follow the same schedule as the initial 91-day course: a pink tablet once a day for 84 days, and a white tablet once a day for 7 days. If the patient does not immediately start her next pill pack, instruct her to protect herself from pregnancy by using a non-hormonal back-up method of contraception until she has taken a pink tablet daily for 7 consecutive days.

Switching from another contraceptive method to SETLAKIN Start SETLAKIN: Another oral contraceptive On the day when the new pack of the previous COC would have been started Transdermal patch On the day when the next application would have been scheduled. Vaginal ring On the day when the next insertion would have been scheduled. Injection On the day when the next injection would have been scheduled.

Intrauterine contraceptive (IUD) On the day of removal. If the IUD is not removed on first day of the patient’s menstrual cycle, additional non-hormonal contraception (such as condoms or spermicide) is needed for the first seven days of the first 91-day course. Implant On the day of removal.

Starting SETLAKIN after Abortion or Miscarriage First-trimester After a first-trimester abortion or miscarriage, SETLAKIN may be started immediately. An additional method of contraception is not needed if SETLAKIN is started immediately. If SETLAKIN is not started within 5 days after termination of the pregnancy, the patient should use additional non-hormonal contraception (such as condoms or spermicide) for the first seven days of her first 91-day course of SETLAKIN.

Second-trimester Do not start SETLAKIN until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start SETLAKIN following the instructions in Table 1 for Sunday start. Use additional non-hormonal contraception (such as condoms or spermicide) for the first seven days of the patient’s first 91-day course of SETLAKIN [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )].

Starting SETLAKIN after Childbirth Do not start SETLAKIN until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with SETLAKIN following the instructions in Table 1 for women not… [Excerpted — this section continues on DailyMed.]

3 DOSAGE FORMS AND STRENGTHS SETLAKIN (levonorgestrel and ethinyl estradiol tablets) are available as round, coated, biconvex, unscored tablets, packaged in Extended-Cycle Tablet Dispensers, each containing a 13-week supply of tablets in the following order: 84 pink tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol; debossed with “ S1 ” on one side 7 white inert tablets debossed with “ P ” on one side and “ N ” on the other side. SETLAKIN consists of 84 round, pink tablets containing 0.15 mg of levonorgestrel and 0.03 mg of ethinyl estradiol, and 7 round, white inert tablets.

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17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Cigarette Smoking Cigarette smoking increases the risk of serious cardiovascular events from COC use. Women who are over 35 years old and smoke should not use SETLAKIN [see Boxed Warning and Warnings and Precautions ( 5.1 )].

Venous Thromboembolism The increased risk of VTE compared to non-users of COCs is greatest after initially starting a COC or restarting (following a 4-week or greater pill-free interval) the same or a different COC [see Warnings and Precautions ( 5.1 )]. Use During Pregnancy Instruct females to stop further intake of SETLAKIN if pregnancy is confirmed during treatment. Sexually Transmitted Infections SETLAKIN does not protect against HIV-infection (AIDS) and other sexually transmitted infections.

Dosing and Missed Pill Instructions Patients should take one tablet daily by mouth at the same time every day [see Dosage and Administration ( 2.1 )] . Instruct patients what to do in the event tablets are missed. See “What should I do if I miss any SETLAKIN pills” section in FDA-approved Instructions for Use [see Dosage and Administration ( 2.3 )].

Need for Additional Contraception Postpartum females who start SETLAKIN who have not yet had a period when they start SETLAKIN need to use an additional method of contraception until they have taken a pink tablet for 7 consecutive days [see Dosage and Administration ( 2.1 )] . There is a need for a back-up or alternative method of contraception when enzyme inducers are used with SETLAKIN [see Drug Interactions ( 7.1 )] . Lactation SETLAKIN may reduce breast milk production.

This is less likely to occur if breastfeeding is well established . When possible, nursing women should use other methods of contraception until they have discontinued breastfeeding [see Use in Specific Populations ( 8.2 )] . Amenorrhea and Possible Symptoms of Pregnancy Amenorrhea may occur.

Because women using SETLAKIN will likely have scheduled bleeding only 4 times per year, advise women to contact their health care provider in the event of amenorrhea with symptoms of pregnancy such as morning sickness or unusual breast tenderness [see Warnings and Precautions ( 5.9 )] . Depression Depressed mood and depression may occur. Women should contact their healthcare provider if mood changes and depressive symptoms occur, including shortly after initiating the treatment [see Warnings and Precautions ( 5.10 )] .

Manufactured for: Northstar Rx LLC Memphis TN 38141 Manufactured by: Novast Laboratories Ltd. Nantong, China 226009 Revised: 06/2023 I0018 Rev D. image description

PATIENT INFORMATION SETLAKIN [set-LACK-inn] (levonorgestrel and ethinyl estradiol tablets) WARNING TO WOMEN WHO SMOKE Do not use SETLAKIN if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects from birth control pills, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.

What is the most important information I should know about SETLAKIN ? Do not use SETLAKIN if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects from birth control pills, including death from heart attack, blood clots or stroke.

This risk increases with age and the number of cigarettes you smoke. What is SETLAKIN? SETLAKIN is a birth control pill (oral contraceptive) used by women to prevent pregnancy.

It contains two female hormones, an estrogen called ethinyl estradiol, and a progestin called levonorgestrel. SETLAKIN does not protect against HIV infections (AIDS) and other sexually transmitted infections. How does SETLAKIN work for contraception?

Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The better you follow the directions, the less chance you have of get… [Excerpted — this section continues on DailyMed.]

INSTRUCTIONS FOR USE SETLAKIN [set-LACK-inn] (levonorgestrel and ethinyl estradiol tablets) Important information about taking SETLAKIN Take 1 pill every day at the same time. Take the pills in the order directed on your pill dispenser. Do not skip your pills, even if you do not have sex often.

If you miss pills (including starting the pack late) you could get pregnant . The more pills you miss, the more likely you are to get pregnant. If you have trouble remembering to take SETLAKIN, talk to your healthcare provider.

When you first start taking SETLAKIN, spotting or light bleeding in between your periods may occur. Contact your healthcare provider if this does not go away after a few months. You may feel sick to your stomach (nauseous), especially during the first few months of taking SETLAKIN.

If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If your nausea does not go away, call your healthcare provider.

Missing pills can also cause spotting or light bleeding, even when you take the missed pills later. On the days you take 2 pills to make up for missed pills (see, “What should I do if I miss any SETLAKIN pills?” below), you could also feel a little sick to your stomach. It is not uncommon to miss a period.

However, if you miss a period and have not taken SETLAKIN according to directions, or feel like you may be pregnant, call your healthcare provider. If you have a positive pregnancy test, you should stop taking SETLAKIN. If you have vomiting or diarrhea within 3-4 hours of taking a pink pill, take another pink pill as soon as possible.

Continue taking one pill a day until the 91-day course is finished. If you have vomiting or diarrhea for more than 1 day, your birth control pills may not work as well. Use an additional birth control method, like condoms or spermicide, until you check with your healthcare provider.

Stop taking SETLAKIN at least 4 weeks before you have major surgery and do not restart after the surgery without asking your healthcare provider. Be sure to use other forms of contraception (like condoms or spermicide) during this time period. Before you start taking SETLAKIN: Decide what time of day you want to take your pill.

It is important to take it at about the same time every day. Look at your Extended-Cycle Tablet Dispenser. Your Tablet Dispenser consists of 3 trays with cards that hold 91 individually sealed pills (a 13-week or 91-day cycle).

The 91 pills consist of 84 pink and 7 white pills. The cards in trays 1 and 2 each contain 28 pink pills (4 rows of 7 pills). The card in tray 3 contains 35 pills consisting of 28 pink pills (4 rows of 7 pills) and 7 white pills (1 row of 7 pills). • Also find: ° Where on the first tray in the pack to start taking pills (upper left corner) and ° In what order to take the pills (follow the weeks) • Be sure you have ready at all times another kind of birth control (such as condoms or spermicide), to use as a back-up in case you miss pills.

When should I start taking SETLAKIN? If you start taking SETLAKIN and you have not used a hormonal birth control method before: Take the first pink pill on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the first pink pill that same day.

Use another method of birth control (such as condoms or spermicides) as a back-up method if you have sex anytime from the Sunday you start your first pink pill until the next Sunday (first 7 days). If you have recently given birth and have not yet had a period , use another method of birth control if you have sex (such as condoms and spermicides) as a back-up method until you have taken SETLAKIN for 7 days. If you start taking SETLAKIN and you are switching from another birth control pill: Start your new SETLAKIN pack on the same day that you would start the next pack of your previous birth control method.

Do not continue taking the pills from your previous birth control pack. If you start tak… [Excerpted — this section continues on DailyMed.]