SETLAKIN (wera (norethindrone and ethinyl estradiol) kit) Dailymed

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 currently using hormonal contraception. SETLAKIN is not recommended for use in lactating women [see Use in Specific Populations (8.2)]. If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of SETLAKIN [see Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.1 and 8.2)].

Stop SETLAKIN if an arterial or venous thrombotic/thromboembolic event occurs. Stop SETLAKIN if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately. Discontinue SETLAKIN during prolonged immobilization. If feasible, stop SETLAKIN at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism. Start SETLAKIN no earlier than 4 weeks after delivery in females who are not breastfeeding. The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the likelihood of ovulation increases after the third postpartum week. Before starting SETLAKIN evaluate any past medical history or family history of thrombotic or thromboembolic disorders and consider whether the history suggests an inherited or acquired hypercoagulopathy. SETLAKIN is contraindicated in females with a high risk of arterial or venous thrombotic/thromboembolic diseases [see Contraindications (4)]. Arterial Events COCs increase the risk of cardiovascular events and cerebrovascular events, such as myocardial infarction and stroke. The risk is greater among older women (> 35 years of age), smokers, and females with hypertension, dyslipidemia, diabetes, or obesity. SETLAKIN is contraindicated in women over 35 years of age who smoke [see Contraindications (4)]. Cigarette smoking increases the risk of serious cardiovascular events from COC use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. Venous Events Use of COCs increases the risk of venous thromboembolic events (VTEs), such as deep vein thrombosis and pulmonary embolism. Risk factors for VTEs include smoking, obesity, and family history of VTE, in addition to other factors that contraindicate use of COCs [see Contraindications (4)]. While the increased risk of VTE associated with use of COCs is well-established, the rates of VTE are even greater during pregnancy, and especially during the postpartum period (see Figure 1). The rate of VTE in females using COCs has been estimated to be 3 to 9 cases per 10,000 woman years. The risk of VTE is highest during the first year of use of a COC and when restarting hormonal contraception after a break of four weeks or longer. The risk of thromboembolic disease due to COCs gradually disappears after COC use is discontinued. Figure 1 shows the risk of developing a VTE for females who are not pregnant and do not use oral contraceptives, for females who use oral contraceptives, for pregnant females and for females in the postpartum period. To put the risk of developing a VTE into perspective: If 10,000 females who are not pregnant and do not use oral contraceptives are followed for one year, between 1 and 5 of these females will develop a VTE. Use of SETLAKIN provides women with more hormonal exposure on a yearly basis than conventional monthly COCs containing the same strength synthetic estrogens and progestins (an additional 9 weeks of exposure per year). In the clinical trial, one case of pulmonary embolism was reported. Postmarketing adverse reactions of VTE have been reported in women who used SETLAKIN.

Studies suggest a small increased relative risk of developing gallbladder disease among COC users. Use of COCs, including SETLAKIN, may worsen existing gallbladder disease. A past history of COC-related cholestasis predicts an increased risk with subsequent COC use. Females with a history of pregnancy-related cholestasis may be at an increased risk for COC-related cholestasis.

Bleeding and/or spotting that occurs at any time while taking the first 84 tablets of each extended-cycle regimen is considered “unscheduled” bleeding/spotting. Bleeding that occurs during the time a woman takes the seven white inert tablets is considered “scheduled” bleeding. Unscheduled Bleeding and Spotting Females using SETLAKIN may experience unscheduled (breakthrough or intracyclic) bleeding and spotting especially during the first 3 months of use. Bleeding irregularities may resolve over time or by changing to a different contraceptive product. If unscheduled bleeding persists or occurs after previously regular cycles, evaluate for causes such as pregnancy or malignancy. Before prescribing SETLAKIN, advise the woman to weigh the occurrence of fewer scheduled menses (4 per year instead of 13 per year) against the occurrence of increased unscheduled bleeding and/or spotting. The clinical trial of the efficacy of levonorgestrel and ethinyl estradiol 0.15mg/0.03mg (91-day cycles) in preventing pregnancy also assessed scheduled and unscheduled bleeding. The participants in the study were composed primarily of women who had used oral contraceptives previously as opposed to new users. Women with a history of breakthrough bleeding/spotting ≥ 10 consecutive days on oral contraceptives were excluded from the study. More levonorgestrel and ethinyl estradiol 0.15mg/0.03mg (91-day cycles) subjects, compared to subjects on the comparator 28-day cycle regimen, discontinued prematurely for unacceptable bleeding (7.7% [levonorgestrel and ethinyl estradiol 0.15mg/0.03mg (91-day cycles)] vs. 1.8% [28-day cycle regimen]). Unscheduled bleeding and unscheduled spotting decreased over successive 91-day cycles. Table 3 below presents the number of days with unscheduled bleeding and/or spotting for each respective 91-day cycle. Table 3: Number of Unscheduled Bleeding and/or Spotting Days per 91-day Cycle Cycle (N) Days of Unscheduled Bleeding and/or Spotting per 84-Day Interval Median Days Per Subject-Month Mean Q1 Median Q3 1 (446) 15.1 3.0 12 23.0 3.0 2 (368) 11.6 2.0 6 17.5 1.5 3 (309) 10.6 1.0 6 15.0 1.5 4 (282) 8.8 1.0 4 14.0 1.0 Q1=Quartile 1: 25% of women had ≤ this number of days of unscheduled bleeding/spotting Median: 50% of women had ≤ this number of days of unscheduled bleeding/spotting Q3=Quartile 3: 75% of women had ≤ this number of days of unscheduled bleeding/spotting Table 4 shows the percentages of women with ≥7 days and ≥20 days of unscheduled spotting and/or bleeding in the levonorgestrel and ethinyl estradiol 0.15mg/0.03mg (91-day cycles) and the 28-day cycle treatment groups. Table 4: Percentage of Subjects with Unscheduled Bleeding and/or Spotting Days of unscheduled bleeding and/or spotting Percentage of Subjects a Levonorgestrel and ethinyl estradiol tablets (91-day regimen) Cycle 1 (N=385) Cycle 4 (N=261) ≥ 7 days 65% 42% ≥ 20 days 35% 15% 28-day regimen Cycles 1-4 (N=194) Cycles 10-13 (N=158) ≥ 7 days 38% 39% ≥ 20 days 6% 4% a Based on spotting and/or bleeding on days 1-84 of a 91 day cycle in the levonorgestrel and ethinyl estradiol tablets subjects and days 1-21 of a 28 day cycle over 4 cycles in the 28-day dosing regimen. Total days of bleeding and/or spotting (scheduled plus unscheduled) were similar over one year of treatment for levonorgestrel and ethinyl estradiol tablets subjects and subjects on the 28-day cycle regimen. Amenorrhea and Oligomenorrhea Females who use SETLAKIN may experience absence of scheduled (withdrawal) bleeding, even if they are not pregnant. Based on data from the clinical trial of levonorgestrel and ethinyl estradiol tablets, amenorrhea occurred in approximately 0.8% of females during Cycle 1, 1.2% of females during Cycle 2, 3.7% of females during Cycle 3, and 3.4% of females during Cycle 4. Because females using SETLAKIN will likely have scheduled bleeding only 4 times per year, rule out pregnancy at the time of any missed menstrual period. After discontinuation of SETLAKIN, amenorrhea or oligomenorrhea may occur, especially if these conditions were pre-existent.



Risk Summary There is no use for contraception in pregnancy; therefore, SETLAKIN should be discontinued during 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 COCs before conception or during early pregnancy. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively.

COCs prevent pregnancy primarily by suppressing ovulation.

COCs prevent pregnancy primarily by suppressing ovulation.

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 getting pregnant. Based on the results of clinical studies, about 1 to 5 out of 100 women may get pregnant during the first year they use SETLAKIN. The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a ul of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant. Who should not take SETLAKIN? Do not take SETLAKIN if you: smoke and are over 35 years of age have or had blood clots in your arms, legs, lungs, or eyes had a stroke had a heart attack have certain heart valve problems or heart rhythm abnormalities that can cause blood clots to form in the heart have or had a problem with your blood that makes it clot more than normal have high blood pressure that cannot be controlled by medicine or have high blood pressure with blood vessels problems have diabetes and are over the age of 35 with high blood pressure with kidney, eye, nerve, or blood vessel damage for more than 20 years have certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision, or any migraine headaches if you are over 35 years of age have or had breast cancer have liver problems, including liver tumors have any unexplained vaginal bleeding take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. This may increase levels of the liver enzyme “alanine aminotransferase” (ALT) in the blood. If any of these conditions happen to you while you are taking SETLAKIN, stop taking SETLAKIN right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking SETLAKIN. What should I tell my healthcare provider before taking SETLAKIN? Tell your healthcare provider if you: are pregnant or think you may be pregnant are scheduled for surgery. SETLAKIN may increase your risk of blood clots after surgery. You should stop taking SETLAKIN at least 4 weeks before you have surgery and not restart SETLAKIN until at least 2 weeks after your surgery. are depressed now or have been depressed in the past had yellowing of your skin or eyes (jaundice) caused by pregnancy (cholestasis of pregnancy) are breastfeeding or plan to breastfeed. SETLAKIN may decrease the amount of breast milk you make. A small amount of the hormones in SETLAKIN may pass into your breast milk. Talk to your healthcare provider about the best birth control method for you while breastfeeding. Tell your healthcare provider if you have ever had any of the conditions uled in, “Who should not take SETLAKIN ” above. Your healthcare provider may recommend another method of birth control. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. SETLAKIN may affect the way other medicines work, and other medicines may affect how well SETLAKIN works. Some medicines and herbal products may make birth control pills less effective, including: barbiturates bosentan carbamazepine felbamate griseofulvin oxcarbazepine phenytoin rifampin St. John’s wort topiramate Use a back-up or alternative birth control method when you take medicines that may make birth control pills less effective. Birth control pills may interact with lamotrigine, an anticonvulsant used for epilepsy. This may increase the risk of seizures, so your physician may need to adjust the dose of lamotrigine. Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone. Know the medicines you take. Keep a ul of them to show your healthcare provider and pharmacist when you get a new medicine. How should I take SETLAKIN? Read the Instructions for Use at the end of this Patient Information. What are the most serious risks of taking SETLAKIN? Like pregnancy, SETLAKIN may cause serious side effects, including blood clots in your lungs, heart attack, or a stroke that may lead to death. Some other examples of serious blood clots include blood clots in the legs or eyes. Serious blood clots can happen especially if you smoke, are obese, or are older than 35 years of age. Serious blood clots are more likely to happen when you: first start taking birth control pills restart the same or different birth control pills after not using them for a month or more Call your healthcare provider or go to a hospital emergency room right away if you have: leg pain that will not go away sudden severe shortness of breath sudden change in vision or blindness chest pain a sudden, severe headache unlike your usual headaches weakness or numbness in your arm or leg trouble speaking yellowing of your skin or eyes Other serious side effects include: liver problems, including: rare liver tumors jaundice (cholestasis), especially if you previously had cholestasis of pregnancy. high blood pressure. You should see your healthcare provider to check your blood pressure regularly. gallbladder problems changes in the sugar and fat (cholesterol and triglycerides) levels in your blood new or worsening headaches including migraine headaches irregular or unusual vaginal bleeding and spotting between your menstrual periods, especially during the first 3 months of taking SETLAKIN. depression, especially if you have had depression in the past. Call your healthcare provider immediately if you have any thoughts of harming yourself. possible cancer in your breast and cervix swelling of your skin especially around your mouth, eyes, and in your throat (angioedema). Call your healthcare provider if you have a swollen face, lips, mouth tongue or throat, which may lead to difficulty swallowing or breathing. Your chance of having angioedema is higher is you have a history of angioedema. dark patches of skin around your forehead, nose, cheeks and around your mouth, especially during pregnancy (chloasma). Women who tend to get chloasma should avoid spending a long time in sunlight, tanning booths, and under sun lamps while taking SETLAKIN. Use sunscreen if you have to be in the sunlight. What are the most common side effects of SETLAKIN? headache (migraine) heavier or longer periods, pain with periods nausea acne breast tenderness increase in weight These are not all the possible side effects of SETLAKIN. For more information, ask your healthcare provider or pharmacist. You may report side effects to the FDA at 1-800-FDA-1088. What else should I know about taking SETLAKIN? If you are scheduled for any lab tests, tell your healthcare provider you are taking SETLAKIN. Certain blood tests may be affected by SETLAKIN. Do not skip any pills, even if you do not have sex often. Birth control pills should not be taken during pregnancy. However, birth control pills taken by accident during pregnancy are not known to cause birth defects. You should stop SETLAKIN at least four weeks before you have major surgery and not restart it for at least two weeks after the surgery, due to an increased risk of blood clots. If you are breastfeeding, consider another birth control method until you are ready to stop breastfeeding. Birth control pills that contain estrogen, like SETLAKIN, may decrease the amount of milk you make. A small amount of the pill's hormones pass into breast milk, but this has not caused harmful effects in breastfeeding infants. If you have vomiting or diarrhea, your birth control pills may not work as well. Use another birth control method, like condoms or a spermicide, until you check with your healthcare provider. How should I store SETLAKIN? Store SETLAKIN at room temperature between 68°F to 77°F (20°C to 25°C). Protect from light. Keep SETLAKIN and all medicines out of the reach of children. General information about the safe and effective use of SETLAKIN. Medicines are sometimes prescribed for purposes other than those uled in a Patient Information leaflet. Do not use SETLAKIN for a condition for which it was not prescribed. Do not give SETLAKIN to other people, even if they have the same symptoms that you have. This Patient Information summarizes the most important information about SETLAKIN. You can ask your pharmacist or healthcare provider for information about SETLAKIN that is written for health professionals. For more information, call 1-800-206-7821. Do birth control pills cause cancer? It is not known if hormonal birth control pills cause breast cancer. Some studies, but not all, suggest that there could be a slight increase in the risk of breast cancer among current users with longer duration of use. If you have breast cancer now, or have had it in the past, do not use hormonal birth control because some breast cancers are sensitive to hormones. Women who use birth control pills may have a slightly higher chance of getting cervical cancer. However, this may be due to other reasons such as having more sexual partners. What if I want to become pregnant? You may stop taking the pill whenever you wish. Consider a visit with your healthcare provider for a pre-pregnancy checkup before you stop taking the pill. What should I know about my period when taking SETLAKIN? When you take SETLAKIN, which has a 91-day extended dosing cycle, you should have 4 scheduled periods a year (bleeding when you are taking the 7 white pills). However, you will probably have more bleeding or spotting between your scheduled periods than if you were using a birth control pill with a 28-day dosing cycle. During the first SETLAKIN 91-day treatment cycle, about 1 in 3 women may have 20 or more days of unplanned bleeding or spotting. This bleeding or spotting tends to decrease with time. Do not stop taking SETLAKIN because of this bleeding or spotting. If the spotting continues for more than 7 days in a row or if the bleeding is heavy, call your healthcare provider. What if I miss my scheduled period when taking SETLAKIN? You should consider the possibility that you are pregnant if you miss your scheduled period (no bleeding on the days that you are taking white pills). Since scheduled periods are less frequent when you are taking SETLAKIN, notify your healthcare provider that you have missed your period and that you are taking SETLAKIN. Also notify your healthcare provider if you have symptoms of pregnancy such as morning sickness or unusual breast tenderness. It is important that your healthcare provider evaluates you to determine if you are pregnant. Stop taking SETLAKIN if it is determined that you are pregnant. What are the ingredients in SETLAKIN? Active ingredients: Each pink pill contains levonorgestrel and ethinyl estradiol. Inactive ingredients: Pink pills: polyvinyl alcohol, titanium dioxide, talc, macrogol/ polyethylene glycol 3350, lecithin (soya), FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake, and FD&C Yellow #6 Aluminum Lake, lactose, magnesium stearate, pregelatinized corn starch and microcrystalline cellulose. White pills: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/ polyethylene glycol 8000, lactose, magnesium stearate and pregelatinized corn starch.

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 taking SETLAKIN and previously used a vaginal ring: Start using SETLAKIN on the day you would have reapplied the next ring. If you start taking SETLAKIN and previously used a transdermal patch: Start using SETLAKIN on the day you would have started a new cycle (first patch application). If you start taking SETLAKIN and you are switching from a progestin-only method such as an implant or injection: Start taking SETLAKIN on the day of removal of your implant, or on the day when you would have had your next injection. If you start taking SETLAKIN and you are switching from an intrauterine device or system (IUD or IUS): Start taking SETLAKIN on the day of removal of your IUD or IUS. You do not need back-up contraception if your IUD or IUS is removed on the first day (Day 1) of your period. If your IUD or IUS is removed on any other day, use non-hormonal back-up contraception such as condoms or spermicide for the first 7 days that you take SETLAKIN. Keep a calendar to track your period: If this is the first time you are taking birth control pills, read, “When should I start taking SETLAKIN?” above. Follow these instructions for a Sunday Start. Instructions for using your SETLAKIN Extended-Cycle Tablet Dispenser: Sunday Start: Take pill 1 on the Sunday after your period starts. To remove your pill from the dispenser, press the pill through the hole in the bottom of the dispenser. If your period starts on a Sunday, take pill “1” that same day. Take 1 pill at about the same time every day until you have taken the last pill in the tablet dispenser. After taking the last white pill on Day 91 from the pill dispenser, start taking the first pink pill from a new Extended-Cycle Tablet Dispenser on the very next day(this should be a Sunday). Take the first pill in the new pack whether or not you are having your period. Use non-hormonal back-up contraception such as condoms or spermicide for the first 7 days of the first cycle that you take SETLAKIN. What should I do if I miss any SETLAKIN pills? If you miss 1 pink pill, follow these steps: Take it as soon as you remember. Take the next pill at your regular time. This means you may take 2 pills in 1 day. Then continue taking 1 pill every day until you finish the pack. You do not need to use a back-up birth control method if you have sex. If you miss 2 pink pills in a row, follow these steps: Take 2 pills on the day you remember and 2 pills the next day. Then continue to take 1 pill every day until you finish the pack. You could become pregnant if you have sex in the 7 days after you miss two pills. You must use a non-hormonal birth control method (such as a condom or spermicide) as a back-up if you have sex during the first 7 days after you restart your pills. If you miss 3 or more pink pills in a row, follow these steps: Do not take the missed pills. Keep taking 1 pill every day until you have completed all of the remaining pills in the pack. For example, if you start taking the pill on Thursday, take the pill under “Thursday” and do not take the missed pills. You may have bleeding during the week following the missed pills. You could become pregnant if you have sex during the days of missed pills or during the first 7 days after restarting your pills. You must use a non-hormonal birth control method (such as a condom or spermicide) as a back-up when you miss pills and for the first 7 days after you restart your pills. If you do not have your period when you are taking the white pills, call your healthcare provider because you may be pregnant. If you miss any of the 7 white pills: Throw away the missed pills. Keep taking the scheduled pills until the pack is finished. You do not need a back-up method of birth control. Finally, if you are still not sure what to do about the pills you have missed Use a back-up method anytime you have sex. Keep taking one pill each day until you contact your healthcare provider. If you have any questions or are unsure about the information in this leaflet, call your healthcare provider. Manufactured for: Northstar Rx LLC Memphis TN 38141 Manufactured by: Novast Laboratories Ltd. Nantong, China 226009 This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.