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General MedicationsOralBlack Box

SETLAKIN

LEVONORGESTREL AND ETHINYL ESTRADIOL

Standard Dose
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 ) 2.1 How 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 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 )]. 2.2 Dosing SETLAKIN Instruct patients to take one tablet by mouth at the same time every day. The dosing of SETLAKIN is one pink pill containing levonorgestrel and ethinyl estradiol daily for 84 consecutive days, followed by one white pill (inactive pills without hormone) for 7 days. To achieve maximum contraceptive effectiveness, SETLAKIN must be taken exactly as directed, in the order directed on the Tablet Dispenser, and at intervals not exceeding 24 hours. Start taking the first pink pill from a new Tablet Dispenser the very next day after taking the last white inactive pill in the Tablet Dispenser. The failure rate may increase when pills are missed or taken incorrectly. 2.3 Missed Doses Table 2: Instructions for Missed SETLAKIN Tablets If one active tablet (pink) is missed in Days 1 through 84 Take the tablet as soon as possible. Take the next tablet at the regular time and continue taking one tablet a day until the 91-day course is finished. If two consecutive active tablets (pink) are missed in Days 1 through 84 Take 2 tablets on the day remembered and 2 tablets the next day. Then continue taking one tablet a day until the 91-day course is finished. Additional non-hormonal contraception (such as condoms or spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets. If three or more consecutive active tablets (pink) are missed in Days 1 through 84 Do not take the missed tablets. Continue taking one tablet a day until the 91-day course is finished. Additional non-hormonal contraception (such as condoms or spermicide) must be used as back-up if the patient has sex within 7 days after missing tablets. If any of the seven white (inactive) tablets are missed Throw away the missed tablets. Continue taking the remaining tablets until the pack is finished. A backup birth control method is not needed. 2.4 Advice in Case of Gastrointestinal Disturbances In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting or diarrhea occurs within 3-4 hours after taking a pink tablet, handle this as a missed tablet.
Max Dose
See official label
Primary Use
1 INDICATIONS AND USAGE SETLAKIN is indicated for use by females of reproductive potential to prevent pregnancy.
Summary

Indications and usage 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 ) Dosage and administration 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 ) 2.1 How to Start and Take SETLAKIN SETLAKIN is dispensed in an Extended-Cycle Tablet Dispenser [see How Supplied/Storage and Handling (16)].

Structured Monograph

Clinical summary

Indications and usage 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 ) Dosage and administration 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 ) 2.1 How 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 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 )]. 2.2 Dosing SETLAKIN Instruct patients to take one tablet by mouth at the same time every day. The dosing of SETLAKIN is one pink pill containing levonorgestrel and ethinyl estradiol daily for 84 consecutive days, followed by one white pill (inactive pills without hormone)

Boxed Warning

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including SETLAKIN, are contraindicated in women who are over 35 years of age and smoke [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )] . WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning. SETLAKIN is contraindicated in women over 35 years old who smoke. ( 4 ) Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. ( 5.1 )

Monitoring

  • • 5 WARNINGS AND PRECAUTIONS Vascular risks: Stop if a thrombotic or thromboembolic event occurs.
  • • Stop at least 4 weeks before and through 2 weeks after major surgery.
  • • Start no earlier than 4 weeks after delivery, in women who are not breastfeeding.
  • • Consider cardiovascular risk factors before initiating in all females, particularly those over 35 years.

Interaction Notes

  • • 7 DRUG INTERACTIONS The sections below provide information on substances for which data on drug interactions with COCs are available.
  • • There is little information available about the clinical effect of most drug interactions that may affect COCs.
  • • However, based on the known pharmacokinetic effects of these drugs, clinical strategies to minimize any potential adverse effect on contraceptive effectiveness or safety are suggested.
  • • Consult the approved product labeling of all concurrently used drugs to obtain further information about interactions with COCs or the potential for metabolic enzyme or transporter system alterations.