Medically reviewed by Drugs.com. Last updated on Nov 2, 2023.
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)
Consider the possibility of ovulation and conception prior to initiation of this product.
For each 91-day course, take in the following order:
Switching from another contraceptive method to SETLAKIN
Another oral contraceptive
On the day when the new pack of the previous COC would have been started
On the day when the next application would have been scheduled.
On the day when the next insertion would have been scheduled.
On the day when the next injection would have been scheduled.
Intrauterine contraceptive (IUD)
On the day of removal.
Starting SETLAKIN after Abortion or Miscarriage
- 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.
- 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)].
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.
Table 2: Instructions for Missed SETLAKIN Tablets
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.
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.
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.
Throw away the missed tablets. Continue taking the remaining tablets until the pack is finished. A backup birth control method is not needed.
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