JOLESSA- levonorgestrel / ethinyl estradiol
RPK Pharmaceuticals, Inc.
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 are contraindicated in women who are over 35 years of age and smoke [see Contraindications (4)].
JOLESSA® (levonorgestrel and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy.
JOLESSA is dispensed in an Extended-Cycle Tablet Dispenser [see How Supplied/Storage and Handling (16) ]. JOLESSA 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.
Instruct patients to take JOLESSA once a day by mouth at the same time every day for 91 days. To achieve maximum contraceptive effectiveness, JOLESSA should be taken exactly as directed and at intervals not exceeding 24 hours. For patient instructions regarding missed pills, see F DA-approved patient labeling.
Table 1: Instructions for Administration of JOLESSA
Starting COCs in women not currently using 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 to JOLESSA from another oral contraceptive
Start on the same day that a new pack of the previous oral contraceptive would have started.
Switching from another contraceptive method to JOLESSA
Complete instructions to facilitate patient counseling on proper tablet usage are located in the FDA-approved patient labeling.
Starting JOLESSA after Abortion or Miscarriage
- After a first-trimester abortion or miscarriage, JOLESSA may be started immediately. An additional method of contraception is not needed if JOLESSA is started immediately.
- If JOLESSA 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 JOLESSA.
- Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start JOLESSA 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 JOLESSA [see Contraindications (4), Warnings and Precautions (5.1), and FDA-approved Patient Labeling].
Starting JOLESSA after Childbirth
- Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with JOLESSA following the instructions in Table 1 for women not currently using hormonal contraception.
- JOLESSA is not recommended for use in lactating women [see Use in Specific Populations (8.3) and FDA-Approved Patient Labeling].
- If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of JOLESSA [see Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.1 and 8.3), and FDA-approved Patient Labeling].
Tablet Dispenser Instructions:
- The 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 pills (active pills with hormones) and 7 white pills (inactive pills without hormone).
- The cards in trays 1 and 2 each contain 28 pink pills (4 rows of 7 pills). See Figure A.
- 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). See Figure B.
- Advise the patient to remove the first pill in the upper left corner by pushing down on the pill. The pill will come out through a hole in the back of the Tablet Dispenser.
- Advise the patient to wait 24 hours to take the next pill, and continue to take one pill each day until all the pills have been taken.
- Advise the patient, after taking the last white pill, to start taking the first pink pill from a new Tablet Dispenser the very next day, regardless of when their period started.
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