How to Start and Take LOSEASONIQUE

Begin LOSEASONIQUE on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, take the first orange tablet that day.

For each 91-day course, take in the following order:

1. Take one orange tablet daily for 84 consecutive days. Use a non-hormonal back-up method of contraception (such as condoms or spermicide) until an orange tablet has been taken daily for 7 consecutive days.
2. Then take one yellow tablet for 7 consecutive days. A scheduled period should occur during the 7 days that the yellow tablets are taken.

Begin the next and all subsequent 91-day cycles without interruption on the same day of the week (Sunday) on which the patient began her first dose of LOSEASONIQUE, following the same schedule: 84 days taking an orange tablet followed by 7 days taking a yellow tablet. 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 an orange tablet daily for 7 consecutive days.

Switching to LOSEASONIQUE from another oral hormonal contraceptive or from another contraceptive method (transdermal patch, vaginal ring, injection, intrauterine contraceptive, implant)

Start on the Sunday after the patient’s next period starts. Use additional non-hormonal contraceptive (such as condoms and spermicide) until the patient has taken an orange tablet for 7 consecutive days.

Starting LOSEASONIQUE after Abortion or Miscarriage

First-trimester

LOSEASONIQUE may be started on the Sunday after an abortion or miscarriage. The patient must use additional non-hormonal contraception (such as condoms and spermicide) until the patient has taken an orange tablet for 7 consecutive days.

Second-trimester

Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start contraceptive therapy with LOSEASONIQUE following the instructions for women not currently using hormonal contraception. Use additional non-hormonal contraception (such as condoms and spermicide) until the patient has taken an orange tablet for 7 consecutive days [see Contraindications (4) and Warnings and Precautions (5.1)].

Starting LOSEASONIQUE after Childbirth

Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with LOSEASONIQUE following the instructions for women not currently using hormonal contraception. Use additional non-hormonal contraception (such as condoms and spermicide) until the patient has taken an orange tablet for 7 consecutive days [see Contraindications (4) and Warnings and Precautions (5.1)].

If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of LOSEASONIQUE [see Warnings and Precautions (5.1), Use in Specific Populations (8.1)].

Dosing LOSEASONIQUE

Take one tablet by mouth at the same time every day. The dosage of LOSEASONIQUE is one orange tablet daily for 84 consecutive days, followed by one yellow tablet daily for 7 days. To achieve maximum contraceptive effectiveness, LOSEASONIQUE must be taken exactly as directed, in the order directed, and at intervals not exceeding 24 hours. The failure rate may increase when pills are missed or taken incorrectly.

Missed Doses

Table 1. Instructions for Missed LOSEASONIQUE Tablets

Advice in Case of Gastrointestinal Disturbances

In case of prolonged vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken.