Day 1 Start

During the first cycle of Gianvi use, instruct the patient to take one light pink Gianvi daily, beginning on Day 1 of her menstrual cycle. (The first day of menstruation is Day 1.) She should take one light pink Gianvi daily for 24 consecutive days, followed by one white inert tablet daily on Days 25 through 28. Gianvi should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid, as needed. Gianvi can be taken without regard to meals. If Gianvi is first taken later than the first day of the menstrual cycle, Gianvi should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.

Sunday Start

During the first cycle of Gianvi use, instruct the patient to take one light pink Gianvi daily, beginning on the first Sunday after the onset of her menstrual period. She should take one light pink Gianvi daily for 24 consecutive days, followed by one white inert tablet daily on Days 25 through 28. Gianvi should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid, as needed. Gianvi can be taken without regard to meals. Gianvi should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.

The patient should begin her next and all subsequent 28-day regimens of Gianvi on the same day of the week that she began her first regimen, following the same schedule. She should begin taking her light pink tablets on the next day after ingestion of the last white tablet, regardless of whether or not a menstrual period has occurred or is still in progress. Anytime a subsequent cycle of Gianvi is started later than the day following administration of the last white tablet, the patient should use another method of contraception until she has taken a light pink Gianvi daily for seven consecutive days.

When switching from a different birth control pill

When switching from another birth control pill, Gianvi should be started on the same day that a new pack of the previous oral contraceptive would have been started.

When switching from a method other than a birth control pill

When switching from a transdermal patch or vaginal ring, Gianvi should be started when the next application would have been due. When switching from an injection, Gianvi should be started when the next dose would have been due. When switching from an intrauterine contraceptive or an implant, Gianvi should be started on the day of removal.

Withdrawal bleeding usually occurs within 3 days following the last light pink tablet. If spotting or breakthrough bleeding occurs while taking Gianvi, instruct the patient to continue taking Gianvi by the regimen described above. Counsel her that this type of bleeding is usually transient and without significance; however, advise her that if the bleeding is persistent or prolonged, she should consult her healthcare provider.

Although the occurrence of pregnancy is low if Gianvi is taken according to directions, if withdrawal bleeding does not occur, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one or more active tablets or started taking them on a day later than she should have), consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures. If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy. Discontinue Gianvi if pregnancy is confirmed.

The risk of pregnancy increases with each active light pink tablet missed. For additional patient instructions regarding missed pills, see the "WHAT TO DO IF YOU MISS PILLS" section in the FDA Approved Patient Labeling. If breakthrough bleeding occurs following missed tablets, it will usually be transient and of no consequence. If the patient misses one or more white tablets, she should still be protected against pregnancy provided she begins taking a new cycle of light pink tablets on the proper day.

For postpartum women who do not breastfeed or after a second trimester abortion, start Gianvi no earlier than 4 weeks postpartum due to the increased risk of thromboembolism. If the patient starts on Gianvi postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken Gianvi for 7 consecutive days.