To achieve maximum contraceptive and PMDD effectiveness, Gianvi (drospirenone and ethinyl estradiol) must be taken exactly as directed at intervals not exceeding 24 hours.

Gianvi consists of 24 light pink active tablets of a monophasic combined hormonal preparation plus 4 inert white tablets. The dosage of Gianvi is one light pink tablet daily for 24 consecutive days followed by 4 white inert tablets per menstrual cycle. A patient should begin to take Gianvi either on the first day of her menstrual period (Day 1 Start) or on the first Sunday after the onset of her menstrual period (Sunday Start).

Day 1 Start. During the first cycle of Gianvi use, the patient should be instructed to take one light pink Gianvi daily, beginning on Day one (1) of her menstrual cycle. (The first day of menstruation is Day one.) She should take one light pink Gianvi daily for 24 consecutive days, followed by one white inert tablet daily on menstrual cycle days 25 through 28. It is recommended that Gianvi be taken at the same time each day, preferably after the evening meal or at bedtime. 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. The possibility of ovulation and conception prior to initiation of medication should be considered.

Sunday Start.  During the first cycle of Gianvi use, the patient should be instructed 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 menstrual cycle days 25 through 28. It is recommended that Gianvi be taken at the same time each day, preferably after the evening meal or at bedtime. 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. 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 another oral contraceptive, Gianvi should be started on the same day that a new pack of the previous oral contraceptive would have been started.

Withdrawal bleeding usually occurs within 3 days following the last light pink tablet. If spotting or breakthrough bleeding occurs while taking Gianvi, the patient should be instructed to continue taking her Gianvi as instructed and by the regimen described above. She should be instructed that this type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient should be advised to consult her physician. 

Although the occurrence of pregnancy is low if Gianvi is taken according to directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be considered. 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), the possibility of pregnancy should be considered at the time of the first missed period and appropriate diagnostic measures taken. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out. Hormonal contraceptives should be discontinued 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 DETAILED PATIENT LABELING which follows. 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 light pink tablets again on the proper day.

In the nonlactating mother, Gianvi may be initiated 4-6 weeks postpartum, for contraception. When the tablets are administered in the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered. (See CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS concerning thromboembolic disease.)