YASMIN is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive.

Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.

TABLE II.
Percentage of women experiencing a unintended pregnancy during the first year of typical use and first year of perfect use of contraception and the percentage continuing use at the end of the first year: United States.

In clinical efficacy studies of YASMIN of up to 2 years duration, 2,629 subjects completed 33,160 cycles of use without any other contraception. The mean age of the subjects was 25.5 ± 4.7 years. The age range was 16 to 37 years. The racial demographic was: 83 % Caucasians, 1 % Hispanic, 1% Black, < 1% Asian, < 1% other, < 1% missing data, 14% not inquired and < 1% unspecified. Pregnancy rates in the clinical trials were less than one per 100 woman-years of use.

YASMIN

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

YASMIN consists of 21 tablets of a monophasic combined hormonal preparation plus 7 inert tablets. The dosage of YASMIN is one yellow tablet daily for 21 consecutive days followed by 7 white inert tablets per menstrual cycle. A patient should begin to take YASMIN 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 YASMIN use, the patient should be instructed to take one yellow YASMIN daily, beginning on day one (1) of her menstrual cycle. (The first day of menstruation is day one.) She should take one yellow YASMIN daily for 21 consecutive days, followed by one white inert tablet daily on menstrual cycle days 22 through 28. It is recommended that YASMIN be taken at the same time each day, preferably after the evening meal or at bedtime. If YASMIN is first taken later than the first day of the menstrual cycle, YASMIN 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 YASMIN use, the patient should be instructed to begin to take one yellow YASMIN daily, beginning on the first Sunday after the onset of her menstrual period. She should take one yellow YASMIN daily for 21 consecutive days, followed by one white inert tablet daily on menstrual cycle days 22 through 28. It is recommended that YASMIN be taken at the same time each day, preferably after the evening meal or at bedtime. YASMIN 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 YASMIN on the same day of the week that she began her first regimen, following the same schedule. She should begin taking her yellow 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 YASMIN 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 yellow YASMIN daily for seven consecutive days.

When switching from another oral contraceptive, YASMIN 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 yellow tablet. If spotting or breakthrough bleeding occurs while taking YASMIN, the patient should be instructed to continue taking her YASMIN 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 unlikely if YASMIN 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 yellow 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 yellow tablets again on the proper day.

In the nonlactating mother, YASMIN may be initiated 4 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.)

YASMIN 28 Tablets (drospirenone and ethinyl estradiol) are available in packages of 3 BLISTER packs (NDC 50419-402-03).

Each pack contains 21 active yellow round, unscored, film coated tablets each containing 3mg drospirenone and 0.03mg ethinyl estradiol, and 7 inert white round, unscored, film coated tablets.

Store at 25º C (77º F); excursions permitted to 15-30oC (59-86oF) [See USP Controlled Room Temperature].

REFERENCES FURNISHED UPON REQUEST

Manufactured for Berlex Laboratories
Manufactured in Germany
BERLEX® Laboratories, Wayne, NJ 07470
FDA rev date: 5/9/2003

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