Cyclessa® (desogestrel/ethinyl estradiol) Tablets are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.

Oral contraceptives are highly effective. Table 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and implants depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates.

TABLE 2: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF TYPICAL USE AND THE FIRST YEAR OF PERFECT USE OF CONTRACEPTION AND THE PERCENTAGE CONTINUING USE AT THE END OF THE FIRST YEAR, UNITED STATES.

To achieve maximum contraceptive effectiveness, Cyclessa® (desogestrel/ethinyl estradiol) Tablets must be taken exactly as directed, at the same time every day, and at intervals not exceeding 24 hours. Cyclessa® may be initiated using either a Sunday start or a Day 1 start.

NOTE: Each cycle pack dispenser is preprinted with the days of the week, starting with Sunday, to facilitate a Sunday start regimen. Six different “day label strips” are provided with each cycle pack dispenser in order to accommodate a Day 1 start regimen. In this case, the patient should place the self-adhesive “day label strip” that corresponds to her starting day over the preprinted days.

During the first cycle of use

IMPORTANT: The possibility of ovulation and conception prior to initiation of use of Cyclessa® should be considered. A woman can begin to take Cyclessa® either on the first Sunday after the onset of her menstrual period (Sunday Start) or on the first day of her menstrual period (Day 1 Start). When switching from another oral contraceptive, Cyclessa® should be started on the same day that a new pack of the previous oral contraceptive would have been started.

Sunday Start

When initiating a Sunday start regimen, another method of contraception, such as condoms or spermicide, should be used for the first 7 consecutive days of taking Cyclessa®.

Using a Sunday start, tablets are taken daily without interruption as follows: The first light yellow tablet should be taken on the first Sunday after menstruation begins (if menstruation begins on Sunday, the first light yellow tablet is taken on that day). Tablets are then taken sequentially following the arrows marked on the dispenser. One light yellow tablet is taken daily for 7 days, followed by 1 orange tablet daily for 7 days, 1 red tablet daily for 7 days, and then 1 green (inactive) tablet daily for 7 days. For all subsequent cycles, the patient then begins a new 28-tablet regimen on the next day (Sunday) after taking the last green tablet. [If switching from a Sunday Start oral contraceptive, the first Cyclessa® (desogestrel/ethinyl estradiol) tablet should be taken on the second Sunday after the last tablet of a 21 day oral contraceptive regimen or should be taken on the first Sunday after the last inactive tablet of a 28 day regimen.]

If a patient misses 1 active tablet in Weeks 1, 2, or 3, she should take the missed tablet as soon as she remembers. If the patient misses 2 consecutive active tablets in Week 1 or Week 2, the patient should take 2 tablets the day she remembers and 2 tablets the next day; thereafter, the patient should resume taking 1 tablet daily until she finishes the cycle pack. The patient should be instructed to use a back-up method of birth control (such as condoms or spermicide) if she has intercourse in the 7 days after she restarts her pills. If the patient misses 2 consecutive red (active) tablets in the third week or misses 3 or more active tablets in a row at any time during the cycle, the patient should keep taking 1 active tablet daily until the next Sunday. On Sunday the patient should throw out the rest of that cycle pack and start a new cycle pack that same day. The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after restarting her pills.

Complete instructions to facilitate patient counseling on proper pill usage can be found in Detailed or Brief Patient Labeling ("How to Take the Pill" section).

DAY 1 START

Counting the first day of menstruation as “Day 1”, the first light yellow tablet should be taken on the first day of menstrual bleeding. Tablets are then taken sequentially without interruption as follows: One light yellow tablet daily for 7 days, then 1 orange tablet daily for 7 days, followed by 1 red tablet daily for 7 days and then 1 green (inactive) tablet daily for 7 days. For all subsequent cycles, the patient then begins a new 28-tablet regimen on the next day after taking the last green tablet. [If switching directly from another oral contraceptive, the first light yellow tablet should be taken on the same day that a new pack of the previous oral contraceptive would have been started.

If a patient misses 1 active tablet in Weeks 1, 2, or 3, she should take the missed tablet as soon as she remembers. If the patient misses 2 consecutive active tablets in Week 1 or Week 2, the patient should take 2 tablets the day she remembers and 2 tablets the next day; thereafter, the patient should resume taking 1 tablet daily until she finishes the cycle pack. The patient should be instructed to use a back-up method of birth control (such as condoms or spermicide) if she has intercourse in the 7 days after she restarts her pills. If the patient misses 2 consecutive red tablets in the third week or misses 3 or more active tablets in a row at any time during the cycle, the patient should throw out the rest of that cycle pack and start a new cycle pack that same day. The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after she restarts her pills.

Complete instructions to facilitate patient counseling on proper pill usage can be found in Detailed or Brief Patient Labeling ("How to Take the Pill" section).

ADDITIONAL INSTRUCTIONS FOR BOTH SUNDAY AND DAY 1 STARTS

If Spotting or Breakthrough Bleeding Occurs

Breakthrough bleeding, spotting, and amenorrhea are frequent reasons for patients discontinuing oral contraceptives. In breakthrough bleeding, as in all cases of irregular bleeding from the vagina, non-functional causes should be considered. In undiagnosed persistent or recurrent abnormal bleeding from the vagina, adequate diagnostic measures are indicated to rule out pregnancy or malignancy. If both pregnancy and pathology have been excluded, time or a change to another preparation may solve the problem. Changing to an oral contraceptive with a higher estrogen content, while potentially useful in minimizing menstrual irregularity, should be done only if necessary since this may increase the risk of thromboembolic disease.

Use of Cyclessa®in the Event of a Missed Menstrual Period

1. If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period and Cyclessa®use should be discontinued if pregnancy is confirmed.
2. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out. Cyclessa®should be discontinued if pregnancy is confirmed.

Use of Cyclessa® Postpartum

The use of Cyclessa® for contraception may be initiated 4 to 6 weeks postpartum in women who elect not to breast feed. When the tablets are administered during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered (see CONTRAINDICATIONS and WARNINGS concerning thromboembolic disease. See also PRECAUTIONS for “Nursing Mothers”).

If the patient starts on Cyclessa® postpartum, and has not yet had a period, she should be instructed to use another method of contraception until a light yellow tablet has been taken daily for 7 consecutive days.

Cyclessa® (desogestrel/ethinyl estradiol) Tablets are available in a 28-day blister card within a recyclable plastic dispenser. Each 28-day treatment cycle pack consists of four different dosing phases, as follows:
- 7 coated, round light yellow tablets (debossed with “^T0^R” on one side and “Organon*” on the other side) containing 0.100 mg desogestrel and 0.025 mg ethinyl estradiol;
- 7 coated, round orange tablets (debossed with “^T6^R” on one side and “Organon*” on the other side) containing 0.125 mg desogestrel and 0.025 mg ethinyl estradiol;
- and 7 coated, round red tablets (debossed with “^T1^R” on one side and “Organon*” on the other side) containing 0.150 mg desogestrel and 0.025 mg ethinyl estradiol.
- Seven round green tablets (debossed with “^K2^H” on one side and “Organon*” on the other side) contain inert ingredients.

Boxes of 6 NDC 0052-0283-06

Storage

Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].

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Manufactured for Organon USA Inc.,
Roseland, NJ 07068 by N.V. Organon, Oss,
The Netherlands and packaged by Organon (Ireland)
Ltd., Swords, Co. Dublin, Ireland
©2003 Organon USA Inc.
FDA rev date: 3/26/2007

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