Oral contraceptives 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 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, the IUD, and Norplant^Ò System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.

Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.⁹

Source: Trussell J. Contraceptive efficacy. In: Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowel D, Guest F. Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers; 1998.

1. Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.

2. Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.

3. Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.

4. The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.

5. Foams, creams, gels, vaginal suppositories, and vaginal film.

6. Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.

7. With spermicidal cream or jelly.

8. Without spermicides.

9. However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age.

In a clinical trial with Alesse, (levonorgestrel and ethinyl estradiol tablets), 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills.

To achieve maximum contraceptive effectiveness, Alesse^Ò (levonorgestrel and ethinyl estradiol tablets) must be taken exactly as directed and at intervals not exceeding 24 hours. The possibility of ovulation and conception prior to initiation of medication should be considered. The dispenser should be kept in the wallet supplied to avoid possible fading of the pills. If the pills fade, patients should continue to take them as directed.

The dosage of Alesse-28 is one pink tablet daily for 21 consecutive days, followed by one light-green inert tablet daily for 7 consecutive days, according to the prescribed schedule.

It is recommended that Alesse-28 tablets be taken at the same time each day.

During the first cycle of medication, the patient is instructed to begin taking Alesse-28 on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet (pink) is taken that day. One pink tablet should be taken daily for 21 consecutive days, followed by one light-green inert tablet daily for seven consecutive days. Withdrawal bleeding should usually occur within three days following discontinuation of pink tablets and may not have finished before the next pack is started. During the first cycle, contraceptive reliance should not be placed on Alesse-28 until a pink tablet has been taken daily for 7 consecutive days, and a nonhormonal back-up method of birth control should be used during those 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.

The patient begins her next and all subsequent 28-day courses of tablets on the same day of the week (Sunday) on which she began her first course, following the same schedule: 21 days on pink tablets — 7 days on light-green inert tablets. If in any cycle the patient starts tablets later than the proper day, she should protect herself against pregnancy by using a nonhormonal back-up method of birth control until she has taken a pink tablet daily for 7 consecutive days.

During the first cycle of medication, the patient is instructed to begin taking Alesse-28 during the first 24 hours of her period (day one of her menstrual cycle). One pink tablet should be taken daily for 21 consecutive days, followed by one light-green inert tablet daily for seven consecutive days. Withdrawal bleeding should usually occur within three days following discontinuation of pink tablets and may not have finished before the next pack is started. If medication is begun on day one of the menstrual cycle, no back-up contraception is necessary. If Alesse-28 tablets are started later than day one of the first menstrual cycle or postpartum, contraceptive reliance should not be placed on Alesse-28 tablets until after the first 7 consecutive days of administration, and a nonhormonal back-up method of birth control should be used during those 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.

When the patient is switching from a 21-day regimen of tablets, she should wait 7 days after her last tablet before she starts Alesse. She will probably experience withdrawal bleeding during that week. She should be sure that no more than 7 days pass after her previous 21-day regimen. When the patient is switching from a 28-day regimen of tablets, she should start her first pack of Alesse on the day after her last tablet. She should not wait any days between packs. The patient may switch any day from a progestin-only pill and should begin Alesse the next day. If switching from an implant or injection, the patient should start Alesse on the day of implant removal or, if using an injection, the day the next injection would be due. In switching from a progestin-only pill, injection, or implant, the patient should be advised to use a nonhormonal back-up method of birth control for the first 7 days of tablet-taking.

If spotting or breakthrough bleeding occur, the patient is instructed to continue on the same regimen. This type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her physician. While there is little likelihood of ovulation occurring if only one or two pink tablets are missed, the possibility of ovulation increases with each successive day that scheduled pink tablets are missed. Although the occurrence of pregnancy is unlikely if Alesse 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 schedule (missed one or more tablets or started taking them on a day later than she should have), the probability of pregnancy should be considered at the time of the first missed period and appropriate diagnostic measures taken before the medication is resumed. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen.

The risk of pregnancy increases with each active (pink) tablet missed. For additional patient instructions regarding missed tablets, see the WHAT TO DO IF YOU MISS PILLS section in the DETAILED PATIENT LABELING below.

Alesse may be initiated no earlier than day 28 postpartum in the nonlactating mother or after a second-trimester abortion due to the increased risk for thromboembolism (see CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS concerning thromboembolic disease). The patient should be advised to use a nonhormonal back-up method for the first 7 days of tablet-taking. However, if intercourse has already occurred, pregnancy should be excluded before the start of combined oral contraceptive use or the patient must wait for her first menstrual period.

In the case of first-trimester abortion, if the patient starts Alesse immediately, additional contraceptive measures are not needed.

Alesse^Ò-28 tablets (0.10 mg levonorgestrel and 0.02 mg ethinyl estradiol) are available in packages of 3 MINI-PACKÔ dispensers of 28 tablets each, NDC 0008-2576-02, as follows:

21 active tablets, NDC 0008-0912, pink, round tablet marked "W" and "912".

7 inert tablets, NDC 0008-0650, light-green, round tablet marked "W" and "650".

Store at controlled room temperature 20° to 25°C (68° to 77°F).

Wyeth Pharmaceuticals Inc. Philadelphia, PA 19101 W10491C001 ET01 Rev 04/04

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