Cyclessa

CYCLESSA® Tablets (desogestrel and ethinyl estradiol tablets USP) is 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.

% of Women Experiencing an Unintended Pregnancy within the First Year of Use Method Chance§ Spermicides¶ Periodic abstinence Calendar Ovulation Method Sympto-Thermal# Post-Ovulation

Typical Use†

Perfect Use‡

% of Women Continuing Use at One Year*

Withdrawal

Cap Þ Parous Women

Nulliparous Women

Sponge Parous Women

Nulliparous Women

DiaphragmÞ

Condom β Female (Reality)

Male

Pill

Progestin Only

Combined

IUD Progesterone T

Copper T 380A

LNg 20

Depo-Provera

Norplant and Norplant-2

Female sterilization

Male sterilization

Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces

risk of pregnancy by at least 75%.à Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception.è Source: Trussell J, Stewart F, Contraceptive Efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York, NY: Irvington Publishers, 1998.

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

year 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 ‡ 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 à The treatment schedule is one dose within 72 hours after unprotected intercourse and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 2 light orange pills), Lo/Ovral ® (1 dose is 4 white pills), Triphasil® or Tri-Levlen® (1 dose is 4 yellow pills) è 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 six months of age

• The percentage of women becoming pregnant noted in columns and 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% became pregnant in one year. This estimate was lowered slightly (to 85%) to represent the percentage that would become pregnant within one year among women now relying on reversible methods of contraception if they abandon contraception altogether ¶ Foams, creams, gels, vaginal suppositories and vaginal film # Cervical mucous (ovulation) method supplemented by calendar in the preovulatory and basal body temperature in the postovulatory phases Þ With spermicidal cream or jelly β Without spermicides †