SEASONIQUE^TM
(levonorgestrel / ethinyl estradiol tablets) 0.15 mg / 0.03 mg and
(ethinyl estradiol tablets) 0.01 mg

Rx only

Patients sh ould be counseled that this product does not protect against HIV-infection (AIDS) and other sexually transmitted diseases.

Seasonique^TM (levonorgestrel/ethinyl estradiol combination tablets and ethinyl estradiol tablets) is an extended-cycle oral contraceptive consisting of 84 light blue-green tablets each containing 0.15 mg of levonorgestrel, a synthetic progestogen and 0.03 mg of ethinyl estradiol, and 7 yellow tablets containing 0.01 mg of ethinyl estradiol. The chemical formula of levonorgestrel USP is 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α-, (-)-, and the chemical formula of ethinyl estradiol USP is 19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. The structural formulas are as follows:

Each light blue-green tablet contains the following inactive ingredients: anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C yellow no. 6/Sunset yellow aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin.

Each yellow tablet contains the following inactive ingredients: anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6/Sunset yellow aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol, polysorbate 80 and titanium dioxide.

Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and changes in the endometrium (which reduce the likelihood of implantation).

No formal studies on the effect of race on the pharmacokinetics of Seasonique^TM were conducted.

No formal studies have been conducted to evaluate the effect of hepatic disease on the pharmacokinetics of Seasonique^TM. However, steroid hormones may be poorly metabolized in patients with impaired liver function.

No formal studies have been conducted to evaluate the effect of renal disease on the pharmacokinetics of Seasonique^TM.

See PRECAUTIONS section – Drug Interactions. 

Seasonique^TM tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

PSE-301 was a randomized, multicenter, open-label study designed to evaluate the safety and efficacy of Seasonique^TM for approximately 1 year (four 91-day Seasonique^TM extended cycles). A total of 1,006 sexually active adult women of childbearing potential, 18 to 40 years of age, were treated and completed 2,488 Seasonique^TM 91-day cycles. The principal cohort for efficacy included only patients 18 to 35 years of age who completed at least one 91-day cycle treatment cycle. Cycles in which another form of birth control was used (including condoms) were  excluded from the efficacy analysis. The overall Pearl Index was 1.77, based on 7 pregnancies in 1,578 completed 91-day treatment cycles.

Oral contraceptives are highly effective for pregnancy prevention. Table 2 uls 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 Norplant^® Implant System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.

Source: Trussell J. 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.

Oral contraceptives should not be used in women who currently have the following conditions:

• Thrombophlebitis or thromboembolic disorders
• A past history of deep vein thrombophlebitis or thromboembolic disorders
• Cerebrovascular or coronary artery disease (current or history)
• Valvular heart disease with thrombogenic complications
• Uncontrolled hypertension
• Diabetes with vascular involvement
• Headaches with focal neurological symptoms
• Major surgery with prolonged immobilization
• Known or suspected carcinoma of the breast or personal history of breast cancer
• Carcinoma of the endometrium or other known or suspected estrogen­dependent neoplasia
• Undiagnosed abnormal genital bleeding
• Cholestatic jaundice of pregnancy or jaundice with prior pill use
• Hepatic adenomas or carcinomas, or active liver disease
• Known or suspected pregnancy
• Hypersensitivity to any component of this product

Use of Seasonique^TM provides women with more hormonal exposure on a yearly basis than conventional monthly oral contraceptives containing similar strength synthetic estrogens and progestins (an additional 13 weeks exposure to birth control pill hormones per year).

One study gathered data from a variety of sources which have estimated the mortality rate associated with different methods of contraception at different ages (Table 3). These estimates include the combined risk of death associated with contraceptive methods plus the risk attributable to pregnancy in the event of method failure. Each method of contraception has its specific benefits and risks. The study concluded that with the exception of oral contraceptive users 35 and older who smoke and 40 and older who do not smoke, mortality associated with all methods of birth control is less than that associated with childbirth. The observation of a possible increase in risk of mortality with age for oral contraceptive users is based on data gathered in the 1970's--but not reported until 1983. However, current clinical practice involves the use of lower estrogen dose formulations combined with careful restriction of oral contraceptive use to women who do not have the various risk factors uled in this labeling.

Because of these changes in practice and, also, because of some limited new data which suggest that the risk of cardiovascular disease with the use of oral contraceptives may now be less than previously observed, the Fertility and Maternal Health Drugs Advisory Committee was asked to review the topic in 1989. The Committee concluded that although cardiovascular disease risks may be increased with oral contraceptive use after age 40 in healthy nonsmoking women (even with the newer low-dose formulations), there are greater potential health risks associated with pregnancy in older women and with the alternative surgical and medical procedures which may be necessary if such women do not have access to effective and acceptable means of contraception.

Therefore, the Committee recommended that the benefits of oral contraceptive use by healthy nonsmoking women over 40 may outweigh the possible risks. Of course, older women, as all women who take oral contraceptives, should take the lowest possible dose formulation that is effective.

Adapted from H.W. Ory, Family Planning Perspectives, 15: 57-63, 1983.

Numerous epidemiological studies have been performed on the incidence of breast, endometrial, ovarian and cervical cancer in women using oral contraceptives. Although the risk of having breast cancer diagnosed may be slightly increased among current and recent users of combined oral contraceptives (RR=1.24), this excess risk decreases over time after combination oral contraceptive discontinuation and by 10 years after cessation the increased risk disappears. The risk does not increase with duration of use and no consistent relationships have been found with dose or type of steroid. The patterns of risk are also similar regardless of a woman's reproductive history or her family breast cancer history. The subgroup for whom risk has been found to be significantly elevated is women who first used oral contraceptives before age 20, but because breast cancer is so rare at these young ages, the number of cases attributable to this early oral contraceptive use is extremely small. Breast cancers diagnosed in current or previous oral contraceptive users tend to be less clinically advanced than in never-users. Women who currently have or have had breast cancer should not use oral contraceptives because breast cancer is a hormone sensitive-tumor.

Some studies suggest that oral contraceptive use has been associated with an increase in the risk of cervical intraepithelial neoplasia or invasive cervical cancer in some populations of women. However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors. In spite of many studies of the relationship between oral contraceptive use and breast cancer and cervical cancers, a cause-and-effect relationship has not been established.

Benign hepatic adenomas are associated with oral contraceptive use, although their occurrence is rare in the United States. Indirect calculations have estimated the attributable risk to be in the range of 3.3 cases/100,000 for users, a risk that increases after four or more years of use. Rupture of hepatic adenomas may cause death through intra-abdominal hemorrhage.

Studies from Britain have shown an increased risk of developing hepatocellular carcinoma in long-term (>8 years) oral contraceptive users. However, these cancers are extremely rare in the U.S., and the attributable risk (the excess incidence) of liver cancers in oral contraceptive users approaches less than one per million users.

There have been clinical case reports of retinal thrombosis associated with the use of oral contraceptives that may lead to partial or complete loss of vision. Oral contraceptives should be discontinued if there is unexplained partial or complete loss of vision; onset of proptosis or diplopia; papilledema; or retinal vascular lesions. Appropriate diagnostic and therapeutic measures should be undertaken immediately.

Because women using Seasonique^TM will likely have withdrawal bleeding only 4 times per year, pregnancy should be ruled out at the time of any missed menstrual period (see DOSAGE AND ADMINISTRATION). Oral contraceptive use should be discontinued if pregnancy is confirmed.

Extensive epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy. Studies also do not suggest a teratogenic effect, particularly in so far as cardiac anomalies and limb-reduction defects are concerned, when taken inadvertently during early pregnancy (see CONTRAINDICATIONS).

The administration of oral contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy. Oral contraceptives should not be used during pregnancy to treat threatened or habitual abortion.

Earlier studies have reported an increased lifetime relative risk of gallbladder surgery in users of oral contraceptives and estrogens. More recent studies, however, have shown that the relative risk of developing gallbladder disease among oral contraceptive users may be minimal. The recent findings of minimal risk may be related to the use of oral contraceptive formulations containing lower hormonal doses of estrogens and progestogens.

Oral contraceptives have been shown to cause glucose intolerance in a significant percentage of users. Oral contraceptives containing greater than 75 micrograms of estrogens cause hyperinsulinism, while lower doses of estrogen cause less glucose intolerance. Progestogens increase insulin secretion and create insulin resistance, this effect varying with different progestational agents. However, in the nondiabetic woman, oral contraceptives appear to have no effect on fasting blood glucose. Because of these demonstrated effects, prediabetic and diabetic women should be carefully observed while taking oral contraceptives.

A small proportion of women will have persistent hypertriglyceridemia while on the pill. As discussed earlier (see WARNINGS 1a. and 1d.), changes in serum triglycerides and lipoprotein levels have been reported in oral contraceptive users.

Women with significant hypertension should not be started on hormonal contraceptive. An increase in blood pressure has been reported in women taking oral contraceptives and this increase is more likely in older oral contraceptive users and with continued use. Data from the Royal College of General Practitioners and subsequent randomized trials have shown that the incidence of hypertension increases with increasing concentrations of progestogens.

Women with a history of hypertension or hypertension-related diseases, or renal disease should be encouraged to use another method of contraception. If women with hypertension elect to use oral contraceptives, they should be monitored closely, and if significant elevation of blood pressure occurs, oral contraceptives should be discontinued (see CONTRAINDICATIONS). For most women, elevated blood pressure will return to normal after stopping oral contraceptives, and there is no difference in the occurrence of hypertension among ever- and never-users.

The onset or exacerbation of migraine or development of headache with a new pattern that is recurrent, persistent, or severe requires discontinuation of oral contraceptives and evaluation of the cause. (See WARNINGS, 1c.)

When prescribing Seasonique™, the convenience of fewer planned menses (4 per year instead of 13 per year) should be weighed against the inconvenience of increased intermenstrual bleeding and/or spotting.

The primary clinical trial (PSE-301) that evaluated the efficacy of Seasonique™ was also assessed intermenstrual bleeding. The participants in the study (N=1,006) were composed primarily of women who had used oral contraceptives previously (89.3%) as opposed to new users (10.7%). A total of 82 (8.2%) of the women discontinued Seasonique™, at least in part, due to bleeding or spotting.

Figure 2 shows the percentage of Seasonique™ subjects participating in trial PSE-301 with ≥ 7 days or ≥ 20 days of intermenstrual bleeding or spotting during each treatment cycle. During the first 91-day treatment cycle, 64% of subjects experienced 7 or more days of intermenstrual bleeding or spotting with 29% of this cohort experiencing 20 or more days of intermenstrual bleeding or spotting. During the fourth 91-day treatment cycle, these percentages were 39% and 11%, respectively.

 As in any case of bleeding irregularities, nonhormonal causes should always be considered and adequate diagnostic measures taken to rule out malignancy or pregnancy.

In the event of amenorrhea, pregnancy should be ruled out. Some women may encounter post-pill amenorrhea or oligomenorrhea (possibly with anovulation), especially when such a condition was preexistent.

Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

A periodic history and physical examination are appropriate for all women, including women using oral contraceptives. The physical examination, however, may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology, and relevant laboratory tests. In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate diagnostic measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care.

Women who are being treated for hyperlipidemias should be followed closely if they elect to use oral contraceptives. Some progestogens may elevate LDL levels and may render the control of hyperlipidemias more difficult. (See WARNINGS 1d.)

In patients with familial defects of lipoprotein metabolism receiving estrogen-containing preparations, there have been case reports of significant elevations of plasma triglycerides leading to pancreatitis.

If jaundice develops in any woman receiving such drugs, the medication should be discontinued. Steroid hormones may be poorly metabolized in patients with impaired liver function.

Oral contraceptives may cause some degree of fluid retention. They should be prescribed with caution, and only with careful monitoring, in patients with conditions, which might be aggravated by fluid retention.

Women with a history of depression should be carefully observed and the drug discontinued if depression recurs to a serious degree. Patients becoming significantly depressed while taking oral contraceptives should stop the medication and use an alternate method of contraception in an attempt to determine whether the symptom is drug related.

Contact-lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.

Changes in contraceptiveeffectiveness associatedwith co-administration of other products

a. Anti-infective agents and anticonvulsants

Contraceptive effectiveness may be reduced when hormonal contraceptives are co-administered with antibiotics, anticonvulsants, and other drugs that increase the metabolism of contraceptive steroids. This could result in unintended pregnancy or breakthrough bleeding. Examples include rifampin, barbiturates, phenylbutazone, phenytoin, carbamazepine, felbamate, oxcarbazepine, topiramate, and griseofulvin. Several cases of contraceptive failure and breakthrough bleeding have been reported in the literature with concomitant administration of antibiotics such as ampicillin and tetracyclines. However, clinical pharmacology studies investigating drug interaction between combined oral contraceptives and these antibiotics have reported inconsistent results.

b. Anti-HIV protease inhibitors

Several of the anti-HIV protease inhibitors have been studied with co-administration of oral combination hormonal contraceptives; significant changes (increase and decrease) in the plasma levels of the estrogen and progestin have been noted in some cases. The safety and efficacy of combination oral contraceptive products may be affected with co-administration of anti-HIV protease inhibitors. Healthcare providers should refer to the label of the individual anti-HIV protease inhibitors for further drug-drug interaction information.

c. Herbal products

Herbal products containing St. John’s Wort (hypericum perforatum) may induce hepatic enzymes (cytochrome P450) and p-glycoprotein transporter and may reduce the effectiveness of contraceptive steroids. This may also result in breakthrough bleeding.

Co-administration of atorvastatin and certain combination oral contraceptives containing ethinyl estradiol increase AUC values for ethinyl estradiol by approximately 20%. Ascorbic acid and acetaminophen may increase plasma ethinyl estradiol levels, possibly by inhibition of conjugation. CYP 3A4 inhibitors such as itraconazole or ketoconazole may increase plasma hormone levels.

Combination hormonal contraceptives containing some synthetic estrogens (e.g., ethinyl estradiol) may inhibit the metabolism of other compounds. Increased plasma concentrations of cyclosporin, prednisolone, and theophylline have been reported with concomitant administration of combination oral contraceptives. Decreased plasma concentrations of acetaminophen and increased clearance of temazepam, salicylic acid, morphine and clofibric acid, due to induction of conjugation have been noted when these drugs were administered with combination oral contraceptives.

Certain endocrine and liver function tests and blood components may be affected by oral contraceptives:

a. Increased prothrombin and factors VII, VIII, IX, and X; decreased antithrombin 3; increased
norepinephrine-induced platelet aggregability.

b. Increased thyroid­binding globulin (TBG) leading to increased circulating total thyroid
hormone, as measured by protein­bound iodine (PBI), T4 by column or by radioimmunoassay.
Free T3 resin uptake is decreased, reflecting the elevated TBG, free T4 concentration is
unaltered.

c. Other binding proteins may be elevated in serum.

d. Sex hormone binding globulins are increased and result in elevated levels of total circulating
sex steroids and corticoids; however, free or biologically active levels remain unchanged.

e. Triglycerides may be increased and levels of various other lipids and lipoproteins may be
affected.

f. Glucose tolerance may be decreased.

g. Serum folate levels may be depressed by oral contraceptive therapy. This may be of clinical
significance if a woman becomes pregnant shortly after discontinuing oral contraceptives.

See WARNINGS.

Pregnancy Category X. See CONTRAINDICATIONS and WARNINGS.

Small amounts of oral contraceptive steroids and/or metabolites have been identified in the milk of nursing mothers, and a few adverse effects on the child have been reported, including jaundice and breast enlargement. In addition, oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk. If possible, the nursing mother should be advised not to use oral contraceptives but to use other forms of contraception until she has completely weaned her child.

Safety and efficacy of Seasonique^TM tablets have been established in women of reproductive age. Safety and efficacy are expected to be the same in postpubertal adolescents under the age of 16 and users 16 and older. Use of Seasonique^TM before menarche is not indicated.

Seasonique^TM tablets have not been studied in women who have reached menopause.

See Patient Labeling Printed Below.

An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS):

• Thrombophlebitis
• Arterial thromboembolism
• Pulmonary embolism
• Myocardial infarction
• Cerebral hemorrhage
• Cerebral thrombosis
• Hypertension
• Gallbladder disease
• Hepatic adenomas or benign liver tumors

There is evidence of an association between the following conditions and the use of oral contraceptives:

• Mesenteric thrombosis
• Retinal thrombosis

The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug related:

• Nausea
• Vomiting
• Gastrointestinal symptoms (such as abdominal cramps and bloating)
• Breakthrough bleeding
• Spotting
• Change in menstrual flow
• Amenorrhea
• Temporary infertility after discontinuation of treatment
• Edema/fluid retention
• Melasma/chloasma which may persist
• Breast changes: tenderness, enlargement, and secretion
• Change in weight or appetite (increase or decrease)
• Change in cervical ectropion and secretion
• Possible diminution in lactation when given immediately postpartum
• Cholestatic jaundice
• Migraine headache
• Rash (allergic)
• Mood changes, including depression
• Vaginitis, including candidiasis
• Change in corneal curvature (steepening)
• Intolerance to contact lenses
• Decrease in serum folate levels
• Exacerbation of systemic lupus erythematosus
• Exacerbation of porphyria
• Exacerbation of chorea
• Aggravation of vericose veins
• Anaphylactic/anaphylactoid reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms

The following adverse reactions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted:

• Premenstrual syndrome
• Cataracts
• Optic neuritis which may lead to partial or complete loss of vision
• Cystitis-like syndrome
• Headache
• Nervousness
• Dizziness
• Hirsutism
• Loss of scalp hair
• Erythema multiforme
• Erythema nodosum
• Hemorrhagic eruption
• Impaired renal function
• Hemolytic uremic syndrome
• Budd-Chiari syndrome
• Acne
• Changes in libido
• Colitis
• Pancreatitis
• Dysmenorrhea

Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea, and withdrawal bleeding may occur in females.

The following noncontraceptive health benefits related to the use of oral contraceptives are supported by epidemiological studies which largely utilized oral contraceptive formulations containing doses exceeding 0.035 mg of ethinyl estradiol or 0.05 mg of mestranol.

Effects on menses:

• May decrease blood loss and may decrease incidence of iron-deficiency anemia
• May decrease incidence of dysmenorrhea

Effects related to inhibition of ovulation:

• May decrease incidence of functional ovarian cysts
• May decrease incidence of ectopic pregnancies

Effects from long-term use:

• May decrease incidence of fibroadenomas and fibrocystic disease of the breast
• May decrease incidence of acute pelvic inflammatory disease
• May decrease incidence of endometrial cancer
• May decrease incidence of ovarian cancer

Although the occurrence of pregnancy is unlikely if Seasonique™ is taken according to directions, if withdrawal bleeding does not occur while taking yellow (ethinyl estradiol) tablets, the possibility of pregnancy must be considered. Appropriate diagnostic measures to rule out pregnancy should be taken at the time of any missed menstrual period. Seasonique™ should be discontinued if pregnancy is confirmed.

The dosage of Seasonique™ is one light blue-green tablet containing levonorgestrel and ethinyl estradiol daily for 84 consecutive days, followed by 7 days of yellow ethinyl estradiol tablets. To achieve maximum contraceptive effectiveness, Seasonique™ must be taken exactly as directed and at intervals not exceeding 24 hours. Ideally, the tablets should be taken at the same time of the day on each day. The tablets should not be removed from the protective buler packaging and outer plastic dispenser to avoid damage to the product. The plastic dispenser should be kept in the foil pouch until dispensed to the patient.

During the first cycle of medication, the patient is instructed to begin taking Seasonique™ on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first light blue-green tablet is taken that day. One light blue-green tablet should be taken daily for 84 consecutive days, followed by 7 days of yellow tablets. Withdrawal bleeding should occur during the 7 days of yellow tablets. During the first cycle, contraceptive reliance should not be placed on Seasonique™ until a light blue-green tablet has been taken daily for 7 consecutive days and a non-hormonal back-up method of birth control (such as condoms or spersmicides) 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 91-day courses of tablets without interruption on the same day of the week (Sunday) on which she began her first course, following the same schedule: 84 days on which light blue-green tablets are taken followed by 7 days on which yellow tablets are taken. If in any cycle the patient starts tablets later than the proper day, she should protect herself against pregnancy by using a non-hormonal back-up method of birth control until she has taken a light blue-green tablet daily for 7 consecutive days.

If spotting or breakthrough bleeding occurs, the patient is instructed to continue on the same regimen. This type of bleeding may be transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her healthcare provider.

For patient instructions regarding missed pills, see the “WHAT TO DO IF YOU MISS PILLS” section in the DETAILED PATIENT LABELING. Any time the patient misses two or more light blue-green tablets, she should also use another method of non-hormonal back-up contraception until she has taken a light blue-green tablet daily for seven consecutive days. If the patient misses one or more yellow tablets, she is still protected against pregnancy provided she begins taking light blue-green tablets again on the proper day. The possibility of ovulation increases with each successive day that scheduled light blue-green tablets are missed. The risk of pregnancy increases with each active (light blue-green) tablet missed.

In the nonlactating mother, Seasonique^TM may be initiated for contraception no earlier than day 28 postpartum, due to the increased risk for thromboembolism. 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). 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, the possibility of ovulation and conception prior to initiation of medication should be considered. Seasonique^TM may be initiated immediately after a first-trimester abortion; if the patient starts Seasonique^TM immediately, additional contraceptive measures are not needed.

Seasonique^TM tablets (levonorgestrel / ethinyl estradiol tablets) 0.15 mg / 0.03 mg and (ethinyl estradiol tablets) 0.01 mg are available in Extended-Cycle Tablet Dispensers (NDC 51285-087-87), each containing a 13-week supply of tablets: 84 light blue-green tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol, and 7 yellow tablets each containing 0.01 mg of ethinyl estradiol. The light blue-green tablets are round, film-coated, biconvex, unscored tablets debossed with (stylized b) on one side and 555 on the other side. The yellow tablets are round, biconvex, film-coated, unscored tablet debossed with (stylized b) on one side and 556 on the other side.

Store at 20° to 25° C (68° to77° F) [See USP Controlled Room Temperature].

Supplied upon request

This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.

Oral contraceptives, also known as “birth control pills” or “the pill”, are taken to prevent pregnancy, and when taken correctly, have a failure rate of approximaly 1.0% per year (1 pregnancy per 100 women per year of use). The typical failure rate of pill users is approximately 5% per(5 pregnancies per 100 women per year) year when women who miss pills are included.

For the majority of women, oral contraceptives can be taken safely. But for some women oral contraceptive use is associated with certain serious diseases that can be life-threatening or may cause temporary or permanent disability or death. The risks associated with taking oral contraceptives increase significantly if you:

• smoke
• have high blood pressure, diabetes, high cholesterol or are obese
• have or have had clotting disorders, heart attack, stroke, angina pectoris, cancer of the breast or sex organs, jaundice, or malignant or benign liver tumors

You should not take the pill if you are pregnant.

Although cardiovascular disease risks may be increased with oral contraceptive use after age 40 in healthy, non-smoking women (even with the newer low-dose formulations), there are also greater potential health risks associated with pregnancy in older women.

This product (like all oral contraceptives) is intended to prevent pregnancy. Oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.

INTRODUCTION

Any woman who considers using oral contraceptives (“the birth control pill” or “the pill”) should understand the benefits and risks of using this form of birth control. Although oral contraceptives have important advantages over other methods of contraception, they have certain risks that no other method has, and some of these risks may continue after you have stopped using the oral contraceptive. This leaflet will give you much of the information you will need to make this decision and will also help you determine if you are at risk of developing any of the serious side effects of the pill. It will tell you how to use Seasonique^TM properly so that it will be as effective as possible. However, this leaflet is not a replacement for a careful discussion between you and your healthcare provider. You should discuss the information provided in this leaflet with your healthcare provider, both when you first start taking Seasonique^TM and during your revisits. You should also follow your healthcare provider's advice with regard to regular check-ups while you are on Seasonique^TM.

EFFECTIVENESS OF ORAL CONTRACEPTIVES

Oral contraceptives or “the birth control pill” or “the pill” are used to prevent pregnancy and are more effective than most other nonsurgical methods of birth control. The chance of becoming pregnant is approximately 1% per year (1 pregnancy per 100 women per year of use) when the pills are used correctly, and no pills are missed. Typical failure rates are approximately 5% per year (5 pregnancies per 100 women per year of use) when women who miss pills are included. The chance of becoming pregnant increases with each missed pill during the menstrual cycle.

In comparison, typical failure rates for other methods of birth control during the first year of use are as follows:

No methods: 85%

Vaginal sponge: 20 to 40%

Cervical cap: 20 to 40%

Spermicides alone: 26%

Periodic abstinence: 25%

Condom (female): 21%

Diaphragm with spermicides: 20%

Withdrawal: 19%

Condom (male): 14%

Female sterilization: 0.5%

IUD: 0.1 to 2.0%

Injectable progestogen: 0.3%

Male sterilization: 0.15%

Norplant system: 0.05%

WHO SHOULD NOT TAKE ORAL CONTRACEPTIVES