LoSeasonique

LOSEASONIQUE — levonorgestrel/ethinyl estradiol and ethinyl estradiol
Physicians Total Care, Inc.

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke. [See CONTRAINDICATIONS (4).]

1 INDICATIONS AND USAGE

LoSeasonique (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) is indicated for use by women to prevent pregnancy.

2 DOSAGE AND ADMINISTRATION

Take one tablet by mouth at the same time every day. The dosage of LoSeasonique is one orange tablet containing levonorgestrel and ethinyl estradiol daily for 84 consecutive days, followed by one yellow ethinyl estradiol tablet for 7 days. To achieve maximum contraceptive effectiveness, LoSeasonique must be taken exactly as directed and at intervals not exceeding 24 hours.

Instruct the patient to begin taking LoSeasonique on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first orange tablet is taken that day. One orange tablet should be taken daily for 84 consecutive days, followed by one yellow tablet for 7 consecutive days. A non-hormonal back-up method of contraception (such as condoms or spermicide) should be used until an orange tablet has been taken daily for 7 consecutive days. A scheduled period should occur during the 7 days that the yellow tablets are taken.

Begin the next and all subsequent 91-day cycles without interruption on the same day of the week (Sunday) on which the patient began her first dose of LoSeasonique, following the same schedule: 84 days taking an orange tablet followed by 7 days taking a yellow tablet. If the patient does not immediately start her next pill pack, she should protect herself from pregnancy by using a non-hormonal back-up method of contraception until she has taken an orange tablet daily for 7 consecutive days.

If unscheduled spotting or bleeding occurs, instruct the patient to continue on the same regimen. If the bleeding is persistent or prolonged, advise the patient to consult her healthcare provider.

For patient instructions regarding missed pills, see PATIENT COUNSELING INFORMATION (17.2).

For postpartum women who are not breastfeeding, start LoSeasonique no earlier than four to six weeks postpartum. If the patient starts on LoSeasonique postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken an orange tablet for 7 consecutive days.

3 DOSAGE FORMS AND STRENGTHS

LoSeasonique tablets are available in Extended-Cycle Tablet Dispensers, each containing a 13-week supply of tablets: 84 orange tablets, each containing 0.1 mg of levonorgestrel and 0.02 mg ethinyl estradiol, and 7 yellow tablets each containing 0.01 mg of ethinyl estradiol. The orange tablets are round, film-coated, unscored tablets with a debossed stylized b on one side and 28 on the other side. The yellow tablets are round, film-coated, unscored tablet with a debossed stylized b on one side and 556 on the other side.

4 CONTRAINDICATIONS

Do not prescribe LoSeasonique to women who are known to have the following conditions:

  • A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:
    • Smoke, if over age 35
    • Have deep vein thrombosis or pulmonary embolism, now or in the past
    • Have cerebrovascular disease
    • Have coronary artery disease
    • Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation)
    • Have hypercoagulopathies
    • Have uncontrolled hypertension
    • Have diabetes with vascular disease
    • Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35
  • Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past
  • Liver tumors, benign or malignant, or liver disease
  • Pregnancy, because there is no reason to use OCs during pregnancy

5 WARNINGS AND PRECAUTIONS

5.1 Vascular Events

Stop COCs if an arterial or deep venous thrombotic event occurs. Although use of COCs increases the risk of venous thromboembolism, pregnancy increases the risk of venous thromboembolism as much or more than the use of COCs. The risk of venous thromboembolism in women using COCs is 3 to 9 per 10,000 woman-years. Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events.

Use of LoSeasonique provides women with more hormonal exposure on a yearly basis than conventional monthly oral contraceptives containing the same strength synthetic estrogens and progestins (an additional 9 and 13 weeks of exposure to progestin and estrogen, respectively, per year.)

If feasible, stop COCs at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism.

Start COCs no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.

Stop COCs if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.

5.2 Carcinoma of the Breast and Cervix

Women who currently have or have had breast cancer should not use COCs because breast cancer may be hormonally sensitive.

There is substantial evidence that COCs do not increase the incidence of breast cancer. Although some past studies have suggested that COCs might increase the incidence of breast cancer, more recent studies have not confirmed such findings.

Some studies suggest that COCs are associated with an increase in the risk of cervical cancer or intraepithelial neoplasia. However, there is controversy about the extent to which these findings are due to differences in sexual behavior and other factors.

5.3 Liver Disease

Discontinue COCs if jaundice develops. Steroid hormones may be poorly metabolized in patients with impaired liver function.

Hepatic adenomas are associated with COC use. An estimate of the attributable risk is 3.3 cases/100,000 COC users. Rupture of hepatic adenomas may cause death through intra-abdominal hemorrhage.

Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (> 8 years) COC users. However, the attributable risk of liver cancers in COC users is less than one case per million users.

Oral contraceptive-related cholestasis may occur in women with a history of pregnancy-related cholestasis. Women with a history of COC-related cholestasis may have the condition recur with subsequent COC use.

5.4 High Blood Pressure

For women with well-controlled hypertension, monitor blood pressure and stop COCs if blood pressure rises significantly. Women with uncontrolled hypertension or hypertension with vascular disease should not use COCs.

An increase in blood pressure has been reported in women taking COCs, and this increase is more likely in older women and with extended duration of use. The incidence of hypertension increases with increasing concentration of progestin.

5.5 Gallbladder Disease

Studies suggest a small increased relative risk of developing gallbladder disease among COC users.

5.6 Carbohydrate and Lipid Metabolic Effects

Carefully monitor prediabetic and diabetic women who are taking COCs. COCs may decrease glucose tolerance in a dose-related fashion.

Consider alternative contraception for women with uncontrolled dyslipidemias. A small proportion of women will have adverse lipid changes while on COCs.

5.7 Headache

If a woman taking COCs develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue COCs if indicated.

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