Company:

Wyeth

Oral contraceptive (progestin + estrogen)

Levonorgestrel 0.09mg, ethinyl estradiol 20micrograms (28 tabs).

Oral contraception.

Lybrel is a non-cyclic oral contraceptive product that is given every day, without a hormone-free interval. Rather than experiencing withdrawal bleeding on a monthly basis, patients using Lybrel do not have regular menstrual cycles. However, unscheduled bleeding and spotting may occur.

The safety and efficacy of Lybrel were evaluated in 2 one-year trials. The first study, which was a one-year open-label study conducted in North America, treated 2,134 patients (mean weight 70.38kg), of whom 1,213 discontinued prematurely; 18% discontinued due to bleeding that was reported as either an adverse event or where bleeding was given as one of the reasons for discontinuation.

Among subjects ≤35 years old, there were 23 pregnancies during 12,572 pill-packs of use (4 of which occurred in the 14-day period after the last day of pill use), resulting in a total Pearl Index of 2.38 and a 1-year life table pregnancy rate of 2.39. Among those ≤35 years old who took the pills completely as directed, there were 15 pregnancies, resulting in a Pearl Index of 1.55 and a one-year life table pregnancy rate of 1.59.

In a study conducted in Europe, 641 patients (mean weight 63.86kg) were randomized to either Lybrel or a comparator (cyclic levonorgestrel 0.1mg + ethinyl estradiol 20mcg). One pregnancy occurred within the 14 days following the last dose of Lybrel, compared to 3 pregnancies in the comparator group.

Take at the same time each day.
1 tab daily (no tablet-free days). Start on Day 1 of cycle. Switching from other contraceptives or post-partum: see literature; may need back-up method for 1^st week.

Premenarchal: not recommended.

Thrombophlebitis or thromboembolic disorders. Cerebrovascular or coronary artery disease. Valvular heart disease. Breast or other estrogen-dependent neoplasias. Undiagnosed abnormal genital bleeding. Cholestatic jaundice of pregnancy or jaundice with prior oral contraceptive use. Uncontrolled hypertension. Prolonged immobilization. Diabetes with vascular involvement. Headaches with focal neurological symptoms. Liver tumors or disease. Pregnancy (Cat.X).

Smokers >35 years old: not recommended. Hypertriglyceridemia. Discontinue if jaundice, visual disturbances, migraine, or other severe headaches occur. Do regular complete physical exams. Nursing mothers: not recommended.

Antagonized by hepatic enzyme inducing drugs (eg, rifampin, griseofulvin, St. John’s Wort, carbamazepine, phenytoin, protease inhibitors), others. Ethinyl estradiol levels may be increased by atorvastatin, CYP3A4 inhibitors, others. May affect measurement of sex hormone binding globulin levels.

Hypertension, nausea, vomiting, breakthrough bleeding, amenorrhea, transient delay in ovulation after discontinuation, edema, chloasma, mastodynia, headache, intolerance to contact lenses, increased risk of gallbladder disease, thromboembolic events.

ClickCase (28 tabs)—1

For more information call (800) 934-5556 or visit www.Lybrel.com.

8/1/07