General Information

Quarette is an ascending-dose, extended-regimen oral contraceptive comprised of levonorgestrel/ethinyl estradiol and ethinyl estradiol.

Quartette is specifically indicated for use by females of reproductive age to prevent pregnancy.

Mechanism of Action

Quarette is an ascending-dose, extended regimen oral contraceptive comprised of levonorgestrel/ethinyl estradiol and ethinyl estradiol. Levonorgestrel is a progestin and ethinyl estradiol is an estrogen. Quarette prevents conception primarily by suppressing ovulation. It may also induce cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.

Side Effects

Adverse events associated with the use of Quartette may include, but are not limited to, the following:

• Headaches
• Heavy/irregular vaginal bleeding
• Nausea/vomiting
• Acne
• Dysmenorrhea
• Weight increase
• Mood changes
• Anxiety/panic attack
• Breast pain
• Migraines

Dosing/Administration

Quartette is supplied as ascending dose tablets for oral administration. Quartette should be administered once a day by mouth at the same time every day for 91 days. To achieve maximum contraceptive effectiveness, Quartette must be taken exactly as directed and at intervals not exceeding 24 hours.

Clinical Trial Results

FDA approval of Quartette was based on a phase 3 trial in 3,565 women, 18-40 years old, who were treated for up to four 91-day cycles (thirteen 28-day cycles). The pregnancy rate (Pearl Index [PI]) in women aged 18-35 years was 3.19 pregnancies per 100 woman-years of use, based on 70 pregnancies that occurred after the onset of treatment and up to and including seven days after the last pill (97 percent efficacy rate). Breakthrough bleeding and unscheduled spotting also decreased over successive 91-day cycles.

Additional Information

For additional information regarding Quartette or contraceptives, please visit the Teva Pharmaceuticals web page.