Plan B One-Step (levonorgestrel) tablet. 1.5 mg
Brief Summary (See Package Brochure For Full Prescribing Information)
Rx only for women younger than age 17 years
For women younger than age 17 years, Plan B? One-Step is a prescription- only emergency contraceptive. Plan B’ One-Step is indicated to prevent pregnancy after known or suspected contraceptive failure or unprotected intercourse. To obtain optimal efficacy, the tablet should be taken as soon as possible within 72 hours of intercourse. It is not indicated for routine use as a contraceptive. CONTRAINDICATIONS
Plan B » One-Step is contraindicatcd lor use in the case of known or suspected pregnancy.
WARNINGS AND PREC AUTIONS Ectopic Pregnancy
Ectopic pregnancies account for approximately 2% of all reported pregnancies. Up to 10% of pregnancies reported in clinical studies of routine use of progestin-only contraceptives are ectopic. A history of ectopic pregnancy is not a contraindication to use of this emergency contraceptivc method. Healthcare providers, however, should consider the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain after taking Plan B* One-Step. A follow-up physical or pelvic examination is recommended if there is any doubt concerning the general health or pregnancy status of any woman after taking Plan B* One-Step. Existing Pregnancy
Plan B* One-Step is not effective in terminating an existing pregnancy. Effects on Menses
Some women may experience spotting a few days after taking Plan B* One- Step. Menstrual bleeding patterns are often irregular among women using progestin-only oral contraceptives and women using levonorgestrel for postcoital and emergency contraception. If there is a delay in the onset of expected menses beyond 1 week, consider the possibility of pregnancy. ST1/HIV
Plan H’ One-Step does not protect against IIIV infection (AIDS) or other sexually transmitted infections (STls). Physical Examination and Follow-up
A physical examination is not required prior to prescribing Plan B » One- Step. A follow-up physical or pelvic examination is recommended if there is any doubt concerning the general health or pregnancy status of any woman after taking Plan B* One-Step. Fertility Following Discontinuation
A rapid return of fertility is likely following treatment with Plan B’ One-Step for emergency contraception; therefore, routine contraception should be continued or initiated as soon as possible following use of Plan B* One-Step to ensure ongoing prevention of pregnancy. ADVERSE REACTIONS Clinical Trials Experience
The most common adverse events (> 10%) in the clinical trial for women receiving Plan B’ One-Step included heavier menstrual bleeding (30.9%). nausea (13.7%), lower abdominal pain (13.3%), fatigue (13.3%), and headache (10.3%). Table I lists those adverse events that were reported in > 4% of Plan B* One-Step users.
Table I. Adverse Events in > 4% of Women, by % Frequency