My Way

MY WAY — levonorgestrel tablet
GAVIS Pharmaceuticals, LLC.

1 INDICATIONS AND USAGE

My Way is a progestin-only emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. To obtain optimal efficacy, the tablet should be taken as soon as possible within 72 hours of intercourse.

My Way is available only by prescription for women younger than age 17 years, and available over the counter for women 17 years and older. My Way is not indicated for routine use as a contraceptive.

2 DOSAGE AND ADMINISTRATION

Take My Way orally as soon as possible within 72 hours after unprotected intercourse or a known or suspected contraceptive failure. Efficacy is better if the tablet is taken as soon as possible after unprotected intercourse. My Way can be used at any time during the menstrual cycle.

If vomiting occurs within two hours of taking the tablet, consideration should be given to repeating the dose.

3 DOSAGE FORMS AND STRENGTHS

The My Way tablet is supplied as a white to off-white, round, flat tablets containing 1.5 mg of levonorgestrel and debossed with “NL 620” on one side and plain on the other side.

4 CONTRAINDICATIONS

My Way is contraindicated for use in the case of known or suspected pregnancy.

5 WARNINGS AND PRECAUTIONS

5.1 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 contraceptive 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 My Way. 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 My Way.

5.2 Existing Pregnancy

My Way is not effective in terminating an existing pregnancy.

5.3 Effects on Menses

Some women may experience spotting a few days after taking My Way. 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.

5.4 STI/HIV

My Way does not protect against HIV infection (AIDS) or other sexually transmitted infections (STIs).

5.5 Physical Examination and Follow-up

A physical examination is not required prior to prescribing My Way. 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 My Way.

5.6 Fertility Following Discontinuation

A rapid return of fertility is likely following treatment with My Way for emergency contraception; therefore, routine contraception should be continued or initiated as soon as possible following use of My Way to ensure ongoing prevention of pregnancy.

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

My Way was studied in a randomized, double-blinded multicenter clinical trial. In this study, all women who had received at least one dose of study medication were included in the safety analysis: 1,379 women in the My Way group, and 1,377 women in the Plan B group (2 doses of 0.75 mg levonorgestrel taken 12 hours apart). The mean age of women given My Way was 27 years. The racial demographic of those enrolled was 54% Chinese, 12% Other Asian or Black, and 34% were Caucasian in each treatment group. 1.6% of women in the My Way group and 1.4% in Plan B group were lost to follow-up.

The most common adverse events (>10%) in the clinical trial for women receiving My Way included heavier menstrual bleeding (30.9%), nausea (13.7%), lower abdominal pain (13.3%), fatigue (13.3%), and headache (10.3%). Table 1 lists those adverse events that were reported in > 4% of My Way users.

Table 1. Adverse Events in > 4% of Women, by % Frequency

Most Common Adverse Events (MedDRA)
Heavier menstrual bleeding	30.9
Nausea	13.7
Lower abdominal pain	13.3
Fatigue	13.3
Headache	10.3
Dizziness	9.6
Breast tenderness	8.2
Delay of menses (> 7 days)	4.5

6.2 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Plan B (2 doses of 0.75 mg levonorgestrel taken 12 hours apart). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Gastrointestinal Disorders

Abdominal Pain, Nausea, Vomiting

General Disorders and Administration Site Conditions

Fatigue

Nervous System Disorders

Dizziness, Headache

Reproductive System and Breast Disorders

Dysmenorrhea, Irregular Menstruation, Oligomenorrhea, Pelvic Pain

7 DRUG INTERACTIONS

Drugs or herbal products that induce certain enzymes, such as CYP3A4, may decrease the effectiveness of progestin-only pills. (7)

Drugs or herbal products that induce enzymes, including CYP3A4, that metabolize progestins may decrease the plasma concentrations of progestins, and may decrease the effectiveness of progestin-only pills. Some drugs or herbal products that may decrease the effectiveness of progestin-only pills include:

• barbiturates
• bosentan
• carbamazepine
• felbamate
• griseofulvin
• oxcarbazepine
• phenytoin
• rifampin
• St. John’s wort
• topiramate

Significant changes (increase or decrease) in the plasma levels of the progestin have been noted in some cases of co-administration with HIV protease inhibitors or with non-nucleoside reverse transcriptase inhibitors.

Consult the labeling of all concurrently used drugs to obtain further information about interactions with progestin-only pills or the potential for enzyme alterations.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Many studies have found no harmful effects on fetal development associated with long-term use of contraceptive doses of oral progestins. The few studies of infant growth and development that have been conducted with progestin-only pills have not demonstrated significant adverse effects.

8.3 Nursing Mothers

In general, no adverse effects of progestin-only pills have been found on breastfeeding performance or on the health, growth, or development of the infant. However, isolated post-marketing cases of decreased milk production have been reported. Small amounts of progestins pass into the breast milk of nursing mothers taking progestin-only pills for long-term contraception, resulting in detectable steroid levels in infant plasma.