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 Levonorgestrel Tablet. 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 Levonorgestrel Tablet.

5.2 Existing Pregnancy

Levonorgestrel tablet is not effective in terminating an existing pregnancy.

5.3 Effects on Menses

Some women may experience spotting a few days after taking Levonorgestrel Tablet. 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

Levonorgestrel Tablet 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 Levonorgestrel Tablet. 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 Levonorgestrel Tablet.

5.6 Fertility Following Discontinuation

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

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.

Levonorgestrel Tablet 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 Levonorgestrel Tablet 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 Levonorgestrel Tablet 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 Levonorgestrel Tablet 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 Levonorgestrel Tablet 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 Levonorgestrel Tablet users.

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

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.

8.4 Pediatric  Use

Safety and efficacy of progestin-only pills for long-term contraception have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents less than 17 years and for users 17 years and older. Use of Levonorgestrel Tablet emergency contraception before menarche is not indicated.

8.5 Geriatric Use

This product is not intended for use in postmenopausal women.

8.6 Race

No formal studies have evaluated the effect of race. However, clinical trials demonstrated a higher pregnancy rate in Chinese women with both Plan B and the Yuzpe regimen (another form of emergency contraception). There was a non-statistically significant increased rate of pregnancy among Chinese women in the Levonorgestrel Tablet trial. The reason for this apparent increase in the pregnancy rate with emergency contraceptives in Chinese women is unknown.

8.7 Hepatic Impairment

No formal studies were conducted to evaluate the effect of hepatic disease on the disposition of Levonorgestrel Tablet.

8.8 Renal Impairment

No formal studies were conducted to evaluate the effect of renal disease on the disposition of Levonorgestrel Tablet.

12.1 Mechanism of Action

Emergency contraceptive pills are not effective if a woman is already pregnant. Levonorgestrel Tablet is believed to act as an emergency contraceptive principally by preventing ovulation or fertilization (by altering tubal transport of sperm and/or ova). In addition, it may inhibit implantation (by altering the endometrium). It is not effective once the process of implantation has begun.

12.3 Pharmacokinetics

Absorption

Following a single dose administration of Levonorgestrel Tablet in 30 women under fasting conditions, maximum plasma concentrations of levonorgestrel of 19.1 ng/mL were reached at 1.7 hours. See Table 2.

Administration of Levonorgestrel tablet to 30 Healthy Female Volunteers under Fasting Conditions[/TC]

Cmax = maximum concentration

AUCt = area under the drug concentration curve from time 0 to time of last determinable concentration

AUCinf = area under the drug concentration curve from time 0 to infinity

Tmax = time to maximum concentration

t1/2= elimination half life

* N=29

** median (range)

Effect of Food: The effect of food on the rate and the extent of levonorgestrel absorption following single oral administration of Levenorgestrel Tablet has not been evaluated.

Distribution

The apparent volume of distribution of levonorgestrel is reported to be approximately 1.8 L/kg. It is about 97.5 to 99% protein-bound, principally to sex hormone binding globulin (SHBG) and, to a lesser extent, serum albumin.

Metabolism

Following absorption, levonorgestrel is conjugated at the 17β-OH position to form sulfate conjugates and, to a lesser extent, glucuronide conjugates in plasma. Significant amounts of conjugated and unconjugated 3α, 5β-tetrahydrolevonorgestrel are also present in plasma, along with much smaller amounts of 3α, 5α-tetrahydrolevonorgestrel and 16βhydroxylevonorgestrel. Levonorgestrel and its phase I metabolites are excreted primarily as glucuronide conjugates. Metabolic clearance rates may differ among individuals by several-fold, and this may account in part for the wide variation observed in levonorgestrel concentrations among users.

Excretion

About 45% of levonorgestrel and its metabolites are excreted in the urine and about 32% are excreted in feces, mostly as glucuronide conjugates.

Specific Populations

Pediatric

This product is not intended for use in the premenarcheal population, and pharmacokinetic data are not available for this population.

Geriatric

This product is not intended for use in postmenopausal women, and pharmacokinetic data are not available for this population.

Race

No formal studies have evaluated the effect of race. However, clinical trials demonstrated a higher pregnancy rate in Chinese women with both Plan B and the Yuzpe regimen (another form of emergency contraception). There was a non-statistically significant increased rate of pregnancy among Chinese women in the Levonorgestrel Tablet trial. The reason for this apparent increase in the pregnancy rate with emergency contraceptives in Chinese women is unknown [see USE IN SPECIFIC POPULATIONS (8.6)].

Hepatic Impairment

No formal studies were conducted to evaluate the effect of hepatic disease on the disposition of Levonorgestrel Tablet.

Renal Impairment

No formal studies were conducted to evaluate the effect of renal disease on the disposition of Levonorgestrel Tablet.

Drug-Drug Interactions

No formal drug-drug interaction studies were conducted with Levonorgestrel Tablet [see DRUG INTERACTIONS (7)].

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity: There is no evidence of increased risk of cancer with short-term use of progestins. There was no increase in tumorgenicity following administration of levonorgestrel to rats for 2 years at approximately 5 µg/day, to dogs for 7 years at up to 0.125 mg/kg/day, or to rhesus monkeys for 10 years at up to 250 µg/kg/day. In another 7 year dog study, administration of levonorgestrel at 0.5 mg/kg/day did increase the number of mammary adenomas in treated dogs compared to controls. There were no malignancies.

Genotoxicity: Levonorgestrel was not found to be mutagenic or genotoxic in the Ames Assay, in vitro mammalian culture assays utilizing mouse lymphoma cells and Chinese hamster ovary cells, and in an in vivo micronucleus assay in mice.

Fertility: There are no irreversible effects on fertility following cessation of exposures to levonorgestrel or progestins in general.

17.1 Information for Patients

• Take Levonorgestrel Tablets as soon as possible and not more than 72 hours after unprotected intercourse or a known or suspected contraceptive failure.
• If you vomit within two hours of taking the tablet, immediately contact your healthcare provider to discuss whether to take another tablet.
• Seek medical attention if you experience severe lower abdominal pain 3 to 5 weeks after taking Levonorgestrel Tablet, in order to be evaluated for an ectopic pregnancy.
• After taking Levonorgestrel Tablet, consider the possibility of pregnancy if your period is delayed more than one week beyond the date you expected your period.
• Do not use Levonorgestrel Tablet as routine contraception.
• Levonorgestrel Tablet is not effective in terminating an existing pregnancy.
• Levonorgestrel Tablet does not protect against HIV-infection (AIDS) and other sexually transmitted diseases/infections.
• For women younger than age 17 years, Levonorgestrel Tablet is available only by prescription.

Mfg. by:

Novel laboratories, Inc.

Somerset, NJ

May 2012

Medication Guide

Levonorgestrel Tablet, 1.5 mg

Emergency Contraceptive

Because the unexpected happens.

Important information about Levonorgestrel Tablets,

Birth Control and Sexually Transmitted Diseases

For additional information intended for healthcare professionals, please see enclosed Product Information for Levonorgestrel Tablet.

What is Levonorgestrel Tablet?

Levonorgestrel Tablet is emergency contraception that helps prevent pregnancy after birth control failure or unprotected sex. It is a backup method of preventing pregnancy and is not to be used routinely.

Levonorgestrel Tablet can reduce your chance of pregnancy after unprotected sex (if your regular birth control was used incorrectly or fails, or if you have had sex without birth control). For example, if you were using a condom and it broke or slipped, if you did not use your regular birth control as you should have, or if you did not use any birth control, Levonorgestrel Tablet may work for you.

What Levonorgestrel Tablet is not.

Levonorgestrel Tablet will not work if you are already pregnant and will not affect an existing pregnancy. Levonorgestrel Tablet should not be used as regular birth control. It is important to have another reliable source of birth control that is right for you. Levonorgestrel Tablet will not protect you from HIV infection (the virus that causes AIDS) and other sexually transmitted diseases.

When is the appropriate time to use Levonorgestrel Tablet?

You can use Levonorgestrel Tablet after you have had unprotected sex in the last 72 hours (3 days), and you do not want to become pregnant.

Levonorgestrel Tablet can be used as a backup or emergency method to regular birth control if, for example,

• Your regular birth control method was used incorrectly or failed (your partner’s condom broke or slipped)
• You made a mistake with your regular method
• You did not use any birth control method

When is it not appropriate to use Levonorgestrel Tablet?

• Levonorgestrel Tablet should not be used as a regular birth control method. It does not work as well as most other forms of birth control when they are used consistently and correctly. Levonorgestrel Tablet is a backup or emergency method of contraception.
• Levonorgestrel Tablet should not be used if you are already pregnant because it will not work.
• Levonorgestrel Tablet should not be used if you are allergic to levonorgestrel or any other ingredients in Levonorgestrel Tablet.
• Levonorgestrel Tablet does not protect against HIV (the virus that causes AIDS) or other sexually transmitted diseases (STDs). The best ways to protect yourself against getting HIV or other STDs are to use a latex condom correctly with every sexual act or not to have sex at all.

How does Levonorgestrel Tablet work?

Levonorgestrel Tablet is one pill with levonorgestrel, a hormone that has been used in many birth control pills for over 35 years. Levonorgestrel Tablet contains a higher dose of levonorgestrel than birth control pills, but works in a similar way to prevent pregnancy. It works mainly by stopping the release of an egg from the ovary. It is possible that Levonorgestrel Tablet may also work by preventing fertilization of an egg (the uniting of sperm with the egg) or by preventing attachment (implantation) to the uterus (womb).

How can I get the best results from Levonorgestrel Tablet?

You have only a few days to try to prevent pregnancy after unprotected sex. The sooner you take Levonorgestrel Tablet, the better it works. Levonorgestrel Tablet should be taken as soon as possible within 72 hours (3 days) after unprotected sex.

How effective is Levonorgestrel Tablet?

The sooner you take Levonorgestrel Tablet, the better it will work. Take Levonorgestrel Tablet as soon as possible after unprotected sex. If it is taken as soon as possible within 72 hours (3 days) after unprotected sex, it will significantly decrease the chance that you will get pregnant. Seven out of every 8 women who would have gotten pregnant will not become pregnant.

How will I know if Levonorgestrel Tablet worked?

Most women will have their next menstrual period at the expected time or within a week of the expected time. If your menstrual period is delayed beyond 1 week, you may be pregnant. You should get a pregnancy test and follow up with your healthcare professional.

What if I am already pregnant and use Levonorgestrel Tablet?

There is no medical evidence that Levonorgestrel Tablet would harm a developing baby. If you take Levonorgestrel Tablet (accidentally) after you are already pregnant or it does not work and you become pregnant, it is not likely to cause any harm to you or your pregnancy. The pregnancy will continue. Levonorgestrel Tablet will not work if you are already pregnant.

What should I do if my menstrual period is delayed beyond 1 week and I have severe lower stomach (abdominal) pain?

If you have severe lower stomach (abdominal) pain about 3 to 5 weeks after taking Levonorgestrel Tablet, you may have a pregnancy outside the uterus, which is called a tubal pregnancy. A tubal pregnancy requires immediate medical treatment, so you should see a healthcare professional right away.

Can I use Levonorgestrel Tablet for regular birth control?

No. Levonorgestrel Tablet should not be used for regular birth control. It is an emergency or backup method to be used if your regular birth control fails or is used incorrectly or if you have sex without birth control. You should protect yourself against STDs and pregnancy every time you have sex. If you have unprotected sex again after taking Levonorgestrel Tablet, it will not help protect you from getting pregnant.

How often can I use Levonorgestrel Tablet?

Levonorgestrel Tablet is meant for emergency protection only, and is not designed to be used frequently. If you find that you need to use emergency contraception often, talk to your healthcare professional and learn about methods of birth control and STD prevention that are right for you.

Will I experience any side effects from Levonorgestrel Tablet?

When used as directed, Levonorgestrel Tablet is safe for women. Some women will have mild, temporary side effects, such as menstrual changes, nausea, lower stomach (abdominal) pain, tiredness, headache, dizziness, breast pain and vomiting. These are similar to the side effects that some women have when taking regular birth control pills. Some women taking Levonorgestrel Tablet will have menstrual changes such as spotting or bleeding before their next period. Some women may have a heavier or lighter next period, or a period that is early or late. If your period is more than a week late, you should get a pregnancy test.

What warnings should I know about when using Levonorgestrel Tablet?

Levonorgestrel Tablet does not protect against AIDS virus (HIV) or other sexually transmitted diseases (STDs).

Do not use:

• If you are already pregnant (because it will not work)
• If you are allergic to levonogestrel or any of the ingredients in Levonorgestrel Tablet
• For regular birth control

When using this product, you may have:

• Menstrual changes
• Headache
• Nausea
• Dizziness
• Lower stomach (abdominal) pain
• Breast pain
• Tiredness
• Vomiting

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

What are the directions for using Levonorgestrel Tablet?

Women 17 years of age and older:

• Take Levonorgestrel Tablet as soon as possible within 72 hours (3 days) after unprotected sex.
• If you vomit within 2 hours of taking the medication, call a healthcare professional to find out if you should repeat the dose.

Prescription only for women younger than age 17. If you are younger than age 17, see a healthcare professional.

What should I do if I have questions about Levonorgestrel Tablet?

If you have questions or need more information about this product, call our toll-free number, 1-800-422-8689, visit our website at www.mywaypill.com, or ask a healthcare professional.

Other information

Tablet is enclosed in a blister seal. Do not use if the blister seal is broken.

Store at room temperature 20–25°C (68–77°F).

You may report side effects to FDA at 1-800-FDA-1088.

Active ingredient: Levonorgestrel 1.5 mg

Inactive ingredients: colloidal silicon dioxide, pregelatinized starch, magnesium stearate, talc, and lactose monohydrate

Protect yourself in more ways than one!

If you are sexually active, but you are not ready for a pregnancy, it is important to use regular pregnancy protection. There are many types of birth control. Whichever type you choose, it is important to use your regular birth control method as directed. This ensures that you have effective protection against pregnancy every time you have sex.

But things do not always go as planned. For example, if you were using a condom and it broke or slipped, or if you did not use your regular birth control as you should have, or if you did not use any birth control, Levonorgestrel Tablet may work for you. Levonorgestrel Tablet is an emergency contraceptive that helps prevent pregnancy after unprotected sex or when your birth control fails or is not used correctly.

Remember, Levonorgestrel Tablet is only for emergency pregnancy prevention. There are many other products that work for regular birth control that are available by prescription or over-the-counter.

There is also another form of protection to think about when you have sex: protection against sexually transmitted diseases (STDs). Some common STDs are HIV/AIDS, chlamydia, genital herpes, gonorrhea, hepatitis, human papilloma virus (HPV), genital warts, syphilis, and trichomonas. Some of these STDs can be very serious and can lead to infertility (inability to have a baby), problems during pregnancy, chronic illness, and even death.

All sexually active women are at risk of catching STDs because they may not know that their partner has an STD (the partner himself may not know). If your partner uses a latex condom correctly each and every time you have sex with him, this will help reduce, but not eliminate, the chance that you will catch an STD.

No other birth control methods will effectively protect you from STDs. The female condom may give you some STD protection, but it is not as effective as a male latex condom.

For more information on STDs, call the Centers for Disease Control and Prevention (CDC) AIDS/STD Hotline. The CDC phone numbers are 1-800-342-AIDS (2437) for English, 1-800-344-7432 for Spanish, or 1-800-243-7889 for hearing impaired, TDD.

Be sure to protect yourself against pregnancy and STDs by using some form of birth control plus a latex condom. Of course, not having sex is the most effective way to prevent pregnancy and stay free of STDs

Levonorgestrel Tablet is used to prevent pregnancy after unprotected sex.

Levonorgestrel Tablet should not be used for regular birth control, if you are already pregnant (because it will not work), or if you are allergic to levonorgestrel or any of the ingredients in Levonorgestrel Tablet.

The sooner you take Levonorgestrel Tablet the better it will work.

Levonorgestrel Tablet does not protect against the AIDS virus (HIV) or other sexually transmitted diseases (STDs)

Common side effects associated with the use of Levonorgestrel Tablet include menstrual changes, nausea, lower stomach (abdominal) pain, tiredness, headache, dizziness, breast pain and vomiting.