Plan B One-Step

Generic Name: levonorgestrel
Date of Approval: July 10, 2009
Company: Teva Pharmaceuticals, Inc.

Treatment for: Emergency Contraception

FDA Approves Plan B One-Step

The U.S. Food and Drug Administration (FDA) has approved Plan B One-Step (levonorgestrel tablet, 1.5 mg), a single dose emergency contraceptive pill to help prevent an unintended pregnancy after unprotected sex or contraceptive failure. Plan B One-Step will be available over-the-counter (OTC) for consumers age 17 or older; women younger than age 17 will require a prescription.

What is Plan B One-Step?

Plan B One-Step 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.

Plan B One-Step 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, Plan B One-Step may work for you.

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

When is the appropriate time to use Plan B One-Step?

You can use Plan B One-Step after you have had unprotected sex in the last 72 hours (3 days), and you do not want to become pregnant.

Plan B One-Step 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 Plan B One-Step?

• Plan B One-Step should not be used as a regular birth control method. It does work as well as most other forms of birth control when they are used consistently and correctly. Plan B One-Step is a backup or emergency method of contraception.
• Plan B One-Step should not be used if you already pregnant because it will not work.
• Plan B One-Step should not be used if you are allergic to levonorgestrel any other ingredients in Plan B One-Step.
• Plan B One-Step 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 Plan B One-Step work?

Plan B One-Step is one pill with levonorgestrel, a hormone that has been used in many birth control pills for over 35 years. Plan B One-Step contains higher dose of levonorgestrel than pills, but works similar way to prevent pregnancy. It works mainly by stopping the release an egg from the ovary. It is possible that Plan B One-Step may also work 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 Plan B One-Step?

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

How effective is Plan B One-Step?

The sooner you take Plan B One-Step, the better it will work. Take Plan B One-Step 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 Plan B One-Step worked?

Most women 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 Plan B One-Step?

There is no medical evidence that Plan B One-Step would harm a developing baby. If you take Plan B One-Step (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. Plan B One-Step will not work if you are already pregnant.

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

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

Can I use Plan B One-Step for regular birth control?

No. Plan B One-Step 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 Plan B One-Step, it will not help protect you from getting pregnant.

How often can I use Plan B One-Step?

Plan B One-Step 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 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 Plan B One-Step?

When used as directed, Plan B One-Step 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 Plan B One-Step 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.

See also: Plan B One-Step side effects in more detail

What warnings should I know about when using Plan B One-Step?

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

Do not use Plan B One-Step

• If you are already pregnant (because it will not work)
• If you are allergic to levonorgestrel or any of the ingredients in Plan B One-Step
• For regular birth control

Plan B One Step Side Effects

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 Plan B One-Step?

Women 17 years of age and older:

• Take Plan B One-Step 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 Plan B One-Step?

If you have questions or need more information about this product, call our toll-free number, 1-800-330-1271, visit www.PlanBOneStep.com, or ask a healthcare professional.

Other Information About Plan B One Step

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.

Ingredients

Active ingredient: levonorgestrel 1.5 mg

Inactive ingredients: colloidal silicon dioxide, potato starch, magnesium stearate, talc, corn lactose monohydrate