Discussing Therapy with Your Patients
It’s likely that your patients will want to discuss the advantages, benefits, and possible risks of taking LYBREL®. To help you with these discussions, we’ve provided answers to some questions your patients may ask you about LYBREL.
- Q: How does LYBREL work?
- A:LYBREL is a birth control pill that delivers the same low dose of hormones every day. As with other birth control pills, it prevents pregnancy by suppressing ovulation. When you take LYBREL, the lining of your uterus does not undergo the changes needed for menstruation, and therefore, you do not have regular menstrual periods or a pill period.1
- Q: Is it OK to not have my period?
- A: Yes. Because women taking the Pill are not ovulating, there is no need to get a period every
month.
LYBREL is the only FDA-approved combination oral contraceptive with which you won’t have your regular monthly period for as long as you take it.1,2 Breakthrough bleeding and spotting are likely while you are taking LYBREL. However, for most women, this usually decreases over time. - Q: If I don't have my monthly period, where does the blood go?
- A: LYBREL is a birth control pill that is taken every day. When you take LYBREL, the lining of your uterus does not undergo the changes needed for menstruation, and therefore, you do not have regular monthly periods.1
- Q: How do I take LYBREL?
- A: You take the same low dose of LYBREL every day. To best prevent pregnancy, simply take a LYBREL pill once a day as directed, at the same time every day.1 LYBREL provides women with more hormonal exposure on a yearly basis (13 additional weeks of hormone intake per year)1 than conventional cyclic oral contraceptives containing the same strength of synthetic estrogens and similar strength of progestins.
- Q: What do I do if I miss a pill?1
- A: Take the missed pill as soon as you remember. THEN, take the next pill at your regular time. This means you may take 2 pills in 1 day. You COULD BECOME PREGNANT if you have sex during the 7 days after you restart your pills. You MUST use a nonhormonal birth control method (such as condoms and/or spermicide) as a backup for those 7 days.
- Q: What if I want to get pregnant?
- A: Stop taking LYBREL. A pregnancy can occur within days of stopping LYBREL.1 However, there may be some delay in becoming pregnant when you stop using oral contraceptives, especially if you had irregular menstrual cycles before using them.
- Q: How can I be sure I’m not pregnant?
- A: You are not likely to get pregnant if you take LYBREL at the same time every day as directed by your health care professional. Because regular monthly bleeding does not occur on LYBREL, it may be difficult to recognize if you get pregnant. If you suspect that you may be pregnant, or if you have symptoms of pregnancy such as nausea/vomiting or unusual breast tenderness, you should take a pregnancy test and contact your health care professional. Stop taking LYBREL if you are pregnant.1
- Q: Will I have spotting or breakthrough bleeding while taking LYBREL?
- A: Unscheduled bleeding or spotting is likely to occur while you are taking LYBREL. Unscheduled
bleeding or spotting occurs most often during the first seven pill packs of LYBREL use. It tends to decrease with subsequent
pill packs of use but may occur after you have been taking LYBREL for some time.1
You should know that, regardless of any unexpected bleeding, LYBREL remains highly effective for preventing pregnancy.1 - Q: What’s the difference between spotting and breakthrough bleeding?
- A: Breakthrough bleeding requires sanitary protection. Spotting does not require any sanitary protection.1
- Q: Will I gain weight with LYBREL?
- A: As with all oral contraceptives, women may experience weight gain or weight loss.1
- Q: What were the most common side effects reported on LYBREL?
- A: In a clinical study, the most commonly reported side effects were headache, menstrual cramps, upper respiratory infection, vaginal bleeding, and nausea.1
You can download a separate, patient-friendly set of answers to frequently asked questions and give copies to patient candidates for LYBREL in your office.
Download Questions Frequently Asked by Patients about LYBREL. Requires Adobe® Reader®
Important Safety Information
- Oral contraceptives (OCs) do not protect against HIV infection or other sexually transmitted diseases.
- When prescribing LYBREL, the convenience of having no scheduled menstrual bleeding should be weighed against the inconvenience of unscheduled breakthrough bleeding and spotting.
- OCs are contraindicated in women who have blood clots; breast, uterine, or liver cancers; a history of heart attack, stroke, or breast cancer; as well as those who are or may be pregnant.
The risks of serious cardiovascular side effects are substantially increased in women who smoke and use OCs, especially
in women over age 35. Women who use oral contraceptives should be strongly advised not to smoke.
- Serious risks associated with OCs include blood clots, heart attack, and stroke.
- LYBREL provides women with more hormonal exposure on a yearly basis (13 additional weeks of hormone intake per year) than conventional cyclic oral contraceptives containing the same strength of synthetic estrogens and similar strength of progestins.
- Scheduled withdrawal bleeding does not occur with the use of LYBREL, therefore, the absence of withdrawal bleeding cannot be used as a sign of an unexpected pregnancy and as such, unexpected pregnancy may be difficult to recognize. Although pregnancy is unlikely if LYBREL is taken as directed, if for any reason, pregnancy is suspected in a woman using LYBREL, a pregnancy test should be performed.
- The most commonly reported treatment emergent adverse events reported with LYBREL in a clinical trial were headache, dysmenorrhea, upper respiratory infection, vaginal bleeding (defined as metrorrhagia and vaginal hemorrhage), and nausea.
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