Femlyv

Pronunciation: fem-liv
Generic name: norethindrone acetate and ethinyl estradiol
Dosage form: orally disintegrating tablet
Drug class: Contraceptives

Medically reviewed by Carmen Pope, BPharm. Last updated on Jul 30, 2024.

What is Femlyv?

Femlyv is an orally disintegrating (ODT) combination birth control pill that contains 2 female hormones, norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen. Femlyv is taken once a day.

• It is not known if Femlyv is effective at preventing pregnancy in females with severe obesity (body mass index of more than 35 kg/m²).

Combination birth control pills, such as Femlyv, primarily work by preventing ovulation (the release of an egg from the ovaries). They may also cause changes to the mucus in the cervix. These changes prevent a pregnancy from happening.

Femlyv gained FDA approval on 22 July 2024 and is the first ODT formulation of a birth control pill. Ethinyl estradiol and norethindrone acetate in combination as an oral contraceptive tablet was first approved in 1968.

See the Femlyv Package Insert for all the information about Femlyv.

Femlyv side effects

The most common side effects of all birth control pills, including Femlyv are:

• spotting or bleeding between menstrual periods
• nausea
• breast tenderness
• headache.

These side effects are usually mild and usually disappear with time.

Less common side effects are:

• acne
• less sexual desire
• bloating or fluid retention
• blotchy darkening of the skin, especially on the face
• high blood sugar, especially in women who already have diabetes
• high fat (cholesterol, triglyceride) levels in the blood
• depression, especially if you have had depression in the past. Call your healthcare provider immediately if you have any thoughts of harming yourself
• problems tolerating contact lenses
• weight gain.

Serious side effects and warnings

Femlyv carries a Boxed Warning for an increased risk of cardiovascular events in women over the age of 35 who take Femlyv and smoke cigarettes.

• Cigarette smoking increases the risk of serious cardiovascular events, including blood clots, heart attacks, and strokes.

Increased risk of cardiovascular events. Like pregnancy, birth control pills increase the risk of serious blood clots, especially in women who have other risk factors, such as smoking, obesity, or age greater than 35. This increased risk is highest when you first start taking birth control pills and when you restart the same or different birth control pills after not using them for a month or more. It is possible to die from a problem caused by a blood clot, such as a heart attack or a stroke. Some examples of serious blood clots are blood clots in the:

• legs (deep vein thrombosis)
• lungs (pulmonary embolus)
• eyes (loss of eyesight)
• heart (heart attack)
• brain (stroke).

Women who take birth control pills may get:

• high blood pressure
• gallbladder problems
• rare cancerous or noncancerous liver tumors.

All of these events are uncommon in healthy women.

Call your healthcare provider right away if you have:

• leg pain that does not go away
• sudden shortness of breath
• sudden blindness, partial or complete
• severe pain or pressure in your chest
• sudden, severe headache unlike your usual headaches
• weakness or numbness in an arm or leg, or trouble speaking
• yellowing of the skin or eyeballs.

These are not all the possible side effects of Femlyv. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking

Femlyv does not protect you against sexually transmitted infections (STIs), including HIV, the virus that causes AIDS. Use a condom as well as Femlyv to protect you against STIs.

Before taking Femlyv, tell your healthcare provider about all your medical conditions. Taking Femlyv when you have certain conditions can be dangerous and your healthcare provider will not give you Femlyv if you have:

• ever had blood clots in your arms, legs (deep vein thrombosis), lungs (pulmonary embolism), or eyes (retinal thrombosis)
• ever had a stroke
• ever had a heart attack
• certain heart valve problems or heart rhythm abnormalities that can cause blood clots to form in the heart
• an inherited problem with your blood that makes it clot more than normal
• high blood pressure that medicine cannot control
• diabetes with kidney, eye, nerve, or blood vessel damage
• ever had certain kinds of severe migraine headaches with aura, numbness, weakness, or changes in vision, or have any migraine headache if you are over age 35
• ever had breast cancer, which may be sensitive to female hormones
• liver disease, including liver tumors
• take any Hepatitis C drug combination containing ombitasvir, paritaprevir, or ritonavir, with or without dasabuvir. This may increase levels of the liver enzyme “alanine aminotransferase” (ALT) in the blood.

Also, do not take birth control pills if you:

• smoke and are over 35 years old
• are or think you are pregnant
• have any abnormal bleeding from the vagina.

Birth control pills may not be a good choice for you if you have ever had jaundice (yellowing of the skin or eyes) caused by pregnancy, also called cholestasis of pregnancy.

If you are scheduled to have surgery, you should stop Femlyv at least 4 weeks before you have surgery and not restart it until at least 2 weeks after the surgery, due to an increased risk of blood clots.

Pregnancy

If you miss a period, you could be pregnant. However, some women miss periods or have light periods on birth control pills, even when they are not pregnant. Contact your healthcare provider for advice if you:

• think you are pregnant
• miss 1 period and have not taken your birth control pills every day
• miss 2 periods in a row.

Birth control pills should not be taken during pregnancy. However, birth control pills taken by accident during pregnancy are not known to cause birth defects.

Breastfeeding

In females who are not breastfeeding, do not start Femlyv sooner than 4 weeks after giving birth. If you are breastfeeding, consider another birth control method until you are ready to stop breastfeeding. Birth control pills that contain estrogen, like Femlyv, may decrease the amount of milk you make. A small amount of the pill's hormones passes into breast milk.

How should I take Femlyv?

Femlyv is taken once a day, every day.

• The Femlyv pack contains 28 tablets: 24 active green tablets (with hormones) to be taken for 24 days, followed by 4 reminder white tablets (without hormones) to be taken for the next four days.
• The tablets should be placed on the tongue, allowed to dissolve, and followed by a glass of water.
• Try to take the tablets at the same time and in the order directed on the package.
• Femlyv can be taken with or without food.
• Do not skip any tablets, even if you do not have sex often.

Starting Femlyv

You have a choice for which day to start taking your first pack of tablets. Decide with your healthcare provider which is the best day for you. Pick a time of day that will be easy to remember.

Day 1 Start:

1. Pick the day label strip that starts with the first day of your period (this is the day you start bleeding or spotting, even if it is almost midnight when the bleeding begins).
2. Place this day label strip on the tablet dispenser over the area that has the days of the week (starting with Sunday) printed on the plastic.
3. Take the first green tablet of the pack during the first 24 hours of your period.
4. You will not need to use a backup method of birth control, since you are starting the tablet at the beginning of your period. However, if you start Femlyv later than the first day of your period, you should use another method of birth control (such as a condom and spermicide) as a backup method until you have taken 7 green tablets.

Sunday Start:

1. Take the first green tablet of the pack on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the pack that same day.
2. Use another method of birth control (such as a condom and spermicide) as a backup method if you have sex anytime from the Sunday you start your first pack until the next Sunday (7 days). This also applies if you start Femlyv after having been pregnant, and you have not had a period since your pregnancy.

What happens if I miss a Femlyv tablet?

If you miss tablets you could get pregnant. This includes starting the pack late. The more tablets you miss, the more likely you are to get pregnant.

Femlyv may not be as effective if you miss any green tablets, especially if you miss the first few or the last few green tablets in a pack. See the table below for advice about what to do.

If you are still not sure what to do about the tablets you have missed, use a backup method (such as a condom) anytime you have sex. Contact your healthcare provider and continue taking 1 active green tablet each day until otherwise directed.

Birth control pills and cancer

It is not known if hormonal birth control pills cause breast cancer. Some studies, but not all, suggest that there could be a slight increase in the risk of breast cancer among current users with longer duration of use.

If you have breast cancer now or have had it in the past, do not use hormonal birth control because some breast cancers are sensitive to hormones.

Women who use birth control pills may have a slightly higher chance of getting cervical cancer. However, this may be due to other reasons such as having more sexual partners.

How effective is Femlyv?

The effectiveness of Femlyv depends on taking it correctly. For every 100 women who take Femlyv correctly, 96-99 will not get pregnant (and 1 to 4 will get pregnant) in the first year of use. Data on obese women is limited.

What happens if I have vomiting or diarrhea while taking Femlyv?

If you have vomiting (within 3 to 4 hours after you take your tablet), you should follow the instructions for "What to Do if You Miss Tablets".

If you have diarrhea or if you take certain medicines, including some antibiotics and some herbal products such as St. John's Wort, your tablets may not work as well.

Use a backup method (such as condoms and spermicides) until you check with your healthcare provider.

Femlyv ingredients

Active ingredients: 1 mg norethindrone acetate 0.020 mg, ethinyl estradiol, and 4 white, round inert ODTs.

Each Green ODT also contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, mint green lake blend, pregelatinized starch, spearmint flavor, sucralose, vitamin E (DL-alpha-tocopherol).

Each white ODT contains croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, pregelatinized starch, spearmint flavor, and sucralose.

Supplied as a carton of three pouches, with each pouch containing a blister card of 28 ODTs. Each blister card contains 24 active ODTs containing norethindrone acetate 1 mg and ethinyl estradiol 0.02 mg, and 4 inert ODTs.

Who makes Femlyv?

Millicent U.S., Inc., makes Femlyv.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer