Important Safety Information for Hailey 24 Fe (norethindrone acetate and ethinyl estradiol and ferrous fumarate)
Warning: Cardiovascular Risk Associated with Smoking
Do not use Hailey 24 Fe if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from combination oral contraceptives, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.
What is the FDA-approved use of Hailey 24 Fe?
Hailey 24 Fe is an oral contraceptive, also called "birth control pill" or "the pill", and it is used to prevent pregnancy. The efficacy of Hailey 24 Fe in women with a body mass index (BMI) of greater than 35 kg/m2 (severe obesity) has not been evaluated.
Your chance of getting pregnant while using oral contraceptives depends on how closely you adhere to the directions for taking your birth control pills. When taken as directed , you reduce your chance of getting pregnant. Based on the results from a clinical study, about 1 to 4 out of every 100 women may get pregnant during the first year they use Hailey 24 Fe.
Hailey 24 Fe does not protect against infection with HIV (the virus that causes AIDS) and other sexually transmitted infections.
Who should not use Hailey 24 Fe?
Do not use Hailey 24 Fe if you have the following conditions:
● If you smoke and are over 35 years of age
● Blood clots in your arms, legs, lungs, or eyes
● A problem with your blood that makes it clot more than normal (thrombophilia such as Factor V Leiden, protein C deficiency, protein S deficiency, antithrombin deficiency, or antiphospholipid syndrome)
● Certain heart valve problems or irregular heartbeat that increases your risk of developing blood clots
● A history of stroke
● A history of heart attack
● High blood pressure that isn’t controlled with medicine
● Diabetes with kidney, eye, nerve, or blood vessel damage
● Certain kinds of migraine headaches with aura, numbness, weakness or changes in vision, or any migraine headaches if you are over 35 years of age
● Liver problems, including liver tumors
● Any unexplained vaginal bleeding
● Had breast cancer or any cancer that is sensitive to hormones
● Take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir,
with or without dasabuvir. This may increase levels of the liver enzyme “alanine aminotransferase” (ALT) in the blood.
How should I take Hailey 24?
● Be sure to read the directions before you start taking your pills or anytime you are not sure what to do
● Take one pill everyday at the same time. Decide what time of day you want to take your pill.
○ If you miss pills, which includes starting the pack late, you could get pregnant.
○ The more pills you miss, the more likely you are to get pregnant.
● Be sure to have ready at all times:
○ Another kind of contraceptive (such as a condom or spermicide) to use as a back-up method in case you miss pills.
○ An extra pill pack.
● Many women may have spotting or light bleeding, or may feel sick to their stomach during the first 1–3 packs of pills.
○ If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away.
○ If it doesn’t go away, reach out to your Ro-affiliated provider.
What should I tell my Ro-affiliated Healthcare provider before using Hailey 24?
● Hailey 24 has certain drug interactions. It’s important to tell your Ro-affiliated provider all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements.
● Some medications and herbal products may make hormonal birth control less effective, including, but not limited to:
○ Certain seizure medications (carbamazepine, felbamate, oxcarbazepine, phenytoin, rufinamide, and topiramate)
○ Aprepitant
○ Barbiturates
○ Bosentan
○ Griseofulvin
○ Rifampicin and rifabutin
○ St. John's wort
Use another birth control method (such as a condom and spermicide or diaphragm and spermicide) when you take medications or supplements that may make Hailey 24 less effective.
● Some medicines and grapefruit juice may increase your level of the hormone ethinyl estradiol in your body if used together, including:
○ Acetaminophen
○ Ascorbic acid
○ Medications that affect how your liver breaks down other substances (itraconazole, ketoconazole, voriconazole, and fluconazole)
○ Certain HIV medications, such as atazanavir, indinavir, atazanavir/ritonavir, and etravirine
○ Cholesterol medications, such as atorvastatin and rosuvastatin
● Some medications may decrease the level of the hormone ethinyl estradiol in your body if used together, including:
○ Nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir, nevirapine
○
● Dose adjustments to other medications may be necessary when you use Hailey 24, including:
○ Lamotrigine, a medication used for epilepsy
○ Thyroid medications
● It’s important to share your entire medical history with your provider. In particular, tell your provider if you are, have, or have had:
○ Pregnant or think you may be pregnant
○ Depressed now or have been depressed in the past
○ Yellowing of your skin or eyes caused by pregnancy
○ Breastfeeding or plan to breastfeed
○ Smoke and are over 35 years of age
○ Blood clots in your arms, legs, lungs, or eyes
○ A problem with your blood that makes it clot more than normal
○ Certain heart valve problems or irregular heartbeat that increases your risk of
stroke
○ Heart attack
○ High blood pressure that isn’t be controlled with medication
○ Diabetes with kidney, eye, nerve, or blood vessel damage
○ Certain kinds of severe migraine headaches with aura, numbness, weakness or
changes in vision, or any migraine headaches if you are over 35 years of age
○ Liver problems, including liver tumors
○ Unexplained vaginal bleeding
○ Breast cancer or any cancer that is sensitive to hormones
○ Take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
● Tell your provider if you are pregnant, planning to become pregnant, or breastfeeding.
Pregnancy: There is no conclusive evidence that oral contraceptive use is associated with an increase in birth defects, when taken inadvertently during early pregnancy. Previously, a few studies had reported that oral contraceptives might be associated with birth defects, but these findings have not been seen in more recent studies. Nevertheless, Hailey 24 Fe should not be used during pregnancy. You should check with your Ro-affiliated provider about risks to your unborn child of any medication taken during pregnancy.
Breastfeeding: Hailey 24 Fe may decrease the amount of breast milk you make. A small amount of the hormones in Hailey 24 Fe may pass into your breast milk. You should use another method of contraception since breastfeeding provides only partial protection from becoming pregnant and this partial protection decreases significantly as you breastfeed for longer periods of time. You should consider starting combined oral contraceptives only after you have weaned your child completely.
Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.
What are the most serious side effects that I or a caregiver should monitor for when taking Hailey 24 Fe?
If you are experiencing a medical emergency, call 911 or seek immediate medical attention.
● Risk of developing blood clots: Blood clots and blockage of blood vessels are some of the most serious potential side effects of taking oral contraceptives and can cause death or serious disability. Serious blood clots can happen especially if you smoke, have obesity, or are older than 35 years of age.
Serious blood clots are more likely to happen when you first start taking birth control pills or restart the same or different birth control pills after not using them for a month or more.
A clot in the legs can cause thrombophlebitis and a clot that travels to the lungs can cause a sudden blockage of the blood vessel that carries blood to the lungs. Rarely, clots occur in the blood vessels of the eye and may cause blindness, double vision, or impaired vision.
If you take oral contraceptives and need elective surgery, need to stay in bed for a prolonged illness or injury, or have recently delivered a baby, you may be at risk for developing blood clots.
You should consult your Ro-affiliated provider about stopping oral contraceptives three to four weeks before surgery and you should not take oral contraceptives for two weeks after surgery or during bed rest. You should also not take oral contraceptives soon after delivery of a baby. It is advisable to wait for at least four weeks after delivery if you are not breastfeeding or four weeks after a second trimester abortion. If you are breastfeeding, you should wait until you have weaned your child before using the pill.
The risk of circulatory disease in oral contraceptive users may be higher in users of high-dose pills and may be greater with longer duration of oral contraceptive use. Some of these increased risks may continue for a number of years after stopping oral contraceptives. The risk of abnormal blood clotting increases with age in both users and nonusers of oral contraceptives, but the increased risk from the oral contraceptive appears to be present at all ages.
● Liver disease and liver tumors: Hailey 24 Fe should not be used if you have impaired liver function. In rare cases, oral contraceptives can cause non-cancerous but still dangerous liver tumors. These benign liver tumors can rupture and cause fatal internal bleeding. In addition, some studies report an increased risk of developing liver cancer. However, liver cancers are rare.
● High blood pressure: Hailey 24 Fe should not be used if you have uncontrolled high blood pressure. Monitor for blood pressure changes.
● Gallbladder disease: Oral contraceptive users probably have a greater risk than nonusers of having gallbladder disease, although this risk may be related to pills containing high doses of estrogens, especially if you previously had cholestasis of pregnancy. Call your healthcare provider if you have yellowing of your skin or eyes.
● Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women. Consider an alternate contraceptive method for women with uncontrolled high cholesterol.
● Cancer of the reproductive organs and breasts: Oral contraceptive use may slightly increase your chance of having breast cancer diagnosed, particularly after using hormonal contraceptives at a younger age. After you stop using hormonal contraceptives, the chances of having breast cancer diagnosed begin to go back down to the levels of people who did not use them. You should have regular breast examinations by a healthcare professional and examine your own breasts monthly. Tell your Ro-affiliated provider if you have a family history of breast cancer or if you have had breast nodules or an abnormal mammogram. Women who currently have or have had breast cancer should not use oral contraceptives because breast cancer is usually a hormone-sensitive tumor.
Some studies have found an increase in the incidence of cancer of the cervix in women who use oral contraceptives. However, this finding may be related to factors other than the use of oral contraceptives.
● Dark patches of skin around your forehead, nose, cheeks and around your mouth, especially during pregnancy (also known as chloasma or melasma): Women who tend to get chloasma should avoid spending a long time in sunlight, tanning booths, and under sunlamps while taking Hailey 24 Fe. Use sunscreen if you have to be in the sun.
● Tell your provider right away if you have:
○ New or worsening headaches: Including migraine headaches
○ Irregular or unusual vaginal bleeding and spotting between your menstrual periods: Especially during the first 3 months of taking Hailey 24 Fe.
○ Symptoms of depression, especially if you have a history of depression
○ Swelling of your skin especially around your mouth, eyes, and in your throat (angioedema). Call your healthcare provider if you have a swollen face, lips, mouth tongue or throat, which may lead to difficulty swallowing or breathing. Your chance of having angioedema is higher if you have a history of angioedema.
What are the most common side effects of Hailey 24 Fe?
● Headache
● Vaginal infections
● Nausea
● Menstrual cramps
● Breast tenderness
● Mood changes
● Acne
● Weight gain
You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
This information is not comprehensive. Please see the full Prescribing Information for complete safety information.
.png)
.png)
.png)
.png)
.svg)
