Generic drug: norethindrone acetate and ethinyl estradiol
Brand name: Fyavolv
What is Fyavolv, and how does it work?
Fyavolv is used after menopause to:
- Reduce moderate to severe hot flushes
Estrogens are hormones made by a woman's ovaries. The ovaries normally stop making estrogens when a woman is between 45 and 55 years old. This drop in body estrogen levels causes the "change of life" or menopause, the end of monthly menstrual periods. Sometimes both ovaries are removed during an operation before natural menopause takes place. The sudden drop in estrogen levels causes "surgical menopause".
When estrogen levels begin dropping, some women get very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden intense episodes of heat and sweating ("hot flashes" or "hot flushes"). In some women the symptoms are mild, and they will not need to take estrogens. In other women, symptoms can be more severe.
- Help reduce your chances of getting osteoporosis (thin weak bones)
If you use Fyavolv only to prevent osteoporosis from menopause, talk with your healthcare provider about whether a different treatment or medicine without estrogens might be better for you. You and your healthcare provider should talk regularly about whether you still need treatment with Fyavolv.
What are the side effects of Fyavolv?
Side effects are grouped by how serious they are and how often they happen when you are treated.
Serious, but less common side effects include:
- heart attack
- blood clots
- breast cancer
- cancer of the lining of the uterus (womb)
- cancer of the ovary
- high blood pressure
- high blood sugar
- gallbladder disease
- liver problems
- changes in your thyroid hormone levels
- enlargement of benign tumors of the uterus ("fibroids")
Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:
- new breast lumps
- unusual vaginal bleeding
- changes in vision or speech
- sudden new severe headaches
- severe pains in your chest or legs with or without shortness of breath, weakness and fatigue
Less serious, but common side effects include:
- breast pain
- irregular vaginal bleeding or spotting
- stomach or abdominal cramps, bloating
- hair loss
- fluid retention
- vaginal yeast infection
These are not all the possible side effects of Fyavolv. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effects that bother you or does not go away.
You may report side effects to Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088.
Estrogen Plus Progestin Therapy
Cardiovascular Disorders and Probable Dementia
- Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia.
- The Women's Health Initiative (WHI) estrogen plus progestin substudy reported an increased risk of deep vein thrombosis (DVT), pulmonary embolism (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo.
- The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.
- The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer.
- In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA and other combinations and dosage forms of estrogens and progestins.
- Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
- There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens.
- Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer.
- Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.
Cardiovascular Disorders and Probable Dementia
- Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia.
- The WHI estrogen-alone substudy reported increased risks of stroke and DVT in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral CE (0.625 mg)-alone, relative to placebo.
- The WHIMS estrogen-alone ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.
- In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and other dosage forms of estrogens. Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
What is the dosage for Fyavolv?
- Use of estrogen-alone, or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman.
- Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.
- Treatment Of Moderate To Severe Vasomotor Symptoms Due To Menopause Fyavolv therapy consists of a single tablet to be taken orally once daily.
- Prevention Of Postmenopausal Osteoporosis Fyavolv therapy consists of a single tablet taken orally once daily.
What drugs interact with Fyavolv?
No drug-drug interaction studies have been conducted for norethindrone acetate and ethinyl estradiol.
Effect Of Other Drugs On Combined Hormonal Products
Substances Decreasing Or Increasing The Plasma Concentration Of Estrogen
- In vitro and in vivo studies have shown that estrogens are metabolized partially by cytochrome P450 3A4 (CYP3A4).
- Therefore, inducers or inhibitors of CYP3A4 may affect estrogen drug metabolism. Inducers of CYP3A4 such as St. John's wort (Hypericum perforatum) preparations, phenobarbital, carbamazepine and rifampin may decrease the plasma concentration of estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile.
- Inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice may increase the plasma concentration of estrogens and may result in side effects.
- Co-administration of atorvastatin and certain hormonal products containing ethinyl estradiol increase AUC values for ethinyl estradiol approximately 20 percent.
- Ascorbic acid and acetaminophen may increase the plasma ethinyl estradiol concentration, possibly by inhibition of conjugation.
Effect Of Combined Hormonal Products On Other Drugs
- Combination hormonal products containing some synthetic estrogens (for example, ethinyl estradiol) may inhibit the metabolism of other compounds.
- Combination hormonal products have been shown to significantly decrease the plasma concentration of lamotrigine likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.
Is Fyavolv safe to use while pregnant or breastfeeding?
- Norethindrone acetate and ethinyl estradiol should not be used during pregnancy.
- There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins as an oral contraceptive inadvertently during early pregnancy.
- Norethindrone acetate and ethinyl estradiol should not be used during lactation.
- Estrogen administration to nursing women has been shown to decrease the quantity and quality of the breast milk. Detectable amounts of estrogen and progestin have been identified in the breast milk of women receiving estrogen plus progestin therapy.
- Caution should be exercised when norethindrone acetate and ethinyl estradiol is administered to a nursing woman.
Latest Women's Health News
Daily Health News
Fyavolv (norethindrone acetate and ethinyl estradiol) is a prescription medicine that contains two kinds of hormones, estrogen and progestin, which is used after menopause to reduce moderate to severe hot flushes. Serious, but less common side effects include heart attack, stroke, blood clots, dementia, breast cancer, cancer of the lining of the uterus (womb), cancer of the ovary, and others.
Multimedia: Slideshows, Images & Quizzes
Menopause & Perimenopause: Symptoms, Signs
What is menopause? What are the signs of menopause? What age does menopause start? Learn about menopause and perimenopause...
Women's Health: 10 Tips to Ease Menopause Symptoms
What happens during menopause? At what age do menopause symptoms start? Women in their 40s or 50s may begin to have hot flashes,...
9 Signs of Perimenopause
Perimenopause occurs before menopause as estrogen levels begin to change. This can cause menopause like symptoms such as hot...
Menopause Quiz: Symptoms & Signs
The Menopause Quiz challenges your knowledge about the time in a woman’s life when menstruation ceases. Menopause can bring many...
Related Disease Conditions
What Happens During Menopause?
Menopause is the time in a woman's life when menstrual periods permanently stop, also called the "change of life." Menopause symptoms and signs include hot flashes, night sweats, irregular vaginal bleeding, vaginal dryness, painful intercourse, urinary incontinence, weight gain, and emotional symptoms such as mood swings. Treatment of menopausal symptoms varies, and should be discussed with your physician.
Perimenopause is the time in a woman's life when she is approaching menopause. During this time a woman starts to develop symptoms of declining estrogen levels that may include mood swings, painful sex, night sweats, hot flashes, and weight gain. Every adult woman eventually will experience perimenopause.
Premature menopause is when menopause occurs in a woman before the age of 40. Causes of premature menopause include premature ovarian failure, treatments for cancer and other conditions, surgical removal of the ovaries, or chronic diseases of the pituitary or thyroid gland, or psychiatric disorders. Treatment is directed at menopausal symptoms.
Sex and Menopause
How Long Does Menopause Last?
Some symptoms of menopause such as hot flashes (a sudden feeling of warmth in the upper part of the body) usually last for one to two years. However, they can continue for 10 years or longer.
Sex and Menopause (What to Expect)
Menopause is often associated with a change in sexual functioning. Loss of estrogen, bladder control issues, anxiety, stress, health concerns, medications, and sleep disturbances often result in a decrease in libido. Though there are currently no good drugs for treating sexual problems in women, there are ways to increase intimacy with a partner and treat vaginal dryness.
What Are the 40 Symptoms of Menopause?
Menopause is the end of the reproductive era of a woman’s life that is characterized by drastic changes in her emotional and physical aspects. Studies have identified around 40 signs and symptoms of menopause, but not every woman gets all of them.
Male menopause refers to the decline in testosterone production in men. As men age, they often experience many of the same symptoms that women experience in menopause. Testosterone replacement therapy may relieve some of these symptoms.
Does Sex Drive Return After Menopause?
Menopause is defined as when you haven’t had your periods for 12 consecutive months. You should accept the fact that it is normal to experience changes in sexual desire after menopause.
15 Things Women Should Know About Menopause
Menopause is a phase in a woman’s life that challenges her physically and emotionally. Many women deal with menopause without any medical treatments, whereas some women with severe symptoms require therapies.
8 Causes of Night Sweats: Menopause and More
Night sweats are episodes of excessive perspiration that happen during sleep. They are often described as soaking or drenching and may require a change of sheets or even clothes. Night sweats can occur during sleep and without physical exertion. They aren’t caused by a heavy blanket or a warm bedroom. Instead, other underlying health issues may be responsible for these episodes of considerable sweating during sleep.
Decreased Response and Pleasure: Sexual Side Effects of Menopause
Menopause marks the end of the reproductive era in a woman’s life. Some women view it positively as periods no longer trouble them and there is no chance of getting pregnant even with unprotected sex. However, as the estrogen and testosterone levels take a plunge during menopause, some women experience the sexual side effects of menopause.
Treatment & Diagnosis
- Male Menopause
- Menopause: Super Nutrition for Menopause
- Menopause and Perimenopause, A Woman's Guide to
- Menopause: The Men's Guide to Understanding It
- Menopause: Making it the Best Years of Your Life
- Menopause: A New Perspective
- Menopause: Change of Life, Change of Diet
- Premature Menopause
- Menopause Made Easy with Carolle Jean-Murat
- Menopause: Taking Charge
- Hormone Therapy After Menopause -- Susan Love, MD
- Menopause FAQs
- Thyroid Disease and Menopause
- The Women's Health Initiative in Perspective: The Last Straw for Estrogen Therapy?
- Menopause: Home Menopause Test Kits, Are They Worth It?
- Hot Flashes: Anxiety Worsens Hot Flashes
- Can Menopause Cause High Cholesterol?
- How Is Menopause Diagnosed After a Hysterectomy?
- How Does Menopause Affect Polycystic Ovarian Syndrome (PCOS)?
- Does Vaginal Moisture Change During Perimenopause?
- Do Soy Isoflavones Treat Menopause Hot Flashes?
- Can You Go Through Menopause at 40?
- Does Perimenopause Cause Mood Swings?
- Does Menopause Cause Pain During Sex?
- Does Menopause Affect Memory?
- Are Night Sweats a Sign of Menopause?
- Can Soy Help Menopause Symptoms?
- Do I Need Birth Control After Menopause?
- Does Menopause Cause High Blood Pressure?
- Do You Get More UTIs During Menopause?
- Can You Still Get Menopause After Hysterectomy?
- Do All Women Get Menopause?
- Male Menopause
- Menopause: 10 Questions To Ask Your Doctor
- Menopause Symptoms
- Ask the Experts - Menopause
- Menopause: Change of Life, Change of Diet
Medications & Supplements
Health Solutions From Our Sponsors
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.