Fyavolv (norethindrone acetate/ethinyl estradiol) Side Effects & Warnings

Side Effects
- What are the side effects of Fyavolv?
Dosage
- What is the dosage for Fyavolv?
Interactions
- What drugs interact with Fyavolv?
Warnings
- Is Fyavolv safe to use while pregnant or breastfeeding?
Comments
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Generic drug: norethindrone acetate and ethinyl estradiol

Brand name: Fyavolv

What is Fyavolv, and how does it work?

Fyavolv (norethindrone acetate and ethinyl estradiol) is a prescription medicine that contains two kinds of hormones, an estrogen and a progestin.

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
stroke
blood clots
dementia
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:

headache
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.

WARNING

CARDIOVASCULAR DISORDERS, BREAST CANCER , ENDOMETRIAL CANCER AND PROBABLE DEMENTIA

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.

Breast Cancer

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.

Estrogen-Alone Therapy

Endometrial Cancer

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.

QUESTION

If menopause occurs in a woman younger than ___ years, it is considered to be premature. See Answer

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.

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Summary

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.