Fyavolv (norethindrone acetate and ethinyl estradiol)

Fyavolv is a prescription medicine that contains two hormones, estrogen and progestin, and is used after menopause to reduce hot flushes.

Estrogens are hormones made by a woman’s ovaries. The ovaries stop making estrogens between 45 and 55 years old, causing menopause. Sometimes both ovaries are removed before natural menopause, causing "surgical menopause".

When estrogen levels drop, some women experience uncomfortable symptoms, such as warmth in the face, neck, and chest, or sudden intense episodes of heat and sweating ("hot flashes" or "hot flushes"). Symptoms can range from mild to severe.

Fyavolv can also help reduce the risk of osteoporosis (weak bones) in postmenopausal women. If you are using Fyavolv for osteoporosis prevention, talk to your healthcare provider about alternative treatments without estrogens.

Side effects of Fyavolv

Side effects are categorized by seriousness and frequency during treatment.

Serious, less common side effects include heart attack, stroke, blood clots, dementia, breast cancer, cancer of the uterus, cancer of the ovary, high blood pressure, high blood sugar, gallbladder disease, liver problems, changes in thyroid hormone levels, and enlargement of uterine tumors.

Call your healthcare provider immediately if you experience warning signs or other unusual symptoms, such as new breast lumps, unusual vaginal bleeding, changes in vision or speech, sudden severe headaches, or chest or leg pain 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 cramps, bloating, hair loss, fluid retention, and vaginal yeast infection.

These are not all possible side effects of Fyavolv. For more information, consult your healthcare provider or pharmacist.

If you experience side effects that bother you or do not go away, report them to Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088.

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 to prevent cardiovascular disease or dementia.

A study reported an increased risk of deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction, and probable dementia in postmenopausal women during treatment with estrogen and progestin compared to placebo.

Breast Cancer

Another study demonstrated an increased risk of invasive breast cancer with estrogen and progestin therapy.

To minimize risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and individual risks.

Estrogen-Alone Therapy

Endometrial Cancer

Using estrogen alone can increase the risk of endometrial cancer. Adding a progestin to estrogen therapy can reduce the risk of endometrial hyperplasia, a precursor to endometrial cancer.

Postmenopausal women with undiagnosed abnormal genital bleeding should undergo diagnostic measures, including endometrial sampling, to rule out malignancy.

Cardiovascular Disorders and Probable Dementia

Estrogen-alone therapy should not be used to prevent cardiovascular disease or dementia.

A study reported an increased risk of stroke and deep vein thrombosis in postmenopausal women during treatment with estrogen alone compared to placebo. There was also an increased risk of developing probable dementia.

Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and individual risks.

Dosage for Fyavolv

Use the lowest effective dose and shortest duration of estrogen-alone or combination therapy. Re-evaluate postmenopausal women periodically to determine if treatment is still necessary.

For the treatment of moderate to severe hot flushes, take one tablet orally once daily. For the prevention of postmenopausal osteoporosis, take one tablet orally once daily.

Drug interactions 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

Estrogens are metabolized partially by CYP3A4, and substances that induce or inhibit CYP3A4 can affect estrogen metabolism. Inducers can decrease estrogen plasma concentration, while inhibitors can increase it.

Co-administration of certain medications (e.g., atorvastatin, ascorbic acid, and acetaminophen) may affect the plasma concentration of ethinyl estradiol.

Effect of Combined Hormonal Products on Other Drugs

Combined hormonal products may inhibit the metabolism of other compounds.

Combination hormonal products have been shown to significantly decrease the plasma concentration of lamotrigine, so dosage adjustments may be necessary.

Is Fyavolv safe during pregnancy or breastfeeding?

Norethindrone acetate and ethinyl estradiol should not be used during pregnancy or lactation. Estrogen administration to nursing women can decrease breast milk quantity and quality, and detectable amounts of estrogen and progestin have been found in breast milk.

Caution should be exercised when using norethindrone acetate and ethinyl estradiol while breastfeeding.

Summary

Fyavolv is a prescription medicine containing estrogen and progestin. It is used to reduce hot flushes in menopausal women. Serious side effects include heart attack, stroke, blood clots, dementia, breast cancer, and others.