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May 26, 2021Myfembree Approved to Manage Heavy Menstrual Bleeding Due to Uterine Fibroids
May 26, 2021 – The U.S. FDA has approved Myfembree® (relugolix 40mg/estradiol 1mg/norethindrone acetate 0.5mg), manufactured by Myovant and Pfizer, to manage heavy menstrual bleeding associated with uterine fibroids in premenopausal females. It is the first and only once-daily therapy to receive FDA approval for this indication.
Uterine fibroids are non-cancerous tumors that develop in the uterus. They can cause pain, trouble with urination and constipation, heavy menstrual bleeding, long menstrual periods, spotting or bleeding between periods, anemia (due to blood loss), infertility, and pregnancy loss or complications.
In two clinical studies, 72.1% and 71.2% of participants receiving Myfembree responded to treatment, with a response defined as menstrual blood loss volume of less than 80mL and a 50% or greater reduction from baseline in menstrual blood loss volume during the last 35 days of treatment. Myfembree reduced menstrual blood loss from baseline by 82.0% and 84.3% in the clinical studies.
Recommended dosing is one tablet taken by mouth once daily. Treatment should be initiated as soon as possible after the onset of menses but no later than seven days after menses have started. The duration of therapy should not exceed 24 months due to a risk of continued, potentially irreversible bone loss. If the individual is taking hormonal contraceptives, these should be discontinued before starting
Myfembree. Concomitant use of the drug with oral P-gp inhibitors should be avoided whenever possible. If not possible, then Myfembree should be taken first, at least six hours before and six hours after taking an oral P-gp inhibitor.
A black box warning cautions that estrogen and progestin combination products, including Myfembree, increase the risk of thromboembolic disorders and vascular events. This includes an increased risk of pulmonary embolism, deep vein thrombosis, stroke, and heart attack. Myfembree is contraindicated in women who have a history of or current thrombotic or thromboembolic disorders and in women at increased risk for these events, including women over 35 years of age who smoke or women who have uncontrolled hypertension.
Myfembree has launched at a wholesale acquisition cost (WAC) of $974.54 per 28-day supply.