Menorrhagia:

Indications for MYFEMBREE:

Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.

Limitations of Use:

Limit use to 24 months due to the risk of continued bone loss, which may not be reversible.

Adult Dosage:

Exclude pregnancy and discontinue hormonal contraceptives prior to initiating. Start as early as possible after onset of menses but no later than 7 days after menses has started. Take at same time each day. 1 tab once daily.

Children Dosage:

Not established.

MYFEMBREE Contraindications:

High risk of arterial, venous thrombotic, or thromboembolic disorder (eg, smokers or migraineurs over 35 years of age, history of DVT or PE, vascular disease, thrombogenic valvular disease, atrial fibrillation, subacute bacterial endocarditis, hypercoagulopathies, uncontrolled hypertension, headaches with focal neurologic symptoms). Pregnancy. Osteoporosis. Hepatic impairment or disease. Breast cancer or other hormonally-sensitive malignancies. Undiagnosed abnormal uterine bleeding.

Boxed Warning:

Thromboembolic disorders. Vascular events.

MYFEMBREE Warnings/Precautions:

Increased risk of thrombotic or thromboembolic disorders. Discontinue if thrombotic, cardiovascular or cerebrovascular event, unexplained visual changes, gallbladder disease, or jaundice occurs and at least 4–6 weeks prior to surgery associated with increased risk of thromboembolism or during periods of immobilization. Risk of decrease in bone mineral density (BMD). Assess BMD at baseline and periodically thereafter. Consider treatment benefits/risks in those with a history of low-trauma fracture or other risk factors for osteoporosis or bone loss; supplementation with calcium and Vit.D may be beneficial. Perform breast exams and regular mammography. Discontinue if a hormonally-sensitive malignancy develops. Evaluate if new onset or worsening depression, anxiety, other mood changes occur. Monitor BP; discontinue if significant rise occurs. History of cholestatic jaundice associated with prior estrogen use or with pregnancy. Risk of uterine fibroid prolapse or expulsion in women with known or suspected submucosal uterine fibroids. Monitor lipid levels; consider discontinuing if hypertriglyceridemia or hypercholesterolemia worsens. Diabetes. Prediabetes. Hypothyroidism. Hypoadrenalism. Reduced ability to recognize pregnancy. Perform pregnancy testing if suspected; discontinue if confirmed. Advise women of reproductive potential to use effective non-hormonal contraception during and for 1 week after discontinuation. Nursing mothers.

MYFEMBREE Classification:

GnRH antagonist + estrogen + progestin.

MYFEMBREE Interactions:

Avoid concomitant use with hormonal contraceptives. Potentiated by oral P-gp inhibitors: avoid; if unavoidable, take Myfembree first, separate dosing by at least 6hrs; monitor for adverse reactions. Antagonized by combined P-gp and strong CYP3A inducers (eg, rifampin): avoid. May affect levels of thyroid-binding globulin, corticosteroid-binding globulin, coagulation factors, sex hormone binding globulin, lipids, glucose.

Adverse Reactions:

Hot flush, hyperhidrosis or night sweats, uterine bleeding, alopecia, decreased libido; uterine expulsion or prolapse, menorrhagia, cholecystitis, pelvic, pain, bone loss, elevated hepatic transaminase, elevated lipids, hypertension, depression-related adverse reactions, mood changes, hypersensitivity reactions (discontinue if occurs).

Generic Drug Availability:

NO

How Supplied:

Tabs—28