Mimvey

Mimvey (estradiol and norethindrone acetate) is a combination of female hormones used in women who have a uterus to treat moderate to severe vasomotor symptoms associated with menopause, and to prevent postmenopausal osteoporosis. Common side effects of Mimvey include headache, irregular vaginal bleeding or spotting, nausea and vomiting, back pain, pain in the extremities, hair loss, breast pain, stomach/abdominal cramps, bloating, depression, weight gain, diarrhea, runny or stuffy nose, and sore throat.

Mimvey therapy consists of a single tablet to be taken once daily. Mimvey may interact with other drugs. Tell your doctor all medications and supplements you use. Mimvey is not recommended for use during pregnancy. It may cause birth defects. This drug passes into breast milk and may affect the quality and quantity of milk produced. Consult your doctor before breastfeeding.

Our Mimvey (estradiol and norethindrone acetate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Mimvey Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
• swelling or tenderness in your stomach;
• jaundice (yellowing of the skin or eyes);
• memory problems, confusion, unusual behavior;
• unusual vaginal bleeding, pelvic pain;
• a lump in your breast; or
• high levels of calcium in your blood--nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy.

Common side effects may include:

• nausea, vomiting, bloating, stomach cramps;
• fluid retention (swelling, rapid weight gain);
• headache;
• breast pain;
• thinning scalp hair; or
• vaginal itching or discharge, changes in your menstrual periods, breakthrough bleeding.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Mimvey (Estradiol and Norethindrone Acetate Tablets)

 

Mimvey Professional Information

SIDE EFFECTS

See BOXED WARNINGS, WARNINGS and PRECAUTIONS.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

Adverse events reported with estradiol and norethindrone acetate 1 mg/0.5 mg by investigators in the Phase 3 studies regardless of causality assessment are shown in Table 6.

TABLE 6 : ALL TREATMENT-EMERGENT ADVERSE EVENTS REGARDLESS OF RELATIONSHIP REPORTED AT A FREQUENCY OF ≥ 5% WITH ESTRADIOL AND NORETHINDRONE ACETATE 1 MG/0.5 MG

	Endometrial Hyperplasia Study (12-Months)		Vasomotor Symptoms Study (3-Months)		Osteoporosis Study (2-Years)
	Estradiol and Norethindrone Acetate 1 mg/0 .5 mg (n=295)	1 mg E2 (n=296)	Estradiol and Norethindrone Acetate 1 mg /0.5 mg (n=29)	Placebo (n=34)	Estradiol and Norethindrone Acetate 1 mg/0 .5 mg (n=47)	Placebo (n=48)
Body as a Whole
Back Pain	6%	5%	3%	3%	6%	4%
Headache	16%	16%	17%	18%	11%	6%
Digestive System
Nausea	3%	5%	10%	0%	11%	0%
Gastroenteritis	2%	2%	0%	0%	6%	4%
Nervous System
Insomnia	6%	4%	3%	3%	0%	8%
Emotional Lability	1%	1%	0%	0%	6%	0%
Respiratory System
Upper Respiratory Tract Infection	18%	15%	10%	6%	15%	19%
Sinusitis	7%	11%	7%	0%	15%	10%
Metabolic and Nutritional
Weight Increase	0%	0%	0%	0%	9%	6%
Urogenital System
Breast Pain	24%	10%	21%	0%	17%	8%
Post- Menopausal Bleeding	5%	15%	10%	3%	11%	0%
Uterine	5%	4%	0%	0%	4%	8%
Fibroid
Ovarian Cyst	3%	2%	7%	0%	0%	8%
Resistance Mechanism
Infection Viral	4%	6%	0%	3%	6%	6%
Moniliasis Genital	4%	7%	0%	0%	6%	0%
Secondary Terms
Injury Accidental	4%	3%	3%	0%	17%*	4%*
Other Events	2%	3%	3%	0%	6%	4%
*including one upper extremity fracture in each group

Adverse events reported with estradiol and norethindrone acetate 0.5 mg/0.1 mg by investigators during the Phase 3 study regardless of causality assessment are shown in Table 7.

TABLE 7 : ALL TREATMENT-ADVERSE EVENTS REGARDLESS OF RELATIONSHIP REPORTED AT A FREQUENCY OF ≥ 5% WITH ESTRADIOL AND NORETHINDRONE ACETATE 0.5 MG/0.1 MGG

	Estradiol and Norethindrone Acetate 0 .5 mg /0.1 mg (n=194)	Placebo (n=200)
Body as a Whole
Back Pain	10%	4%
Headache	22%	19%
Pain in extremity	5%	4%
Digestive System
Nausea	5%	4%
Diarrhea	6%	6%
Respiratory System
Nasopharyngitis	21%	18%
Urogenital System
Endometrial thickening	10%	4%
Vaginal hemorrhage	26%	12%

The following adverse reactions have been reported with estrogen and/or progestin therapy:

Genitourinary System

Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding; spotting; dysmenorrhea, increase in size of uterine leiomyomata; vaginitis, including vaginal candidiasis; change in amount of cervical secretion; changes in cervical ectropion; premenstrual-like syndrome; cystitis-like syndrome; ovarian cancer; endometrial hyperplasia; endometrial cancer.

Breasts

Tenderness, enlargement, pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer.

Cardiovascular

Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction, stroke; increase in blood pressure.

Gastrointestinal

Nausea, vomiting; changes in appetite; cholestatic jaundice; abdominal pain/cramps, flatulence, bloating; increased incidence of gallbladder disease; pancreatitis; enlargement of hepatic hemangiomas.

Skin

Chloasma or melasma that may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; seborrhea; hirsutism; itching; skin rash; pruritus.

Eyes

Retinal vascular thrombosis, intolerance to contact lenses.

Central Nervous System

Headache; migraine; dizziness; mental depression; chorea; insomnia; nervousness; mood disturbances; irritability; exacerbation of epilepsy; probable dementia.

Miscellaneous

Increase or decrease in weight; aggravation of porphyria; edema; leg cramps; changes in libido; fatigue; reduced carbohydrate tolerance; anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides; back pain; arthralgia; myalgia.

Read the entire FDA prescribing information for Mimvey (Estradiol and Norethindrone Acetate Tablets)

&Copy; Mimvey Patient Information is supplied by Cerner Multum, Inc. and Mimvey Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.