ANGELIQ (Drospirenone/Estradiol)

ANGELIQ (Drospirenone/Estradiol)

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prescription

What is this medication?

Drospirenone+Estradiol/Angeliq
Estrogen and Progestin Combination 

Officially indicated for vasomotor symptoms, vulvar, and vaginal atrophy associated with menopause.

“ALERT: US Boxed Warning

Estrogen plus progestin therapy:
Estrogens and progestins should not be used for the prevention of cardiovascular disease or dementia.

The Women’s Health Initiative (WHI) study reported increased risks of myocardial infarction (MI), stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis (DVT) in postmenopausal women 50 to 79 years of age during 5.6 years of treatment with daily oral conjugated estrogens 0.625 mg combined with medroxyprogesterone acetate 2.5 mg relative to placebo.

The Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years and older during 4 years of treatment with daily oral conjugated estrogens 0.625 mg plus medroxyprogesterone 2.5 mg relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.

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 conjugated estrogens and medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins. Estrogens and 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:
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.

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 conjugated estrogens 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 and older during 5.2 years of treatment with daily conjugated estrogens 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 conjugated estrogens and other dosage forms of estrogens.

Prescribe estrogens with or without progestins at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.”

How does this medication work? 

Estradiol is an estrogen steroid hormone that supports the development and function of the female reproductive system, secondary sex characteristics and urogenital structures.  Estradiol is the principle female estrogen and inhibits the pituitary release of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) thereby inhibiting ovulation through a negative feedback system.  

Drospirenone is a progestin is a synthetic form of progesterone which is another female reproductive hormone.  Progestin inhibits gonadotropin production which will prevent follicular maturation and subsequently ovulation.  Progestin also reduces the risk of endometrial hyperplasia as it thins out the endometrial lining of the uterus.

How should I take this medication?

Vasomotor symptoms
Oral: Take one tablet daily.

Vulvar and vaginal atrophy 
Oral: Take one tablet daily. 

How to take: You can take tablets with food or after a meal to reduce nausea.   Take the medication exactly as prescribed by your doctor at the same time each day.

How to Switch Hormone Therapy: You can start anytime if you are not taking estrogen or are switching from a continuation combination therapy.  Women who have been on sequential or cyclic hormone therapy should complete their current cycle before switching to Drospirenone+Estradiol/Angeliq.

Contact Your Doctor if You Ever Experience:  If you experience a sudden, intense, severe headache or chest pain; sudden loss of coordination; sudden loss of vision or speech disturbances; chest or calf pain; weakness in the extremities; sudden shortness of breath of pain with breathing (may indicate thromboembolic disorder); persistent or recurrent vaginal bleeding (may indicate endometrial cancer); edema; abdominal pain or jaundice (may indicate hepatitis or gallbladder disease).  

What should I watch for while using this medication? 

Do not use in women with an increased risk of invasive breast cancer

Do not use in women to prevent or treat dementia

Do not use unopposed estrogen in women with a uterus

Do not use in women with endometriosis

Use with caution in women with pre-existing hypertriglyceridemia

Use with caution in women with ovarian cancer

Use with caution in women with retinal vascular thrombosis

Use with caution in asthma, carbohydrate intolerance, cardiovascular disease, fluid retention, hepatic dysfunction, hypoparathyroidism, migraines, porphyria, and system lupus erythematosus

What if I miss a dose?

If you miss a dose, make sure to take it as soon as possible.  However, if it is almost time for your next dose, skip the missed dose and continue with your regular schedule.  Bleeding may occur if you miss several doses in a row.

How should I store this medication?

Keep out of the reach of children at all times.  Store at room temperature, 59 to 86° F (15 to 30° C).  Protect from light.  Keep the container tightly closed.  Properly dispose of any unused medication after the expiration date.

What are the possible side effects of using this medication?

The frequency of side effects is not well defined and some of the adverse reactions are dependent on the dosage form and combination therapy used:

>10%

Genitourinary: Mastalgia (6% to 18%), vaginal bleeding (3% to 14%)