Bijuva for Hot Flashes: Drug Side Effects, Dosage & Warnings

What is Bijuva (estradiol and progesterone), and what is it used for?

Bijuva is a prescription medicine that contains two kinds of hormones, an estrogen and progesterone. Bijuva is used after menopause to reduce moderate to severe hot flashes.

What are the side effects of Bijuva?

Side effects are grouped by how serious they are and how often they happen when you are treated.

Serious but less common side effects include:

heart attack
stroke
blood clots
breast cancer
cancer of the lining of the uterus (womb)
cancer of the ovary
dementia
gallbladder disease
high or low blood calcium levels
changes in vision
high blood pressure
high levels of fat in your blood (triglycerides)
liver problems
changes in thyroid hormone levels
swelling or fluid retention
enlargement of benign tumors of the uterus (“fibroids”)
worsening swelling of face or tongue (angioedema) in women who have a history of angioedema
changes in laboratory test results such as bleeding time and high blood sugar levels

Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:

new breast lumps
unusual vaginal bleeding
changes in vision or speech
sudden new severe headaches
severe pains in your chest or legs with or without shortness of breath, weakness and fatigue
swelling of legs or calves
vomiting

The most common side effects of Bijuva include:

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of Bijuva. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA- 1088.

You may also report side effects to TherapeuticsMD at 1-888-228-0150.

What can I do to lower my chances of a serious side effect with Bijuva?

Talk with your healthcare provider regularly about whether you should continue taking Bijuva.
If you have a uterus, talk with your healthcare provider about whether the addition of a progestogen is right for you.
The addition of a progestogen is generally recommended for a woman with a uterus to reduce the chance of getting cancer of the uterus (womb).
See your healthcare provider right away if you get vaginal bleeding while taking Bijuva.
Have a pelvic exam, breast exam and mammogram (breast X-ray) every year unless your healthcare provider tells you something else.
If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram (breast X-ray), you may need to have breast exams more often.
If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease.

Ask your healthcare provider for ways to lower your chances for getting heart disease.

Is Bijuva addictive?

No information provided

What is the dosage for Bijuva?

Use of estrogen, alone or in combination with a progestogen, should be limited to the lowest effective dose available and for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be reevaluated periodically as clinically appropriate to determine if treatment is still necessary.

Treatment Of Moderate To Severe Vasomotor Symptoms Due To Menopause

Take a single Bijuva (estradiol and progesterone) capsule, 1 mg/100 mg, orally each evening with food.

What drugs interact with Bijuva?

No drug-drug interaction studies have been conducted with Bijuva.

Metabolic Interactions

Effects Of Other Drugs On Estrogens And Progestins

In-vitro and in-vivo studies have shown that estrogens and progestins are metabolized partially by cytochrome P450 3A4 (CYP3A4). Therefore, inducers or inhibitors of CYP3A4 may affect estrogen and progestin drug metabolism. Inducers of CYP3A4 such as St. John's wort (Hypericum perforatum) preparations, phenobarbital, carbamazepine, and rifampin may reduce plasma concentrations of estrogens and progestins, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile. Inhibitors of CYP3A4, such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice, may increase plasma concentrations of the estrogen or the progestin or both and may result in side effects.

Bijuva contraindications, and pregnancy and breastfeeding safety

Contraindications

Do not take Bijuva if you have had your uterus (womb) removed (hysterectomy).

Bijuva contains progesterone to decrease the chance of getting cancer of the uterus. If you do not have a uterus, you do not need progesterone and you should not take Bijuva.

Do not take Bijuva if you:

have any unusual vaginal bleeding. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
currently have or have had certain cancers. Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should take Bijuva.
currently have or have had blood clots.
had a stroke or heart attack.
currently have or have had liver problems.
have been diagnosed with a bleeding disorder.
are allergic to Bijuva or any of its ingredients. See the list of ingredients in Bijuva in the prescribing information.

Pregnancy

Bijuva (estradiol and progesterone) capsules, 1 mg/100 mg, are not indicated for use in pregnancy. There are no data with the use of Bijuva in pregnant women, however, epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limbreduction defects) following exposure to combined hormonal contraceptives (estrogen and progestins) before conception or during early pregnancy.

Breastfeeding

Bijuva (estradiol and progesterone) capsules, 1 mg/100 mg, are not indicated for use in females of reproductive potential. Estrogens are present in human milk and can reduce milk production in breastfeeding females. This reduction can occur at any time but is less likely to occur once breastfeeding is well-established.