Bijuva is a brand-name prescription drug. It’s FDA-approved to treat moderate to severe vasomotor symptoms related to menopause. (Vasomotor symptoms are commonly known as hot flashes.) For this purpose, Bijuva should only be used by adult females* who have a uterus.

Bijuva contains two types of hormones: estradiol and progesterone. Estradiol is a kind of estrogen hormone, and progesterone is a type of progestin hormone. Bijuva belongs to a group of drugs called hormone replacement therapy (HRT). HRT increases the hormone levels in your body so that your menopause symptoms are less intense.

Bijuva comes as a capsule that you swallow. You’ll likely take the drug once a day in the evening. Bijuva comes in one strength: 1 milligram (mg) of estradiol/100 mg of progesterone.

* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.

FDA approval

The Food and Drug Administration (FDA) first approved Bijuva in 2018 to treat hot flashes related to menopause.

Effectiveness

For information on the effectiveness of Bijuva, see the “Bijuva uses” section below.

Bijuva is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active drug in a brand-name medication. Generics usually cost less than brand-name drugs.

Bijuva contains two active drug ingredients: estradiol and progesterone.

Bijuva can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Bijuva. These lists don’t include all possible side effects.

For more information on the possible side effects of Bijuva, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to report to the FDA a side effect you’ve had with Bijuva, you can do so through MedWatch.

Mild side effects

Mild side effects of Bijuva can include:*

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Bijuva. To learn about other mild side effects, talk with your doctor or pharmacist, or see Bijuva’s Patient Information.

Serious side effects

Serious side effects from Bijuva aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

* For more information on these side effects, see “Side effect details” below.
Bijuva has boxed warnings for these side effects. A boxed warning is the most serious warning from the FDA. For more information, see “FDA warnings” at the beginning of this article.

Side effect details

You may wonder how often certain side effects occur with this drug, or whether certain side effects pertain to it. Here’s some detail on certain side effects this drug may or may not cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Bijuva. But it isn’t known how many people had an allergic reaction to this drug in clinical studies.

Symptoms of a mild allergic reaction can include:

  • skin rash
  • itchiness
  • flushing (warmth and redness in your skin)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have a severe allergic reaction to Bijuva. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Gallbladder disease

Some people taking Bijuva may develop gallbladder disease. (Your gallbladder is a small organ located under your liver.) People who have been through menopause and are taking drugs, such as Bijuva, that contain estrogen are two to four times more likely to develop gallbladder disease. However, the percentage of people who had gallbladder disease after taking Bijuva in clinical studies isn’t known.

The term “gallbladder disease” may refer to several different types of gallbladder problems, such as:

  • Gallstones. Gallstones are hardened lumps that form when liquid substances become solid inside your gallbladder. Most people don’t experience any symptoms of gallstones unless the gallstones cause gallbladder inflammation (swelling and damage). See “Cholecystitis” right below to learn more.
  • Cholecystitis.Cholecystitis” is the term used to described gallbladder inflammation. Symptoms of this condition may include:
    • pain in your shoulder, back, or the right side of your body below your ribs

If you’re taking Bijuva, talk with your doctor about your risk of developing gallbladder disease.

Abnormal vaginal bleeding

Abnormal vaginal bleeding can occur with Bijuva treatment. In a clinical study, vaginal bleeding occurred in 3.4% of adult females* who used Bijuva. In comparison, no one had vaginal bleeding after using a placebo (treatment without an active drug). The amount of time that vaginal bleeding lasted in these studies isn’t known.

Vaginal bleeding after menopause can be a sign of endometrial cancer† (cancer in the uterus). Tell your doctor right away if you have vaginal bleeding after menopause while using Bijuva.

For other symptoms of endometrial cancer, see the “Endometrial cancer” section below.

* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.
Bijuva has a boxed warning for endometrial cancer. A boxed warning is the most serious warning from the FDA. For more information, see “FDA warnings” at the beginning of this article.

Cardiovascular problems

A study of females* found that estrogen plus progestin therapy (Bijuva is a type of this therapy) may increase the risk of certain cardiovascular problems.† Using certain estrogen-alone therapies can also increase this risk.

These problems are conditions that affect the heart and blood vessels. It isn’t known how many people experienced this side effect after taking Bijuva in clinical studies.

If your menopausal hot flashes are bothersome enough to try hormone replacement therapy (HRT), it’s a good idea to talk with your doctor. They can review the benefits and risks of taking HRT like Bijuva, which contains estrogen and progestin.

If you’re concerned about heart attack, stroke, blood clots, or other cardiovascular problems while using Bijuva, talk with your doctor. They can review your risks for experiencing these side effects.

Your doctor will likely prescribe Bijuva for the shortest length of time that’s needed to manage your symptoms.

* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.
Bijuva has a boxed warning for cardiovascular problems. A boxed warning is the most serious warning from the FDA. For more information, see “FDA warnings” at the beginning of this article.

Heart attack

In some people, taking Bijuva may increase the risk of having a heart attack. A heart attack can feel like pain, squeezing, tightness, or pressure in your chest that may spread to your back, jaw, or neck. Other symptoms of heart attack can include:

Stroke

Bijuva use may increase the risk of stroke. Symptoms of stroke can include:

  • confusion
  • headache
  • trouble speaking, seeing, or walking
  • weakness in your arm, leg, or face (usually on one side of your body)

Blood clots

In some people, taking Bijuva can increase the risk of developing blood clots, including deep vein thrombosis (DVT) and pulmonary embolism (PE). A DVT is a blood clot in a deep vein, and a PE is a blood clot in the lungs.

Symptoms of DVTs and PEs can include:

  • pain in your chest, arm, or leg
  • swelling of your arm or leg
  • trouble breathing
  • warmth of the affected area

Cancer

Bijuva use may increase the risk of certain types of cancer, including breast,* endometrial,* and ovarian cancer. It isn’t known how many people developed cancer after taking Bijuva in clinical studies.

If you’re concerned about developing breast, endometrial, or ovarian cancer while taking Bijuva, talk with your doctor. They can discuss the risks with you.

Your doctor can also recommend ways to help lower your risk of ovarian, breast, and endometrial cancer. This may include having pelvic and clinical breast exams, as well as mammograms. They’ll also likely talk with you about any history of these cancers in your family.

Your doctor will likely prescribe Bijuva for the shortest length of time that’s needed to manage your symptoms.

* Bijuva has boxed warnings for breast and endometrial cancer. A boxed warning is the most serious warning from the FDA. For more information, see “FDA warnings” at the beginning of this article.

Breast cancer

In some cases, Bijuva treatment may increase the risk of developing invasive breast cancer. “Invasive” means the cancer has spread outside of the breast and into nearby tissue.

Symptoms of breast cancer can include:

  • a lump in your breast or armpit
  • nipple discharge that isn’t breast milk, such as blood
  • breast pain or nipple pain
  • swelling of your breasts
  • change in the size or shape of your breast
  • dimpling of breast tissue
  • flakiness or redness of your nipple or breast

Endometrial cancer

Bijuva use may increase the risk of endometrial cancer. This type of cancer starts in the uterus (womb).

People who use estrogen plus progestin therapy, such as Bijuva, have a lower chance of developing endometrial cancer than people who use estrogen therapy alone. If you’re a woman with a uterus (you haven’t had a hysterectomy), estrogen can cause increased growth of the uterine lining. This can lead to cancer. The progesterone hormone that’s in Bijuva helps prevent this extra growth. As a result, progesterone lessens the risk of endometrial cancer.

Symptoms of endometrial cancer can include:

Ovarian cancer

In some cases, Bijuva treatment may increase the risk of ovarian cancer. This type of cancer starts in the ovaries.

Symptoms of ovarian cancer can include:

  • unexpected vaginal bleeding
  • abdominal (belly) pain
  • bloating
  • urinating more frequently than usual
  • constipation
  • loss of appetite
  • weight loss
  • fatigue

Dementia

One large study looked at females* between the ages of 65 and 79 years who had gone through menopause. Researchers found that taking a drug that includes estrogen, like Bijuva, may increase the risk of developing dementia.† (Dementia is a condition that affects communication, memory, and thinking.)

Because the studies were conducted in older females, it isn’t known if the risk of dementia also applies to younger females who have gone through menopause. The percentage of people who developed dementia after taking Bijuva in clinical studies isn’t known.

Your doctor will likely prescribe Bijuva for the shortest length of time that’s needed to manage your symptoms.

* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.
Bijuva has a boxed warning for dementia. A boxed warning is the most serious warning from the FDA. For more information, see “FDA warnings” at the beginning of this article.

Dementia symptoms

Symptoms of dementia can include:

  • changes in mood or personality
  • memory loss
  • trouble completing familiar tasks
  • trouble communicating
  • forgetting where you’ve placed everyday items
  • feeling disoriented (lost or confused)
  • showing a decreased interest in activities

If you’re using Bijuva and have any concerns about developing dementia, talk with your doctor.

Weight gain or weight loss (not side effects)

Weight gain and weight loss weren’t reported as side effects in clinical studies of Bijuva. However, some people reported having weight gain after Bijuva was approved.

Also, keep in mind that weight gain during menopause is common. Clinical studies suggest that females* gain an average of 1.5 pounds (0.7 kilograms) each year during their 50s and 60s. Some people also have an increase in belly fat during menopause. The reason for weight and body structure changes during menopause isn’t fully understood. It’s thought that age, lifestyle, and genetics may be factors.

Changes in levels of estrogen and other hormones during menopause may also increase your likelihood of gaining weight. Since Bijuva contains the hormones estradiol (a form of estrogen) and progesterone, it’s possible that you may experience weight gain as a side effect of Bijuva.

If you’re concerned about weight gain or weight loss while taking Bijuva, talk with your doctor. They can suggest healthy ways for you to manage your weight during menopause.

* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.

You may wonder how Bijuva compares with other medications that are prescribed for similar uses. Here we look at how Bijuva and Prempro are alike and different.

Ingredients

Bijuva contains two active drug ingredients: estradiol and progesterone.

Prempro also contains two different active drug ingredients: conjugated estrogens and medroxyprogesterone.

Both Bijuva and Prempro belong to a group of drugs called hormone replacement therapy (HRT).

Uses

The Food and Drug Administration (FDA) has approved Bijuva and Prempro to treat moderate to severe vasomotor symptoms related to menopause. (Vasomotor symptoms are commonly known as hot flashes.) For this purpose, Bijuva and Prempro should only be used by adult females* who have a uterus (womb). Females who have had a hysterectomy don’t have a uterus.

Prempro is also FDA-approved for the following conditions in adult females who have a uterus:

* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.

Drug forms and administration

Bijuva comes as a capsule that you swallow. You’ll likely take it once a day in the evening.

Prempro comes as a tablet that you swallow. You’ll likely take it once a day.

Side effects and risks

Bijuva and Prempro both contain a combination of estrogen plus progestin. (Estrogen and progestin are sex hormones that are involved in the menstrual cycle.) Therefore, these medications can cause very similar side effects, but some different ones as well. Below are examples of these side effects.

Mild side effects

These lists contain up to 10 of the most common mild side effects that can occur with Bijuva, with Prempro, or with both drugs (when taken individually).

Serious side effects

These lists contain examples of serious side effects that can occur with Bijuva or with both drugs (when taken individually).

* Bijuva and Prempro have boxed warnings for these side effects. A boxed warning is the most serious warning from the FDA. For more information on Bijuva, see “FDA warnings” at the beginning of this article.

Effectiveness

Bijuva and Prempro have different FDA-approved uses, but they’re both used to treat certain symptoms of menopause.

These drugs haven’t been directly compared in clinical studies, but studies have found both Bijuva and Prempro to be effective for treating these symptoms.

Costs

Bijuva capsules generally cost more than Prempro tablets per package. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Bijuva and Prempro are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

You should take Bijuva according to your doctor’s or healthcare professional’s instructions.

Bijuva comes as a capsule that you swallow.

When to take

You’ll likely take Bijuva once a day in the evening.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm on your phone or downloading a reminder app. A kitchen timer can work, too.

Taking Bijuva with food

You should take Bijuva with food.

Why take Bijuva at night?

It’s recommended that you take Bijuva at night. One clinical study showed that Bijuva helped promote better sleep.

Can Bijuva be crushed, split, or chewed?

It may not be safe to crush, split, or chew the Bijuva capsules. If you have trouble swallowing Bijuva capsules, talk with your doctor. They may suggest a different drug for you instead.

As with all medications, the cost of Bijuva can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Before approving coverage for Bijuva, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.

If you’re not sure if you’ll need to get prior authorization for Bijuva, contact your insurance company.

Financial assistance

If you need financial support to pay for Bijuva, help is available. TherapeuticsMD, Inc., the manufacturer of Bijuva, offers the Bijuva Savings Program. For more information and to find out if you’re eligible for support, visit the program website.

Generic version

Bijuva isn’t available in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.

Here are answers to some frequently asked questions about Bijuva.

Is Bijuva a type of hormone replacement therapy?

Yes, Bijuva is a type of hormone replacement therapy (HRT).

During menopause, the levels of estrogen and progesterone hormones in your body begin to lower. (Specifically, estrogen and progesterone are sex hormones that are involved in the menstrual cycle.) This decrease can cause typical menopause symptoms, such as mood changes and hot flashes.

HRT involves taking estrogen, progesterone, or both, to increase your hormone levels. As your hormone levels rise, your menopause symptoms become less intense.

Talk with your doctor if you have questions about using Bijuva or other forms of HRT to treat your menopause symptoms.

Is Bijuva a bioidentical?

Yes. Bijuva is a kind of bioidentical hormone replacement therapy (HRT). For more information about HRT, see the previous question.

Bijuva contains artificial versions of two types of hormones: estradiol (a type of estrogen) and progesterone. These artificial hormones are called bioidentical because they have the same chemical makeup as the estradiol and progesterone that your body produces naturally.

With traditional HRT, the hormones are either artificial or made from an animal source. They work in the same way as the body’s natural hormones, but they’re different on a molecular level.

The hormones in bioidentical HRT are closer to the body’s natural hormones than the hormones in traditional HRT. Bioidentical HRT is just as effective and safe as traditional HRT.

If you have questions about the risks and benefits of using bioidentical HRT, talk with your doctor.

Why can’t I use Bijuva if I’ve had a hysterectomy?

You shouldn’t use Bijuva if you’ve had a hysterectomy because of possible side effects from progesterone, an ingredient in Bijuva. A hysterectomy is a procedure to remove the uterus (womb).

In people who have a uterus, estrogen can cause an increase in the growth of the uterus lining. This can lead to endometrial cancer. The progesterone hormone that’s in Bijuva helps prevent this extra growth, lessening the risk of endometrial cancer.

Taking Bijuva after you’ve had a hysterectomy may not provide any extra benefit over taking estrogen alone. But the drug may increase your risk of side effects from progesterone. Examples of progesterone side effects can include:

If you’ve had a hysterectomy, Bijuva may not be right for you. Talk with your doctor about other treatment options for easing your menopause symptoms.

Can I take Bijuva if I’m planning to have surgery?

Maybe. Having surgery can increase your risk of developing a blood clot. Blood clots are also a possible side effect of Bijuva. Therefore, taking Bijuva while you’re planning to have surgery can further increase your risk of blood clots when you have the procedure. (For information on side effects, see the “Bijuva side effects” section above.)

If you’re planning to have surgery, be sure to tell your doctor if you take Bijuva. They’ll decide if it’s safe for you to keep using Bijuva before the procedure.

There aren’t any known interactions between Bijuva and alcohol. However, drinking alcohol during menopause may worsen certain menopause symptoms, such as hot flashes.

If you drink alcohol while taking Bijuva, you may be more likely to have certain side effects of Bijuva. (For more information about side effects, see the “Bijuva side effects” section above.) These side effects include:

  • Breast cancer. According to the American Cancer Society, drinking alcohol can raise your risk of breast cancer. Taking Bijuva can also increase your likelihood of developing breast cancer. Therefore, drinking alcohol while taking Bijuva may raise your risk even more.
  • Blood clots. Drinking alcohol may increase your risk of developing a blood clot. Taking Bijuva can also raise your risk of a blood clot. So drinking alcohol while taking Bijuva can increase the likelihood of having a blood clot even more.

If you drink alcohol, talk with your doctor about how much is safe for you to drink while using Bijuva.

Other drugs are available that can treat your hot flashes. Some may be a better fit for you than others. If you’re interested in finding an alternative to Bijuva, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Alternatives for moderate to severe hot flashes due to menopause

Bijuva contains two active drug ingredients: estradiol (a type of estrogen hormone) and progesterone (a type of progestin hormone).

There are other drugs that combine estradiol with a progestin hormone that may be used to treat hot flashes. Examples of these drugs include:

  • estradiol/drospirenone (Angeliq)
  • estradiol/levonorgestrel (Climara Pro)
  • estradiol/norethindrone (Activella, Amabelz)
  • estradiol/norgestimate
  • ethinyl estradiol/norethindrone (Femhrt, Jinteli)

There are also other forms of estradiol that may be used to treat hot flashes. Examples of these drugs include:

  • oral estradiol
  • estradiol topical gel (Divigel, Elestrin, EstroGel)
  • estradiol injected into the muscle (Depo-Estradiol, Delestrogen)
  • estradiol topical spray (Evamist)
  • estradiol patch (Alora, Climara, Minivelle, Vivelle-Dot)
  • estradiol vaginal ring (Femring)

In addition, other types of estrogen hormone may be used to treat hot flashes, including:

  • oral estrogen (Menest, Premarin)
  • estrogen/methyltestosterone
  • estrogen/bazedoxifene (Duavee)
  • estrogen/medroxyprogesterone (Prempro, Premphase)
  • estropipate

Examples of nonhormonal prescription drugs that may be used to treat hot flashes include:

Like Prempro (discussed above), the drug Duavee has uses similar to those of Bijuva. Here’s a comparison of how Bijuva and Duavee are alike and different.

Ingredients

Bijuva contains two active drug ingredients: estradiol and progesterone. Estradiol is a type of estrogen hormone. Progesterone is a type of progestin hormone.

Duavee also contains two active drug ingredients: conjugated estrogens and bazedoxifene. Bazedoxifene is a type of drug called a selective estrogen receptor modulator (SERM). Bazedoxifene works by acting like an estrogen hormone in certain parts of the body.

Uses

The Food and Drug Administration (FDA) has approved Bijuva and Duavee to treat moderate to severe vasomotor symptoms related to menopause. (Vasomotor symptoms are commonly known as hot flashes.) For this purpose, Bijuva and Duavee should only be used by adult females* who have a uterus.

Duavee is also FDA-approved for the prevention of osteoporosis after menopause.

* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.

Drug forms and administration

Bijuva comes as a capsule that you swallow. You’ll likely take it once a day in the evening.

Duavee comes as a tablet that you swallow. You’ll likely take it once a day.

Side effects and risks

Bijuva and Duavee both contain drugs used to treat symptoms of menopause. Therefore, these medications can cause very similar side effects, but some different ones as well. Below are examples of these side effects.

Mild side effects

These lists contain up to 10 of the most common mild side effects that can occur with Bijuva, with Duavee, or with both drugs (when taken individually).

Serious side effects

These lists contain examples of serious side effects that can occur with Bijuva or with both drugs (when taken individually).

* Bijuva and Duavee have boxed warnings for these side effects. A boxed warning is the most serious warning from the FDA. For more information on Bijuva, see “FDA warnings” at the beginning of this article.

Effectiveness

Bijuva and Duavee have different FDA-approved uses, but they’re both used to treat certain symptoms of menopause.

These drugs haven’t been directly compared in clinical studies, but studies have found both Bijuva and Duavee to be effective for treating these symptoms.

Costs

Bijuva capsules generally cost more than Duavee tablets. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Bijuva and Duavee are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

Your doctor will start you on the typical Bijuva dosage used to treat hot flashes. Then they’ll monitor you periodically to decide if you need to keep taking the drug. Your doctor will ultimately prescribe Bijuva for the shortest amount of time needed to treat your hot flashes while keeping your risk of side effects low. (For information on side effects, see the “Bijuva side effects” section above.)

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Bijuva comes as a capsule that you swallow. Each capsule contains two active ingredients: estradiol and progesterone.

Bijuva comes in one strength: 1 milligram (mg) of estradiol/100 mg of progesterone.

Dosage for moderate to severe hot flashes due to menopause

Bijuva is used to treat moderate to severe vasomotor symptoms (hot flashes) related to menopause.

The typical dosage of Bijuva for this use is one capsule every day in the evening. You should take each dose of Bijuva with food.

What if I miss a dose?

If you miss a dose of Bijuva, you should take your next dose with food as soon as you remember. If it’s within 2 hours of your next dose, skip your missed dose and take your next dose at its regular time. Don’t take an extra dose to make up for your missed dose. Doing this can increase your risk of side effects. (For more information on side effects, see the “Bijuva side effects” section above.)

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm on your phone or downloading a reminder app. A kitchen timer can work, too.

Will I need to use this drug long term?

Bijuva isn’t meant to be used as a long-term treatment. You should take Bijuva only as long as you need to treat your hot flashes. Your doctor will likely check in with you every 3 to 6 months about whether you need to keep using Bijuva.

The Food and Drug Administration (FDA) approves prescription drugs such as Bijuva to treat certain conditions.

Bijuva for moderate to severe hot flashes due to menopause

Bijuva is a brand-name prescription drug. It’s FDA-approved to treat moderate to severe vasomotor symptoms (hot flashes) related to menopause. For this purpose, Bijuva should be used only by adult females* who have a uterus (womb). Females who have had a hysterectomy don’t have a uterus.

Menopause begins when you no longer have a period. According to the National Institute on Aging, this usually occurs between ages 45 and 55 years. During menopause, the levels of estrogen and progesterone in your body begin to decrease. (Estrogen and progesterone are sex hormones that are involved in the menstrual cycle.) This decrease in hormone levels causes menopause symptoms, such as:

Bijuva belongs to a group of drugs called hormone replacement therapy (HRT). HRT increases the hormone levels in your body so that your menopause symptoms are less intense.

* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.

Effectiveness for moderate to severe hot flashes due to menopause

Bijuva has been found effective for treating hot flashes in adult females* going through menopause.

In a 12-week clinical study, Bijuva was compared with a placebo (treatment with no active drug). People who were given Bijuva had fewer hot flashes each week than those who were given a placebo.

Researchers compared the number of hot flashes people experienced before and after starting treatment.

After 4 weeks of treatment:

  • People given Bijuva had an average of 40.6 fewer hot flashes each week.
  • People given a placebo had an average of 26.4 fewer hot flashes each week.

After 12 weeks of treatment:

  • People given Bijuva had an average of 55.1 fewer hot flashes each week.
  • People given a placebo had an average of 40.2 fewer hot flashes each week.

After 4 weeks of treatment, people who were given Bijuva also had less severe hot flashes each week than those who were given a placebo. After 12 weeks of treatment, the severity of hot flashes had eased even more.

* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.

Bijuva and children

Bijuva isn’t approved for use in children. It isn’t known if the drug is safe or effective for children.

There aren’t any known interactions between Bijuva and other medications, herbs, supplements, or foods.

The manufacturer of Bijuva didn’t study drug interactions in clinical studies of the drug. But this doesn’t mean that drug interactions can’t occur.

Before taking Bijuva, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Certain products that should be used with caution while taking Bijuva

Using certain products with Bijuva may affect how well the drug works to treat your condition. These products may also increase your risk of side effects. (To learn about possible side effects, see the “Bijuva side effects” section above.) Some of these products are described below.

Bijuva and other medications

Here’s some information on certain medications that can affect Bijuva.

Bijuva and CYP3A4 inhibitors

Your body uses an enzyme called CYP3A4 to break down Bijuva. CYP3A4 inhibitors are a group of drugs that work by inhibiting (blocking) this enzyme. Blocking the CYP3A4 enzyme can raise the level of Bijuva in your blood and increase your risk of side effects. (To learn about possible side effects, see the “Bijuva side effects” section above.)

Examples of CYP3A4 inhibitors include:

  • clarithromycin (Biaxin XL)
  • erythromycin (Ery-Tab)
  • ketoconazole
  • itraconazole (Sporanox)
  • ritonavir (Norvir)

Bijuva and CYP3A4 inducers

Your body uses an enzyme called CYP3A4 to break down Bijuva. CYP3A4 inducers are a group of drugs that work by inducing (increasing) the activity of this enzyme. When CYP3A4 is too active, the level of Bijuva in your blood can decrease, making Bijuva less effective.

Examples of CYP3A4 inducers include:

  • carbamazepine (Carbatrol, Tegretol)
  • phenobarbital
  • rifampin (Rifadin)

Before you start treatment with Bijuva, tell your doctor about any drugs you’re taking. They can determine if any of them are CYP3A4 inhibitors or CYP3A4 inducers. Then your doctor can adjust your medications as necessary.

Bijuva and thyroid replacement therapy

Thyroid replacement drugs are a group of medications used to increase thyroid hormone levels in people with hypothyroidism (underactive thyroid). Examples of these medications include:

If you take Bijuva with any of these medications, your doctor may need to increase the dosage of your thyroid replacement therapy. This is because Bijuva can lower the thyroid hormone levels in your body.

Your doctor may also perform more frequent thyroid function tests while you’re taking Bijuva. Talk with your doctor if you have questions about taking Bijuva with thyroid replacement therapy.

Bijuva and herbs and supplements or foods

Here’s some information on how certain herbs, supplements, and foods can affect Bijuva.

Bijuva and black cohosh

Black cohosh is an herbal supplement used to treat hot flashes due to menopause. Black cohosh can cause side effects that are similar to those of Bijuva. Therefore, using these products together may increase your risk of side effects even more. (To learn about possible side effects, see the “Bijuva side effects” section above.)

If you’re interested in using black cohosh to treat your hot flashes, talk with your doctor or pharmacist about whether it might be safe and effective for you. And be sure to tell them about any herbs or supplements you’re using while taking Bijuva.

Bijuva and St. John’s wort

Using Bijuva with St. John’s wort may cause Bijuva to be less effective. Be sure to check with your doctor or pharmacist before using any herbs or supplements while taking Bijuva.

Bijuva and grapefruit

Eating grapefruit or drinking grapefruit juice while taking Bijuva may raise the level of Bijuva in your blood. This could increase your risk of side effects. (To learn about possible side effects, see the “Bijuva side effects” section above.) If you have questions about eating certain foods with Bijuva, talk with your doctor.

Bijuva and lab tests

Bijuva may interfere with the results of certain lab tests, including:

If you have questions about how Bijuva may affect results of your lab tests, talk with your doctor.

Menopause begins in adult females* when they no longer have periods. According to the National Institute on Aging, this usually occurs between ages 45 and 55 years.

During menopause, the levels of estrogen and progesterone in your body begin to decrease. (Estrogen and progesterone are sex hormones that are involved in the menstrual cycle.) This decrease in hormone levels can cause typical menopause symptoms, such as mood changes and hot flashes.

Bijuva belongs to a group of drugs called hormone replacement therapy (HRT). HRT increases the hormone levels in your body so that your menopause symptoms are less intense.

* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.

How long does it take to work?

It may take about 1 month for Bijuva to start working and for your menopause symptoms to begin to ease.

It isn’t known if Bijuva is safe to take during pregnancy. The drug hasn’t been studied in pregnant people.

If you’re pregnant or planning to become pregnant, ask your doctor what treatments other than Bijuva are right for you.

Bijuva may not be safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Bijuva.

For more information about taking Bijuva during pregnancy, see the “Bijuva and pregnancy” section above.

You shouldn’t use Bijuva while you’re breastfeeding. Bijuva can pass into your breast milk and potentially cause side effects in children. The drug can also decrease the amount of breast milk that your body produces.

Talk with your doctor if you’re breastfeeding or planning to breastfeed. They can advise you on healthy ways to feed your child. Your doctor may also suggest treatment options other than Bijuva.

This drug comes with several precautions.

FDA warnings

This drug has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.

  • Cardiovascular problems. Bijuva shouldn’t be used to prevent cardiovascular problems (heart and blood vessel problems). The use of estrogen with progestin therapy, which is used in Bijuva, can increase the risk of certain conditions. These conditions include heart attack, stroke, and blood clots called deep vein thrombosis (DVT) and pulmonary embolism. The use of certain estrogen-alone therapies can also increase the risk of a stroke and DVT.
  • Dementia. Bijuva shouldn’t be used to prevent dementia (a condition that affects communication, memory, and thinking). In some cases, taking estrogen with or without progestin therapy may increase your risk of dementia. This risk is higher if you’ve gone through menopause and are age 65 years or older.
  • Breast cancer. Using treatment, such as Bijuva, that includes estrogen and progestin may increase your risk of invasive breast cancer. (“Invasive” means the cancer has spread outside of the breast and into nearby tissue.)
  • Endometrial cancer. If you have a uterus (you haven’t had a hysterectomy), taking estrogen therapy alone may increase your risk of endometrial cancer. This type of cancer starts in the uterus. People who use estrogen plus progestin therapy, such as Bijuva, have a lower risk of endometrial cancer than people who use estrogen therapy alone.

Other precautions

Before taking Bijuva, talk with your doctor about your health history. Bijuva may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • Asthma. Taking Bijuva may worsen asthma. Changes in estrogen levels after taking Bijuva can cause your airways to become inflamed (swollen). Tell your doctor about any asthma conditions you may have before you start taking Bijuva. If you have asthma, they may suggest a different treatment for your menopause symptoms.
  • Diabetes. Bijuva can affect your blood glucose (blood sugar) levels. If you have diabetes, your doctor may want to monitor your blood glucose more closely while you’re taking Bijuva. They may also need to adjust your dosage of diabetes medications. Be sure to tell your doctor if you have diabetes before you start using Bijuva.
  • Epilepsy. Epilepsy (a condition that causes seizures) can be stimulated by estrogen. Bijuva contains a form of estrogen called estradiol. Therefore, taking Bijuva may worsen epilepsy. If you have epilepsy, make sure to tell your doctor before starting Bijuva treatment. They may need to monitor your condition more closely. Or your doctor may recommend a different treatment option for you.
  • Migraine. Changes in estrogen levels can worsen migraine. Be sure to tell your doctor if you experience migraine before you start taking Bijuva. They may suggest a different treatment for your menopause symptoms.
  • Porphyria. Porphyria is the term used for a group of genetic conditions that can affect your skin and nervous system. Bijuva contains a form of estrogen, and estrogens can worsen the symptoms of porphyria. Before you start taking Bijuva, be sure to tell your doctor if you have this condition. They may recommend a different treatment choice for you.
  • Lupus. If you have lupus, you may experience a lupus flare after starting Bijuva treatment. (A lupus flare is an increase in the severity or number of lupus symptoms, or both.) These flares can happen because of changes in estrogen levels. Be sure your doctor knows whether you have lupus before you start taking Bijuva. They may suggest a different treatment for your symptoms of menopause.
  • Liver tumors. Treatment with Bijuva may worsen certain types of liver tumors. Tell your doctor if you have liver cancer before you start treatment with Bijuva.
  • High levels of triglycerides. If you have high levels of triglycerides, it’s important to use Bijuva with caution. In this case, Bijuva may increase triglyceride levels so high that pancreatitis (inflammation of the pancreas) develops. Your doctor may check your triglyceride levels before you start using Bijuva. If your levels are high, they may monitor your levels closely while you take Bijuva. Or they may recommend a different treatment option for you.
  • Hereditary angioedema. Treatment with Bijuva can worsen swelling of your face or tongue. Therefore, you may have an even higher risk of experiencing swelling if you take Bijuva when you have hereditary angioedema (HAE). Talk with your doctor about the risks and benefits of using Bijuva if you have HAE.
  • Breast cancer that has spread to your bones. If you have breast cancer that has spread to your bones, using Bijuva may cause hypercalcemia (a high calcium level). Hypercalcemia can cause kidney stones or heart problems. Before you start taking Bijuva, be sure to tell your doctor if you have breast cancer that has spread to your bones. They may want to monitor your calcium levels more closely.
  • History of jaundice. If you’ve ever had jaundice, you may be at an increased risk of having jaundice again after you start using Bijuva. Tell your doctor about any liver problems you’ve experienced before your Bijuva treatment. They may monitor you or recommend a different medication.
  • Hypothyroidism. Bijuva can decrease the thyroid hormone levels in your body. If you take Bijuva while you have hypothyroidism, your thyroid hormone levels may drop even lower. If you’re using thyroid replacement drugs to treat your condition, your doctor may need to change your dosage while you’re taking Bijuva. Your doctor may also want to perform more frequent thyroid function tests. Talk with your doctor if you have hypothyroidism and have questions about taking Bijuva.
  • Hypoparathyroidism. Hypoparathyroidism can cause a low level of calcium in your body. This condition is known as hypocalcemia. In people with this condition, Bijuva can cause calcium levels to drop even lower. If your calcium level becomes too low, you may develop osteoporosis. Be sure to tell your doctor if you have hypoparathyroidism before you start taking Bijuva. They may want to monitor your calcium levels closely.
  • Heart failure. Swelling or water retention is a common side effect of Bijuva. This usually occurs in your hands or lower legs. If you have heart failure, your body has trouble getting rid of fluids. This can also cause swelling in your hands or lower legs. Therefore, taking Bijuva when you have heart failure can make your swelling even worse. Make sure your doctor knows your medical history before you start treatment with Bijuva. They may need to monitor your body’s fluid levels closely if you have heart failure and take this drug. (For more information on swelling and other side effects, see the “Bijuva side effects” section above.)
  • Kidney problems. Bijuva may cause swelling or water retention, usually in your hands or lower legs. If you have kidney problems, you may also experience swelling usually in your hands or lower legs. Taking Bijuva while you have kidney problems can make your swelling even worse. Be sure to tell your doctor if you have kidney problems before you start taking Bijuva. They may monitor you more closely than usual.
  • Surgery or bed rest. Having surgery or going on bed rest can increase your risk of developing a blood clot. Blood clots are also a possible side effect of Bijuva. Therefore, taking Bijuva before having surgery or going on bed rest can increase your risk of blood clots even more. Be sure to tell your doctor if you’re using Bijuva and have surgery or bed rest planned. They’ll decide if it’s safe for you to keep taking Bijuva. (For information on blood clots and other side effects, see the “Bijuva side effects” section above.)
  • Allergic reaction. If you’ve had an allergic reaction to Bijuva or any of its ingredients, you shouldn’t take Bijuva. Ask your doctor what other medications are better options for you.
  • Pregnancy. It isn’t known if Bijuva is safe to take during pregnancy. For more information, please see the “Bijuva and pregnancy” section above.
  • Breastfeeding. You shouldn’t use Bijuva while you’re breastfeeding. For more information, please see the “Bijuva and breastfeeding” section above.

Note: For more information about the potential negative effects of Bijuva, see the “Bijuva side effects” section above.

Using more than the recommended dosage of Bijuva can lead to serious side effects. Do not use more Bijuva than your doctor recommends.

Overdose symptoms

Symptoms of an overdose can include:

What to do in case of overdose

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.

When you get Bijuva from the pharmacy, the pharmacist will add an expiration date to the label on the carton. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee that the medication is effective during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk with your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

You should store Bijuva capsules at room temperature from 68°F to 77°F (20°C to 25°C). Keep them in their carton and sealed packaging away from light. Avoid storing this medication in areas where it could get damp or wet, such as bathrooms.

Disposal

If you no longer need to take Bijuva and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

This article provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.

The following information is provided for clinicians and other healthcare professionals.

Indications

Bijuva is indicated for the treatment of moderate to severe menopausal vasomotor symptoms in adult females who have a uterus.

Administration

Each capsule of Bijuva contains 1 mg of estradiol and 100 mg of progesterone. The recommend dosage is one capsule by mouth daily in the evening. Bijuva should be taken with food.

Mechanism of action

Estrogen moderates the secretion of luteinizing hormone, gonadotropins, and follicle stimulating hormone via negative feedback. Estrogen reduces the levels of these hormones in females who have gone through menopause.

Progesterone acts by opposing the action of estrogens, increasing metabolism of estrogens, or blunting cellular response to estrogens.

Pharmacokinetics and metabolism

After administration, peak concentrations of estrogen occur at 5 hours. Steady-state levels are achieved within 7 days. The half-life of estradiol is about 26 hours. It is metabolized primarily in the liver and excreted in the urine.

Peak concentrations of progesterone occur at about 3 hours after administration. Steady-state levels are achieved within 7 days. Its half-life is about 10 hours after repeated dosing. Progesterone is metabolized in the liver and excreted in the bile.

Contraindications

Bijuva is contraindicated in females who have:

Storage

Bijuva capsules should be stored at room temperature from 68°F to 77°F (20°C to 25°C). Temporary temperature deviations are permitted from 59°F to 86°F (15°C to 30°C). Bijuva should be kept in its blister packaging away from light. It should not be stored in areas where it could get damp or wet, such as bathrooms.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

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