Bijuva (Estradiol and Progesterone) – Oral

Warning:

The Food and Drug Administration (FDA) has a black box warning of an increased risk of blood clots, stroke, heart attack, and breast cancer for Bijuva. Bijuva may also raise the likelihood of dementia (memory problems) in postmenopausal people assigned female at birth who are at least 65 years old.

What Is Bijuva?

Bijuva is a medication option that can relieve moderate to severe menopause symptoms in people assigned female at birth who still have a uterus.

It's a combination hormonal therapy that contains the sex hormones estradiol (a form of estrogen) and progesterone. Bijuva works by influencing sex hormones. This prescription is available in an oral capsule form.

Drug Facts

Generic Name: Estradiol and progesterone

Brand Name(s): Bijuva

Drug Availability: Prescription

Therapeutic Classification: Combination hormonal therapy

Available Generically: No

Controlled Substance: No

Administration Route: Oral (by mouth)

Active Ingredient: Estradiol and progesterone

Dosage Form(s): Capsule

What Is Bijuva Used For?

Bijuva is used to relieve moderate to severe menopausal symptoms. It can betaken by people assigned female at birth who still have a uterus. In other words, you can take this medication if you haven't had a hysterectomy procedure.

Menopause is the permanent stop of your menstrual periods. The average age to experience menopause in the United States is 52 years old. For people assigned female at birth, menopause is considered a normal part of life.

During menopause, your hormone levels will change. These changes might cause symptoms that will go away without treatment. Some people assigned female at birth, however, might experience some distress from bothersome symptoms of hot flashes and night sweats. Bijuva is a potential option to treat these symptoms.

How to Take Bijuva

Take Bijuva by mouth in the evening with food.

Storage

When you receive Bijuva from the pharmacy, keep it at room temperature, between 68 degrees and 77 degrees Fahrenheit—with a short-term safety storage range of 59 degrees to 86 degrees.

Keep your medications tightly closed and out of the reach of children and pets, ideally locked in a cabinet or closet.

Try to avoid pouring unused and expired drugs down the drain or in the toilet. Visit the FDA's website to learn where and how to discard all unused and expired drugs. You can also find disposal boxes in your area. Ask your pharmacist or healthcare provider if you have any questions about the best ways to dispose of your medications.

If you plan to travel with Bijuva, get familiar with your final destination's regulations. Checking with the U.S. Embassy or U.S. Consulate might be a helpful resource. Make a copy of your Bijuva prescription, and keep your medication in its original container from your pharmacy with your name on the label. If you have any questions about traveling with your medicine, be sure to ask your pharmacist or healthcare provider.

How Long Does Bijuva Take to Work?

You may notice an improvement in your menopausal symptoms within four to five weeks of taking Bijuva.

What Are the Side Effects of Bijuva?

This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 800-FDA-1088.

Common Side Effects

Common side effects with Bijuva may include:

Severe Side Effects

Get medical help right away if you experience the following serious side effects:

  • Abnormal heart rhythm
  • Abnormal vaginal bleeding
  • Blood pressure changes
  • Breathing difficulties
  • Clots
  • Heart attack
  • Loss of awareness or consciousness
  • Memory problems
  • New and sudden severe headache
  • New breast lumps
  • Severe pain in the chest or legs
  • Severe stomach pain
  • Severe tiredness or low energy
  • Speech or vision changes
  • Stroke
  • Swelling
  • Vomiting
  • Worsening diabetes
  • Yellowing of eyes or skin

Call 911 if your symptoms feel life-threatening.

Long-Term Side Effects

Long-term use of Bijuva is linked to the following possible side effects:

Report Side Effects

Bijuva may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your provider may send a report to the FDA's MedWatch Adverse Event Reporting Program or by phone (800-332-1088).

Dosage: How Much Bijuva Should I Take?

Drug Content Provided and Reviewed by IBM Micromedex®

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (capsules):
    • For moderate to severe hot flashes:
      • Adults—One capsule once a day, in the evening. Each capsule contains 1 milligram (mg) estradiol and 100 mg progesterone.
      • Children—Use is not recommended.

Modifications

The following modifications (changes) should be kept in mind when using Bijuva:

Severe allergic reaction: Avoid using Bijuva if you have a known allergy to it or any of its ingredients. Ask your pharmacist or healthcare provider for a complete list of the ingredients if you're unsure.

Pregnancy: There is no data on Bijuva use during pregnancy. In studies for combination hormonal birth control options, the combination of estrogen and progestin (human-made version of progesterone) isn't linked to negative effects on the unborn fetus during early pregnancy. Discuss with your healthcare provider if you plan to become pregnant or are pregnant. They can help you weigh the benefits and risks of Bijuva during pregnancy.

Breastfeeding: In general, the combination of estrogen and progesterone can be present in breast milk—with possible negative effects on milk production. This effect is less likely to happen once breastfeeding is well-established with the nursing baby. Talk with your healthcare provider if you plan to breastfeed. Your healthcare provider can help you weigh the benefits and harms of Bijuva while nursing. They can also discuss other ways to feed your baby.

Older adults over the age of 65 years: There isn't enough data to assess Bijuva-related response differences between older and younger adults. In Women's Health Initiative (WHI) studies, however, the combination of estrogen and progestin is linked to a higher chance of stroke and breast cancer in older adults assigned female at birth. There was also a higher risk of memory problems in adults assigned female at birth who were between 65 and 79 years old.

Children: Bijuva hasn't been studied in children.

Liver problems: If you have liver problems, your liver may have trouble breaking down estrogen and clearing it out of your body. In people with liver impairment, taking Bijuva might increase the likelihood of problems with bile flow from the liver. This is a condition of cholestasis that can lead to yellowing of the skin and eyes. Your healthcare provider will use extreme caution with this medication in people with a liver condition.

Medical conditions with an edema risk: Edema is swelling that happens because of a buildup of fluid in your body. It's a common symptom in certain heart and kidney conditions. Bijuva might worsen this symptom. Therefore, your healthcare provider may want to closely monitor your edema while you're taking Bijuva.

Hypothyroidism: Hypothyroidism is a condition of low or underactive thyroid. Bijuva may worsen your thyroid function. If you're taking levothyroxine (Synthroid), your healthcare provider may need to increase the dose while you're on Bijuva.

Missed Dose

If you accidentally forgot your Bijuva dose, take it with food as soon as you remember. If it's within two hours of your next scheduled dose, however, then skip the missed dose and take the following dose at your next scheduled dosing time. Don't try to double up to make up for the missed dose.

Try to find ways that work for you to help yourself remember to routinely keep your appointments and take your medication. If you miss too many doses, Bijuva might be less effective at relieving your menopausal symptoms.

Your healthcare provider, however, may like to follow up with you every three to six months. During these visits, they will assess whether Bijuva is still necessary for your symptoms. They'll also want to make sure that its risks aren't outweighing its benefits.

Overdose: What Happens If I Take Too Much Bijuva?

The symptoms of a suspected overdose of Bijuva might include:

  • Breast tenderness
  • Drowsiness
  • Nausea and vomiting
  • Stomach pain
  • Tiredness or low energy
  • Vaginal bleeding

If you think that you're experiencing an overdose or life-threatening symptoms, seek immediate medical attention.

What Happens If I Overdose on Bijuva?

If you think you or someone else may have overdosed on Bijuva, call a healthcare provider or the Poison Control Center (800-222-1222).

If someone collapses or isn't breathing after taking Bijuva, call 911 immediately.

Precautions

Drug Content Provided and Reviewed by IBM Micromedex®

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and does not cause unwanted effects. These visits may be every 3 to 6 months. Pelvic exam, breast exam, and mammogram (breast x-ray) may be needed to check for unwanted effects, unless your doctor tells you otherwise. Be sure to keep all appointments.

It is unlikely that a postmenopausal woman may become pregnant. But, you should know that using this medicine while you are pregnant could harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

Using this medicine over a long period of time may increase your risk of breast cancer or endometrial cancer. Talk with your doctor about this risk. Do not use this medicine if you have had your uterus (womb) removed (hysterectomy). Check with your doctor immediately if you experience abnormal vaginal bleeding.

Using this medicine may increase your risk of dementia, especially in women 65 years of age and older.

Using this medicine may increase your risk for having blood clots, strokes, or heart attacks. This risk may continue even after you stop using the medicine. Your risk for these serious problems is even greater if you have high blood pressure, high cholesterol in your blood, diabetes, or if you are overweight or smoke cigarettes. Contact your doctor immediately if you experience chest pain, confusion, difficulty speaking, double vision, headaches, an inability to move arms, legs or facial muscle, or an inability to speak.

Tell the medical doctor or dentist in charge that you are using this medicine before any kind of surgery (including dental surgery) or emergency treatment. Your doctor will decide whether you should continue using this medicine. This medicine may also affect the results of certain medical tests.

Check with your doctor immediately if severe headache or sudden loss of vision or any other change in vision occurs while you are using this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

What Are Reasons I Shouldn’t Take Bijuva?

Before taking Bijuva, talk with your healthcare provider if any of the following applies to you:

  • Abnormal vaginal bleeding without your healthcare provider's awareness or follow-up
  • Estrogen-dependent neoplasms (abnormal growths)
  • History of breast cancer
  • History of clots
  • History of a heart attack, stroke, or similar conditions
  • Liver problems

The following situations or conditions may also require your healthcare provider's attention before starting you on Bijuva:

  • Severe allergic reaction: If you have a severe allergic reaction to Bijuva or any of its components (ingredients), Bijuva isn't a viable option for you.
  • Pregnancy: There is no data on Bijuva use during pregnancy. In studies for combination hormonal birth control options, the combination of estrogen and progestin isn't linked to negative effects on the unborn fetus during early pregnancy. Reach out to your healthcare provider to discuss the benefits and risks of Bijuva during pregnancy.
  • Breastfeeding: The combination of estrogen and progesterone can be present in breast milk—with possible negative effects on milk production. This effect is less likely to happen once breastfeeding is well-established with the nursing baby. Your provider can help you weigh the benefits and harms of Bijuva while nursing.
  • Children: Bijuva hasn't been studied in children.
  • Older adults over 65 years of age: Based on available information from the WHI studies, the combination of estrogen and progestin might increase the likelihood of a stroke and breast cancer in older adults assigned female at birth. This combo is also linked to memory problems in people between people age 65–79 assigned female at birth.
  • History of certain medical conditions that raise your clot risk: Certain medical conditions can raise your likelihood of experiencing a clot. Examples include protein C, protein S, and antithrombin deficiency. These conditions are different, but in general, there is a lack of certain proteins to prevent clotting from happening. Bijuva will likely worsen these conditions with its high clot risk.

What Other Medications Interact With Bijuva?

In general, Bijuva is likely to interact with CYP3A4 inducers and inhibitors. CYP3A4 is a protein in the liver that's responsible for breaking down and clearing out medications—like Bijuva—from the body.

CYP3A4 inducers are medications that encourage the CYP3A4 protein to quickly break down Bijuva. Therefore, Bijuva might be less effective at relieving your menopausal symptoms. Examples of CYP3A4 inducers include carbamazepine (Tegretol) for seizures and rifampin for tuberculosis (TB).

CYP3A4 inhibitors are medications that prevent the CYP3A4 protein from working as well. As a result, there's likely a buildup of Bijuva in your body that's raising your risk of side effects. Examples of CYP3A4 inhibitors include the erythromycin antibiotic and the ketoconazole antifungal.

This is one key interaction with Bijuva. There might be others. For more detailed information about medication interactions with Bijuva, talk with your pharmacist or healthcare provider.

And be sure to talk with your healthcare provider about any other medicines you take or plan to take, including nonprescription products, vitamins, herbs, or plant-based medicines.

What Medications Are Similar?

There are many medications available to help relieve your menopausal symptoms. Hormonal therapy is one option that has many dosage forms, including pills, creams, gels, patches, vaginal inserts, and vaginal rings. Hormonal therapy is also available with just one hormone or a combination of estrogen and progesterone.

Bijuva is a combination hormonal therapy available as an oral capsule. Other oral combination hormonal therapies may include:

  • Activella (estradiol and norethindrone)
  • Amabelz (estradiol and norethindrone)
  • Angeliq (estradiol and drospirenone)
  • Fyavolv (estradiol and norethindrone)
  • Jinteli (estradiol and norethindrone)
  • Mimvey (estradiol and norethindrone)
  • Prefest (estradiol and norgestimate)
  • Premphase (conjugated estrogens and medroxyprogesterone)
  • Prempro (conjugated estrogens and medroxyprogesterone)

Of these listed options, none contains the same combination of estradiol and naturally-occurring progesterone that Bijuva has. Interestingly, the naturally-occurring progesterone in Bijuva might be linked to a lower risk of breast cancer compared to other choices that have progestin (a human-made version of progesterone). More research, however, is needed.

With so many options, it may help to consider the following when deciding:

  • Estrogen dose: Estrogen raises your risk of clots. Therefore, choosing the lowest dose that effectively relieves your menopausal symptoms is recommended.
  • Progestin type: There are different types of progestins. Each type is linked to slightly different side effects that might be more pronounced in some people.

In general, the best treatment for menopausal symptoms will vary by person. Reach out to your healthcare provider. They can help you sort through the different options and choose a viable one for you.

Since all of these options are considered combination hormone therapy, however, they're not typically used together for menopausal symptoms.

Frequently Asked Questions

  • Where is Bijuva available?

    Bijuva is available with a prescription from your healthcare provider. Your local retail pharmacy may carry this medication. If your pharmacy doesn't have it in stock, the staff will likely be able to order Bijuva for you.

  • How much does Bijuva cost?

    Bijuva isn't available as a generic product. As a result, it might be costly.

    If cost is a concern, other oral (by mouth) combination hormonal therapies may have generic versions. Bijuva's manufacturer also has a savings program. For eligibility questions, visit the TherapeuticsMD website or call 844-536-6711.

    Other potentially helpful resources may include NeedyMeds, FundFinder, Simplefill, BenefitsCheckUp, Medicare Rights Center, State Pharmaceutical Assistance Programs (SPAPs), and Rx Outreach.

  • Will I gain weight with Bijuva?

    Weight gain isn't a common side effect of Bijuva, but there are some reports of weight gain with this medication.

  • Will I get cancer with Bijuva?

    Bijuva may raise your risk of breast cancer.

    Interestingly, the naturally occurring progesterone component of Bijuva might have a lower risk of breast cancer when compared to other menopausal treatments that have progestin (human-made version of progesterone). More research, however is needed.

  • Can I stop Bijuva cold turkey?

    Technically, the answer is yes. Some people are able to stop Bijuva cold turkey. For other people, however, slowly stopping Bijuva over time might be more beneficial.

    The best decision will vary depending on your body and your symptoms. When you're ready to discontinue Bijuva, talk with your healthcare provider. They'll be able to advise you on next steps.

How Can I Stay Healthy While Taking Bijuva?

If you're taking Bijuva, chances are menopausal symptoms have been negatively affecting your quality of life. You may have tried different approaches or treatments for your bothersome symptoms of hot flashes and night sweats.

While menopause is a normal part of life, it can happen simultaneously with other challenges and stressors. Thankfully, there are ways to help improve your quality of life. Below are some general suggestions to support your health:

  • Take menopause-related medications as recommended by your healthcare provider.
  • Stay in touch with your healthcare provider. They will regularly assess the need to continue taking Bijuva. When the risks outweigh the benefits, they will help you slowly stop this medication.
  • Consider exercise to help you reduce stress, limit weight gain, and prevent osteoporosis (bone loss).
  • Perform Kegel exercises to improve bladder control and prevent urine (pee) leakage issues.
  • Consider over-the-counter (OTC) vaginal lubricants or moisturizers to relieve vaginal and sexual-related symptoms of menopause.
  • To decrease the severity and duration of your hot flashes, consider dressing in fewer layers, adjusting the temperature, avoiding hot environments, and slowly taking deep breaths.
  • Drinking enough water and avoiding hot or spicy food may help with your hot flashes.
  • Use memory aids such as bulletin boards or phone apps, develop a routine, or write things down to minimize forgetfulness.
  • Consider support groups or mental health professionals to help you find coping strategies that change the way you think, feel, react, or respond to living with menopause.

Medical Disclaimer

Verywell Health's drug information is meant for educational purposes only and is not intended as a replacement for medical advice, diagnosis, or treatment from a healthcare provider. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.

11 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
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  2. Office on Women's Health. Menopause basics.

  3. Office on Women's Health. Menopause symptoms and relief.

  4. MedlinePlus. Estrogen and progestin.

  5. ScienceDirect. CYP3A4.

  6. Office on Women's Health. Menopause treatment.

  7. Food and Drug Administration. Fyavolv label.

  8. Food and Drug Administration. Amabelz label.

  9. Stuenkel CA, Davis SR, Gompel A, et al. Treatment of symptoms of the menopause: an Endocrine Society clinical practice guideline. The Journal of Clinical Endocrinology & Metabolism. 2015;100(11):3975-4011. doi: https://doi.org/10.1210/jc.2015-2236

  10. Food and Drug Administration. Orange book: approved drug products with therapeutic equivalence evaluations.

  11. Hill DA, Crider M, Hill SR. Hormone therapy and other treatments for symptoms of menopause. American Family Physician. 2016;94(11):884-889.

By Ross Phan, PharmD, BCACP, BCGP, BCPS
Ross is a writer for Verywell with years of experience practicing pharmacy in various settings. She is also a board-certified clinical pharmacist and the founder of Off Script Consults.