Bijuva: Weighing the Benefits, Risks, and Costs of this Menopause Treatment

Bijuva (estradiol and progesterone) is an oral prescription medication approved by the Food and Drug Administration (FDA) on October 29, 2018, for women who suffer from hot flashes related to menopause. Bijuva contains bioidentical estradiol and progesterone. While Bijuva is generally noted for its effectiveness in treating menopause symptoms and hot flashes, concerns regarding access and high costs may limit its use.

What is Bijuva?

Bijuva is a brand-name capsule prescribed for treating certain menopausal symptoms. It is a type of hormone replacement therapy (HRT) that includes estradiol and progesterone as the active ingredients, with estradiol being solubilized and progesterone micronized in a capsule. This medication is available in capsule form with dosage strengths of 0.5 mg estradiol/100 mg progesterone and 1 mg estradiol/100 mg progesterone.

Menopause happens when a woman’s ovaries stop producing hormones, and she no longer gets her monthly menstrual cycles. According to the Mayo Clinic, the average age of menopause in the United States is 51. Menopause is officially diagnosed when it’s been a full year since a woman has had her last menstrual period. But menopausal symptoms can happen any time a woman starts to lose estrogen, which includes the transition period leading up to menopause, which is known as perimenopause, and after menopause happens, which is known as postmenopause.

When women are going through menopause, their bodies will slow production of specific hormones like estrogen and progesterone. This relatively sudden dip in hormone levels is what causes the frustrating vaginal dryness, fatigue, and mood swings that characterize menopause. Through HRT, people who are dealing with particularly tricky symptoms may be able to attain relief while their bodies get used to the new norm.

How Bijuva Works

Bijuva works by helping you balance your hormones during a time in your life when being unbalanced is the norm. Bijuva works by replacing a woman’s natural hormones with bioidentical ones. Estradiol directly replaces your body’s lessening levels of estrogen. Progesterone helps keep your uterine lining managed to avoid potentially dangerous overgrowth. The estradiol helps reduce hot flashes, while the progesterone lowers a woman’s risk for endometrial cancer. This combination therapy tends to work very well for many people. Since this helps avoid the necessity of taking multiple medications, it’s an intuitive way to keep menopause symptoms at bay.

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For most people, it’s recommended they take Bijuva at night. Taking Bijuva at night gives the medication the best chance to absorb fully. Your body’s metabolism slows down a bit when you fall asleep, which gives HRT time to seep into your body and work hard for you (instead of immediately being processed and eliminated). Taking Bijuva at night, before bed, at the same time every night, helps maintain stable levels of the hormone in your body. When hormone levels rise and fall, that contributes to tough symptoms for you. Striving for consistent medication administration times and, therefore, consistent blood concentration levels of your HRT, can contribute to more consistent symptom relief.

How to Stay Consistent with Bijuva Dosage

  • Set a reminder in your phone or purchase a dedicated Bijuva alarm clock to give yourself a daily reminder to take the medication at the same time each night.
  • Stack the habit of taking Bijuva with things that you already do each and every night. For example, if you have an already-cemented habit of brushing your teeth, put your supply of Bijuva underneath your toothbrush.
  • Use a pill organizer with dedicated and labeled compartments for each day of the week. This allows you to see at a glance whether you’ve taken your Bijuva for a specific day or not.
  • Download a medication management app, like MyTherapy or Medisafe. This can help you with Bijuva dosage reminders, and also provide a dedicated space for you to track symptoms or take any other relevant notes about your experience with Bijuva.
  • If habit stacking with an existing habit (like brushing your teeth) isn’t working, create a new habit-one you really look forward to! Consider investing in a special type of herbal tea, or checking out a book from your library that you know will hold your attention. Each night, as you enjoy your tea or your book, take your Bijuva.
  • Place a sticky note on your bedside table, your lamp, your water bottle, or your bathroom mirror to take your Bijuva.

A typical starting dosage for most people starting with Bijuva is estradiol 1 mg/progesterone 100 mg. If your doctor wants you to consider a larger dose, they’ll let you know what steps to take.

Clinical Trial Results

Researchers analyzed Bijuva in a large study known as the pivotal REPLENISH trial. Results of this trial, published in June 2017 in the journal Maturitas, which included 1,835 menopausal women, showed Bijuva significantly reduced hot flashes and lowered the risk of a potentially precancerous condition known as endometrial hyperplasia. The medicine should only be used by women who haven’t had their uterus removed surgically. If you don’t have a uterus (due to hysterectomy), you don’t need to take progesterone. Bijuva is taken once every evening with food.

Potential Side Effects of Bijuva

As with other drugs, Bijuva can cause side effects that range from mild to serious. It’s important to be aware of these potential side effects before starting treatment.

Common Side Effects

Some of the more common side effects reported by people who took Bijuva in clinical trials include:

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  • Breast tenderness
  • Headache
  • Nausea
  • Vaginal bleeding
  • Vaginal discharge
  • Pelvic pain

These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

Serious Side Effects

Bijuva may cause serious side effects. If you develop serious side effects while taking Bijuva, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number. Serious side effects that have been reported and their symptoms include:

  • Enlarged fibroids (noncancerous tumors in the uterus), which may include symptoms such as heavy menstrual bleeding and painful sex.
  • Gallbladder disease, which may include symptoms such as abdominal pain, nausea, and vomiting.
  • High blood pressure, which typically doesn’t cause symptoms.
  • Blood clots in your retina. Symptoms can include sudden partial or complete vision loss, double vision, migraine, and proptosis (bulging of one or both eyes).

Boxed Warnings

Bijuva has several boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).

  • Risk of cardiovascular problems: Estrogen plus progestin therapy, including Bijuva, can increase the risk of cardiovascular problems. Examples of these problems include blood clots, heart attack, and stroke. Due to this risk, you should not use Bijuva to prevent cardiovascular problems. (Bijuva is not approved to prevent cardiovascular problems.) Immediately seek medical attention if you develop symptoms of a cardiovascular problem while using Bijuva. Call 911 or go to the closest emergency room. Due to this risk, doctors typically won’t prescribe Bijuva if you have a blood clot or have had one in the past. They also won’t prescribe the medication if you’ve had a heart attack or stroke in the past. Symptoms of blood clots can include pain, swelling, and warmth in the affected arm or leg. A blood clot in the lungs may cause difficulty breathing and chest pain. Symptoms of a heart attack include chest pain or tightness, pain or discomfort in one or both arms, the jaw, neck, or back, shortness of breath, lightheadedness, nausea, or vomiting. Symptoms of a stroke include numbness or weakness on one side of the body, facial drooping, and difficulty with speech.
  • Risk of dementia: Taking estrogen with or without progestin can increase your risk for dementia. (Bijuva contains both estrogen and progestin.) Due to this risk, Bijuva should not be used to prevent dementia. (Bijuva isn’t approved to prevent dementia.) This risk is specific for postmenopausal females ages 65 years and older. The drug’s studies suggest that postmenopausal females under the age of 65 years who took estrogen with or without progestin did not show a risk of dementia. Symptoms of dementia include memory loss, confusion, and trouble communicating.
  • Risk of breast cancer: Treatment that contains estrogen and progestin, including Bijuva, may increase your risk for invasive breast cancer. “Invasive” refers to breast cancer that has spread outside the breast into nearby tissue. Symptoms of breast cancer include pitting or dimpling of breast tissue, nipple or breast pain, and nipple discharge. Due to this risk, doctors aim to prescribe estrogen/progestin treatment (such as Bijuva) for the shortest time at the lowest dose needed to treat your condition. Doctors typically won’t prescribe Bijuva if you have or have had breast cancer.
  • Risk of endometrial cancer: People with a uterus who take estrogen therapy alone may face an increased risk for endometrial cancer. Bijuva contains estrogen, but it also contains progestin. Doctors typically won’t prescribe Bijuva if there’s a history of estrogen-dependent cancer, including endometrial cancer.

Allergic Reactions

For some people, Bijuva can cause an allergic reaction. In general, symptoms of an allergic reaction can be mild or serious. For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication. For severe allergic reaction symptoms, such as swelling or difficulty breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Bijuva, your doctor may recommend taking a different medication instead.

Other Side Effects

  • Weight Gain: It’s not thought to cause weight gain. Weight gain wasn’t reported as a side effect in studies of Bijuva. Weight gain has been reported by people using Bijuva since the drug was approved for use. But because these reports occurred outside controlled studies, it’s not known if Bijuva or other factors caused weight gain. There are many different factors that can contribute to or cause weight gain.
  • Hair Loss: No, hair loss isn’t a known side effect caused by Bijuva. Hair loss wasn’t reported by people taking Bijuva in studies. It’s important to note that hair loss can happen during menopause in some people. Experts believe that this is due to hormonal imbalances that happen during menopause. But Bijuva isn’t known to cause hair loss.

Precautions Before Taking Bijuva

Before taking Bijuva, discuss your health history with your doctor. Bijuva may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:

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  • Asthma
  • Type 1 or type 2 diabetes
  • Epilepsy
  • Migraine
  • Porphyria
  • Lupus
  • Hemangioma of the liver or other liver condition, such as cirrhosis
  • Hereditary angioedema (HAE)
  • High level of triglycerides in your blood
  • Hypothyroidism (underactive thyroid) or hypoparathyroidism (low parathyroid hormone production)
  • Previous allergic reaction to this or a similar drug
  • Pregnancy
  • Breastfeeding
  • Alcohol consumption

Drug Interactions

Bijuva may interact with other medications, herbs, non-prescription drugs, or dietary supplements. Give your health care provider a list of all the medicines you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

Cost of Bijuva

In the United States, people who want to take Bijuva may pay as much as $265.00 for a supply of 30 capsules ($8.80 per capsule). Since Bijuva is generally taken once daily, this amount will last a typical patient one month. Fortunately, you may have other options to consider. Through NorthWestPharmacy.com, a reliable and accredited online Canadian drug store and international pharmacy, you can buy 28 capsules of Bijuva for around $44.00, or approximately $1.50 per capsule.

The reasons for the price difference include:

  • In the United States, pharmaceutical companies often spend huge amounts of money marketing their drugs directly to consumers. They pass those costs directly to the people buying their medication.
  • The United States government can’t step in and set price caps or otherwise regulate how much money pharmaceutical companies can make off their drugs.

Safety Precautions When Ordering Online

  • Verifying the online pharmacy’s credentials through third-party accreditation bodies, such as the Canadian International Pharmacy Association.
  • Making sure that the pharmacy you’re looking at requires prescriptions.
  • Reading previous customer reviews.

User Reviews

User-generated content areas are not reviewed by a WebMD physician or any member of the WebMD editorial staff for accuracy, balance, objectivity, or any other reason except for compliance with WebMD's Terms and Conditions.

  • One user reported that after inquiring about HRT for hot flashes/night sweats, and brain fog, their doctor recommended Bijuva, and after only 2 days, hot flashes were GONE!
  • Another user took Bijuva for perimenopausal mood swings, but it didn’t help with that or sleep. They also gained weight and stopped taking it due to this reason plus questioning any benefit.

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