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Overview: Bijuva is a combination medicine used to replace estrogen in the body to relieve hot flashes due to menopause. The progesterone component is a progestin hormone that decreases the chance of uterine cancer while taking an estrogen-containing medicine. Common side effects include headache and nausea. Before taking Bijuva, make sure to tell your health care provider about any health conditions or medicines you are taking. Get emergency help if you have trouble breathing, chest pain, or vision changes.

Uses

What is Bijuva used for?

Bijuva is commonly used to treat hot flashes and night sweats due to hormonal changes in menopause.

Bijuva may also be used for other conditions as determined by your health care provider.

How does Bijuva work (mechanism of action)?

Bijuva contains two kinds of hormones: estradiol (an estrogen) and progesterone (a progestin). Estradiol works by replacing estrogen, a hormone your body makes less of during menopause. Progesterone is a progestin hormone that helps balance the effect of estrogen, decreasing the chance of uterine cancer while taking an estrogen-containing medicine. 

How is Bijuva supplied (dosage forms)?

Brands and other names

  • Bijuva

Dosage forms and strengths

  • 0.5 mg/100 mg, 1 mg/100 mg oral capsules

How should I store Bijuva?

Bijuva should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Side Effects

What are the most common side effects of Bijuva?

The most common side effects of Bijuva are listed below. Tell your health care provider if you have any of these side effects that bother you.

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

There may be other side effects of Bijuva that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Bijuva?

While less common, the most serious side effects of Bijuva are described below, along with what to do if they happen.

Severe Allergic Reactions. Bijuva may cause allergic reactions, which can be serious. Stop taking Bijuva and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Blood Clots. Bijuva may cause a blood clot in your arteries or veins and could cause a stroke, heart attack, or venous thromboembolism (VTE), including a blood clot in the lungs (pulmonary embolism), in the back of your eye (retinal vein occlusion), or in your legs or arms (deep venous thrombosis). Stop taking Bijuva and get emergency help if you have any of the following signs of a blood clot.

  • Chest pain or pressure
  • Fast or abnormal heartbeat
  • Trouble breathing
  • Pain in your back, jaw, throat, or arm
  • Sweating, upset stomach, vomiting, or dizziness
  • Sudden weakness on one side of your body
  • Sudden and severe headache
  • Slurred speech or trouble understanding speech
  • Pain, swelling, or tenderness in your arm or leg
  • Vision loss
  • Bulging eyes
  • Double vision

Breast Cancer. You may be at higher risk for breast cancer if you take Bijuva. Call your health care provider right away if you have any of the following symptoms.

  • New lump in your breast or armpit
  • Changes in the size, shape, texture, or temperature of your breast
  • Nipple changes

Ovarian Cancer. You may be at higher risk for cancer in your ovaries (ovarian cancer) if you take Bijuva. Call your health care provider right away if you have any of the following symptoms.

  • Unusual vaginal discharge
  • Belly or back pain
  • Need to pee more often or urgently

Endometrial Cancer. You may be at higher risk for cancer in the lining of your uterus (endometrial cancer) if you take Bijuva. Call your health care provider right away if you have any abnormal vaginal bleeding.

Dementia. Bijuva may increase your risk of a slowing of your brain function, especially if you are 65 or older. Tell your health care provider right away if you or your friends or family notice that you have any of the following.

  • Memory problems, such as asking the same question over and over
  • Confusion or disorientation
  • Trouble with complex but familiar tasks, such as cooking a meal or paying your bills
  • Personality changes, such as depression, agitation, paranoia, and mood swings

Gallbladder Problems. Taking Bijuva can cause gallbladder problems, including cholecystitis and cholelithiasis (also known as gallstones). Call your health care provider right away if you have any of the following symptoms.

  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
  • Fever
  • Pain in your upper stomach area
  • Stool (poop) that is clay-colored

Increased Blood Pressure (Hypertension). Bijuva may increase your blood pressure or make it worse if you have a history of high blood pressure. Call your health care provider if your blood pressure increases while taking this medicine.

If you measure your blood pressure and the top number (systolic) is 180 mm Hg or higher or the bottom number (diastolic) is 120 mm Hg or higher, get medical attention right away. Increases in blood pressure may not be noticeable, but look out for and tell your health care provider right away if you have any of the following symptoms of severely high blood pressure.

  • Sudden severe headache
  • Chest pain
  • Dizziness or confusion
  • Trouble breathing
  • Nausea or vomiting
  • Blurry or other changes to vision
  • Anxiety
  • Buzzing in the ears
  • Nosebleed
  • Feeling of skipped heartbeats

Fluid Retention (Edema). Bijuva can cause fluid retention, also called edema. Fluid retention can cause serious issues in people with certain conditions, such as heart failure or kidney problems. Call your health care provider right away if you have any of the following symptoms.

  • Chest pain
  • Irregular heartbeat
  • Shortness of breath
  • Stretched or shiny skin
  • Swollen body parts, such as the belly or ankles

Warnings & Precautions

Who should not use Bijuva?

Allergies to Ingredients. People who are allergic to any of the following should not take Bijuva.

  • Bijuva
  • Estradiol
  • Progesterone
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Bijuva.

Unusual Vaginal Bleeding. Bijuva should not be used if you have bleeding from the uterus or vagina that is not part of your menstrual cycle or is unusual. 

Cancer. Bijuva should not be used if you have, suspect, or had breast cancer, or a cancer that is sensitive to estrogen. These conditions could worsen if you use Bijuva.

Blood Clots. Bijuva should not be used if you have or had blood clots, including a blood clot in the lungs (pulmonary embolism) or deep venous thrombosis (DVT). In addition, the medicine should not be used if you have a condition that makes your blood more prone to getting blood clots (thrombophilia). Bijuva can increase the risk of developing a blood clot that could be dangerous, even life-threatening.

Heart Attack or Stroke. Bijuva should not be used if you have or had a stroke or heart attack. Bijuva can increase the risk of having a heart attack or stroke that could be dangerous, even life-threatening.

Liver Problems. Bijuva should not be used if your liver is not working as well as it should be. If there is a concern about the health of your liver, your health care provider may do tests to determine if it is working well enough to take this medicine. 

What should I know about Bijuva before using it?

Do not take Bijuva unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Bijuva with other people, even if they have the same condition as you. It may harm them.

Keep Bijuva out of the reach of children.

Take Bijuva once a day in the evening with food.   

People who are 65 and older can be at greater risk for some side effects from Bijuva. Talk to your health care provider about your risks if you are in this age group.

Make sure to keep all follow up appointments with your health care provider. They will use these appointments to check if your dose or medicine needs to be changed. Estrogen-containing medicines should be used at the lowest possible dose for only as long as they are needed.

Perform monthly self-breast exams and have regular pelvic exams (female exam), breast exams (done by a health care provider), and mammograms (x-ray to look closely at breast tissue) before taking Bijuva and during treatment with it.

What should I tell my health care provider before using Bijuva?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Bijuva is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

Tobacco Use. Smoking and tobacco use can increase your risk of getting heart disease, which increases your risk of having a heart attack, stroke, or blood clots. Tell your health care provider if you use any tobacco products before starting Bijuva. 

Upcoming Surgery or Bed Rest. You may be at increased risk for some side effects of Bijuva if you do not move around normally for an extended period of time. Tell your health care provider if you have any upcoming surgeries or need to be on bed rest. Your health care provider can tell you if or when you need to stop taking Bijuva.

High Triglyceride Levels. If you have high triglyceride levels, Bijuva may make your triglycerides even higher. Very high triglyceride levels can lead to inflammation of the pancreas, which is called pancreatitis. Tell your health care provider if you have high triglyceride levels.

Hysterectomy. Bijuva contains a progestin to decrease the chance of getting cancer of the uterus. Tell your health care provider if you have had a hysterectomy and do not have a uterus.

Uterine Fibroids. Bijuva may cause tumors (fibroids) in your uterus to get bigger. Some fibroids are small and cause no symptoms, while others may grow and cause problems. Talk to your health care provider if you have any of the following symptoms.

  • Heavy, long, painful periods
  • Pain in the lower belly or back
  • Painful sex
  • Peeing often 
  • Discomfort in the rectum

Other Medicines and Supplements. Bijuva may interact with other medicines and supplements. Before taking Bijuva, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. People who can become pregnant are not usually prescribed Bijuva. Tell your health care provider if you are pregnant or plan to become pregnant. If you become pregnant while using Bijuva, stop using the medicine right away and contact your health care provider.

Breastfeeding. Bijuva can pass into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should use Bijuva while breastfeeding.

How can I get more information about Bijuva?

For more information about Bijuva, you can visit the drugmaker’s website at www.bijuva.com or call them at 844-825-8500.

Interactions

Does Bijuva interact with foods or drinks?

Bijuva should be taken with food.

Eating grapefruit or drinking grapefruit juice while taking Bijuva can increase the level of estrogens in your body. Talk to your health care provider if you eat grapefruit or drink grapefruit juice. 

It is unknown if drinking alcohol will affect Bijuva.

Does Bijuva interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Bijuva.

  • Carbamazepine (Carbatrol, Tegretol, and others), which is a medicine commonly used to treat seizures or nerve pain
  • Clarithromycin or erythromycin (Ery-Tab and others), which is a medicine used for bacterial infections
  • Ketoconazole or itraconazole (Sporanox, Tolsura), which is a medicine used for fungal infections
  • Phenobarbital, which is a medicine that may be used to treat seizures
  • Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis
  • Ritonavir (Norvir), which is a medicine commonly used to treat HIV
  • St. John’s wort, which is a supplement that may be used to treat depression 

Some other medicines may alter the blood levels of Bijuva. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Bijuva. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Bijuva?

If you or someone else has used too much Bijuva, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Bijuva?

If you miss a dose, take it with food as soon as you remember. If it is within two hours of your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.