Patient Medication Information: uses, side effects, how to take - Bijuva
What is BIJUVA used for?
- BIJUVA is used to reduce and relieve vasomotor symptoms (hot flashes and night sweats). It is only used in postmenopausal women with an intact uterus.
You should carefully discuss the risks and benefits of hormone replacement therapy (HRT) with your healthcare professional. You should regularly talk with your healthcare professional about whether you still need treatment with HRT.
Serious Warnings and Precautions
The Women’s Health Initiative (WHI) trial was a large clinical study. This study assessed the benefits and risks of two oral therapies (combined estrogen plus progestin and estrogen-alone) compared with placebo (a pill with no active ingredients) in postmenopausal women. In postmenopausal women taking oral combined estrogen plus progestin, the WHI trial indicated an increased risk of myocardial infarction (heart attack), stroke, breast cancer, pulmonary emboli (blood clots in the lungs), and deep vein thrombosis (blood clots in the large veins). In postmenopausal women taking oral estrogen-alone, who had a prior surgery to remove the uterus (called a hysterectomy), the WHI trial indicated an increased risk of stroke and deep vein thrombosis. Therefore, you should highly consider the following:
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How does BIJUVA work?
BIJUVA contains 2 female hormones, called estradiol and progesterone. Estradiol is a type of estrogen. Progesterone is a type of progestogen. Estrogen acts on different tissues in the body to help treat symptoms of menopause.
Like estrogens produced by your body, BIJUVA may also cause overgrowth of the lining of the uterus. This may increase the risk of endometrial cancer (cancer of the lining of the uterus). The risk is lowered if progestogen is given together with estrogen.
What are the ingredients in BIJUVA?
Medicinal ingredients: estradiol (as estradiol hemihydrate) and progesterone (micronized).
Non-medicinal ingredients: FD&C Red #40, gelatin, glycerin, hydrolyzed gelatin, lauryl polyoxyl-32 glycerides, lecithin, medium chain mono and di-glycerides, medium chain triglycerides, pharmaceutical ink, purified water, and titanium dioxide.
BIJUVA comes in the following dosage forms:
Oral capsules provided in two strengths:
- 1 mg estradiol / 100 mg progesterone (micronized);
- 0.5 mg estradiol / 100 mg progesterone (micronized).
Do not use BIJUVA if:
- you are allergic to estradiol or progesterone or to any of the non-medicinal ingredients in BIJUVA or a component of the container (see What are the ingredients in BIJUVA?)
- you have or have had liver problems, and blood tests to measure how your liver is working have not returned to normal
- you have, might have or had cancer that is sensitive to estrogens or progestogen (e.g. breast cancer or endometrial cancer)
- you have an untreated overgrowth of the lining of the uterus (endometrial hyperplasia)
- you have (or have had) a personal history of known or suspected breast cancer
- you have unexplained bleeding from the vagina
you are pregnant or think you may be pregnant. Since pregnancy may be possible early in menopause while you are still having spontaneous periods, you should talk to your healthcare professional about using non-hormonal birth control. BIJUVA is not a birth control.
- you are breast-feeding
- you have or have had a heart attack, stroke, a blockage or narrowing of the arteries around the heart (called coronary heart disease)
- you have migraine (headaches)
you have or have had blood clotting problems:
- deep vein thrombosis (blood clots in big veins)
- pulmonary embolism (blood clots in the lung)
- thrombophlebitis (inflammation of a vein caused by a blood clot)
- you have eye problems that are caused by low blood flow to the eyes.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take BIJUVA. Talk about any health conditions or problems you may have, including if you:
have or had uterus problems:
- fibroids (growths) inside your uterus
- endometriosis (growth of the uterine lining outside your uterus)
- a history of endometrial hyperplasia (overgrowth of the lining of the uterus)
- have had a hysterectomy (surgical removal of the uterus).
have a personal or family history of:
- breast problems (including breast lumps and breast cancer)
- blood clots, heart disease or stroke.
- have a history of allergy or intolerance to any drugs or other substances
- have ear problems affecting the eardrum and hearing called otosclerosis
- have a history of liver problems like liver tumours (hepatic hemangioma), yellowing of the eyes and/or skin (jaundice) or itching
- have been told that you have a condition called hereditary or acquired angioedema or if you have had events of rapid swelling of the hands, feet, face, lips, eyes, tongue, throat (airway blockage), or digestive tract
- have or had migraine, headaches, trouble speaking, paralysis or loss of consciousness. These are symptoms of blood blockage to the brain.
- have or had high blood pressure
- have or had asthma
- have kidney problems
- have seizures (epilepsy)
- have a disease of the immune system that affects many organs of the body. This is called systemic lupus erythematosus.
- have or had bone disease (this includes certain conditions or cancers that can affect blood levels of calcium and phosphorus)
- have low or high levels of calcium
- have or had diabetes or a family history of diabetes
- have or had high levels of fat in your blood (cholesterol, triglycerides)
- had or will have surgery
- have a disease that affects how the blood functions (porphyria)
- have thyroid problems
- have biliary problems (gallbladder disease, bile problems)
- smoke.
- You are less than 18 years of age or over 65 years of age
Other warnings you should know about:
Cancer
Breast Cancer: The results of the WHI trial indicated an increased risk of breast cancer in post-menopausal women taking combined estrogen plus progestin compared to women taking placebo.
The results of the WHI trial indicated no difference in the risk of breast cancer in postmenopausal women with prior hysterectomy taking estrogen-alone compared to women taking placebo.
There is an increased risk for breast cancer in women taking menopausal HRT for many years. The risk increases the longer you take HRT and persists for more than 10 years after stopping treatment with both estrogen plus progestin therapy and estrogen-alone therapy.
If you have had breast cancer, you should not take estrogens with or without progestins.
If you have a family history of breast cancer or have had breast lumps, breast biopsies or abnormal mammograms (breast x-rays), talk to your healthcare professional before starting HRT.
Women should have a mammogram before starting HRT and at regular intervals during treatment as recommended by their healthcare professional.
Regular breast examination by a healthcare professional and regular self-breast examinations are recommended for all women. You should review techniques for breast self-examination with your healthcare professional.
- Ovarian Cancer: Women who take estrogen-only or combined HRT (estrogen-progestin) for 5 or more years have a slightly higher chance of ovarian cancer.
Overgrowth of the lining of the uterus and cancer of the uterus
There are reports of endometrial hyperplasia (overgrowth of the lining of the uterus) seen in women using BIJUVA.
The use of estrogen-alone therapy increases the risk of developing endometrial hyperplasia, which increases the risk of endometrial cancer (cancer of the lining of the uterus). These risks apply to post-menopausal women with a uterus.
Progestogen is added to estrogen therapy to reduce the risk of endometrial hyperplasia.
Talk to your healthcare professional about the risk factors for overgrowth and cancer of the uterus lining. You should report any unexpected or unusual vaginal bleeding.
Heart Disease (Heart Attack) and Stroke
The WHI trial showed:
- An increased risk of stroke and coronary heart disease in postmenopausal women taking combined estrogen plus progestin.
- An increased risk of stroke, but no difference in the risk of coronary heart disease in postmenopausal women with a previous hysterectomy taking estrogen-alone.
Abnormal Blood Clotting (including pulmonary embolism and deep vein thrombosis)
The WHI trial showed:
- An increased risk of pulmonary emboli and deep vein thrombosis (blood clots in the lung and in big veins) in postmenopausal women taking combined estrogen plus progestin.
- An increased risk of deep vein thrombosis, but no difference in the risk of pulmonary emboli in postmenopausal women with previous hysterectomy taking estrogen-alone.
You are more likely to get a blood clot in your veins as you get older. Blood clots can be life-threatening or cause serious disability. Talk to your healthcare professional if any of the below situations apply to you:
- you use estrogens
- you are overweight and your BMI is greater than 30
- you have any blood clotting problem that needs long-term treatment with a medicine used to prevent blood clots
- any of your close relatives has ever had a blood clot in the leg, lung or another organ
- you smoke
- you have systemic lupus erythematosus (an autoimmune disease)
- you have cancer
The risk for blood clots is also temporarily higher if you are immobilized for long periods of time and following major surgery. If you are going to have a surgery, tell your healthcare professional that you are taking BIJUVA. You may need to stop taking BIJUVA at least 4 weeks before the surgery to reduce the risk of a blood clot. Ask your healthcare professional when you can start taking BIJUVA again.
Gallbladder Disease
The use of estrogens by postmenopausal women has been associated with an increased risk of gallbladder disease that needs surgery.
Dementia
The Women’s Health Initiative Memory Study (WHIMS) was a sub-study of the WHI trial. The WHIMS study showed:
- An increased risk of dementia (loss of memory and intellectual function) in postmenopausal women age 65 and over who were taking oral combined estrogen plus progestin.
- No difference in the risk of dementia in postmenopausal women aged 65 and over who had previously had a hysterectomy and were taking oral estrogen-alone.
Physical exam, tests, and check-ups:
Before you start taking BIJUVA, you will need to have examinations and tests. These will include a physical exam, a Pap smear and a breast exam. Your healthcare professional will ask you about your personal and your family’s health history. You will also have your blood pressure taken as well as blood tests and a mammogram (breast x-ray). A uterus tissue sample might be needed.
While you are taking BIJUVA, check your breasts often and get regular check-ups with your healthcare professional.
Your first check-up should be within 3 to 6 months of starting BIJUVA. Thereafter, these should be scheduled at least once a year. These check-ups will help to identify any side effects you may have. Your visits may include a blood pressure check, a breast exam, a Pap smear, and pelvic exam. You will also have repeat mammograms and blood tests. Your healthcare professional will decide when these are necessary and will interpret the results.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with BIJUVA:
- medicines used for the prevention or treatment of blood clots (anticoagulants), such as warfarin
- medicines used to treat diabetes, such as glyburide and insulin
- medicines used to treat HIV/AIDS, such as ritonavir, nelfinavir, amprenavir, efavirenz, nevirapine and fosamprenavir
- medicines used to treat high blood pressure, such as verapamil and diltiazem
- medicines used to help you relax or sleep, such as barbiturates and meprobamates
- phenylbutazone, a nonsteroidal anti-inflammatory drug (NSAID) used to treat fever, pain and inflammation
- rifampicin, used to treat tuberculosis
- medicines used to treat epilepsy and seizures (anticonvulsants), such as phenobarbital, phenytoin, oxcarbazepine, hydantoins, and topiramate
- St. John’s Wort, used to treat depression
- medicines used to treat bacterial or viral infections, such as clarithromycin, erythromycin, rifampin, and rifabutin
- medicines used to treat fungal infections, such as ketoconazole, fluconazole and itraconazole
- medicines used for the treatment of Hepatitis C Virus infections, such as boceprevir, and telaprevir
- grapefruit juice
- alcohol
How to take BIJUVA:
- Always take BIJUVA exactly as your healthcare professional has told you.
Take BIJUVA, by mouth, each evening with food.
Usual dose:
- One capsule per day.
Your healthcare professional will monitor your health. They may interrupt, change, or stop your dose. This may occur based on your current health, if you take certain other medications or if you have certain side effects.
Overdose:
Signs of an overdose may include feeling sick, breast discomfort, fluid retention, bloating and vaginal bleeding. Other signs may include feeling sad, tiredness, acne, and excess hair growth.
| If you think you, or a person you are caring for, have taken too much BIJUVA, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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Missed Dose:
If you forget to take a capsule, take it as soon as you remember. However, if the dose is close to the next scheduled dose, skip the missed dose and continue with your next scheduled dose. Do not take a double dose to make up for a missed one. If you forget several capsules, you may get some slight vaginal bleeding or spotting.
What are possible side effects from using BIJUVA?
These are not all the possible side effects you may have when taking BIJUVA. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- Headache, dizziness, irritability
- Stomach, abdominal, back and joint pain
- Pelvic pain and cramping
- Nausea
- Abdomen that is swollen outward
- Diarrhea
- Not feeling like yourself
- Feeling bloated and gassy
- Feeling tired (fatigue)
- Weight gain
- Vaginal bleeding, spotting, discharge
- Vaginal infection: discomfort, pain, odor, itching
- Urinary tract infection: pain or burning feeling when urinating
- Loss of scalp hair
- Excess hair on face, chest, abdomen or legs
- Breast tenderness, pain, swelling
- Acne, rash, dry and itchy skin
- Congested or runny nose
- Upper respiratory infection: cough, fever, sore throat, runny nose
BIJUVA can cause abnormal blood test results. Your healthcare professional will decide when these are necessary and will interpret the results. They will tell you if your test results are abnormal and if you need treatment.
The risks related to oral estrogen should be considered as well. Serious side effects that are possible with BIJUVA, as well as oral estrogen, are listed in the table below.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Uncommon | |||
| Breast abnormalities (including breast cancer): dimpling or sinking of the skin, changes in the nipple, or any lumps you can see or feel, discharge from breasts, enlarged breasts, swelling | √ | ||
| Gallbladder problems: fever, nausea, pain that radiates to your shoulder or back, severe pain in your upper right abdomen, vomiting | √ | ||
| Deep vein thrombosis (blood clot in the legs) or Thrombophlebitis (inflammation of a vein often in the leg): sudden leg swelling or pain; redness, warmth, tenderness and pain in affected area | √ | ||
| Hypersensitivity (allergic reaction): fever, skin rash, hives, itching, swelling, shortness of breath, wheezing, runny nose, itchy, watery eyes | √ | ||
| Dementia (memory and thinking problems): memory loss, impaired thinking, difficulty speaking, loss of control of body movements, disorientation, trembling | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Stroke (blood clot in the brain): sudden severe headache, vomiting, dizziness, fainting, problems with your vision or speech, weakness or numbness in the face, arm, or leg | √ | ||
| Pancreatitis (inflammation of the pancreas): upper abdominal pain, fever, rapid pulse, nausea, vomiting, tenderness when touching the abdomen | √ | ||
| Pulmonary embolism (blood clot in the lungs): sharp chest pain, coughing up blood, or sudden shortness of breath | √ | ||
| RARE | |||
| Coronary artery disease (blocked or narrowing of heart arteries): crushing chest pain and pressure, shortness of breath | √ | ||
| Depression (sad mood that won’t go away): difficulty sleeping or sleeping too much, changes in appetite or weight, feelings of worthlessness or hopelessness, withdrawal from social situations, reduced libido (sex drive) and thoughts of death or suicide. | √ | ||
| Endometrial hyperplasia or cancer (abnormal growth or cancer of the lining of the uterus): unexpected, abnormal and/or severe vaginal bleeding | √ | ||
| Erythema multiforme (an allergic skin reaction): raised red or purple skin patches, possibly with blister or crust in the center; possibly swollen lips, mild itching or burning | √ | ||
| Erythema nodosum (swelling of the fat cells under the skin): tender red lumps usually on both shins | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Neuro-ocular lesions (damaged eye nerves): blurred vision, sudden complete or partial loss of vision in eye, eye pain | √ | ||
| Hypertension (high blood pressure): shortness of breath, fatigue, dizziness or fainting, chest pain or pressure, swelling in your ankles and legs, blush colour to your lips and skin, racing pulse or heart palpitations | √ | ||
| Liver problems: yellowing of your skin and eyes (jaundice), right upper stomach area pain or swelling, nausea or vomiting, unusual dark urine, light coloured stool, unusual tiredness | √ | ||
| Ovarian cancer: abdominal pain or bloating, quickly feeling full after eating, weight loss, pain in pelvis, change in bowel habits, need to urinate often | √ | ||
| Peripheral edema (swelling of the legs or hands caused by fluid retention): swollen or puffy legs or hands, feeling heavy, achy or stiff | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Store the container at room temperature (15°C - 25°C).
Protect from light.
Keep out of reach and sight of children.
If you want more information about BIJUVA:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (https://knighttx.com), by emailing medinfo@knighttx.com or by calling 1-844-483-5636.