Bijuve Capsules

What are Bijuve 1mg/100mg Capsules?

Normally women would use Utrogestan 100mg oral capsules as part of their HRT regime. Currently, there is a shortage of this product from the manufacturer Besins. However, during this time to avoid interrupting the HRT treatment we are sourcing other progesterone-containing options so that you can continue with your HRT.

Bijuve is a new Hormone Replacement Therapy (HRT) containing oestrogen and progesterone. It is designed for women who have not had a hysterectomy and whose last period was at least 12 months ago as it is a continuous combined version of HRT

Both oestradiol and progesterone in Bijuve are ‘body identical’ – that is chemically and biologically the same as hormones that naturally circulate in a woman’s body. Bijuve can be used in place of an oestrogen patch (e.g. Evorel) and Utrogestan capsules combination if oral HRT is suitable for you.

What is Bijuve used for?

During menopause, the oestrogen levels in a woman's body drop, which can cause women to experience some unwanted symptoms. Taking Bijuve can help to alleviate these symptoms to help you to continue to enjoy your daily life.

Menopause symptoms include:

• Hot flushes & night sweats
• Disturbed sleep
• Reduced sex drive
• Difficulty remembering or concentrating
• Vaginal dryness
• Headaches
• Low mood or anxiety
• Fragile bones (osteoporosis)
• After menopause, many women are diagnosed with osteoporosis. The condition is marked by weak bones and an increased risk of fractures.

How does Bijuve work?

Women's ovaries gradually produce less oestrogen as they approach menopause, and oestrogen levels in the blood decline as a result. These declining levels can cause distressing symptoms.

Oestrogen in the form of estradiol can be given as a supplement to replace the falling hormonal levels in the body and help reduce symptoms. This is known as HRT. HRT is usually only required for short-term relief from menopausal symptoms. You should review your use at least once a year with your doctor.

Women who have not had a hysterectomy need a progestogen as part of their HRT. This is because, in women with an intact uterus, oestrogen stimulates the growth of the endometrium (uterine lining), which can increase the chance of endometrial cancer occurring if the growth goes unrestricted. Progestogen opposes oestrogen’s effect on the endometrium and reduces the risk of cancer though does not eliminate it entirely. This is known as combined HRT.

Bijuve and weight gain

Although Bijuve, like other HRT, has been reported to cause weight gain in some women, research suggests that this is more likely to be fluid retention and bloating rather than true weight gain.

During menopause generally, it is not uncommon for women to gain weight, especially around their abdomen. It is thought that this is partly due to the imbalance in hormones but is also a natural part of ageing for both males and females as you start to lose muscle mass and your metabolism slows.

Most importantly for both men and women, it is therefore essential that you always try to get enough sleep, eat healthily and exercise regularly as you get older to reduce unwanted weight gain.

Alternatives to Bijuve

The Independent Pharmacy offers a wide range of HRT in the form of tablets, patches and vaginal creams.

Bijuve is unique as it is the first, and only all-in-one oral, body-identical hormone therapy treatment. We do have a range of other oral and topical HRT treatments that we can advise on that could be suitable for you.

If you are currently prescribed Bijuve or HRT shortages affect your prescribed HRT and you would like a suitable alternative, you can start a free online consultation with The Independent Pharmacy. It’s quick and easy to do: just answer a few questions and one of our qualified prescribers can issue your treatment for next-day delivery.

Sources

https://pcwhf.co.uk/news/theramex-launches-bijuva-bijuve-estradiol-and-progesterone-the-first-and-only-body-identical-combined-hormone-therapy-treatment-for-post-menopausal-women/

https://www.medicines.org.uk/e...

https://www.nhs.uk/conditions/...

https://www.nhs.uk/conditions/...

https://www.nhs.uk/conditions/...

https://www.nhs.uk/conditions/stroke/symptoms/

Archer DF, Bernick BA, Mirkin S. A combined, bioidentical, oral, 17β-estradiol and progesterone capsule for the treatment of moderate to severe vasomotor symptoms due to menopause. Expert Rev Clin Pharmacol. 2019;12(8):729–39.

FDA Summary Review. 2018. Available at https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210132Orig1s000SumR.pdf. Accessed May 2023

How to take Bijuve

Read the Patient Information Leaflet carefully before starting Bijuve capsule for full details on how to set up the Bijuve calendar pack and how to take this medication.

Take 1 capsule each day, at around the same time, either before or after eating. Take the capsule continuously, without a break between packs.

Bijuve ingredients

The active ingredients in each BIJUVE capsule are:

1 mg estradiol (as estradiol hemihydrate) and 100 mg progesterone.

Capsule content contains:

• Medium chain mono/diglycerides
• Lauroyl Macrogolglycerides 32
• Capsule shell contains:
• Gelatin, 200 Bloom
• Hydrolyzed gelatin
• Glycerin (E422)
• Allura Red (E129)
• Titanium Dioxide (E171)
• Printing ink (Opacode® White WB) contains:
• Propylene glycol (E1520)
• Titanium dioxide (E171)
• Polyvinyl acetate phthalate
• Polyethylene glycol (E1521)
• Ammonium hydroxide (E527)

Bijuve side effects

Bijuve, like other medications, may cause some people to experience side effects.

If you experience severe side effects or an allergic reaction when taking Bijuve, you must seek medical advice or attend your nearest emergency department as soon as possible. If you are concerned about side effects or they are bothering you, please speak to a pharmacist or doctor for advice.

You should also take time to familiarise yourself with all the warnings and precautions as Bijuve, like other HRT, may increase your chances of getting certain health conditions. You should discuss any questions you have with your doctor before taking this medicine.

The most commonly reported side effects can include:

• Vaginal bleeding
• Breast tenderness or pain
• Headache
• Weight gain caused by water retention
• Vaginal inflammation
• Migraine, new or worse than before
• Fungal vaginal infection
• Depression, new or worse than before
• Nausea
• Abdominal pain, swelling or discomfort
• Breast enlargement or swelling
• Leg cramps
• Back pain
• Uterine fibroid aggravation, occurrence or recurrence
• Swollen arms and legs
• Weight gain

If you are concerned about these effects, or if the product affects you in a different way, stop using it and talk to your doctor or pharmacist.

For more detail read our full guide on Bijuve side effects.

Bijuve warnings

Read the following warnings carefully to ensure you are selecting an appropriate product.

Treatment with HRT carries risks that you should consider before deciding to start it or continue taking it. Once you have started on Bijuve you should see your doctor at least once a year. At these check-ups, discuss with your doctor the benefits and risks of continuing with Bijuve .

Do not take Bijuve if any of the following applies to you:

• If you have, have had or suspect that you have breast cancer
• If you have, have had or suspect that you have cancer of the uterus lining (endometrial cancer) or any other oestrogen-dependent cancer
• If you have unexplained vaginal bleeding
• If you have excessive thickening of the uterus lining that is untreated
• If you have or have ever had a blood clot in a vein such as in the legs or the lungs.
• If you have a blood clotting disorder
• If you have had angina, heart attack, or stroke
• If you have or have ever had a liver disease and your liver function tests have not returned to normal
• If you have a rare, hereditary blood problem called porphyria
• If you are allergic to any of the other ingredients of Bijuve.

Before you start treatment, inform your doctor if you have or have had any of the following conditions since they may return or worsen during treatment with Bijuve:

• Fibroids inside your uterus
• Endometriosis or a history of excessive growth of the uterus lining
• Elevated risk of developing blood clots
• Elevated risk of developing an oestrogen-sensitive cancer
• A liver disorder
• High blood pressure
• Diabetes
• Gallstones
• Migraine or severe headaches
• Systemic lupus erythematosus, SLE
• Epilepsy
• Asthma
• Otosclerosis
• A very high level of triglycerides in your blood.
• Fluid retention as part of cardiac or kidney problems
• If you take medication for an underactive thyroid gland, your doctor will test you during your treatment with HRT to ensure that your hormone levels remain acceptable
• A hereditary condition causing recurrent episodes of severe swelling or if you have experienced rapid swelling of the hands, face, lips, feet, eyes, throat, tongue, or digestive tract
• Lactose intolerance.

Stop taking Bijuve and see a doctor immediately if you notice any of the following:

• Any of the conditions mentioned in the ‘Warnings’ section
• Signs of jaundice. This may signal liver disease
• A significant rise in your blood pressure. Symptoms include headache, tiredness, dizziness.
• Headaches that happen for the first time that resemble migraines
• If you become pregnant

If you notice signs of a blood clot, such as:

• Painful swelling and redness in the legs
• Pain in the chest which comes on suddenly
• Difficulty in breathing

Note: Bijuve is not a contraceptive. If it has been less than a year since your last menstrual period or you are under 50 years old, you may still need additional contraception. Consult your doctor for advice.

Bijuve and cancer

While taking HRT you are at an increased risk of developing an excessive thickening of the lining of the uterus (endometrial hyperplasia), cancer of the lining of the uterus (endometrial cancer) and a slight increase in risk of developing ovarian cancer. The synthetic progesterone in Bijuve protects you from this extra risk.

This risk of developing breast cancer appears to increase the longer you take HRT but does return to normal up to 5 years after stopping treatment. For this reason, it is recommended that you only take HRT for the shortest amount of time to manage your symptoms.

Check your breasts regularly. Talk to your doctor if you notice any changes such as:

dimpling of the skin

changes in the nipple

lumps you can see or feel.

Additionally, you are advised to schedule regular mammogram screenings During the screening, inform the nurse or healthcare professional about your use of HRT, as this medication may increase the density of your breasts and affect the mammogram’s outcome. Where the breast has increased density, mammography may not detect all lumps.

HRT’s Effect on heart and Circulation

Blood clots

Bijuve contains oral oestradiol and so there is likely to be a small increase in the risk of blood clots or stroke when compared with taking oestrogen transdermally (through the skin). However, as the progesterone is body‑identical hormones it is associated with lower risks compared to synthetic versions.

Blood clots can be serious, and if a clot enters the lungs, it can cause chest pain, breathlessness, fainting or even death.

You are more likely to develop a blood clot in your veins as you age and if any of the following applies to you:

• You are unable to walk for an extended period of time due to major surgery, injury or illness.
• If any of your close relatives have had a blood clot in the leg, lung or another organ
• You are overweight (BMI > 30 kg/m2)
• You have systemic lupus erythematosus (SLE)
• You have a blood clotting problem that requires long-term treatment with a medication used to prevent blood clots
• You have cancer

Heart disease (heart attack)

Women over the age of 60 who take oestrogen-progestagen HRT have a slightly higher risk of developing heart disease than those not taking HRT. There is no evidence that HRT will prevent a heart attack.

Stroke

The risk of having a stroke is about 1.5 times higher for HRT users than non-users. The number of extra cases of stroke linked to HRT use will increase with age.

Bijuve and using other medications

Some medicines may interfere with Bijuve. This might lead to irregular bleeding and applies to the following medications:

• Medications for epilepsy
• Medications for tuberculosis
• Medications for HIV infection
• Medications for hepatitis C infections
• remedies containing St John’s Wort (Hypericum perforatum).
• Some medicines increase the effects of Bijuve these include:
• Medicines containing ketoconazole.

You should tell your doctor or pharmacist if you take or have recently taken any other medications, including over-the-counter, herbal medications or other natural products.

Bijuve, Pregnancy and breastfeeding

Bijuve is only suitable in postmenopausal women and is not a contraceptive. If you have had a menstrual period in the last 12 months or are under 50 years old you should discuss contraception with your doctor before taking Bijuve.

If you become pregnant while taking Bijuve stop taking it straight away and contact your doctor. You should also not take Bijuve while breastfeeding.

Before taking Bijuve it is important that you read the Patient Information Leaflet thoroughly