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Author Topic: Bijuve HRT now approved combined Bio identical capsule in UK  (Read 8682 times)

pepperminty

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Bijuve HRT now approved combined Bio identical capsule in UK
« on: January 08, 2022, 07:23:52 AM »

Hi ladies ,

a new HRT has now been approved . I have included a few links and info . It would be good if the admin here could add it to the treatment tabs above. I wonder if the same issue about eating near taking separate Utrogestan applies? - OOW it advises you should take with food! Just found this link also below to patient leaflet .

https://www.medicines.org.uk/emc/files/pil.12922.pdf

Approval of Bijuve (bioidentical estradiol and progesterone) capsules as hormone replacement therapy in the United Kingdom
Publisher: Biospace Inc. Publication date: 09 April 2021
Abstract
This is the first and only oral combined HRT with bio-identical hormones made available to patients across Europe in line with the licensing agreement. It is a combination of 1 mg bio-identical estradiol and 100 mg bio-identical progesterone in a once-daily oral softgel capsule.

https://bnf.nice.org.uk/clinical-medicinal-product-information/bijuve.html

https://www.medicines.org.uk/emc/product/12922

https://www.theramex.com/uk/news/theramex-now-has-approval-for-bijuva/


Dr Paula Briggs, incoming Chair of the British Menopause Society, said, “We know women can be concerned about taking hormones and the impact they may have on their health beyond treating menopause symptoms. The availability of a body-identical progesterone which is well tolerated and has a lower risk profile than oral synthetic progestogens, combined with estradiol in a single capsule, is great news for women. As a healthcare community we should encourage our patients to reconsider the benefits of newer therapeutic options, allowing them to make informed choices.”

Theramex CEO, Robert Stewart, commented, “For many years menopausal women and their healthcare providers have been seeking an EMA approved bio-identical combination therapy. The approval of Bijuva® / Bijuve® represents an important new opportunity for menopausal women suffering from moderate to severe vasomotor symptoms.”


PMxx




« Last Edit: January 08, 2022, 07:30:39 AM by pepperminty »
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Perinowpost

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Re: Bijuve HRT now approved combined Bio identical capsule in UK
« Reply #1 on: January 08, 2022, 08:13:42 AM »

That’s great news Pepperminty, well done for finding it. I’ve just had a quick look and although it says the prog is biodentical it doesn’t say which kind it is (or have I missed it). Either way though a step in the right direction xx
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pepperminty

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Re: Bijuve HRT now approved combined Bio identical capsule in UK
« Reply #2 on: January 08, 2022, 08:56:26 AM »

Hi Perinowpost,

I was under the impression that it is utro as it says body identical . Hopefully the other very well informed and supportive members can help shed some more light.  I wonder what the consensus is -where it has been in use abroad - i am assuming it has in Europe maybe ?  Getting NICE to approve anything for women and menopause here is not an easy task .

PMxx
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Perinowpost

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Re: Bijuve HRT now approved combined Bio identical capsule in UK
« Reply #3 on: January 08, 2022, 09:10:20 AM »

Ah yes might be (I’m always hopeful about new friendly progs, but is that even possible? 🤣). I live in Spain now so will ask if they can get it at my local pharmacy and report back. Currently you can get estrodot and gel but not evorel.

I must say I would be tempted to give it a try x
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Nas

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Re: Bijuve HRT now approved combined Bio identical capsule in UK
« Reply #4 on: January 08, 2022, 10:19:31 AM »

I tried it.
If you take it with an evening meal, it can make you feel very whoozy.
It also gave me awful headaches.
It may work for some though.
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Sfifties

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Re: Bijuve HRT now approved combined Bio identical capsule in UK
« Reply #5 on: January 08, 2022, 11:13:20 AM »

Hi ladies ,
Does anyone know if  the amount of oestrogen in Bijuve would be the equivalent of 1 or 2 pumps of oestrogel?
I am wondering how it compares with the oestrogel and utro?( i am right in thinking those are the only bioidentical option ?)
Since it is only suitable in postmeno with a minimum of one year no periods , i was wondering if anyone who has used oestrogel and utrogestan continuously has used it and if it was better or worse in terms of side effect /bleeding or any other symptoms .
It’s has only been approved recently in Uk but been around longer in  other  countries , so maybe somebody who doesn’t live here would have tried it for a while ….

« Last Edit: January 08, 2022, 11:40:34 AM by Sfifties »
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Nas

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Re: Bijuve HRT now approved combined Bio identical capsule in UK
« Reply #6 on: January 08, 2022, 11:59:46 AM »

Its 1mg so equivalent of 2 pumps i guess?
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pepperminty

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Re: Bijuve HRT now approved combined Bio identical capsule in UK
« Reply #7 on: January 08, 2022, 06:08:46 PM »

Hi Ladies,

Any other option is a bonus - how do we get admin to put it on the treatment tabs?

It could be a slightly tweaked utro version if you can take with food - and then why on earth they can't do that with the separate one - I don't know!

Sorry it did not work for you Nas

PMxx
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Perinowpost

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Re: Bijuve HRT now approved combined Bio identical capsule in UK
« Reply #8 on: January 08, 2022, 06:55:44 PM »

Yes it should be added to the treatment options x
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Dotty

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Re: Bijuve HRT now approved combined Bio identical capsule in UK
« Reply #9 on: January 08, 2022, 07:07:32 PM »

1mg in tablet form is roughly equivalent to a 25mg patch or 1 pump of Oestrogel . X
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sheila99

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Re: Bijuve HRT now approved combined Bio identical capsule in UK
« Reply #10 on: January 08, 2022, 09:56:46 PM »

What a pity they chose to make it a combined pill so there's no option to change the oestrogen dose. We really need more options for progesterone only (and preferably not oral). Hopefully it will help some women.
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pepperminty

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Re: Bijuve HRT now approved combined Bio identical capsule in UK
« Reply #11 on: January 09, 2022, 08:09:47 AM »

What a pity they chose to make it a combined pill so there's no option to change the oestrogen dose. We really need more options for progesterone only (and preferably not oral). Hopefully it will help some women.

Hi Sheila99,

I agree - obviously made by men or non menopausal women! - without any meaningful consultation - But the dose of Utro if using gel is the same for non bleed regime - so I am assuming that one could add a little estrogen if required under supervision of course perhaps.

 I am still wondering how thy managed to get a Utro that you can take with food? And if they did why they can't do that with the separate tablet? 

I would be interested to know the reasoning  why that one you can and one you can't.

PMxx 
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Perinowpost

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Re: Bijuve HRT now approved combined Bio identical capsule in UK
« Reply #12 on: January 09, 2022, 08:46:57 AM »

Yes I was wondering if you could top up with gel to make it useable. Re the taking it with food aspect maybe email Theramex and ask them Pepperminty (I think we’ve been here before 🤣), but worth a try x
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Hurdity

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Re: Bijuve HRT now approved combined Bio identical capsule in UK
« Reply #13 on: January 09, 2022, 10:46:19 AM »

This is great news pepperminty - thanks for posting and all the links. Now I recall in the distant past there was some talk about such a product being developed. Personally I think it is a great alternative for women who just want to take one pill but still take bio-identical hormones.

Re the food issue - its not a question that you can or can't. It's a question of differential absorption under fasting or fed states. Previous studies have shown that the bioavailability of progesterone is increased with food and the instruction is to take without food. Whatever is done (with or without food) needs to be consistent to ensure greater consistency in systemic levels.

If you look at the links pepperminty gave the SPC for Bijuve says this:

 Food Effect

"Concomitant food ingestion increased the extent of absorption (AUC) and peak plasma concentration (Cmax) of the progesterone component of Bijuve relative to a fasting state when administered at a dose of 100 mg. Concomitant food ingestion had no effect on the AUC of the estradiol component of Bijuve, but the rate of estradiol absorption was faster under fasting conditions compared to the fed state. Food increased the Cmax and AUC of the progesterone by 82% and 2.7-fold, respectively, relative to the fasting state.

After multiple doses of Bijuve (estradiol and progesterone) capsules, 1 mg/100 mg taken under fed conditions, the tmax (the time at which the maximum concentration is attained) for estradiol is approximately 5 hours and approximately 3 hours for progesterone (See Table 2, below). Steady state for both estradiol and progesterone components of Bijuve, as well as estradiol's main metabolite, estrone, is achieved within seven days. "


So it looks like the idea of taking it with food is to slow down the rate of absorption of estradiol compared with fasting state - so you don't get sudden peaks (and troughs), and also this (taking with food) has the effect of increasing the bio-availability of progesterone - which is good in terms of endometrial protection.

If one needed more oestrogen ie topping up with gel then really there would be no point in having the combined pill as one might as well stay with gel for the oestrogen component I would say?

Hi Perinowpost,

I was under the impression that it is utro as it says body identical . Hopefully the other very well informed and supportive members can help shed some more light.  I wonder what the consensus is -where it has been in use abroad - i am assuming it has in Europe maybe ?  Getting NICE to approve anything for women and menopause here is not an easy task .

PMxx

Just to clarify - Utrogestan is the brand name for the commercial progesterone preparation manufactured by Besins. It is not a type of progesterone. Progesterone = progesterone. Biologically and medically there is only one type. So when the product says it contains progesterone, that is what it contains - the one and only bio-identcial progesterone structurally identical to our own.

In non-medical "lay" conversations we always refer to progesterone when in fact we mean "progestogen" ie the progesterone like compound used to protect the endometrium. Progesterone is a progestogen....If the term progesterone is used in a medical product then it means progesterone...

So you can take Bijuve or Utrogestan with or without food but it will have a different metabolic time course in the body (known as pharmacokinetic properties - as written in the SPC info!).

I also agree with sheila99 - as has been said many time over the past 10 years on this forum - that we also need more licesned options for progesterone only! This might mean using exsiting products but varying dosages eg licensed alternate day vaginal progesterone and the oestrogen doses that this can work for - to eliminate all the trial and error going on...or longer cycles for post-menopausal women etc How many times do we have to shout about this and when will they listen?!!!

Hurdity x

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pepperminty

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Re: Bijuve HRT now approved combined Bio identical capsule in UK
« Reply #14 on: January 09, 2022, 04:31:16 PM »

Hi Hurdity,

great explanation thanks - have had a busy day so I will read again when my poor meno brain is working.

PMXX
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