name brand Entocort no longer available

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DebE13
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name brand Entocort no longer available

Post by DebE13 »

Has anyone else been told that the name brand Entocort is temporarily unavailable and is being discontinued. I was going to see if the name brand product would be more effect that the generic budesonide. Went to pick it up yesterday and the Walgreens said they had nothing for me (didn't even call me to give a heads up either). I couldn't fill my old prescription since the new name brand one cancelled it out. Needless to say I wasn't too thrilled to have wasted a trip. I called my GI and they weren't aware of this either.

If the budesonide isn't that effective to begin with, is the tapering process as tricky? I'm getting the refill since I don't want to just stop taking it. The nurse asked if I wanted to schedule another appointment as a follow up since I told them it isn't helping. This has been the case for quite some time and I've already told them I won't take prednisone again. I'm not sure what other options they would have to offer. The cholestyramine didn't help so I know I can check that off the list. I told them I wanted to hold off for a few months since I wanted to see if the adjustment in my thyroid meds might help. She probably thought I was nuts and making excuses but at this point it doesn't pay to waste time and money if I'm not receptive to their alternative suggestions.
Deb

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tex
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Post by tex »

Deb,

That's a heck of a note. AstraZeneca developed Entocort EC roughly 20 years ago. In 2004 they sold the rights to market Entocort to Promethius Laboratories. After their patent expired, they sold the rights to market a generic that was identical to Entocort EC except for the packaging, to Par Pharmaceuticals. In July of 2015 they sold all rights (not just marketing rights, but a complete divestiture) for Entocort EC and the generic version that Par was selling to Perrigo Company plc for 380 million bucks, according to a news release. The deal was completed in November, 2015.

But Perrigo's third quarter financial report (2016) showed some substantial losses and a significant reduction in share value. It's possible that the board of directors may have stopped production of some products as a cost cutting measure. Or maybe it's just a temporary interruption. We can only guess, because I haven't been able to find any recent news releases.

Despite the fact that budesonide may not help with digestive system symptoms, it will still almost surely have a normal effect on your adrenal function, so if you have been taking it for more than a year, weaning the dose would be prudent, in order to prevent any corticosteroid-related withdrawal effects.

I would guess that your GI doc may have in mind suggesting the Pepto treatment, or an immune system suppressant, such as Imuran or methotrexate, but that's nothing more than just a guess.

Tex
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It is suspected that some of the hardest material known to science can be found in the skulls of GI specialists who insist that diet has nothing to do with the treatment of microscopic colitis.
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Post by bttory »

First I am sorry to hear of your troubles I hope things get better for you soon. Second your email about the brand-name pill no longer being available is of great concern to me. Here's why: I was put on the generic form of the Entocort pill within the last two or three weeks. I assumed it was a cost saving measure and didn't think much about it. I had been making progress weaning off the pill, before I was put on the generic brand. But as Tex knows, my progress started to reverse recently, and I have been dealing with significant bloating, gas, and discomfort for the last two or three weeks or so, despite being on Entocort. Well, after much thinking about what could be causing my issues, it dawned on me that the issues came about after I started on the generic pill. I was fortunate enough to have stashed away a week or so of the brand-name Entocort as a just in case safety measure. I tried the brand name Entocort and took that instead of the generic brand. Within a day or two of being on the brand-name pill,all of my gas, significant bloating, and other issues went away. I was going to wait until I had another two or three weeks of this test under my belt to inform the group that perhaps there is a problem with the generic pills. But, given your message, it seemed appropriate to raise the issue with the group now. i'm not sure what differences there are between the two pills, and even if they are identical, perhaps the manufacturing facility where they are made as open the door for some cross contamination of some sort, or something that bothers my stomach. Either way, this is and issue of concern for me, and I'd be interested in hearing if others have any issues with the generic brand. The brand I take is a pink or red pill, with " Mylan 7155" printed on the pill. Thanks for letting us know and my thoughts and prayers will be with you as you are finding a solution and recovering.
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Post by DebE13 »

I was surprised too but wasn't expecting the name brand would do much better anyway. I just wanted to check it off my list as something I gave a try. I couldn't find anything on the internet either related to it. I've only been back on it for a couple months. Previous to that my last dose was on December 18, 2015 so I did have a bit of a break from it but I am still going to taper off slowly. I discontinued the budesonide about the same time I started the LDN and though that was the reason for my success but that is not the case. I've tried the Pepto protocol- not even a slight improvement. I am sure the immune system suppressant is next on their list because I've tried all the others when I was first dx. I'm not sure if it would be worth trying them again now that I do have a better grip on what's going on but I seriously doubt it. I did try the cholestyramine for a second time, hoping I would find some relief, but it actually made me feel worse and I discontinued. Maybe I didn't give it long enough to take effect but feeling worse just wasn't worth it. If I'm not going to try it their way, I can't see the sense in making a repeat follow up visit. I'd rather stick with the annual check in to keep me as a patient. I'd avoid them all together but I'm on the three colonoscopy plan due to pre cancerous polyps. For that reason, I need to stick with them.

bttory- I take the same pink pill from Mylan.
Deb

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-Ralph Waldo Emerson

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2013 Hashimoto's - numbers always "normal"
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Post by tex »

Here is a listing of current manufacturers of generic Entocort EC (budesonide) capsules:

Manufacturer: BARR LABS DIV TEVA
Approval date: April 2, 2014

Manufacturer: MAYNE PHARMA
Approval date: April 8, 2016

Manufacturer: MYLAN
Approval date: May 16, 2011

While the active ingredient is the same, note that most generic drugs use different inactive ingredients, and inactive ingredients are a very common cause of adverse reactions to drugs

I would ask my pharmacist about this one, introduced only last April:

https://www.maynepharma.com/products/us ... -capsules/

Or this one, introduced in April, 2014:

https://www.tevagenerics.com/product/bu ... ric-coated

Tex
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It is suspected that some of the hardest material known to science can be found in the skulls of GI specialists who insist that diet has nothing to do with the treatment of microscopic colitis.
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Post by bttory »

Good info, thanks. My hope is the issues I had with the generic pill are unique to me (i.e., something in the pill doesn't settle well with me) and does not affect anyone else. Either way, I'll let you all know if I learn anything more about the brand name Entocort issue.
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Post by jlbattin »

I took Budesonide when I was diagnosed and went back on it over Thanksgiving when I had my minor setback. It works very effectively for me. In fact, I took only 2 capsules a day for about 3 days and had to cut back because I was getting constipated.
Jari


Diagnosed with Collagenous Colitis, June 29th, 2015
Gluten free, Dairy free, and Soy free since July 3rd, 2015
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Post by Sylsmith »

I took budesonide when I was first diagnosed in September 2015. I took 3mg a day for 6 weeks, then tapered off over the next few weeks. My Diarrhea stopped within 3 or 4 days of taking the pills, and the remission lasted for several months. The next time it flared up in late July, I took it again, but this time it took longer for the D to stop. I am still dealing with the 3rd episode and took 3mg Budesonide for 3 weeks, then tapered off as I only had 50 pills left. It doesn't seem to have had any effect, even though I'm watching my diet and have cut out a lot of foods. I need to get this under control, but not sure I want to go to the expense of more budesonide.

As a side note, the first time I took it, I got it from Walgreens. The second time I got it from a Canadian pharmacy and it was manufactured in India. I had borrowed a box from a friend until my order came in - same manufacturer. I order 300 pills at that time and took the last 50 during the last 3 weeks. My friend, who has collagenous MC, says it works great for her and she only takes 1 pill every 2 or 3 days, after the initial peroid of 3mg/day to control symptoms.

If anyone else has had this type of experience, I would be interested in your comments.

Thanks!

Sylvia
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tex
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Post by tex »

Hi Sylvia,

The declining effectiveness with repeat treatments is a known issue with all corticosteroids. They simply do not work as well after a treatment is stopped and then started again. As long as corticosteroids are working, they will continue to work as long as the treatment is continued. But after the treatment is stopped for a couple of months, if a new treatment is started again, they will not be as effective as they were previously. And this will be true for each and every subsequent treatment period. Eventually a point will be reach at which they will no longer be effective. In many cases a larger dose will be effective, but the same repeat limitations apply, so that larger and larger doses will be needed with repeat treatments. Most gastroenterologists are not willing to prescribe budesonide on this basis because of the increasing risk of adverse side effects with larger doses.

This is discussed in more detail on pages 60–61 of the MC book.

For most people, the product from the Indian pharmacy seems to work just as well as any version sold in the U. S., at a small fraction of the cost of the versions sold in the U. S.

It's likely that your MC symptoms are being perpetuated either by a food sensitivity that remains in your diet (or cross-contamination of your diet), or a drug or supplement that you are taking, or a high stress level.

I hope that some of this is helpful.

Tex
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It is suspected that some of the hardest material known to science can be found in the skulls of GI specialists who insist that diet has nothing to do with the treatment of microscopic colitis.
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Post by Sylsmith »

Thanks for the info. I'm going to order your book today. I just marvel at the fact that doctors won't tell you about how budesonide works. All my MD said about it was he didn't want me to take it long term, but didn't offer any other solutions except to try the FODMAP diet. It conflicts with what I'm hearing on this website in several ways, so I've been listening more to what my fellow MC sufferers say.

Thanks again!

Sylvia
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Post by Gloria »

My copay for Budesonide from Walgreens has gone up from $132 for 90 capsules in 2016 to $311.38 for the same 90 capsules in 2017, a cost that is 2.4 times as much.

I called a local compounding pharmacy to see how much it would cost for a compounded prescription. The pharmacist said that they cannot compound the identical pill because it is copyrighted. He said he could make a 2 mg capsule, but not a 3 mg capsule, because he can't make the pill in identical form as one that is available in the market. In addition, the capsule would contain powder, not granules. That last condition bothers me because the encapsulation of the Budesonide makes it less systemic and safer to take long-term.

I regularly take apart the capsule to distribute the granules between two capsules. There is some variation in the quantity of granules per capsule; 19-21 are usually in each capsule.

I'm considering ordering the Budesonide from India. I'm wondering if the capsules contain powder or coated granules. Can anyone who gets Budesonide tell me what type of medication, powder or granules, is in the capsule? If is in the form of granules, how many are in a capsule?
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tex
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Post by tex »

Hi Gloria,

The "CR" in Budez CR stands for controlled release, so I'm sure the granules have an enteric coating/encapsulation. It's manufactured by Sun Pharma, and the listed inactive ingredients are ethyl cellulose, tributyl acetylcitrate, methacrylic acidcopolymer, triethylcitrate, Antifoam M, polysorbate 80, talc, sucrose, maize (corn) starch, gelatine, and iron oxide.

FWIW, Sun Pharmna makes many of the generic drugs sold by the big pharmaceutical companies. They just mark the pills and packages to match the respective drug companies. Most people just assume that they're made by the company that owns the brand on the package, but that's not true for most generics. Sun Pharma is a huge company and they have manufacturing plants in many countries in the world, including the U. S.

https://en.wikipedia.org/wiki/Sun_Pharmaceutical

I see that their price for 90 capsules has crept up to $49.66. About a 10 % increase over what it was a year or 2 ago. Apparently they're not as greedy as the U. S. pharmaceutical and insurance companies.

Tex
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It is suspected that some of the hardest material known to science can be found in the skulls of GI specialists who insist that diet has nothing to do with the treatment of microscopic colitis.
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