Plaquenil / hydroxychloroquine shortage update and a question

[milkwoman]

Hi all -

There's been talk on several of the HU boards regarding the shortage of Plaquenil and hydroxychloroquine. Since I've only been able to tolerate the name brand (generics cause me stomach/GI issues), I was concerned to hear this so I spoke with my pharmacist and also did some research. (The two generics I have tried are by Ranbaxy and Prasco Labs - I cannot tolerate either).

It's important to note that I am in the United States.

Here's some history:

On April 4, 2013, Covis Pharma (a Swiss-based company) acquired full commercial rights for Plaquenil (and 4 other products) in the United States from Sanofi. Sanofi retained the existing rights for Plaquenil in countries outside the United States. Covis is the manufacturer of the name brand Plaquenil tablets I have been taking for about a year with no issues.

In April 2015, Concordia acquired Plaquenil from Covis (this is the manufacturer of the Plaquenil tablets I have been taking and have no issues with). The ASHP (American Society of Health-System Pharmacists) reported a shortage of certain generics manufactured by Ranbaxy and Sandoz. No shortage in the U.S. for the name brand or other generics.

I went onto the Concordia website and they list Hydroxychloroquine Zentiva as the generic for their name brand. I took this information to my pharmacist to day with the hope they could order THIS SPECIFIC generic for me to try. If I can tolerate it, my medication costs would be significantly lower. The pharmacist didn't see it listed for her to order, but she was going to look into it and get back to me.

QUESTION: are there any folks, in the U.S. or otherwise, who have tried the Zentiva generic? Does it work for you (when other generics did not)? Anyone in the U.S. been able to get the Zentiva generic?

Thanks!

p.s. I've crossposted this information across several boards so everyone gets the information.

[Paul_Howard Partner LUPUS UK]

I can't say for certain whether the names between the UK and the US will be the same - as they often aren't, but Zentiva has the same formulation as Plaquenil here. It is actually produced by a sister company of Sanofi.

Here is detailed information about what is happening here in the UK - lupusuk.org.uk/latest-news/...

[milkwoman in reply to Paul_Howard]

Thanks, Paul.

You could very well be right in that the names over here might be different.

In fact, I'm actually worried that will exactly be the case and that the generic "equivalent" in the U.S. just might be the Prasco Labs generic that I recently tried (pills look IDENTICAL to the Plaquenil tablets and are even stamped 'Plaqenil' to make things even more confusing).

If that is the case then I would indeed be out of luck with regards to switching to a generic since my stomach cannot tolerate the Prasco Labs tablet even tho the package insert lists the same ingredients (sans percentages, of course).

This is why I posted the question here on HU to see if any other U.S. person has successfully tried the Zentiva version.

Still holding out hope!

[EOLHPC in reply to milkwoman]

Thanks so much for this discussion milkwoman....I vvvvv much hope you do get a reply from someone with chronic gi conditions who is finding the rebranded plaquenil as easy to tolerate as the original...

This is vvvv interesting & important to all of us who've needed plaquenil because of our chronic gi conditions....I'm in the UK & am about to go to an appt @ my GP surgery during which I'm going to discuss my this debranding etc etc with my GP & ask him:

- to revise the plaquenil specification on my repeat prescription form

-to write me a prescription so I can hunt around local pharmacies if the surgery dispensery can't fulfill with the plaquenil equivalent.

last week I put a note in to our surgery pharmacist explaining the ID info she needs in order to get me the UK plaquenil equivalent...so before I see the GP this morning I'll see how my surgery dispensery has gotten on with obtaining the plaquenil equivalent for me.

meanwhile I've been thinking to myself: heads up BC, even IF you do get hold of the plaquenil equivalent, will it REALLY be TOTALLY identical to that of the branded form of plaquenil????....the aged cynic in me has been grumbling: NO NO NO!!!!!....

[EOLHPC in reply to EOLHPC]

PS am now back from my GP surgery: hooray: the dispensary had got hold of the debranded Zentiva plaquenil equivalent....it comes in the same colour box as branded Plaquenil had, but a slightly different size box. the dispensary told me they'd fix the spec on my repeat prescrips form to match the name on this box (Hydroxychloroquine sulfate 200mg Film-coated Tablets ZENTIVA) but we'll see if they get that revision right....fingers crossed the debranded zentiva formulation doesn't stir up my chronic oespohagitis & gastritis (good old branded plaquenil never did stir them up)...

[milkwoman in reply to EOLHPC]

Do you have the actual medication in hand?? I've been wondering what the Zentiva branded tablets look like.

Keeping my fingers crossed the rebranded meds work for you!!

Tracy

p.s. I understand the "cynic" in me is rearing its head as well on this one....

[EOLHPC in reply to milkwoman]

yes: just compared the 2 versions & the tablets are identical: same size & shape, whiteness, with same impressions on both sides...even the foil on the reverse side of the laminate has the usual printed stuff on it....hmmmmm

will let you know how i get on...am trying to decide what to do: after 4 years on 400mg daily, i've been off daily plaquenil for 4 months while being investigated by immunology for immunodeficiency. last week rheumatology gave the ok for me to go back on daily hydroxy. have started up on 200mg daily, am now feeling fine in my 2nd week. am to go up to 400mg daily in week 6. i have 1 1/2 boxes of original plaquenil + today got this box of the new equivalent....am thinking about trying the new equivalent in say, week 12...when my bod will have become accustomed to being on hydroxy again so possibly any reaction (ie to the new equivalent being a wee bit different) may be more muted....hmmmmm

hoping to learn how you get on too

[milkwoman in reply to EOLHPC]

Hmmm, so the name brand and the new generic are identical. This has me worried for my situation since the recent generic I have also looks IDENTICAL to the name brand Plaquenil (so much so that I have had to mark the generic tablets with a food marker so that I don't get the two mixed up!) and the new generic caused me stomach/GI issues (which disturb my sleep - not good). Sigh.

I do hope you have better results!

Some thoughts....I understand why you may wait to try the Zentiva product BUT, wouldn't you know straight away if it caused you issues? OR, do you NOT have any issues with taking a generic?

Why I ask is, wouldn't it be better to know NOW if you have issues with the Zentiva brand so that you can quickly return to the one that works for you and not fear a gap with no option for meds?

[EOLHPC in reply to milkwoman]

Exactly...am thinking about this...not sure which way I'll swing...but I only have this option to go back to original plaquenil as long as I still have these boxes of original plaquenil in hand...these are the last boxes I expect to see in my lifetime...am tempted to stick to them until am up to my previous therapeutic dose and then reconsider....as far as I know the only option we have is to try other long-time standard generics eg quinoric (which did aggravate my chronic upper GI conditions when I was put on that initially in 2011) or put up with this new plaquenil equivalent by zanofi....am so disappointed you're finding it's making GI trouble for you!!!! But am trying to think positive.....please keep us posted

[milkwoman in reply to EOLHPC]

Just want to clarify... I've not yet tried the Zentiva brand generic - pharmacist is trying to locate. I've only tried two generic brands so far: one by Ranbaxy (that was early on when first diagnosed and experienced intolerable GI issues that affected my sleep so I then went on name brand) and one by Prasco Labs (this is very recent and the tablets look identical to the namebrand). Starting having stomach issues about 4 days in. As a test, I switched back to namebrand (no issues) and then tried the generic again (issues returned). There is a possibility that *might* be able to take 200 mg of generic in the am and then 100 mg of namebrand in the afternoon ((I take 300mg per day, split dose) and see if that somehow is tolerable.

There's still hope but, again the cynic me tends to believe that why would a company formulate the exact same tablet and sell it as generic when they get more money listing it as namebrand? The obvious answer is they don't and the generic has different quantities of fillers to make it less expensive to manufacture and therefore less expensive to sell.

I'm trying to stay positive in spite of my cynic self!

As for you, could you acquire namebrand via the U.S. or Canada? The manufacturers you want is Concordia who took over the rights from Covis April 2015.

Hugs.

[EOLHPC in reply to milkwoman]

Phew: that's a relief: thanks for explaining!

My understanding is that this debranding happens after a certain period of time. It's a 'given' in the pharmaceutical industry.

🍀👍

[milkwoman in reply to EOLHPC]

I have an update since I have spoken to my pharmacist.

The Zentiva brand is NOT available in the U.S. (That actually makes sense to me since the sister company (Sanofi) stopped making it for the U.S. in 2013 (that is when Covis took it over). Concordia is the new manufacturer of Plaquenil for U.S. (since Apr 2015)).

The pharmacist could not tell me which U.S. generic is the equivalent (and to be quite frank, I doubt ANY generic is an EXACT equivalent to the name brand since the manufacturers do not disclose the percentages of inactive ingredients in their formulations. All they are required to do is disclose a list of inactive ingredients, which you can find on sites like Drugs.com or via the actual drug inserts).

So I did some "comparison shopping". Those of you in the UK are actually quite lucky since it "appears" (based solely upon ingredients list), that the Zentiva brand of hydroxychloroquine sulfate is indeed identical to the Sanofi name brand. I do hope that is true!!

So you have the information, here is the inactive ingredients list for Sanofi Plaquenil (white round film-coated tablet imprinted with HCQ 200):

Lactose monohydrate

Maize starch

Magnesium stearate

Polypovidone

Hypromellose

Macrogol

Titanium dioxide (E171)

And here is the inactive ingredients list for the Zentiva Hydroxychloroquine (white round film-coated table imprinted with HCQ 200):

Lactose monohydrate

Maize starch

Magnesium stearate

Polyvidone

Opadry OY-L-28900 (containing hypromellose, macrogol 4000, titanium dioxide (E171), lactose)

Now, for those of us in the U.S., well we don't appear to be quite as lucky. For my own peace of mind, I created a table of all the generic brands I could locate and compared their list of inactive ingredients to what is in the namebrand Plaquenil manufactured by Covis. Most have all sorts of additional fillers. The only one that is the closest is by Prasco Labs, which I already know causes me issues (better than the Ranbaxy one, but still, issues).

So, I can either play the "let's try all the generic brands" game or I can simply stay with the namebrand and perhaps, switch in the Prasco generic every other day or so, or even, take 200mg of the generic in the am and take 100mg of the namebrand in the afternoon (my dose per day is 300 mg, split, and yes, I have to cut pills in half for the afternoon dose).

At least now I have answers and hopefully, this information will help anyone in the same boat.

Tracy

[EOLHPC in reply to milkwoman]

YOU ARE A STAR, TRACY: WOWOWOW

thanks so much

wishing every possible ounce of luck

[milkwoman in reply to EOLHPC]

and the same to you!

[Paul_Howard Partner LUPUS UK in reply to milkwoman]

Have you considered contacting Sanofi customer services in the USA and asking them whether the Zentiva in your country is the same formulation as Plaquenil?

[milkwoman in reply to Paul_Howard]

Hi Paul -

In the states, Sanofi has been out of the Plaquenil game since 2013 so the company I'd need to contact is Concordia, who recently acquired the rights from Covis Pharma.

Concordia is a German company and sadly, I don't speak German!

At this point, I am allowing my pharmacist to do her research as I figure they would know better than I on how to find out what is going on.

Tracy

[milkwoman in reply to milkwoman]

Wait, I just reread your response and I now understand what you are saying. Hmmmm, yes, it might be advisable to contact Sanofi and ask them about the generic equivalent in the U.S. ......

[Veris in reply to milkwoman]

Ok used to have plaquinel.until they decided that they wouldn’t Produce it but their sister company zentiva did and we were told to try it . Now it is difficult to get but no one can tell me the name of another brand that’s the same with no fillers that cause side effects

[milkwoman in reply to Veris]

I’m in the US so I cannot help you with what the equivalent is. I’m able to get name brand Plaquenil but it’s extremely expensive and I had to get prior authorization from my insurance company.

[Tinkywinky]

I too am taking hydroxychloroquine sulphate 400mg daily, and similarly was prescribed plaquenil, since it's become difficult to obtain, I have visited several pharmacies in my quest to obtain film coated alternatives.

The larger chemists are tied to pharmaceutical outlets, as has been explained to me by a pharmacist from Boots Plc. So in my quest I have contacted the smaller independant chemists, lo and behold I've acquired hydroxy film coated generic brand marketed by Blackrock Pharmaceuticals Ltd. Vanderveil House, Vanwall Business Park, Maidenhead. Berkshire SL6.4UB.

[milkwoman in reply to Tinkywinky]

I have tried a film-coated generic and it still gives me stomach/GI issues. I do not know what ingredient in the generic is causing my problems.

I hope your new generic works for you!

Tracy

[chrisj]

I changed to the sulphate a couple of weeks ago as the original plaquenil isn't available here any more. My gp sorted it with the pharmacist who then did some research and found this hydroxy sulfate, not spelt with the usual ph.

Can't see any brand name on it like the ones you all have mentioned, it just says distributed by Teva UK Limited on one side of the box. Its a yellow pill with the word INCEPTA printed on it.

I take 400 and 200m on alternate days, used to be 400 a day but was reduced last year, and its suited me well as plaquenil did. The pharmacist reassured me it had the same fillers as plaquenil so now its on my repeat script...panic over

[milkwoman in reply to chrisj]

Looks like you are on the same generic that is marketed and manufactured by Blackrock Pharmaceuticals.

It is described as: "Hydroxychloroquine Sulfate Tablets are round, light yellow tablets with a score line on one side and Incepta inscribed on the

reverse."

Inactive ingredients are: lactose monohydrate, maize starch,

hypromellose, croscarmellose sodium, magnesium stearate,

talc, titanium dioxide, macrogol 6000, iron oxide yellow E172

and polysorbate 80.

This generic is not available to us in the U.S.

So glad it is working for you! Perhaps it will work for others who are outside the states and are having a difficult time locating the Zentiva generic.

Tracy

[chrisj in reply to milkwoman]

I hope so...

[chrisj]

Just to say its been 2 weeks since the new hydroxy and its been fine, no problems that I've noticed...bit of positive feedback

[milkwoman in reply to chrisj]

So glad!!