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Thankyou Jo for helping Natalie. It is really tough when we see dogs with Addison's then develop another AI condition, which is much harder than Addison's to get under control. Clearly the dose of steroids has to be increased in order to treat the disease, but the effects of doing so, will hopefully just be the same as for a dog that doesn't have Addison's.


Take care at such difficult times for all of us.

Pam

Hi Nathan,
How is your dog doing now ?

It is a great shame that Dechra have not go this right, but if your vet is willing to look at the individual figures for the Na and K, that will be much better than looking at the ratio. I have found over the last 19 years of being around dogs with Addison's disease, that most dog feel better when their K is close to the middle of its reference range.
Also, our Adog, do much better with a low dose of pred each day. It is surprising just how low a dose our dogs do best having.

Do ask any question you may have.
I recently updated an article I wrote for dogs changing over from florinef to Zycortal, but much of it, would apply also to newly diagnosed dogs being started on Zycortal.

Pam

Hi Lesley,
I am glad you have found CIMDA. Hopefully Jo or Penel or even someone else with knowledge of these two conditions will come along soon and offer their advice.

Hang in there,

Pam

Many vets are prescribing much too high a dose of pred for dogs on Zycortal. The dose needed is a replacement dose not a therapeutic dose and should mirror the amount of glucocorticoid a dog was getting from the florinef. Comparisons of glucocorticoids indicate that florinef had the approximate glucocorticoid activity to 0.25 mg pred, so if for example a dog was having 0.6 mg florinef per day, it should easily have enough pred with 1.5 mg pred to start with and then try to reduce that until you fond the best lowest dose, nut as Jo said, some pred must be given every day.

Just to add that it has been documented by a vet in the US and also noted anecdotally, that some dogs as big as 100 lb only need 1 mg pred per day.

Lastly, Zycortal at too high a dose, can cause urination and thirst issues as well as pred. It is really important that the vet aims to get the best lowest dose of both meds for our dogs with Addison's.

Pam

This is really good news Jo. Well done and thank you for pushing for this. I know several people who have already got in touch to submit blood samples.

Pam

Hi Jo,
I have just copied and pasted both documents into new threads.

One other very important thing when chaging over to Zycortal is to make sure the dogs starts off on the right dose of pred each day, with a view to lowering it at some point to the lowest effective dose as  eeds to hapoen with the Zycortal.

For each 0.1 mg florinef, there is the equivalent of 0.25 mg glucocorticoid in it. This table shows the comparison of glucocorticoids

Pam

  Guidance for the owners of dogs with Addison's disease in making the transition from
Florinef to Zycortal and prednisone (or its equivalent)

This document has been written to guide owners of dogs with Addison's disease through the

transition from Florinef to Zycortal.   



1) Introduction: Why the change ?

Florinef is a drug which has both mineralacorticoid and glucocorticoid activity. It replaces

both the aldosterone and cortisol that a dog with Typical Addison's can no longer make.

Licensed as a drug for humans, it has also been used for dogs as there has been no dog

specific drug alternative until now, with the launch of  Zycortal. Production of Florinef was

discontinued at the end of February 2016. (Fludrocortisone acetate, which has replaced

Florinef, is being produced but at a much higher cost to dog owners)



Zycortal is produced by Dechra UK and was first registered to them in 2014, with a license

running until 2024. It is an injectable drug which has only mineralacorticoid activity. It

replaces only the aldosterone our Adogs can no longer produce, hence when making the

change over to Zycortal, it is important to remember to give a small daily dose of

glucocorticoid suchas prednisolone.




Zycortal was launched in the UK at the BSAVA congress in Birmingham in April 2016, with

sessions being run about Addison's disease, helping to raise awareness of this disease. It is

a drug specifically for the management of Addison's disease in dogs and due to the Cascade

system in the UK, must be prescribed ahead of a human drug (e.g. Florinef ) to treat the

same disease.   




Percorten (DOCP) which has the same active substance as Zycortal (desoxycortone

pivalate) has been used successfully in managing Addison's in other parts of the world for

many years now and the experience of owners using this drug for their dogs is now being

used to aid owners transitioning to Zycortal from Florinef. There will be no need to apply for

a special licence to use Zycortal as people who have been importing Percorten into the UK

have had to do. In addition current UK Percorten users may decide to switch to Zycortal

which will be cheaper for them. 



2) How does Zycortal work ?

Zycortal is a 25mg/ml prolonged-release suspension for injection for dogs. Its aim is to

maintain balance of the electrolytes whereas Florinef balanced the electrolytes as well as

provided a cortisol replacement to deal with stress. The Zycortal product information states

giving an initial starting dose of 2.2 mg / kg, testing the electrolytes firstly at 10 days, then

again at around 25 days in order to determine the next dose. After this first 'cycle' it is only

necessary to check the lytes just prior to giving the next dose. When you first start using

Zycortal, you will need to continue to give the normal dose of florinef for 24 hours after the

first injection, before stopping it. The day after the first injection, once you stop the florinef,

you will then start to give the required dose of pred each morning.

 
One of the most important things about using Zycortal effectively and efficiently is to make

sure the lytes results are used to determine the next dose. You are aiming to have well

balanced lytes throughout the cycle just as you did each day with Florinef. Basically, if the K

is below the middle of its reference range at the end of the cycle, then you know too high a

dose has been given last time, so you need to reduce it. Always remember that Zycortal

raises the Na and lowers the K. 



Zycortal does not suddenly stop working, so if you missed giving a dose by a day or so, the

Zycortal will still be working 




3) Does my dog need a daily dose of prednisone ( or its equivalent) and if so how much ?

All dogs having Zycortal will need a daily dose of glucocorticoid to replace the cortisol the

adrenal glands are no longer making and this is one of the noted bonuses of using Zycortal

rather than Florinef as you will now be able to control the amount of glucocorticoid your dog

gets. The glucocorticoids most likely to be prescribed are  prednisone or prednisolone,

though there may be other options (see the chart in Ref 2). Initially as you are transitioning

from Florinef to Zycortal, you need to take into account the amount of glucocorticoid within

the Florinef. Each 0.1 mg Florinef has the glucocorticoid activity equivalent to 0.25 mg pred.

As an example, if your dog is taking 0.8mg Florinef daily, they are taking the equivalent of

2mg prednisolone - so to calculate the starting dose of pred, for each 0.1 mg Florinef your

dog is currently taking you will need to multiply that by 0.25. This is only the starting dose

and over time you will be able to taper that down according to the clinical signs of your dog

until you find the best lowest dose for your dog.   




4) Will my vet let me give the injections myself at home ?

Giving injections at home to our dogs is not something all vets are familiar with in the UK.

However, a precedent has been set by owners of dogs with diabetes, who have to give

insulin injections every day. This is something you need to be comfortable with and have the

discussion with your vet about. Some practices are likely to be much happier about this than

others, some practices also do not charge if a vet nurse gives the injection rather than a vet.

Note it has to be stored at a temperature below 30 deg C and above freezing. It must not be

kept in a fridge. 




5) What happens if I don't need a whole vial of Zycortal at one go ?

Zycortal comes in vials of 4 ml / 100mg. At present this is the only sized vial. The product

has a shelf life of 3 years from production but once opened, the in-use shelf life is  4 months.

It is very likely though, that once you find the best lowest dose for your dog, it can last more

than 4 injections. Only time will tell if it will last for a longer period as the Percorten does.

Initially, if you take your dog to the vet for the injection and your vet practice has more than

one dog using Zycortal and it is being stored stored correctly, it may work out cheaper to be   charged by the ml rather than by the vial, especially for owners of smaller dogs. This would

avoid wastage, so do ask your vet if this is an option. 



6) Where can I buy Zycortal myself ?

Vets will order Zycortal for you unless you have a different arrangement.  You can buy

Zycortal online from internet pharmacies such as viovet.co.uk or vetmedic.com and this is

likely to be a cheaper option than from your vet, but you will need a prescription from your

vet to do this so make sure you figure this into your costs. At the time of writing this, Viovet

were selling a 4 ml vial for £54.21. 




7) What problems might I encounter

Zycortal is a new drug to the vets in the UK and Europe and hence the vets here are not au

fait with using it and nor will most of them be familiar with the Low Dose Protocol research

study carried out for Percorten (see Ref 5), so the first challenge will be in persuading your

vet to dose according to the lytes and not according to the weight going forwards and indeed

the product information does state clearly in cases of hypokalaemia (low potassium),

hypernatremia (high sodium) or a ratio > 32, to lower the dose of Zycortal or extend the time

between injections. However, experience of people using Percorten with their dogs, shows a

clear preference to lowering the dose rather than extending the time between doses in order

to maintain a more consistent balance of the lytes throughout the cycle and in doing so,

avoid highs and lows which is very important in order to keep a dog feeling well all of the

time. 


In a clinical trial of Zycortal, very common adverse reactions were noted as polydipsia

(excessive thirst) and polyuria (excessive urination) but these are very likely to be avoided if

the dose of both the Zycortal and the pred (or its equivalent) are optimised for your dog and

the best lowest dose of each found.



Some vets are concerned that once Zycortal is in the system, you cannot take it out so if the

wrong dose was given, what happens ? Well if a lot too much Zycortal was given, your dog

might display symptoms of hypokalaemia (low potassium) or hypernatremia (high sodium)

and if too little were given the opposite - hyperkalaemia (high potassium) and /or

hyponatremia (low sodium) could occur. If the latter were to occur it can easily be rectified by

giving the next dose earlier and adjusting the amount given and should the former occur, 

your dog should be treated symptomatically and the next dose adjusted as needs. It does

emphasise the need to make sure your vet determines the dose according to the lytes

results of your dog as each dog is different.     

 

  What should I do now ?

 Familiarise yourself with the facts about Zycortal. 

 Arrange an appointment with your vet to discuss a plan going forward, make sure

it takes place well before you finish your last Florinef. Have your questions ready!

 Go armed with knowledge, even take a copy of the Percorten low dose protocol

with you but be prepared for your vet to not feel comfortable using it at this stage.

It should however, give your vet food for thought once they have more

experience in using Zycortal.

 Ask your vet questions: 

a.    will the vet agree to dosing according to the lytes

b.   Will the vet support you giving the injections at home (if that is what you wish

to do) ? 

c.  Will the cost of giving the injection be cheaper if a vet nurse gives it instead of

the vet ?

d.  Will your vet either price match internet prices of Zycortal or give you a

prescription to buy your own ? 

e.  How will they decide what dose of pred (or its equivalent) to prescribe for your

dog ? 


For many people, this is a worrying period of travelling into the unknown, but it is also a time

for  embracing the change in the medication for your dog, comfortable in the knowledge that

this is a UK produced drug which most, if not all dogs with Typical Addison's will be changing

over to, in the coming weeks and which is essentially the same drug, Percorten (DOCP),

that has been used successfully across other parts of the world for many, many years.

Zycortal will enable your dog to continue to live a good happy life.   


Lastly, remember the adage  "There are no problems, only solutions".     





  References

1) EMA CVMP Assessment report for Zycortal -   

http://tinyurl.com/zjq87ql

2) Chart comparing the relative activity of steroids - prednisone equivalent 0.25 mg steroid activity in each 0.1 mg Florinef - also showing other alternatives to prednisone

http://patient.info/doctor/corticosteroids-and-corticosteroid-replacement-therapy

3) Noah's Compendium - a valuable resource of drugs in the UK including data sheets

http://tinyurl.com/zmrnkxf

4) Zycortal Freedom of Information Summary Feb 2016

http://tinyurl.com/gsgfmgc

5) Percorten Low dose protocol  abstract from Wiley

http://tinyurl.com/jdcenok

6) Everything you need to know about Zycortal including the Summary for the public

http://tinyurl.com/jzyy9fu

7) Summary of Zycortal product information  for vets which includes the information found on the product insert

http://tinyurl.com/jtdajob

Viovet - Zycortal product information and where to buy Zycortal from online

http://tinyurl.com/zbhwk4n     




Pam Johnson -  April 2016

Please note that I am not a vet, but I have been helping out on Addison's support groups for over 18

years, having had my own standard poodle with Addison's disease who thrived for 12 years on

Florinef and had he still been here today I would have been in the same position as yourself,

changing over to Zycortal. If you have any feedback on your experience with Zycortal, please get in

touch at Teesidebubbles@aol.com

This is a statement sent to me re the launch and support available for vets.

Statement:

At Dechra Veterinary Products we understand the challenging nature of the diagnosis and management of canine Addison's disease.

To assist in the management of this complex condition, we have recently launched a new injectable POM-V (Prescription Only Medicine-Veterinarian) product licensed for dogs with Addison's

The new product is a prolonged release suspension for injection which provides the confidence that Addison's disease will be controlled for the duration of approximately one month following each injection.

It is efficacious, well tolerated and allows tailored dosing for each dog with Addison's disease. A daily tablet will also be needed to help replace the cortisol.

Following the UK launch at the start of April 2016, we are committed to raising awareness of the product amongst the veterinary profession.

We are engaged in a series of activities with veterinary professionals which include; exhibiting at the UK's largest veterinary congress, print and online advertising in the veterinary press and availability of diagnosis and treatment support tools for veterinary surgeons in print and digital formats. As you can appreciate, it will take a little time for the information to be disseminated but we are passionate about increasing awareness of Addison's disease.

Our Technical Team is manned by a number of vets with a significant amount of first opinion practice experience and are in frequent contact with some of Europes leading experts on the treatment of Addison's. They work with vets on a daily basis to provide support and knowledge to vets treating dogs with Addison's.

Any questions about your dog should be directed to your veterinary practice.



Craig Sankey
Brand Manager,   Strategic Brands
Marketing

Dechra Veterinary Products Ltd

Hmm, it won't let me

Pam

The figures for the 80% and 20% are in a sense like experimeantal probability and hence not set in stone. ZYcortal has the identical main ingredient as found in Percorten, with just the additives being slightly different and over the last 18 years of being around Addison's dogs I can honestly say there was maybe just one dog that didn't do so well on it and it was questionable whether this was due to the way the drug was administered rather than the drug itself.
One of the distinct advantages of Zycortal for people in the UK is that it is being manufactured here, so no worries about having to import it and the worries that transport might bring with it.

Pam

Hi Jo,
This topic has been raised for the last month now on the 6 different Addison's disease in dogs support groips I belong to, so I have written a Guide for UK owners to help them through the process, using information from various sources and also from the experiences of people using Percorten.
I have also been in touch with both Aspen Pharma who have taken over production of fludrocortisone and with Dechra who agreedto provide me with a statement that I could share on the forums I belong to.
Would it help for me to share all of this here ?

Pam

A very belated Happy New Year from me too.

I hope all our dogs are doing well

Pam
Xx

A new study has recently been published which may be of interest to standard poodle owners here.

"The effect of genetic bottlenecks and inbreeding on the incidence of two major autoimmune diseases in standard poodles, sebaceous adenitis and Addison's disease."

Here is the link to the study

http://www.ncbi.nlm.nih.gov/m/pubmed/26401342/

Hope it is useful to some of you  it certainly provides food for thought.

Pam

Hi Beverley,
Have you got the batch number of the vial of percorten you had that you think was dodgy ? There has been some concern from a few people that one or two specific ones may have been compromised in some way. I can find out if yours is from the same batch.

How is Oscar doing now ?

Pam

I hope so very hard this is a turning point in Merlin's life and that he starts to steadily improve. I have lost too many dogs over the years, some much younger than Merlin, so I know just how hard it is to see a special friend struggling.

Please keep us updated

Pam