Non-Regenerative Anemia: Ticking Time Bomb

white shadow

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Perhaps ask your Vet to post the question on VIN (after searching it first, of course
)

Veterinary Information Network:  http://www.vin.com/

Now, if she isn't a member, that might raise some flags...
 
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julia9ca

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White Shadow, is that a US vet website?  Not sure she'd belong, because we're in the UK (I'm an American).

I've asked the Vet about Jakafi (US)/Jakavi (UK), and she's advised we need to make sure it's licensed for use in animals, not just in humans.   There's something here called "The Drugs Cascade":

http://en.wikivet.net/Drug_Legislation

and it's a criminal offense to treat animals outside of this cascade.

I've e-mailed the licensing question to the company here in the UK (Novartis) that makes Jakavi.  I've also contacted the European Medicines Agency.  Still looking for the contact information for the UK Home Office, as licensing for use in animals is shared here between the UK Home Office and the European Medicines Agency. 

LDG, do you have any contacts at Cornell or Texas A&M we could ask about protocols in the US?  The US version of the drug, Jakafi, is made by Incyte. 
 
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julia9ca

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white shadow

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White Shadow, is that a US vet website?  Not sure she'd belong, because we're in the UK (I'm an American).
The Veterinary Information Network (VIN) is the premier online community, continuing education, and information resource for veterinarians. Founded in 1991, VIN reaches over 45,000 veterinarians, veterinary students, and industry partners worldwide. VIN is the leader in unlimited access to medical, product and practice management information. For a FREE one month trial membership, join us at www.VIN.com, phone 800-700-4636, or email [email protected] Let us show you why VIN is the BEST online resource for veterinarians

(http://www.acvr.org/partner/veterinary-information-network-vin    ***this is NOT the VIN site)
Hope that helps!
 

ldg

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I've asked the Vet about Jakafi (US)/Jakavi (UK), and she's advised we need to make sure it's licensed for use in animals, not just in humans.   There's something here called "The Drugs Cascade":

http://en.wikivet.net/Drug_Legislation

and it's a criminal offense to treat animals outside of this cascade.
But all of the links you've provided make it pretty clear the regulations were designed to stop abuse of human generics in animals, when there are existing, approved veterinary drugs for treatment. But when there is no approved treatment for a condition in an animal (and there isn't an approved drug for treating myelofibrosis in animals - Jakafi is the first ever drug approved for humans!), the vet can legally prescribe drugs approved in the UK for human human use. It's the first bullet point on the DOC file, and provided at the end of the Wiki link. So it seems like there shouldn't be any problem, as it was approved by the European Medicines Agency in August 2012. :dk:
 
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julia9ca

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The part of the cascade that's confusing me:

"A veterinary medicine authorised in the UK for use in another animal species or for a different condition in the same species."

It could be argued here that Prednisolone, while no treatment specifically for the disease of Myelofibrosis, is currently being used to treat a wide variety of auto-immune diseases in cats.

As this "different condition in the same species" clause comes in the cascade prior to "a medicine authorised in the UK for human use", the legislation may be telling the vet to stop at the "different condition" part, as it's higher priority in the cascade.

 
 

ldg

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Is this information from your vet, or something you have yet to ask her?

Because steroids treat all kinds of things - but it's not specifically approved for that condition. At least that's the way I see what I'm reading. It's used as a treatment for the condition: but if there were a drug that was approved specifically for myelofibrosis, you'd be using that. It was pretty clear to me the law exists to protect the animals and to prevent abuse of generic brands approved for humans being used in animals instead of existing veterinary drugs approved for specific uses. I find it very difficult to believe anyone would want to prosecute a vet for using a newly approved human drug (with no generic) in a pet, where there is no existing drug specifically treating the disease. Pred is not a JAK inhibitor. :dk:

I have no idea what the potential side-effects or risks of using it are. But ultimately, whether or not to use it needs to be evaluated on the basis of potential outcomes vs. risks for your kitty. And I expect that's all that matters to the regulatory authorities. :dk:
 
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julia9ca

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LDG, you are right.  It's a matter of evaluating it on the basis of potential outcomes vs. risks.  Here's the reply from Defra (UK Home Office):
Thank you for your email that has been passed to me to respond to.

According to our database of UK authorised veterinary medicines, there is no product licensed for use in animals to treat Myelofibrosis.

The Veterinary Medicines Regulations (VMR) recognises that there will be clinical situations where no suitable authorised veterinary medicine is available. The law provides exemptions to allow a veterinary surgeon to treat animals under his or her care in this situation. The cascade allows a veterinary surgeon to legally prescribe medicines that are not authorised for the relevant clinical case or for the relevant species under treatment when there is no authorised veterinary medicinal product available.

The cascade is a risk based decision-tree to help veterinary surgeons decide which product to use. The cascade is based on the principle that, if there is no veterinary medicine authorised in the UK for treating a disease, the veterinary surgeon responsible for the animal may, in particular to avoid unacceptable suffering, treat the animal with a product from one of the following categories in descending order of suitability:
  1. A veterinary medicine authorised in the UK for the same condition in another animal species or for another condition in the same animal species;
  2. Either: (i) a medicine authorised in the UK for human use or (ii) a veterinary medicine not authorised in the UK but authorised in another Member State for use in any animal species in accordance with an import certificate issued by the VMD; or
  3. A medicine prescribed by a veterinary surgeon responsible for treating the animal and prepared extemporaneously by a veterinary surgeon, a pharmacist or a person holding an appropriate manufacturer’s authorisation (so called ‘specials manufacturer’).
The vet can only prescribe under the cascade if they can justify their clinical judgement.

I hope this information is useful to you. Please contact me if you require any further information.

Kind regards,
So, key here is now to best weigh risks, benefits, safety of Pred vs. new drug, or determine if they may be used safely in tandem.  If the new drug can be shown to alleviate more suffering in an animal than usage of Pred alone, then this would be an argument to move from 1. (above) to 2.

I'm now reviewing the public assessment report sent to the EU, and found mention of treatment in mice on page 15:
Treatment of mice with ruxolitinib resulted in a dose-dependent suppression of phosphorylated STAT3 and tumour growth in the cytokine-dependent INA-6 multiple myeloma xenograft model.

Ruxolitinib also inhibited splenomegaly in mice resulting from intravenous inoculation of cells expressing the clinically relevant JAK2V617F mutation. Moreover, genomic PCR analysis of spleen samples to detect JAK2V617F cells showed that the mutant allele burden was significantly decreased by treatment with ruxolitinib (33% decrease, P < 0.01). Mice bearing Ba/F3-JAK2V617F cells and treated with ruxolitinib had a significantly improved survival compared to animals treated with vehicle. After 3 weeks of treatment, > 90% of vehicle-treated mice had succumbed to disease while > 90% of ruxolitinib-treated mice survived. Treatment with ruxolitinib also reduced inflammatory cytokine levels (e.g. TNF-[font=Verdana,Verdana][font=Verdana,Verdana]α[/font][/font], IL-6) in these mice.
 

Beagle Dogs are also mentioned in this report, but still trying to decipher what the report is telling us about dogs (Unfortunately, I don't thing they're treating the dogs, but testing any adverse health effects of extremely high dosages.)
 
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julia9ca

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About the vet:  I'm meeting w/ her & Michelle on Wednesday.  I'll bring in w/ me all the evidence I can find on pros vs cons & safety record.  I'm now very much hoping the drug company responds with documents from their various animal & human studies.
 

ldg

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:hugs: I think it's great you're doing all this research - I'm sure I would too. :hugs: But your vet should be in a position to more easily obtain all of this information. :heart2:

Please keep us posted!

...and continued vibes for your Michelle. :heart2: :vibes: :vibes: :vibes:
 
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julia9ca

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Very quick update:

Michelle is much doing better on the Prednisolone.  No more vomiting, moving around a lot more, and the vet is able to confirm she's gaining weight.  Vet said on our visit it was too soon for a blood test, but will follow up with one on the 28th.  She would like to keep Michelle on the Pred and does not think Jakavi makes sense at this point.

Norvartis, the company that makes Jakavi, has now e-mailed me back:
Thank you for your request for information on Jakavi[emoji]174[/emoji] (ruxolitinib) and its use in cats.

Jakavi is not licensed for use in animals and I have not been able to find any evidence in the literature regarding its use in cats.

Please be advised that information relating to your enquiry, including your contact details, will be retained on the secure, Novartis Medical Information enquiry tracking database...

I am sorry that I could not be of more assistance on this occasion.
I will continue doing research, but I think if we stay with this vet, it is unlikely we will get a go-ahead on Jakavi (since per UK government, the judgment call on the Drug Cascade rests squarely with the vet).
 
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