[split] Skilarence

[jiml]

Try seeking some clarification from the regulator, Jim. If you get an idiotic response then take it to the Health Minister. This is public information for taking a medication so it is not unreasonable to expect a high standard of accuracy.

Thanks Bill
I'll drop an email to the manufacturer pointing out the discrepancies and see what they say

[jiml]

Just found a revised leaflet with information on low white cells I will edit the first post to show the changes

[Bill]

I am glad to hear that, Jim.

[jiml]

I am glad to hear that, Jim.

It certainly makes more sense now although I haven't heard of it causing high white blood counts myself

[Turnedlight]

When you say you haven't heard of people with high white blood count, do you mean among those on fumaderm/ similar?

[jiml]

When you say you haven't heard of people with high white blood count, do you mean among those on fumaderm/ similar?

Yes sorry I should have made that clear , as I haven't heard of Skilarence being prescribed yet,  but other DMF based tablets with similar dosing regimes should produce very similar side effects I would think  

[Caroline]

I have laid hands on some questions and answers concerning Skilarence, seen here below.

@Maryam, you will love this.

Quote:

---

1. As you know dimethylfumarate is irritating for stomach and bowel, what measures were taken to avoid problems. E.g. is Skilarence®protective for the stomach and does it have a slow release mechanism for the bowel?
FAEs such as Skilarence® have a good long-term safety profile. Skilarence® can be prescribed to patients with comorbidities, excluding severe gastrointestinal diseases and severe renal or hepatic damage. The case of patients with hypersensitivity to the active substance of the medicine or to any of its excipients may also be taken into account.

2. In what sizes in mg will Skilarence®be available?
Skilarence® is an oral medicine that will be available in two different doses: in gastro-resistant tablets of 30 mg and 120 mg.

3. What is the dosing scheme?  In what way the build up will be in order to reach the working dose?
Skilarence® comes in an individualized dosing system. Health professionals can adjust the dose depending on the individual clinical response and the tolerability of each patient. The 30 mg dose is used to initiate treatment, manage tolerability and find the optimal dose for each patient, and 120 mg is used in the second phase of treatment and usually as a maintenance treatment.

4. Is Skilarence® pure dimethylfumarate or does it has additional substances added like in Fumaderm?
Skilarence® does not have the same composition. Skilarence® tablets contain only dimethyl fumarate (DMF) as active substance, the most important one within the combination of FAEs and the only that is necessary for clinic effect.

5. What is the maximum dose of Skilarence®?
See answer to question number 3.

6. How often there must be a check up of blood values when using Skilarence®?
Every three months monitoring is necessary during the course of the treatment with Skilarence®

7. What is the estimated price range of Skilarence®?
The cost of Skilarence® is still being decided.

But the conclusion is... this is probably almost for sure, not slow release, as the direct question for that is carefully avoided.
They keep talking about gastro resistent.
Positive is that it only seems to contain DMF, so is different from Fumaderm.
FAE means Fumaric Acid Esters.

[jiml]

Yes they neatly sidestepped question 1

[Bill]

I know you like your slow release formula Caroline, and after experimenting with powdered DMF I somewhat agree with the slow release concept, but isn't the main consideration "Does it work?"? What I did notice from the NICE website is that the NHS, with their deal making prowess, will buy $0.27 US worth of DMF for the miserly sum of 190GBP. What a bunch of dills.

[Caroline]

I know you like your slow release formula Caroline, and after experimenting with powdered DMF I somewhat agree with the slow release concept, but isn't the main consideration "Does it work?"? What I did notice from the NICE website is that the NHS, with their deal making prowess, will buy $0.27 US worth of DMF for the miserly sum of 190GBP. What a bunch of dills.

Yes Bill, it’s true what you are saying.
Of course it is really great that the whole of the EU now has a registered medication on DMF, that is a giant leap forward in the acceptance of DMF with the treatment of Psoriasis and perhaps of many more diseases, like MS and Crohns whenever the doctors finally find out this purposes. They are already known in the Netherlands with certain dermatologists. But you know the kingdom effects in medics.

However for The Netherlands it would be a step back, as the comparison between what we have in slow release and Skilarence is easy to make as we have many years of experience out of the field. Therefore the aim is of course to keep Psorinovo available here, so there is a choice for the patients.