[split] Skilarence

[Caroline]

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

@Maryam, you will love this.

Quote:

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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.