2023-10-03 12:31:43
EMYLIF, a new riluzole specialty.
In neurology, EMYLIF 50 mg orodispersible film is a new riluzole specialty indicated in the treatment of amyotrophic lateral sclerosis (ALS) in adults. EMYLIF has not demonstrated effectiveness in advanced stages of ALS.
Riluzole in orodispersible film
Riluzole is included in the composition of several specialties marketed in France: RILUTEK 50 mg film-coated tablet and its generics, and TEGLUTIK 5 mg/mL oral solution.
EMYLIF is a hybrid* of RILUTEK 50 mg film-coated tablet which is distinguished by its unique pharmaceutical form, in orodispersible film.
In his opinion of January 18, 2023 [1]the Transparency Commission (CT) underlines that:
the marketing authorizations (AMM) for EMYLIF and RILUTEK are superimposable. As a reminder, RILUTEK is indicated to extend lifespan or to delay the need for assisted mechanical ventilation in patients with ALS; the bioequivalence between EMYLIF and RILUTEK has been established; on the other hand, due to lack of comparative data, “it is impossible to measure the benefit of administering riluzole in the form of a dispersible film compared to the tablet form”.
The CT attributed significant actual benefit (SMR) to EMYLIF. EMYLIF does not provide any improvement in actual benefit (ASMR).
EMYLIF in practice: 2 doses per day
The recommended daily dosage for adults or the elderly is 50 mg (1 EMYLIF orodispersible film) every 12 hours, or 100 mg of riluzole per day.
No significant additional benefit can be expected at higher doses.
EMYLIF is contraindicated during pregnancy and breastfeeding.
The orodispersible film is lemon flavored. It is packaged in a single sachet (cf. Boxed).
Once placed on the tongue, the film dissolves in 3 minutes.
Box – Instructions for removing EMYLIF orodispersible film from the sachet
Hands must be clean and dry before handling EMYLIF so that the orodispersible film does not stick to the fingers. Fold the foil packet along the solid line at its top. Holding the folded top of the bag on the solid line, tear at the slit along the arrow on the side of the bag to open it.
Remove the EMYLIF orodispersible film from the aluminum sachet. Do not fold the EMYLIF film. Place the EMYLIF film on the top of the tongue. The film will adhere to the tongue and begin to dissolve. After administration of EMYLIF, hands should be washed.
Instructions to give to patients: be careful of oral hypoesthesia
EMYLIF should not be taken with liquids, chewed or spit out, and the patient should not speak while EMYLIF is dissolving.
Following administration of EMYLIF, mild transient oral hypoesthesia (reduction in mouth sensitivity) has been reported. The median time to onset is 1 minute after administration and the median duration is 40 minutes. If oral hypoesthesia occurs, food intake should be done cautiously until this sensation disappears.
Safety has not been evaluated in patients with severe sialorrhea or dysphagia and caution is advised in these situations.
Patient Monitoring
Riluzole should be used with caution in patients with a history of hepatic dysfunction, or with mild elevations of serum transaminases, bilirubin and/or gamma-glutamyl transferases (GGT). A disturbance of several liver parameters (in particular high bilirubin level) should discourage the use of riluzole.
Monitoring of patients before and/or during treatment with EMYLIF includes the following:
due to the risk of hepatitis, control of the level of serum transaminases, including ALT (SGPT), before starting treatment and during its duration: ALT must be measured every month for the first 3 months, then every 3 months during the first year and periodically thereafter. This monitoring should be more frequent in patients whose ALT level rises during treatment; control of blood counts in the event of a febrile illness. Riluzole treatment should be discontinued in the event of neutropenia; x-ray if respiratory symptoms such as dry cough and/or dyspnea appear: administration of riluzole should be stopped immediately if any findings suggest interstitial lung disease.
Administrative identity
Liste I
Special monitoring during treatment
Initial annual prescription reserved for certain specialists
Prescription reserved for specialists and neurology services
Box of 56 individual sachets, CIP 3400930264355
Refundable at 65% [2]
Prix public TTC = 138,33 euros [3]
Approval for communities [4]
Zambon Laboratory
*A hybrid specialty of a reference specialty does not meet the definition of a generic specialty. It includes differences in relation to the reference specialty relating to therapeutic indications, dosage, pharmaceutical form or route of administration, or when bioequivalence compared to this reference specialty could not be demonstrated by bioavailability studies.
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