Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Biohaven Pharmaceutical Ireland DAC, 6<sup>th</sup> Floor, South Bank House, Barrow Street, Dublin D04 TR29, Ireland
VYDURA is indicated for the
Acute treatment of migraine: The recommended dose is 75 mg rimegepant, as needed, once daily.
Prophylaxis of migraine: The recommended dose is 75 mg rimegepant every other day.
The maximum dose per day is 75 mg rimegepant.
VYDURA can be taken with or without meals.
Another dose of rimegepant should be avoided within 48 hours when it is concomitantly administered with moderate inhibitors of CYP3A4 (see section 4.5).
There is limited experience with rimegepant in patients aged 65 years or older. No dose adjustment is required as the pharmacokinetics of rimegepant are not affected by age (see section 5.2).
No dose adjustment is required in patients with mild, moderate, or severe renal impairment. Severe renal impairment resulted in a >2-fold increase in unbound AUC but less than a 50% increase in total AUC (see section 5.2). Caution should be exercised during frequent use in patients with severe renal impairment. Rimegepant has not been studied in patients with end-stage renal disease and in patients on dialysis. Use of rimegepant in patients with end-stage renal disease (CLcr <15 ml/min) should be avoided.
No dose adjustment is required in patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment. Plasma concentrations (unbound AUC) of rimegepant were significantly higher in subjects with severe (Child-Pugh C) hepatic impairment (see section 5.2). The use of rimegepant in patients with severe hepatic impairment should be avoided.
The safety and efficacy of VYDURA in paediatric patients (<18 years of age) have not been established. No data are available.
VYDURA is for oral use.
The oral lyophilisate should be placed on the tongue or under the tongue. It will disintegrate in the mouth and can be taken without liquid.
Patients should be advised to use dry hands when opening the blister and referred to the package leaflet for complete instructions.
There is limited clinical experience with rimegepant overdose. No overdose symptoms have been reported. Treatment of an overdose of rimegepant should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. No specific antidote for the treatment of rimegepant overdose is available. Rimegepant is unlikely to be significantly removed by dialysis because of high serum protein binding.
3 years.
Do not store above 30°C.
Store in the original package in order to protect from moisture.
Blisters made of polyvinyl chloride (PVC), oriented polyamide (OPA) and aluminium foil and sealed with a peelable aluminum foil (8-count).
Unit dose blisters made of polyvinyl chloride (PVC), oriented polyamide (OPA) and aluminium foil and sealed with a peelable aluminum foil (2-count).
Pack sizes:
8 × 1 oral lyophilisates in a carton.
Unit dose 2 × 1 oral lyophilisates in a wallet carrier inside a carton.
Not all pack sizes may be marketed.
No special requirements for disposal.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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