VYDURA^®▼(rimegepant) Prescribing Information:

▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.

Please refer to the Summary of Product Characteristics (SmPC) before prescribing VYDURA 75 mg oral lyophilisate.
Presentation: Oral lyophilisates containing 75 mg rimegepant. Indications: Acute treatment of migraine with or without aura in adults. Preventive treatment of episodic migraine in adults who have at least 4 migraine attacks per month. Dosage: For acute treatment of migraine, the recommended dose is 75 mg rimegepant, as needed, once daily. For prophylaxis of migraine, the recommended dose is 75 mg rimegepant every other day. The maximum dose per day is 75 mg rimegepant. Another dose of rimegepant should be avoided within 48 hours when it is concomitantly administered with moderate inhibitors of CYP3A4 or with strong inhibitors of Pgp (see SmPC section 4.5). VYDURA can be taken with or without meals. 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. No dose adjustment is required in patients aged 65 and over as the pharmacokinetics of rimegepant are not affected by age (see SmPC section 5.2). No dose adjustment is required in patients with mild, moderate, or severe renal impairment. Caution should be exercised during frequent use in patients with severe renal impairment. 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. 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. Contraindications: Hypersensitivity to the active substance or to any of the excipients listed in SmPC section 6.1. Warnings and Precautions: Hypersensitivity reactions, including dyspnoea and rash, have occurred in less than 1% of patients treated with rimegepant in clinical studies (see SmPC section 4.8). Hypersensitivity reactions, including serious hypersensitivity, can occur days after administration. If a hypersensitivity reaction occurs, rimegepant should be discontinued and appropriate therapy should be initiated. VYDURA is not recommended in patients with severe hepatic impairment (see SmPC section 4.2), in patients with end-stage renal disease (CLcr < 15 ml/min) (see SmPC section 4.2), for concomitant use with strong inhibitors of CYP3A4 (see SmPC section 4.5) or for concomitant use with strong or moderate inducers of CYP3A4 (see SmPC section 4.5). If overuse is experienced or suspected, medical advice should be obtained, and treatment should be discontinued. The diagnosis of medication overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of medicinal products for acute headache.
Drug Interactions: Rimegepant is a substrate of CYP3A4, P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) efflux transporters (see SmPC section 5.2). Concomitant administration of rimegepant with strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, ritonavir) is not recommended (see SmPC section 4.4). Concomitant administration of rimegepant with itraconazole resulted in a significant increase in rimegepant exposure (AUC by 4-fold and C_max 1.5-fold). Concomitant administration of rimegepant with medicinal products that moderately inhibit CYP3A4 (e.g., diltiazem, erythromycin, fluconazole) may increase exposure to rimegepant. Concomitant administration of rimegepant with fluconazole resulted in increased exposures of rimegepant (AUC by 1.8-fold) with no relevant effect on C_max. Another dose of rimegepant within 48 hours should be avoided when it is concomitantly administered with moderate inhibitors of CYP3A4 (e.g., fluconazole) (see SmPC section 4.2). Concomitant administration of VYDURA with strong CYP3A4 inducers (e.g., phenobarbital, rifampicin, St John’s wort (Hypericum perforatum)) or moderate CYP3A4 inducers (e.g., bosentan, efavirenz, modafinil) is not recommended (see SmPC section 4.4). The effect of CYP3A4 induction may last for up to 2 weeks after discontinuation of the strong or moderate CYP3A4 inducer. Concomitant administration of rimegepant with rifampicin resulted in a significant decrease (AUC reduced by 80% and C_max by 64%) in rimegepant exposure, which may lead to loss of efficacy. Inhibitors of P-gp and BCRP efflux transporters may increase plasma concentrations of rimegepant. Another dose of VYDURA within 48 hours should be avoided when it is concomitantly administered with strong inhibitors of P-gp (e.g., cyclosporine, verapamil, quinidine) (see SmPC section 4.2). Concomitant administration of rimegepant with cyclosporine (a potent P-gp and BCRP inhibitor) or with quinidine (a selective P-gp inhibitor) resulted in a significant increase of similar magnitude in rimegepant exposure (AUC and C_max by > 50%, but less than two-fold). Pregnancy & Lactation: There are limited data from the use of rimegepant in pregnant women. Animal studies demonstrate that rimegepant is not embryocidal, and no teratogenic potential has been observed at clinically relevant exposures. As a precautionary measure, it is preferable to avoid the use of VYDURA during pregnancy. The relative percentage of a maternal dose estimated to reach the infant is less than 1%. There are no data on the effects on milk production. The developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for VYDURA and any potential adverse reactions on the breastfed infant from rimegepant or from the underlying maternal condition. Driving and Operating Machinery: VYDURA has no or negligible influence on the ability to drive and use machines. Side Effects: The most common adverse reaction was nausea for acute treatment (1.2%) and for migraine prophylaxis (1.4%). Most of the reactions were mild or moderate in severity. Hypersensitivity, including dyspnoea and severe rash were uncommon side effects observed in the acute treatment and occurred in less than 1% of patients treated. Hypersensitivity reactions can occur days after administration, and delayed serious hypersensitivity has occurred. Legal Category: S1B . Marketing Authorisation Holder: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium. Local Representative: Pfizer Healthcare Ireland, Pfizer Building 9, Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24 + 353 1 4676500. Marketing Authorisation Numbers: VYDURA 75 mg, 2 x 1 oral lyophilisates EU/1/22/1645/001; 8 x 1 oral lyophilisates EU/1/22/1645/002.

For further information on this medicine please contact: Pfizer Medical Information on 1800 633 363 or at [email protected]. For queries regarding product availability please contact: Pfizer Healthcare Ireland Unlimited Company, The Watermarque Building, Ringsend Road, Dublin 4, D04 K7N3, Ireland. Ph + 353 1 4676500.

Last revised: 11/2024
 

Ref: VD 3_1 IE

PP-NNT-IRL-0141. January 2025