Vydura

Posology 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.

5). Special populations Elderly (aged 65 and over) There is limited experience with rimegepant in patients aged 65 years or older. 2). 3 Renal impairment No dose adjustment is required in patients with mild, moderate, or severe renal impairment.

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.

Hepatic impairment No dose adjustment is required in patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment. 2). The use of rimegepant in patients with severe hepatic impairment should be avoided. Paediatric population The safety and efficacy of VYDURA in paediatric patients (< 18 years of age) have not been established.

No data are available. Method of administration 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.

4%). Most of the reactions were mild or moderate in severity. Hypersensitivity, including dyspnoea and severe rash, occurred in less than 1% of patients treated. Tabulated list of adverse reactions Adverse reactions are listed by MedDRA system organ class in Table 1.

The corresponding frequency category for each drug reaction is based on the following convention (CIOMS III): very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).

Table 1 :

List of Adverse Reactions System Organ Class Adverse Reaction Frequency Acute Treatment Immune system disorders Anaphylactic reactiona Hypersensitivity, including dyspnoea and severe rash Uncommon Uncommon Gastrointestinal disorders Nausea Common Prophylaxis Immune system disorders Anaphylactic reactiona Hypersensitivitya Not known Not known Gastrointestinal disorders Nausea Common a Adverse Drug Reactions (ADR) identified post-marketing.

Long-term safety Long-term safety of rimegepant was assessed in two one year, open-label extensions; 1662 patients received rimegepant for at least 6 months and 740 received rimegepant for 12 months for acute or prophylactic treatment.

Description of selected adverse reactions Hypersensitivity reactions Hypersensitivity, including dyspnoea and severe rash, occurred in less than 1% of patients treated in clinical studies. Hypersensitivity reactions can occur days after administration, and delayed serious hypersensitivity has occurred.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

8). 8). Some hypersensitivity reactions can occur days after administration. If a hypersensitivity reaction occurs, rimegepant should be discontinued and appropriate therapy should be initiated. 5). Medication overuse headache (MOH) Overuse of any type of medicinal products for headaches can make them worse.

If this situation is experienced or suspected, medical advice should be obtained, and treatment should be discontinued. The diagnosis of 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.

1.