Aquipta

Posology The recommended dose is 60 mg atogepant once daily. The tablets can be taken with or without meals. 3 Missed dose A missed dose should be taken as soon as it is remembered. If it is forgotten for an entire day, the missed dose should be skipped and the next dose taken as scheduled.

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Table 1:

Dose modifications for interactions Dose modifications Recommended once daily dose Strong CYP3A4 inhibitors 10 mg Strong OATP inhibitors 10 mg Special populations Elderly Population pharmacokinetic modelling suggests no clinically significant pharmacokinetic differences between elderly and younger subjects.

No dose adjustment is needed in elderly patients. 2). In patients with severe renal impairment (creatinine clearance [CLcr] 15-29 mL/min), and in patients with end-stage renal disease (ESRD) (CLcr < 15 mL/min), the recommended dose is 10 mg once daily.

For patients with ESRD undergoing intermittent dialysis, AQUIPTA should preferably be taken after dialysis. 2). Atogepant should be avoided in patients with severe hepatic impairment. Paediatric population The safety and efficacy of atogepant in children (< 18 years of age) have not yet been established.

No data are available. Method of administration AQUIPTA is for oral use. Tablets should be swallowed whole and should not be split, crushed, or chewed.

Summary of the safety profile Safety was evaluated in 2 657 patients with migraine who received at least one dose of atogepant in clinical studies. Of these, 1 225 patients were exposed to atogepant for at least 6 months and 826 patients were exposed for 12 months.

In 12-week, placebo-controlled clinical studies, 678 patients received at least one dose of atogepant 60 mg once daily, and 663 patients received placebo. The most commonly reported adverse drug reactions were nausea (9%), constipation (8%), and fatigue/somnolence (5%).

Most of the reactions were mild or moderate in severity. 4%). Tabulated list of adverse reactions Adverse reactions reported in clinical trials and from post-marketing experience are listed below by system organ class and frequency, most frequent reactions first.

Frequencies are defined as follows: 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), or not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. Table 2. , anaphylaxis, dyspnoea, rash, pruritus, urticaria, facial oedema) Metabolism and nutrition disorders Common Decreased appetite Gastrointestinal disorders Common Nausea, Constipation General disorders and administration site conditions Common Fatigue/somnolence Investigations Common Weight decreased* Uncommon ALT/AST increased** * Defined in clinical trials as weight decrease of at least 7% at any point.

** Cases of ALT/AST elevations (defined as ≥ 3× upper limit of normal) temporally associated with atogepant were observed in clinical trials, including cases with a potential positive dechallenge history that resolved within 8 weeks of discontinuation.

However, the overall frequency of liver enzyme elevations was similar in the atogepant and placebo groups. 6 Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

8). Most serious reactions have 4 occurred within 24 hours of first use, however, some hypersensitivity reactions can occur days after administration. Patients should be warned about the symptoms associated with hypersensitivity. If a hypersensitivity reaction occurs, discontinue AQUIPTA and institute appropriate therapy.

2). Excipients with known effect AQUIPTA 10 mg tablets contain less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. 6% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

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