AQUIPTA

Posology The maximum dose per day for AQUIPTA is 60 mg. For acute treatment of migraine as needed, the recommended dose for AQUIPTA is 60 mg. For prophylaxis of migraine, the recommended dose for AQUIPTA is 60 mg taken orally once daily with or without food.

A missed dose should be taken right away. If it is almost time for the next dose, patients should be instructed to skip the missed dose and take the next dose as scheduled. 5).

Table 1:

Dose modifications for drug interactions Dosage modifications Recommended once daily dose Strong CYP3A4 inhibitors 10 mg Strong OATP inhibitors 10 mg Special populations Elderly (³65 years) There is limited data available in the elderly with no data available in patients over 80 years of age.

Population pharmacokinetic modelling suggests no clinically significant pharmacokinetic differences between elderly and younger subjects. No dose adjustment of AQUIPTA is needed in elderly patients. Hepatic impairment Avoid use of AQUIPTA in patients with severe hepatic impairment.

2). Renal impairment In patients with severe renal impairment (CLcr 15-29 mL/min), and in patients with end-stage renal disease (ESRD) (CLcr <15 mL/min), the recommended dosage of AQUIPTA is 10 mg once daily. For patients with ESRD undergoing intermittent dialysis, AQUIPTA should preferably be taken after dialysis.

2). Paediatric population The safety and efficacy of atogepant in children have not yet been established. No data are available. Method of administration AQUIPTA is to be taken orally once daily with or without food.

Summary of the safety profile The safety of AQUIPTA was evaluated in 3 852 patients with migraine who received at least one dose of AQUIPTA. Of these, 1 225 patients were exposed to AQUIPTA for prophylaxis daily for at least 6 months and 826 patients were exposed for 12 months.

895 patients were exposed during 24 weeks on an as-needed basis for treatment of acute migraine attacks. In 12-week, placebo-controlled prophylaxis clinical studies, 314 patients received at least one dose of AQUIPTA 10 mg once daily, 411 patients received at least one dose of AQUIPTA 30 mg once daily, 343 patients received at least one dose of AQUIPTA 30 mg twice daily, 678 patients received at least one dose of AQUIPTA 60 mg once daily, 91 patients received at least one dose of AQUIPTA 60 mg twice daily, and 663 patients received placebo.

In the placebo-controlled clinical study for acute treatment of migraine, 1 195 patients received at least one dose of AQUIPTA 60 mg, and 1 177 patients received placebo; patients received both AQUIPTA and placebo to treat qualifying migraines.

In placebo-controlled prophylaxis studies, the most commonly reported adverse reactions were nausea (7%), constipation (7%), and fatigue/somnolence (5%). The majority of the cases were mild, and none were serious. 6%). 3%) was the most commonly reported adverse reaction for acute treatment.

Tabulated list of adverse reactions Table 2 lists adverse reactions for which a causal relationship between AQUIPTA and the adverse event is at least a reasonable possibility. Given the lower exposure in the setting of acute treatment of migraine, adverse drug reactions may not occur or may not be as frequent as when used for the prophylaxis of migraine.

The adverse reactions are listed below by system organ class and frequency. 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) or very rare (<1/10 000).

8). Some hypersensitivity reactions can occur days after administration. 3). Excipients AQUIPTA 10 mg tablets contain less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

4).