Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
AQUIPTA is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month.
The recommended dose is 60 mg atogepant once daily.
The tablets can be taken with or without meals.
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.
Dosing modifications for concomitant use of specific medicinal products are provided in Table 1 (see section 4.5).
Table 1. Dose modifications for interactions:
| Dose modifications | Recommended once daily dose |
|---|---|
| Strong CYP3A4 inhibitors | 10 mg |
| Strong OATP inhibitors | 10 mg |
Population pharmacokinetic modelling suggests no clinically significant pharmacokinetic differences between elderly and younger subjects. No dose adjustment is needed in elderly patients.
No dose adjustment is recommended for patients with mild or moderate renal impairment (see section 5.2). 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.
No dose adjustment is recommended for patients with mild or moderate hepatic impairment (see section 5.2). Atogepant should be avoided in patients with severe hepatic impairment.
The safety and efficacy of atogepant in children (<18 years of age) have not yet been established. No data are available.
AQUIPTA is for oral use. Tablets should be swallowed whole and should not be split, crushed, or chewed.
In clinical studies, atogepant was administered as single doses up to 300 mg and as multiple doses up to 170 mg once daily. Adverse reactions were comparable to those seen at lower doses, and no specific toxicities were identified. There is no known antidote for atogepant. Treatment of an overdose should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
3 years.
This medicinal product does not require any special storage conditions.
AQUIPTA 10 mg tablets: Aluminium foil and PVC/PE/PCTFE blisters, each containing 7 tablets. Packs containing 28 or 98 tablets.
AQUIPTA 60 mg tablets: Aluminium foil and PVC/PE/PCTFE blisters, each containing 7 tablets. Packs containing 28 or 98 tablets.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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