ABBREVIATED PRESCRIBING INFORMATION

AQUIPTA^®▼ (atogepant) 10 mg tablets; 60 mg tablets.

Please refer to the Summary of Product Characteristics (SmPC) before prescribing.

PRESENTATION: Each tablet contains: 10 mg atogepant in 10 mg tablet, 60 mg atogepant in 60 mg tablet.

INDICATION: Prophylaxis of migraine in adults who have at least 4 migraine days per month.

DOSAGE AND ADMINISTRATION: The recommended dose is 60 mg taken orally once daily with or without meals; swallowed whole and not split, crushed or chewed. Missed dose to be taken as soon as it is remembered. If forgotten for an entire day, missed dose to be skipped and next dose taken as scheduled. Dose Modification: The recommended dosage of atogepant with concomitant use of strong CYP3A4 inhibitors or strong OATP inhibitors is 10 mg once daily. Special Populations: Elderly: No dose adjustment needed. Renal impairment: 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, atogepant should preferably be taken after dialysis. No dose adjustment is recommended for patients with mild or moderate renal impairment. Hepatic impairment: Avoid use of atogepant in patients with severe hepatic impairment. No dose adjustment is recommended for patients with mild or moderate hepatic impairment. Paediatric Population: The safety and efficacy of atogepant in children (< 18 years of age) have not yet been established. CONTRAINDICATIONS: Hypersensitivity to active substance or any of the excipients. SPECIAL WARNINGS AND PRECAUTIONS: Serious hypersensitivity reactions reported, including anaphylaxis, dyspnoea, rash, pruritus, urticaria and facial oedema. Most serious reactions have occurred within 24 hours of first use, however, some hypersensitivity reactions can occur days after administration. Patients should be warned about symptoms of hypersensitivity. If a reaction occurs, discontinue atogepant and institute appropriate therapy. AQUIPTA 60 mg tablets contain 31.5 mg sodium per tablet; this is equivalent to 1.6% of the WHO recommended maximum daily intake of 2 g sodium for an adult. AQUIPTA 10 mg tablets contain less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’. Atogepant has no or negligible influence on the ability to drive and use machines. However, if affected by somnolence, patients should exercise caution before driving or using machinery. FERTILITY, PREGNANCY AND LACTATION: Pregnancy: Atogepant is not recommended during pregnancy and in women of childbearing potential not using contraception. Breast-feeding: Pharmacokinetic data after single-dose administration showed minimal transfer of atogepant into breast milk. There are no data on the effects of atogepant on the breastfed infant or the effects of atogepant on milk production. The development and health benefits of breast-feeding should be considered along with the mother’s clinical need for atogepant and any potential adverse effects on the breastfed infant from atogepant or from the underlying maternal condition. Fertility: No human data on the effect of atogepant on fertility are available. Animal studies showed no impact on female and male fertility with atogepant treatment. UNDESIRABLE EFFECTS: Common (≥1/100 to < 1/10): Decreased appetite, nausea, constipation, fatigue/somnolence, weight decreased. Refer to Section 4.8 of the SmPC for details of other side effects, and for further 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 via HPRA Pharmacovigilance; website: www.hpra.ie.

LEGAL CATEGORY: POM (S1B)

MARKETING AUTHORISATION NUMBERS: EU/1/23/1750/001 AQUIPTA 10 mg tablets in blisters, in cartons of 28 tablets; EU/1/23/1750/003 AQUIPTA 60 mg tablets in blisters, in cartons of 28 tablets

MARKETING AUTHORISATION HOLDER: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany.

Further information is available on request from: AbbVie Limited, 14 Riverwalk, Citywest Business Campus, Dublin 24.

DATE OF REVISION: May 2025

PI/1750/003