AQUIPTA  (atogepant) 10 mg tablets and 60 mg tablets

Refer to Summary of Product Characteristics (SmPC) before prescribing.

PRESENTATION: Each 10 mg and 60 mg tablet contains 10 mg and 60 mg of atogepant, respectively.

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

DOSAGE AND ADMINISTRATION: See Summary of Product Characteristics for full information. Posology: The recommended dose 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. Dose Modification: for drug interactions – the recommended dosage of AQUIPTA with concomitant use of strong CYP3A4 inhibitors and strong OATP inhibitors is 10 mg once daily. Special Populations: Elderly (≥65 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. 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 dosage of AQUIPTA 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 renal impairment. Hepatic impairment: Avoid use of AQUIPTA 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. No data are available.

CONTRAINDICATIONS: Hypersensitivity to active substance or any of the excipients.

SPECIAL WARNINGS AND PRECAUTIONS: AQUIPTA 60 mg tablets contain 31.5 mg sodium per dose; 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’.

INTERACTIONS: CYP3A4 Inhibitors: The recommended dosage of AQUIPTA with concomitant use of strong CYP3A4 inhibitors is 10 mg once daily. No dosage adjustment of AQUIPTA is needed with concomitant use of moderate or weak CYP3A4 inhibitors. OATP Inhibitors: The recommended dosage of AQUIPTA with concomitant use of strong OATP inhibitors is 10 mg once daily.

FERTILITY, PREGNANCY AND LACTATION: Pregnancy: There are limited data from the use of atogepant in pregnant women. Studies in animals have shown reproductive toxicity. AQUIPTA is not recommended during pregnancy. Breast-feeding: It is unknown whether atogepant is excreted in human milk. Available toxicological data in animals have shown excretion of atogepant in milk. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from AQUIPTA therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. 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.

ABILITY TO DRIVE AND USE MACHINES: AQUIPTA has no or negligible influence on the ability to drive and use machines. However, it may cause somnolence in some patients. Patients should exercise caution before driving or using machinery until they are reasonably certain that atogepant does not adversely affect performance.

UNDESIRABLE EFFECTS: See SmPC for full list of adverse events.

Common (≥1/100 to <1/10): Decreased appetite, nausea, constipation, fatigue/somnolence, weight decreased.

Uncommon (≥1/1 000 to <1/100): ALT/AST increased.

OVERDOSE: There is no known antidote for AQUIPTA. Treatment of an overdose of AQUIPTA should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.

MARKETING AUTHORISATION NUMBERS/ PRESENTATIONS/NHS LIST PRICE:

AQUIPTA 10 mg tablets, 28 tablets, Great Britain (GB) PLGB 41042/0088, Northern Ireland (NI) EU/1/23/1750/001, £182.16

AQUIPTA 60 mg tablets, 28 tablets, Great Britain (GB) PLGB 41042/0089, Northern Ireland (NI) EU/1/23/1750/003, £182.16

LEGAL CLASSIFICATION: POM

MA HOLDER: Further information available from AbbVie Ltd, Maidenhead, SL6 4UB, UK

DATE OF REVISION: April 2024

DOCUMENT NUMBER: AGPT-UK-00003-C