AQUIPTA® is a once‑daily migraine prevention tablet that is simple to take1
- The recommended dose is 60 mg orally, once‑daily1
- In patients with severe renal impairment (creatinine clearance (CrCl) 15-29 mL/min), and in patients with end-stage renal disease (ESRD) (CrCl <15 mL/min), the recommended dosage of AQUIPTA® is 10 mg once‑daily1
- For patients with ESRD undergoing intermittent dialysis AQUIPTA® should preferably be taken after dialysis1
- The recommended dosage of AQUIPTA® with concomitant use of strong cytochrome P450 3A4 (CYP3A4) inhibitors or strong organic anionic transporting polypeptide (OATP) inhibitors is 10 mg once‑daily1
- Avoid use in patients with severe hepatic impairment1
Renal impairment
In patients with severe renal impairment (CrCl 15–29 mL/min), and in patients with ESRD (CrCl <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.
Pregnancy
There are limited data from the use of AQUIPTA® in pregnant women. Studies in animals have shown reproductive toxicity. AQUIPTA® is not recommended during pregnancy.
Breast Feeding
In a study of 12 breast-feeding women administered a single oral dose of AQUIPTA® 60 mg, transfer of AQUIPTA® into breast milk was minimal.
There are no data on the effects of AQUIPTA® on the breastfed infant or the effects of AQUIPTA® on milk production.
The developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for AQUIPTA® and any potential adverse effects on the breastfed infant from AQUIPTA® or from the underlying maternal condition.
Elderly (≥65 years)
There are limited data available in the elderly. 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. No dose adjustment is recommended for patients with mild or moderate hepatic impairment.
Paediatric population
The safety and efficacy of AQUIPTA® in children have not yet been established. No data are available.
Contraindications
The only contraindication with AQUIPTA® is hypersensitivity to the active substance or to any of the excipients. Hypersensitivity reactions, including anaphylaxis, dyspnoea, rash, pruritus, urticaria, and facial oedema, have been reported with use of AQUIPTA®. Some hypersensitivity reactions can occur days after administration. If a hypersensitivity reaction occurs, discontinue AQUIPTA® and institute appropriate therapy.
Special warnings and precautions for use
As excipients, AQUIPTA® 60 mg tablets contain 31.5 mg sodium/dose; this is equivalent to 1.6% of the World Health Organization recommended maximum daily intake of 2 g sodium for an adult.
Effects on ability to drive and use machines
AQUIPTA® 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.
CYP3A4 inhibitors
The recommended dosage of AQUIPTA® with concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, indinavir, nelfinavir, ritonavir, saquinavir) is 10 mg once‑daily. No dosage adjustment of AQUIPTA® is needed with concomitant use of moderate or weak CYP3A4 inhibitors. Co‑administration of AQUIPTA® with itraconazole, a strong CYP3A4 inhibitor, resulted in a significant increase in exposure of AQUIPTA® in healthy subjects.
OATP inhibitors
The recommended dosage of AQUIPTA® with concomitant use of strong OATP inhibitors (e.g., rifampicin, atazanavir, ritonavir, tipranavir, ciclosporin, telmisartan) is 10 mg once‑daily. Co‑administration of AQUIPTA® with single‑dose rifampicin, an OATP inhibitor, resulted in a significant increase in exposure of AQUIPTA® in healthy subjects.
Patients' preference for oral treatments
In a 2016 study conducted in Greece, migraine patients’ preferred choice of preventative treatment was a once‑daily oral tablet rather than a monthly injection. In this survey of 514 patients aged 18–65 years with consecutive headaches who had been taking their preventative treatment for a headache for more than 3 months, including 372 patients with migraine:3
UK-AQP-250066 | Date of preparation: March 2025.
Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk
Adverse events should also be reported to AbbVie on GBPV@abbvie.com