AQUIPTA 60 mg tablets contain atogepant, a prescription-only medicine for migraine in adults. AQUIPTA is licensed for the acute treatment of migraine with or without aura and for the prevention of migraine in adults who have at least 4 migraine days per month.

Atogepant is a selective calcitonin gene-related peptide (CGRP) receptor antagonist. CGRP is associated with migraine, and atogepant works by blocking CGRP from binding to its receptor. AQUIPTA is supplied as tablets for oral use.

Is AQUIPTA the same as atogepant?

AQUIPTA contains atogepant as its active ingredient. Each AQUIPTA 60 mg tablet contains 60 mg of atogepant.

Is AQUIPTA a CGRP migraine treatment?

Yes. Atogepant is a selective CGRP receptor antagonist. CGRP is a molecule associated with migraine. Atogepant blocks CGRP from binding to its receptor and reduces CGRP receptor activity.

Can AQUIPTA be used for migraine with aura?

Yes. AQUIPTA is licensed in adults for the acute treatment of migraine with or without aura. It is also licensed for migraine prevention in adults who have at least 4 migraine days per month.

What did clinical studies show about AQUIPTA 60 mg for an acute migraine attack?

In the 16-week ECLIPSE study, 1,328 adults with migraine were randomised to treat qualifying migraine attacks with AQUIPTA 60 mg or placebo in a specified sequence.

For the first studied attack, 24.3% of people taking AQUIPTA 60 mg were pain-free at 2 hours, compared with 13.1% taking placebo. Pain freedom meant that moderate or severe migraine pain had reduced to no pain. Individual responses to treatment can vary.

Does AQUIPTA cause weight loss or sleepiness?

Weight decrease and tiredness or sleepiness are listed as common adverse reactions to AQUIPTA. Common means they may affect up to 1 in 10 people.

The frequency categories for these adverse reactions are based on once-daily use. Because exposure is lower when AQUIPTA is used only for acute migraine treatment, adverse reactions may not occur or may not occur as frequently as with daily preventive treatment.

AQUIPTA may make some people feel sleepy. Do not drive or use machines if you are affected.

A pharmacist may provide advice about AQUIPTA and migraine treatment where appropriate.

Patient Information Leaflet

Our service does not include a prescription. Instead, your treatment is supplied under a legal framework known as a Patient Group Direction (PGD). The process follows these steps:

1. Complete a health questionnaire

Provide information about your health, medical history, migraine symptoms, previous diagnosis and any medicines you currently take.

2. Pharmacist review

A pharmacist will review your responses and may contact you by phone or video call if further information is needed to support a safe and appropriate supply decision.

3. Private consultation

All interactions are confidential. You can discuss any questions about your migraine treatment and the appropriate use of sumatriptan.

4. Identity verification

You may be asked to provide identification to confirm that you are the intended user. This is typically required for your first order only.

5. Supporting information

You may be asked to provide additional information about your migraine history, previous treatments, medical conditions or medicines to support the pharmacist's assessment.

Your GP can be notified of your request and the outcome of the supply decision, if you wish us to do that.

Purchasing this medication does not guarantee supply. The decision to supply is made by the pharmacist based on the information provided. If supply is not appropriate, your order will be refunded.

Main ingredient: atogepant 60 mg.

Excipients: polyvinylpyrrolidone/vinyl acetate copolymer, vitamin E polyethylene glycol succinate, mannitol, microcrystalline cellulose, sodium chloride, croscarmellose sodium, colloidal silicon dioxide, sodium stearyl fumarate.

AQUIPTA is licensed for Acute treatment of migraine with or without aura in adults.

• The recommended dose is 60 mg as needed for a migraine attack.
• The maximum dose is 60 mg per day.
• Do not take more than 60 mg in one day.

How to take AQUIPTA

• Take AQUIPTA by mouth.
• It can be taken with or without food.
• Always take it exactly as instructed by your doctor or pharmacist.

Lower doses

A lower dose may be required if you take certain interacting medicines or have severe kidney impairment.

The recommended dose is 10 mg once daily in people with severe renal impairment or end-stage renal disease and when AQUIPTA is used with certain strong CYP3A4 or OATP inhibitors. If this applies to you please contact your GP.

If you take more than you should

If you take more AQUIPTA than you should, tell your doctor. There is no specific antidote for an AQUIPTA overdose.

Children and adolescents

AQUIPTA should not be given to people under 18 years because its safety and effectiveness have not been established in this age group.

Do not use this medicine if

• You are allergic to atogepant or any of the other ingredients in AQUIPTA.

Speak to your doctor before use

Tell your doctor, pharmacist or nurse before taking AQUIPTA, particularly if you:

• Have kidney problems.
• Have liver problems.
• Take any other medicines.

Kidney problems

A lower dose is recommended for severe kidney impairment and end-stage renal disease. The recommended dose in these circumstances is 10 mg once daily, rather than 60 mg.

If you receive dialysis, speak to your doctor. In people with end-stage renal disease undergoing intermittent dialysis, AQUIPTA should preferably be taken after dialysis.

Liver problems

AQUIPTA should be avoided in severe liver impairment. No dose adjustment is recommended for mild or moderate liver impairment.

Age restrictions

AQUIPTA has not been studied in children and adolescents under 18 years and should not be given to this age group.

There are limited data in people aged 65 years or over, and no data in patients over 80 years.

Pregnancy

AQUIPTA is not recommended during pregnancy. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking it.

Breastfeeding

If you are breastfeeding, ask your doctor for advice before taking AQUIPTA.

After a single 60 mg dose, transfer of atogepant into breast milk was minimal in a study of 12 breastfeeding women. There are no data on its effects on a breastfed infant or on milk production. The benefits of breastfeeding and the mother's clinical need for treatment should be considered together with any potential effects on the infant.

Interactions with other medicines

Tell your doctor or pharmacist if you take, have recently taken or might take any other medicines.

A 10 mg dose is recommended when AQUIPTA is taken with strong CYP3A4 inhibitors, including examples such as:

• Ketoconazole.
• Itraconazole.
• Voriconazole.
• Clarithromycin.
• Telithromycin.
• Indinavir.
• Nelfinavir.
• Ritonavir.
• Saquinavir.

A 10 mg dose is also recommended with strong OATP inhibitors, including examples such as:

• Rifampicin.
• Atazanavir.
• Ritonavir.
• Tipranavir.
• Ciclosporin.
• Telmisartan.

Do not change your AQUIPTA dose without medical advice.

Driving and using machines

AQUIPTA may cause sleepiness. Do not drive or use machines if you are affected. Take care until you know how atogepant affects you.

Serious allergic reactions

Serious allergic reactions, including anaphylaxis, have been reported with AQUIPTA. Symptoms can include:

• Difficulty breathing.
• Swelling of the face.
• Rash.
• Itching.
• Hives.

Some allergic reactions may occur several days after taking AQUIPTA.

Stop taking AQUIPTA and contact your doctor immediately if you develop symptoms of an allergic reaction.

Sodium

Each AQUIPTA 60 mg tablet contains 31.5 mg of sodium, equivalent to 1.6% of the recommended maximum daily dietary intake of sodium for an adult.

Overdose

If you take more AQUIPTA than you should, tell your doctor. Treatment of an overdose consists of supportive care, including monitoring of vital signs and clinical condition.

Like all medicines, AQUIPTA can cause side effects, although not everyone gets them.

Serious side effects requiring urgent medical attention

Some allergic reactions can occur several days after taking AQUIPTA.

Frequency definitions

• Common: may affect up to 1 in 10 people.
• Uncommon: may affect up to 1 in 100 people.
• Rare: may affect up to 1 in 1,000 people.

Other side effects

Tell your doctor, pharmacist or nurse if you develop side effects, including effects that are not listed in the patient leaflet.