Forest Laboratories Ireland, Limited (IRELAND)🇸🇬 Health Sciences Authority
Approval Date
Nov 29, 2024
Approval ID
bcb37088f2dc3672
Company
Forest Laboratories Ireland, Limited (IRELAND)
Type
Therapeutic
Approval Details
Approval Id
bcb37088f2dc3672
Drug Name
AQUIPTA TABLET 10MG
Product Name
AQUIPTA TABLET 10MG
Approval Number
SIN17145P
Approval Date
2024-11-29
Registrant
ABBVIE PTE. LTD.
Licence Holder
ABBVIE PTE. LTD.
Drug Type
Therapeutic
Forensic Classification
Prescription Only
Dosage Form
TABLET
Dosage
<p><strong>3. DOSAGE AND ADMINISTRATION</strong></p>
<p><strong>3.1 Recommended dosage</strong></p>
<p>The recommended dosage for AQUIPTA™ is 60 mg taken orally once daily with or without food.</p>
<p>There is no data that the 60 mg tablet can be divided into equal halves.</p>
<p><strong>3.2 Missed dose</strong></p>
<p>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.</p>
<p><strong>3.3 Dose modification</strong></p>
<p>Dosing modifications for concomitant use of specific drugs (<em>see</em> <strong>DRUG INTERACTIONS</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>) and for patients with renal impairment are provided in Table 1.</p>
<img src="/TGIF/Aquipta-Table1.png" alt="Aquipta Dosage Table 1" /><br><br>
<p><strong>3.4 Dosing in special populations</strong></p>
<p><u>3.4.1 Pediatrics</u></p>
<p>Safety and effectiveness of AQUIPTA™ in pediatric patients have not been established.</p>
<p><u>3.4.2 Geriatric</u></p>
<p>Population pharmacokinetic modeling suggests no clinically significant pharmacokinetic differences between elderly and younger subjects. No dose adjustment of AQUIPTA™ is needed in elderly patients.</p>
<p><u>3.4.3 Renal impairment</u></p>
<p>For patients with severe renal impairment and ESRD, see dose adjustment in Table 1. No dose adjustment is recommended for patients with mild or moderate renal impairment.</p>
<p>For patients with ESRD undergoing intermittent dialysis, AQUIPTA™ should preferably be taken after dialysis.</p>
<p><u>3.4.4 Hepatic impairment</u></p>
<p>Avoid use of AQUIPTA™ in patients with severe hepatic impairment (Child-Pugh Class C) (<em>see</em> <strong>PHARMACOLOGIC PROPERTIES</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). No dose adjustment is recommended for patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment.</p>
Route Of Administration
ORAL
Indication Info
<p><strong>2. INDICATIONS</strong></p>
<p>AQUIPTA™ is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month.</p>
Contraindications
<p><strong>4. CONTRAINDICATIONS</strong></p>
<p>AQUIPTA™ is contraindicated in patients with a history of hypersensitivity to atogepant or any of the components of AQUIPTA™. Reactions have included anaphylaxis and dyspnea (<em>see</em> <strong>WARNINGS AND PRECAUTIONS</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
