- Approval Id
- ff7bd46e4f196104
- Drug Name
- NURTEC ORALLY DISINTEGRATING TABLET 75MG
- Product Name
- NURTEC ORALLY DISINTEGRATING TABLET 75MG
- Approval Number
- SIN16702P
- Approval Date
- 2023-02-21
- Registrant
- PFIZER PRIVATE LIMITED
- Licence Holder
- PFIZER PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, ORALLY DISINTEGRATING
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><u>Posology</u></p>
<p><em>Acute treatment of migraine</em><br>
The recommended dose is 75 mg rimegepant, as needed, once daily.</p>
<p><em>Prophylaxis of migraine</em><br>
The recommended dose is 75 mg rimegepant every other day.</p>
<p>The maximum dose per day is 75 mg rimegepant.</p>
<p>NURTEC can be taken with or without meals.</p>
<p><em>Concomitant medicinal products</em><br>
Another dose of rimegepant should be avoided within 48 hours when it is concomitantly administered with moderate inhibitors of CYP3A4 (see section 4.5 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><u>Special populations</u></p>
<p><em>Elderly (aged 65 and over)</em><br>
There is limited experience with rimegepant in patients aged 65 years or older. No dose adjustment is required as the pharmacokinetics of rimegepant are not affected by age (see section 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><em>Renal impairment</em><br>
No dose adjustment is required in patients with mild, moderate, or severe renal impairment. Severe renal impairment resulted in a >2-fold increase in unbound AUC but less than a 50% increase in total AUC (see section 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). Caution should be exercised during frequent use in patients with severe renal impairment. Rimegepant has not been studied in patients with end-stage renal disease and in patients on dialysis. Use of rimegepant in patients with end-stage renal disease (CLcr <15 mL/min) should be avoided.</p>
<p><em>Hepatic impairment</em><br>
No dose adjustment is required in patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment. Plasma concentrations (unbound AUC) of rimegepant were significantly higher in subjects with severe (Child-Pugh C) hepatic impairment (see section 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). The use of rimegepant in patients with severe hepatic impairment should be avoided.</p>
<p><em>Paediatric population</em><br>
The safety and efficacy of NURTEC in paediatric patients (<18 years of age) have not been established. No data are available.</p>
<p><u>Method of administration</u></p>
<p>NURTEC is for oral use.</p>
<p>The orally disintegrating tablet should be placed on the tongue or under the tongue. It will disintegrate in the mouth and can be taken without liquid.</p>
<p><u>Instructions for use/Handling</u></p>
<p>Instructions for handling the medicinal product before administration are:</p>
<ul>
<li>Use dry hands when opening the blister pack.</li>
<li>Peel back the foil covering of one blister and gently remove the orally disintegrating tablet. Do not push the tablet through the foil.</li>
<li>Take the tablet immediately after opening the blister pack. Do not store the tablet outside the blister pack for future use.</li>
</ul>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>NURTEC is indicated for the:</p>
<ul>
<li>Acute treatment of migraine with or without aura in adults;</li>
<li>Preventive treatment of episodic migraine in adults who have at least 4 migraine attacks per month.</li>
</ul>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Atc Code
- N02CD06
- Atc Item Name
- rimegepant
- Pharma Manufacturer Name
- PFIZER PRIVATE LIMITED
