- Approval Id
- 8c30f171391164c8
- Drug Name
- VYEPTI CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/ML
- Product Name
- VYEPTI CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/ML
- Approval Number
- SIN16325P
- Approval Date
- 2021-09-16
- Registrant
- ZUELLIG PHARMA PTE. LTD.
- Licence Holder
- ZUELLIG PHARMA PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INFUSION, SOLUTION CONCENTRATE
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p>As for other infusion treatments, VYEPTI treatment should be initiated and supervised by a healthcare professional.</p>
<p><u>Posology</u></p>
<p>The recommended dose is 100 mg administered by intravenous infusion every 12 weeks. Some patients may benefit from a dosage of 300 mg administered by intravenous infusion every 12 weeks (see section 5.1 – <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 years and over)</em></p>
<p>There is limited data available for the use of VYEPTI in patients > 65 years of age.The pharmacokinetics of eptinezumab 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/hepatic impairment</em></p>
<p>No dedicated hepatic or renal impairment studies were conducted to assess the effects of hepatic and renal impairment upon the pharmacokinetics of eptinezumab. Population pharmacokinetic analysis of integrated data from the VYEPTI clinical studies did not reveal any differences in patients with renal or hepatic impairment that would require dose adjustment (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>Paediatric population</em></p>
<p>The safety and efficacy of VYEPTI in children below the age of 18 years has not yet been established. Currently no data are available.</p>
<p><u>Method of administration</u></p>
<p>VYEPTI is for intravenous infusion only after dilution.</p>
<p>For instructions on dilution of the medicinal product prior to administration, see section 3.7 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Route Of Administration
- INTRAVENOUS DRIP
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>VYEPTI is indicated for prophylaxis of migraine in adults.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Hypersensitivity to the active substance or to any of the excipients listed in section 3.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Atc Code
- N02CD05
- Atc Item Name
- eptinezumab
- Pharma Manufacturer Name
- LUNDBECK SINGAPORE PTE. LTD.
