- Approval Id
- 4865784b2c89572b
- Drug Name
- SPEVIGO CONCENTRATE FOR SOLUTION FOR INFUSION 450 MG/7.5 ML
- Product Name
- SPEVIGO CONCENTRATE FOR SOLUTION FOR INFUSION 450 MG/7.5 ML
- Approval Number
- SIN16883P
- Approval Date
- 2023-10-12
- Registrant
- BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.
- Licence Holder
- BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INFUSION, SOLUTION CONCENTRATE
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p>Treatment should be initiated and supervised by physicians experienced in the management of patients with inflammatory skin diseases.</p>
<p><u>Posology</u></p>
<p>The recommended dose is a single dose of 900 mg (two 450 mg/7.5 mL vials) administered as an intravenous infusion.</p>
<p>If flare symptoms persist, an additional 900 mg dose (two 450 mg/7.5 mL vials) may be administered 1 week after the initial dose.<br>
Clinical data for treatment of subsequent flares is very limited (see section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>Clinical data for concomitant use of other GPP treatments with spesolimab is limited. Spesolimab should not be used in combination with other GPP treatments, e.g. systemic immunosuppressants, to treat a flare (see sections 4.4 and 4.5 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><em>Elderly</em><br>
No dose adjustment is required.</p>
<p><em>Renal and/or hepatic impairment</em><br>
SPEVIGO has not been studied in these patient populations. These conditions are generally not expected to have any clinically relevant impact on the pharmacokinetics of monoclonal antibodies and no dose adjustments are considered necessary.</p>
<p><em>Paediatric population</em><br>
The safety and efficacy of spesolimab in adolescents aged 12 to 18 years have not been established.<br>
No data are available.<br>
There is no relevant use of spesolimab in children below the age of 12 years.</p>
<p><u>Method of administration</u></p>
<p>This medicinal product is for intravenous infusion only. It should not be administered as an intravenous push or bolus.<br>
Following dilution with sodium chloride 9 mg/mL (0.9%) solution for injection, it is administered as a continuous intravenous infusion through an intravenous line containing a sterile, non-pyrogenic, low protein binding in-line filter (pore size of 0.2 micron) over 90 minutes. No other infusion should be administered in parallel via the same intravenous access.</p>
<p>In the event that the infusion is slowed or temporarily stopped, the total infusion time (including stop time) should not exceed 180 minutes (see section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>For instructions on dilution of the medicinal product before administration, see section 6.6 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>SPEVIGO is indicated for the treatment of flares in adult patients with generalised pustular psoriasis (GPP) as monotherapy.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Severe or life-threatening hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section 4.4) – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
<p>Clinically important active infections (e.g. active tuberculosis, see section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Atc Code
- L04AC22
- Atc Item Name
- spesolimab
- Pharma Manufacturer Name
- BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.
