- Approval Id
- 2895e57c7c27d673
- Drug Name
- FASENRA SOLUTION FOR INJECTION 30MG/ML (AUTOINJECTOR PEN)
- Product Name
- FASENRA SOLUTION FOR INJECTION 30MG/ML (AUTOINJECTOR PEN)
- Approval Number
- SIN16043P
- Approval Date
- 2020-11-18
- Registrant
- ASTRAZENECA SINGAPORE PTE LTD
- Licence Holder
- ASTRAZENECA SINGAPORE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION, SOLUTION
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><strong>Posology</strong></p>
<p><strong><em><u>Asthma</u></em></strong></p>
<p>The recommended dose is 30 mg of FASENRA by subcutaneous injection every 4 weeks for the first 3 doses, and then every 8 weeks thereafter.</p>
<p>FASENRA is intended for long-term treatment. A decision to continue the therapy should be made at least annually based on disease severity, level of exacerbation control and blood eosinophil counts.</p>
<p><strong><em><u>EGPA</u></em></strong></p>
<p>The recommended dosage is 30 mg of FASENRA (one injection) administered subcutaneously every 4 weeks.</p>
<p>Patients who develop life-threatening manifestations of EGPA should be evaluated for the need for continued therapy, as FASENRA has not been studied in this population.</p>
<p><strong><em><u>Paediatric population</u></em></strong></p>
<p>Available data of FASENRA in adolescents aged 12 to less than 18 years are described in section 5.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>, however no posology recommendations can be made.</p>
<p>The safety and efficacy of FASENRA in children aged less than 12 years have not been established.</p>
<p>The safety and efficacy of FASENRA in children and adolescents (<18 years of age) with EGPA have not been established.</p>
<p><em><u><strong>Elderly patients</strong></u></em></p>
<p>No dose adjustment is required for elderly patients (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><u><strong>Renal and hepatic impairment</strong></u></em></p>
<p>No dose adjustment is required for patients with renal or 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>).</p>
<p><strong>Method of administration</strong></p>
<p>FASENRA is administered as a subcutaneous injection. In line with clinical practice, monitoring of patients after administration of biologic agents is recommended (see section 4.4, Hypersensitivity Reactions – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>Administer FASENRA into the thigh, or abdomen. If somebody else administers the injection, the upper arm can also be used. Do not administer into areas where the skin is tender, bruised, erythematous, or hardened.</p>
<p>After proper training in the subcutaneous injection technique and education about signs and symptoms of hypersensitivity reactions (see section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>), patients or their caregivers may administer Fasenra if their physician determines that it is appropriate, with medical follow-up as necessary. Proper training in subcutaneous injection technique using the autoinjector (FASENRA PEN) should be provided according to the ‘Instructions for Use’ – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Route Of Administration
- SUBCUTANEOUS
- Indication Info
- <p><strong>4.1 Therapeutic indication</strong></p>
<p><strong>Asthma</strong></p>
<p>FASENRA is indicated as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β-agonists.</p>
<p><strong>Eosinophilic granulomatosis with polyangiitis (EGPA)</strong></p>
<p>FASENRA is indicated as an add-on treatment for adult patients with eosinophilic granulomatosis with polyangiitis.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>FASENRA is contraindicated in patients who have known hypersensitivity to benralizumab or any of its excipients (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
- R03DX10
- Atc Item Name
- benralizumab
- Pharma Manufacturer Name
- ASTRAZENECA SINGAPORE PTE LTD
