- Approval Id
- 9565028eb2df3291
- Drug Name
- TEZSPIRE SOLUTION FOR INJECTION 210 MG IN PRE-FILLED SYRINGE
- Product Name
- TEZSPIRE SOLUTION FOR INJECTION 210 MG IN PRE-FILLED SYRINGE
- Approval Number
- SIN16815P
- Approval Date
- 2023-07-04
- 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><strong><em>Adults and adolescents (aged 12 years and older)</em></strong></p>
<p>The recommended dose is 210 mg of TEZSPIRE by subcutaneous injection every 4 weeks. Available data for TEZSPIRE in adolescents aged 12 to 17 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>.</p>
<p><strong><em><u>CRSwNP</u></em></strong></p>
<p>The recommended dose for adult patients is 210 mg of TEZSPIRE by subcutaneous injection every 4 weeks.</p>
<p><strong>Missed dose</strong></p>
<p>If a dose is missed, administer the dose as soon as possible. Thereafter, the patient can resume dosing on the usual day of administration. If the next dose is already due, then administer as planned.</p>
<p><strong>Special populations</strong></p>
<p><u><em><strong>Paediatric population</strong></em></u></p>
<p>The safety and efficacy of TEZSPIRE in children under 12 years of age for the treatment of asthma have not been established.</p>
<p>The safety and efficacy of TEZSPIRE in children under 18 years of age for the treatment of CRSwNP have not been established.</p>
<p><em><u><strong>Elderly population (≥65 years old)</strong></u></em></p>
<p>No dose adjustment is required for elderly patients age 65 or older (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>TEZSPIRE is administered as a subcutaneous (SC) injection.</p>
<p>A patient may self-inject TEZSPIRE or the patient’s caregiver may administer TEZSPIRE after training in SC injection technique. Provide proper training to patients and/or caregivers on the preparation and administration of TEZSPIRE prior to use according to the “Instructions for Use”.</p>
<p>TEZSPIRE should be injected into the thigh or abdomen, except for the 2 inches (5 cm) around the navel. If a healthcare professional or caregiver administers the injection, the upper arm can also be used. A patient should not self-inject in the arm. TEZSPIRE should not be injected into areas where the skin is tender, bruised, erythematous, or hardened. It is recommended to rotate the injection site with each injection. 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
- SUBCUTANEOUS
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p><strong>Asthma</strong></p>
<p>TEZSPIRE is indicated as an add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma who are inadequately controlled despite medium or high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.</p>
<p><strong>Chronic rhinosinusitis with nasal polyps (CRSwNP)</strong></p>
<p>TEZSPIRE is indicated as an add-on therapy to intranasal corticosteroids for the treatment of adult patients with inadequately controlled severe CRSwNP.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>TEZSPIRE is contraindicated in patients who have known hypersensitivity to tezepelumab or any of its 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
- R03DX11
- Atc Item Name
- tezepelumab
- Pharma Manufacturer Name
- ASTRAZENECA SINGAPORE PTE LTD
