Regulatory Information
ASTRAZENECA SINGAPORE PTE LTD
ASTRAZENECA SINGAPORE PTE LTD
Therapeutic
Prescription Only
Formulation Information
INJECTION, SOLUTION
**4.2 Posology and method of administration** **Posology** **_Adults and adolescents (aged 12 years and older)_** 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 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. **_Missed dose_** 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. **Special populations** _**Paediatric population**_ The safety and efficacy of TEZSPIRE in children under 12 years of age have not been established. _**Elderly population (≥65 years old)**_ No dose adjustment is required for elderly patients age 65 or older (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _**Renal and hepatic impairment**_ No dose adjustment is required for patients with renal or hepatic impairment (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Method of administration** TEZSPIRE is administered as a subcutaneous (SC) injection. 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”. 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 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
SUBCUTANEOUS
Medical Information
**4.1 Therapeutic indications** 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.
**4.3 Contraindications** TEZSPIRE is contraindicated in patients who have known hypersensitivity to tezepelumab or any of its excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
R03DX11
tezepelumab
Manufacturer Information
ASTRAZENECA SINGAPORE PTE LTD
Amgen Manufacturing Limited (AML)
Active Ingredients
Documents
Package Inserts
Tezspire Injection Pre-filled Syringe IFU.pdf
Approved: July 4, 2023