TEZSPIRE SOLUTION FOR INJECTION 210 MG IN PRE-FILLED PEN
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.
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.
