Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: AstraZeneca AB, SE-151 85 Södertälje, Sweden
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 high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.
Treatment should be initiated by physicians experienced in the diagnosis and treatment of severe asthma.
The recommended dose is 210 mg of tezepelumab by subcutaneous injection every 4 weeks.
Tezspire is intended for long-term treatment. A decision to continue the therapy should be made at least annually based on the patient’s level of asthma control.
If a dose is missed, the dose should be administered as soon as possible. Thereafter, the patient can resume dosing on the scheduled day of administration. If the next dose is already due, then administer as planned. A double dose must not be administered.
No dose adjustment is required for elderly patients (see section 5.2).
No dose adjustment is required for patients with renal or hepatic impairment (see section 5.2).
The safety and efficacy of Tezspire in children under 12 years of age have not been established. No data are available.
Tezspire is administered as a subcutaneous injection.
A patient may self-inject or the patient’s caregiver may administer this medicinal product after training in subcutaneous injection technique. Proper training should be provided 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 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. It 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.
Comprehensive instructions for administration using the pre-filled syringe is provided in the “Instructions for Use”.
In clinical trials, doses of up to 280 mg were administered subcutaneously every 2 weeks (Q2W) and doses of up to 700 mg were administered intravenously every 4 weeks (Q4W) to patients with asthma without evidence of dose-related toxicities.
There is no specific treatment for an overdose with tezepelumab. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.
3 years.
Tezspire may be kept at room temperature (20°C-25°C) for a maximum of 30 days. After removal from the refrigerator, Tezspire must be used within 30 days or discarded.
Store in a refrigerator (2°C-8°C). For storage after removal from refrigeration, see section 6.3.
Keep the pre-filled syringe in the outer carton in order to protect from light.
Do not freeze. Do not shake. Do not expose to heat.
1.91 mL solution in a siliconized Type I glass pre-filled syringe subassembly consisting of a 27-gauge ½-inch (12.7 mm) stainless steel special thin wall needle covered with a rigid needle cover and bromobutyl plunger-stopper. The pre-filled syringe subassembly is assembled with a needle guard and an extended finger flange.
Pack containing 1 pre-filled syringe.
This medicinal product is for single-use only.
Prior to administration, remove carton from refrigerator and allow Tezspire to reach room temperature. This generally takes 60 minutes.
Visually inspect Tezspire for particulate matter and discolouration prior to administration. Tezspire is clear to opalescent, colourless to light yellow. Do not use this medicinal product if liquid is cloudy, discoloured, or if it contains large particles or foreign particulate matter.
Additional information and instructions for the preparation and administration of Tezspire using the pre-filled syringe are given in the package leaflet and ‘Instructions for Use’.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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