Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: AstraZeneca AB, SE-151 85 Södertälje, Sweden
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 (see section 5.1).
Fasenra treatment should be initiated by a physician experienced in the diagnosis and treatment of severe asthma.
After proper training in the subcutaneous injection technique and education about signs and symptoms of hypersensitivity reactions (see section 4.4), patients with no known history of anaphylaxis or their caregivers may administer Fasenra if their physician determines that it is appropriate, with medical follow-up as necessary. Self-administration should only be considered in patients already experienced with Fasenra treatment.
The recommended dose of benralizumab is 30 mg by subcutaneous injection every 4 weeks for the first 3 doses, and then every 8 weeks thereafter. If an injection is missed on the planned date, dosing should resume as soon as possible on the indicated regimen; a double dose must not be administered.
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.
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 Fasenra in children and adolescents aged 6 to 17 years has not been established. Currently limited data in children 6 to 11 years old and data in adolescents aged 12 to 17 are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
The safety and efficacy of Fasenra in children less than 6 years have not been established. No data are available.
This medicinal product is administered as a subcutaneous injection.
It should be injected into the thigh or abdomen. If the healthcare professional or caregiver administers the injection, the upper arm can also be used. It should not be injected into areas where the skin is tender, bruised, erythematous, or hardened.
Comprehensive instructions for administration using the pre-filled syringe/pre-filled pen are provided in the ‘Instructions for Use’.
Doses of up to 200 mg were administered subcutaneously in clinical trials to patients with eosinophilic asthma without evidence of dose-related toxicities.
There is no specific treatment for an overdose with benralizumab. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.
3 years.
Store in a refrigerator (2°C to 8°C).
Fasenra may be kept at room temperature up to 25°C for a maximum of 14 days. After removal from the refrigerator, Fasenra must be used within 14 days or discarded.
Store in the original package in order to protect from light.
Do not freeze. Do not shake. Do not expose to heat.
Pre-filled syringe:
One mL solution in a single-use pre-filled syringe made from type I glass with a staked 29-gauge ½-inch (12.7 mm) stainless steel needle, rigid needle shield, and Fluorotec-coated plunger stopper in a passive safety device.
Pack containing 1 pre-filled syringe.
Pre-filled pen:
One mL solution in a sterile, single use pre-filled pen made from type I glass with staked 29-gauge ½-inch (12.7 mm) stainless steel needle, rigid needle shield, and Fluorotec-coated stopper in a pre-filled pen.
Pack containing 1 pre-filled pen.
Prior to administration, allow the pre-filled syringe or pre-filled pen to reach room temperature 20°C to 25°C by leaving the carton out of the refrigerator for around 30 minutes.
Visually inspect Fasenra for particulate matter and discolouration prior to administration. Fasenra is clear to opalescent, colourless to yellow, and may contain translucent or white to off-white particles. Do not use Fasenra 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 Fasenra using the pre-filled syringe or pre-filled pen 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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