Hypereosinophilic syndrome (HES)

Active Ingredient: Benralizumab

Indication for Benralizumab

Population group: only adolescents (12 years - 18 years old) , adults (18 years old or older)
Therapeutic intent: Curative procedure

Benralizumab is indicated as an add-on treatment for adult and adolescent patients aged 12 years and older weighing at least 35 kg with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause.

For this indication, competent medicine agencies globally authorize below treatments:

30 mg once every 4 weeks for patients weighing at least 35 kg

For:

Dosage regimens

In the case that patient weight is ≥ 35 kg :

Subcutaneous, 30 milligrams benralizumab, once every 4 weeks.

Detailed description

Benralizumab is intended for long-term treatment. A decision to continue the therapy should be made at least annually based on disease severity, level of disease control and blood eosinophil counts.

The recommended dose of benralizumab for adult and adolescent patients aged 12 years and older weighing at least 35 kg is 30 mg by subcutaneous injection every 4 weeks.

Patients who develop life-threatening manifestations of HES should be evaluated for the need for continued therapy, as Fasenra has not been studied in this population.

Missed dose

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.

Dosage considerations

Benralizumab should be injected into the thigh or abdomen, except for the 5 cm area around the navel. 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.

Active ingredient

Benralizumab

Benralizumab is an anti-eosinophil, humanised afucosylated, monoclonal antibody (IgG1, kappa). It specifically binds to the alpha subunit of the human interleukin-5 receptor (IL-5Rα). The IL-5 receptor is specifically expressed on the surface of eosinophils and basophils. The absence of fucose in the Fc domain of benralizumab results in high affinity for FcɣRIII receptors on immune effector cells such as natural killer (NK) cells. This leads to apoptosis of eosinophils and basophils through enhanced antibody-dependent cell-mediated cytotoxicity (ADCC), which reduces eosinophilic inflammation.

Read more about Benralizumab

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