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FASENRA Solution for injection (2019)

Active ingredients: Benralizumab

Product Name and Form

Fasenra 30 mg solution for injection in pre-filled syringe.
Fasenra 30 mg solution for injection in pre-filled pen.

Pharmaceutical form

Solution for injection in pre-filled syringe (injection).
Solution for injection in pre-filled pen (injection) (Fasenra Pen).

Clear to opalescent, colourless to yellow solution and may contain translucent or white to off-white particles.

Qualitative and Quantitative Composition

Pre-filled syringe: Each pre-filled syringe contains 30 mg benralizumab* in 1 mL.

Pre-filled pen: Each pre-filled pen contains 30 mg benralizumab* in 1 mL.

* Benralizumab is a humanised monoclonal antibody produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.

For the full list of excipients, see section 6.1.

Chemical substance
Description
Benralizumab

Benralizumab is an anti-eosinophil, humanised afucosylated, monoclonal antibody (IgG1, kappa) that binds to the alpha subunit of the human interleukin-5 receptor (IL-5Rα) with high affinity and specificity. 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 effectors 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.

List of excipients

Histidine
Histidine hydrochloride monohydrate
Trehalose dihydrate
Polysorbate 20
Water for injections

Pack sizes and Marketing

Pre-filled syringe:

One mL solution in a single-use pre-filled syringe made from type I glass with a staked 29-gauge 1⁄2-inch (12.7 mm) stainless steel needle, rigid needle shield, and Fluorotec-coated plunger stopper in a passive safety device.

Pack containing 1 single-use 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 1⁄2-inch (12.7 mm) stainless steel needle, rigid needle shield, and Fluorotec-coated stopper in a pre-filled pen.

Pack containing 1 single-use pre-filled pen (Fasenra Pen).

Marketing authorization holder
Authorization dates

AstraZeneca AB, SE-151 85 Södertälje, Sweden

Date of first authorisation: 8 January 2018

Marketing authorization number:

EU/1/17/1252/001 1 pre-filled syringe
EU/1/17/1252/002 1 pre-filled pen