DUPIXENT 300 mg Solution for injection Ref.[8955] Active ingredients: Dupilumab

Source: European Medicines Agency (EU)  Revision Year: 2023  Publisher: Sanofi-aventis groupe, 54, rue La Boétie, 75008, Paris, France

Product name and form

Dupixent 300 mg solution for injection in pre-filled syringe.

Dupixent 300 mg solution for injection in pre-filled pen.

Pharmaceutical Form

Solution for injection (injection).

Clear to slightly opalescent, colourless to pale yellow sterile solution, which is free from visible particulates, with a pH of approximately 5.9.

Qualitative and quantitative composition

Dupilumab 300 mg solution for injection in pre-filled syringe: Each single-use pre-filled syringe contains 300 mg of dupilumab in 2 ml solution (150 mg/ml).

Dupilumab 300 mg solution for injection in pre-filled pen: Each single-use pre-filled pen contains 300 mg of dupilumab in 2 ml solution (150 mg/ml).

Dupilumab is a fully human monoclonal antibody against interleukin (IL)-4 receptor alpha that inhibits IL-4/IL-13 signalling, produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Dupilumab

Dupilumab is a recombinant human IgG4 monoclonal antibody that inhibits interleukin-4 and interleukin-13 signaling. Dupilumab inhibits IL-4 signaling via the Type I receptor (IL-4Rα/γc), and both IL-4 and IL-13 signaling through the Type II receptor (IL-4Rα/IL-13Rα). IL-4 and IL-13 are major drivers of human type 2 inflammatory disease, such as atopic dermatitis, asthma, and CRSwNP. Blocking the IL-4/IL-13 pathway with dupilumab in patients decreases many of the mediators of type 2 inflammation.

List of Excipients

Arginine hydrochloride
Histidine
Polysorbate 80 (E433)
Sodium acetate trihydrate
Glacial acetic acid (E260)
Sucrose
Water for injections

Pack sizes and marketing

Dupixent 300 mg solution for injection in pre-filled syringe

2 ml solution in a siliconised type-1 clear glass pre-filled syringe with or without needle shield, with a fixed 27 gauge 12.7 mm (1⁄2 inch), thin wall stainless steel staked needle.

Pack size:

  • 1 pre-filled syringe
  • 2 pre-filled syringes
  • Multipack containing 6 (3 packs of 2) pre-filled syringes

Dupixent 300 mg solution for injection in pre-filled pen

2 mL solution in a siliconised type-1 clear glass syringe in a pre-filled pen, with a fixed 27 gauge 12.7 mm (½ inch), thin wall stainless steel staked needle.

The pre-filled pen is available either with a round cap and oval viewing window encircled with an arrow or with a square cap with ridges and an oval viewing window without an arrow.

Pack size:

  • 1 pre-filled pen
  • 2 pre-filled pens
  • 6 pre-filled pens
  • Multipack containing 6 (2 packs of 3) pre-filled pens

Not all pack sizes may be marketed.

Marketing authorization holder

Sanofi-aventis groupe, 54, rue La Boétie, 75008, Paris, France

Marketing authorization dates and numbers

EU/1/17/1229/001
EU/1/17/1229/002
EU/1/17/1229/004
EU/1/17/1229/005
EU/1/17/1229/006
EU/1/17/1229/008
EU/1/17/1229/017
EU/1/17/1229/018
EU/1/17/1229/020
EU/1/17/1229/026
EU/1/17/1229/027
EU/1/17/1229/028

Date of first authorisation: 26 September 2017

Date of latest renewal: 02 September 2022

Drugs

Drug Countries
DUPIXENT Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

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