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Dupixent 200 mg solution for injection in pre-filled syringe

*
Pharmacy Only: Prescription

  • Company:

    Sanofi Genzyme

  • Status:

    Updated

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

  • Active Ingredient(s):

    Dupilumab

    *Additional information is available within the SPC or upon request to the company

Updated on 26 March 2024

File name

1.3.1 Leaflet 200 mg PFS IEMTXI (6).pdf

Reasons for updating

  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer

Updated on 26 January 2024

File name

1.3.2 Mock-up PIL 200 mg PFS (3).pdf

Reasons for updating

  • Change to section 3 - dose and frequency
  • Change to section 3 - how to take/use
  • Change to section 3 - duration of treatment
  • Change to section 3 - overdose, missed or forgotten doses

Updated on 05 September 2023

File name

1.3.1 SPC 200mg IE-XI (1).pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 09 August 2023

File name

1.3.1 SPC 200mg IE-XI (13).pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 09 August 2023

File name

1.3.1 Leaflet 200 mg PFS IEMTXI (5).pdf

Reasons for updating

  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 3 - duration of treatment
  • Change to section 3 - overdose, missed or forgotten doses

Updated on 20 June 2023

File name

1.3.1 SPC 200mg IE-XI (12).pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 15 June 2023

File name

1.3.1 Leaflet 200 mg PFS IEMTXI (4).pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 15 June 2023

File name

1.3.2 Mock-up PIL 200 mg Reflex PFP.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 18 April 2023

File name

1.3.1 SPC 200mg IE-XI (11).pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 03 April 2023

File name

1.3.1 SPC 200mg IE-XI (10).pdf

Reasons for updating

  • Correction of spelling/typing errors

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 23 March 2023

File name

1.3.1 SPC 200mg IE-XI (9).pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 23 March 2023

File name

1.3.1 Leaflet 200 mg PFS IEMTXI (3).pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 3 - duration of treatment
  • Change to section 3 - overdose, missed or forgotten doses

Updated on 20 February 2023

File name

1.3.1 Leaflet 200 mg PFS IEMTXI (2).pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 3 - duration of treatment
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 08 February 2023

File name

1.3.1 SPC 200mg IE-XI (7).pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 06 January 2023

File name

1.3.1 SPC 200mg IE-XI (6).pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 06 January 2023

File name

1.3.1 Leaflet 200 mg PFS IEMTXI.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 21 December 2022

File name

1.3.1 SPC 200mg IE-XI (5).pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 04 November 2022

File name

1.3.2 Mock-up PIL 200 mg PFS IE-UKNI.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 12 September 2022

File name

1.3.1 SPC 200mg IE-XI.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 9 - Date of first authorisation/renewal of the authorisation

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 21 April 2022

File name

1.3.1 PIL text 200mg PFS IEUKNI.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 3 - use in children/adolescents

Updated on 13 April 2022

File name

1.3.1 SPC 200mg IE-XI (2).pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 17 November 2021

File name

1.3.1 PIL text 200mg PFS IE-XI (1).pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 17 November 2021

File name

1.3.1 SPC 200mg IE-XI (1).pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 11 October 2021

File name

1.3.1 PIL text 200mg PFS IE-XI.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 11 October 2021

File name

1.3.1 SPC 200mg IE-XI.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 13 July 2021

File name

1.3.1 SPC 200mg IE.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 14 June 2021

File name

1.3.1 PIL text 200mg PFS IE (2).pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for

Updated on 14 June 2021

File name

1.3.1 PIL text 200mg PFS IE (2).pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for

Updated on 03 June 2021

File name

1.3.1 SPC 200mg IE (1).pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 03 June 2021

File name

1.3.1 SPC 200mg IE (1).pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 15 March 2021

File name

1.3.1 PIL text 200mg PFS IE.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 08 February 2021

File name

1.3.1 SPC 200mg IE (6).pdf

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 21 December 2020

File name

1.3.1 PIL text 200mg PFP IE (3).pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 3 - duration of treatment
  • Change to section 3 - overdose, missed or forgotten doses

Updated on 21 December 2020

File name

1.3.1 SPC 200mg IE (4).pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 01 December 2020

File name

1.3.1 SPC 200mg UK (1).pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 02 October 2020

File name

1.3.1 SPC 200mg IE (2).pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 08 July 2020

File name

1.3.1 SPC 200mg IE (1).pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 08 July 2020

File name

1.3.1 PIL text 200mg PFS UK (1).pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 28 May 2020

File name

1.3.1 SPC 200mg IE.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.8

Tabulated list of adverse reactions

​

The safety of dupilumab was evaluated in four randomized, double-blind, placebo-controlled studies and one dose-ranging study in patients with moderate-to-severe atopic dermatitis. In these 5 trials, 1,689 subjects were treated with subcutaneous injections of dupilumab, with or without concomitant topical corticosteroids (TCS). A total of 305 patients were treated with dupilumab for at least 1 year.

​

Listed in Table 2 are adverse reactions observed in atopic dermatitis clinical trials and/or postmarketing setting presented by system organ class and frequency, using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness

​

​

MedDRA System Organ Class

Frequency

Adverse Reaction

Infections and infestations

Common

Conjunctivitis

Oral herpes

Blood and lymphatic system disorders

Common

Eosinophilia

Immune system disorders

Very rare

Serum sickness/serum sickness-like reactions

Nervous system disorders

Common

Headache

Eye disorders

Common

Conjunctivitis allergic

Eye pruritus

Blepharitis

Musculoskeletal and connective tissue disorders

Not known

Arthralgia*

General disorders and administration site conditions

Very common

Injection site reactions

* From postmarketing reporting

​

Table 3: List of adverse reactions in asthma

MedDRA System Organ Class

Frequency

Adverse Reaction

Immune system disorders

Very rare

Anaphylactic reaction

Musculoskeletal and connective tissue disorders

Not known

Arthralgia*

General disorders and administration site conditions

Very common

Common

Common

Common

Injection site erythema

Injection site oedema

Injection site pain

Injection site pruritus

*

Updated on 28 May 2020

File name

1.3.1 PIL text 200mg PFP IE.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - pregnancy, breast feeding and fertility

Updated on 04 May 2020

File name

1.3.2 Mock-up PIL 200mg PFS UK.pdf

Reasons for updating

  • New individual PIL (was previously included in a combined PIL)

Updated on 04 May 2020

File name

1.3.1 SPC 200mg IE.pdf

Reasons for updating

  • Correction of spelling/typing errors

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 13 November 2019

File name

SPC 200mg.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 25 October 2019

File name

SPC-clean-200mg.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

3.       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.

 

6.       PHARMACEUTICAL PARTICULARS

 

6.1     List of excipients

 

arginine hydrochloride

histidine

polysorbate 80 (E433)

sodium acetate trihydrate

glacial acetic acid (E260)

sucrose

water for injections

 

6.5     Nature and contents of container

 

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

 

Dupixent 200 mg solution for injection in pre-filled syringe

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

 

Pack size:

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

 

Dupixent 200 mg solution for injection in pre-filled pen

1.14 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.

 

Pack size:

 

Updated on 12 September 2019

File name

Dupilumab SmPC 200mg.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 12 September 2019

File name

PIL 200mg.pdf

Reasons for updating

  • New PIL for new product