Dupixent 300 mg solution for injection in pre-filled pen

  • Name:

    Dupixent 300 mg solution for injection in pre-filled pen

  • Company:
    info
  • Active Ingredients:

    Dupilumab

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 08/07/20

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Summary of Product Characteristics last updated on medicines.ie: 2/10/2020
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Sanofi Genzyme

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Medicine Name Dupixent 300 mg solution for injection in pre-filled pen Active Ingredients Dupilumab
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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 2 October 2020 SmPC

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 8 July 2020 SmPC

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 8 July 2020 PIL

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 18 May 2020 PIL

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

Updated on 18 May 2020 SmPC

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

 

Table 2: List of adverse reactions in atopic dermatitis

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

 

Listed in Table 3 are adverse reactions observed in asthma 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.

 

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

* From postmarketing reporting

 

Listed in Table 4 are adverse reactions observed in CRSwNP 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.

 

Table 4. List of adverse reactions in CRSwNP

MedDRA System Organ Class

Frequency

Adverse Reaction

Infections and infestations

Common

Conjunctivitis

Blood and lymphatic system disorders

Common

Eosinophilia

Musculoskeletal and connective tissue disorders

Not known

Arthralgia*

General disorders and administration site conditions

Common

Injection site reaction

Injection site swelling

* From postmarketing reporting

Updated on 4 May 2020 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 4 May 2020 PIL

Reasons for updating

  • New PIL for new product