Dupixent 300 mg solution for injection in pre-filled pen
- Name:
Dupixent 300 mg solution for injection in pre-filled pen
- Company:
Sanofi Genzyme
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 18/05/20
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Sanofi Genzyme
Company Products
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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