Dupixent 200 mg solution for injection in pre-filled syringe
- Name:
Dupixent 200 mg solution for injection in pre-filled syringe
- 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: 15/03/21

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Sanofi Genzyme
Company Products
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 15 March 2021 PIL
Reasons for updating
- Improved presentation of PIL
Updated on 8 February 2021 SPC
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 PIL
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 SPC
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 1 December 2020 SPC
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 2 October 2020 SPC
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 SPC
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 28 May 2020 SPC
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 PIL
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 4 May 2020 PIL
Reasons for updating
- New individual PIL (was previously included in a combined PIL)
Updated on 4 May 2020 SPC
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 SPC
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 SPC
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 SPC
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 PIL
Reasons for updating
- New PIL for new product