DUPIXENT safety profile is based on long-term clinical trials and post-marketing experience in more than 300,000 patients, from as young as 6 years old, worldwide 1,2


DUPIXENT safety profile has been investigated3-5
– for 3 years in adults ≥18 years old with moderate-to-severe atopic dermatitis (AD) 
– for 1 year in adolescents 12–17 years old with moderate-to-severe AD 
          – for 1 year in children 6–11 years old with severe AD

The safety profile of DUPIXENT is consistent between adults, adolescents and children 1


No pre-screening or routine laboratory monitoring required 1

 

The most common adverse reactions in clinical studies with DUPIXENT were injection site reactions (includes erythema, oedema, pruritus, pain, and swelling), conjunctivitis, arthralgia, oral herpes, and eosinophilia 1

Adverse reactions for DUPIXENT in clinical studies and post-marketing reporting in Great Britain‡1

SYSTEM ORGAN CLASS

ADVERSE REACTION

FREQUENCY

Infections and infestations

Conjunctivitis,* oral herpes*

Common

Blood and lymphatic system disorders

Eosinophilia

Common

Immune system disorders

Serum sickness reaction/serum sickness-like
reaction, anaphylactic reaction

Rare

Angioedema

Uncommon

Eye disorders

Allergic conjunctivitis*

Common 

Eye pruritus,* blepharitis,* keratitis*

Uncommon 

Ulcerative keratitis*

Rare 

Musculoskeletal and connective tissue disorders

Arthralgia

Common 

General disorders and administration site conditions

Injection site reactions (includes erythema,
oedema, pruritus, pain and swelling)

Common 

 

Adverse reactions for DUPIXENT in clinical studies and post-marketing reporting in Northern and Republic of Ireland‡6

SYSTEM ORGAN CLASS

ADVERSE REACTION

FREQUENCY

Infections and infestations

Conjunctivitis,* oral herpes*

Common

Blood and lymphatic system disorders

Eosinophilia

Common 

Immune system disorders

Serum sickness reaction/serum sickness-like
reaction, anaphylactic reaction

Rare 

Angioedema

Uncommon

Eye disorders

Allergic conjunctivitis*

Common 

Eye pruritus,* blepharitis,* keratitis,* dry eye*

Uncommon 

Ulcerative keratitis*

Rare

Skin and subcutaneous tissue disorders

Facial rash

Uncommon 

Musculoskeletal and connective tissue disorders

Arthralgia

Common 

General disorders and administration site conditions

Injection site reactions (includes erythema,
oedema, pruritus, pain and swelling)

Common 

*Eye disorders and oral herpes occurred predominately in AD studies.1,6 

The frequencies for eye pruritus, blepharitis and dry eye were common and ulcerative keratitis was uncommon in AD studies.1,6 

Adverse reactions observed in atopic dermatitis, asthma, and CRSwNP clinical trials and/or post-marketing 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).1,6

Precautions for use1


Systemic Hypersensitivity

If a systemic hypersensitivity reaction (immediate or delayed) occurs, DUPIXENT should be discontinued 
immediately and appropriate therapy initiated.1

Conjunctivitis

Patients who develop conjunctivitis that does not resolve following standard treatment or signs and 
symptoms suggestive of keratitis should undergo ophthalmological examination, as appropriate.1

Asthma

Patients with comorbid asthma should not adjust or stop their asthma treatments without consulting their 
physicians. Monitor patients with comorbid asthma carefully following discontinuation of DUPIXENT.1

Helminth Infections

Patients with pre-existing helminth infections should be treated before initiating DUPIXENT. If patients 
become infected while receiving treatment with DUPIXENT and do not respond to anti-helminth treatment, 
DUPIXENT should be discontinued until infection resolves.1

 

 


Overview of AD

Find out more about how AD has a continuous inflammation cycle.





Find out more


Dosing

Learn more about how to administer DUPIXENT.






Find out more


Efficacy

Want to know how DUPIXENT can help your patients? Find out more about the Phase 3 clinical trials of DUPIXENT.




Find out more

    AD, atopic dermatitis.

    References

    1. DUPIXENT Summary of Product Characteristics. September 2021. 2. 
    2. Sanofi Data on File. MAT-IE-2000837(v3.0). July 2021. 3. 
    3. Thaçi D, et al. Favorable Safety and Sustained Efficacy With Long-Term Dupilumab Treatment in Adults With Moderate-to-Severe Atopic Dermatitis: An Analysis up to 3 Years (LIBERTY AD OLE) presented at the 20th Annual Las Vegas Dermatology Seminar, Nevada, USA, November 7–9 2019. 4. 
    4. Cork MJ, et al. Br J Dermatol. 2020;182(1):85–96. 5. 
    5. Cork MJ, et al. Br J Dermatol. 2021;184(5):857–870. 6. 
    6. DUPIXENT Summary of Product Characteristics Ireland. November 2021.

MAT-IE-2101005(v6.0) | Date of preparation: February 2022