DUPIXENT is licensed for use in patients 6 years and older as add-on maintenance treatment for severe asthma with Type 2 inflammation characterised by:1
raised blood eosinophils (EOS)
and/or raised fraction of exhaled nitric oxide (FeNO)
who are inadequately controlled with high-dose (ages 12 and older) and medium-to-high dose (ages 6 to 11) inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment
DUPIXENT has a safety profile in asthma studied up to 1 year1
In DRI12544* and QUEST studies, the proportion of patients who discontinued treatment due to adverse events was 4.3% of the placebo group, 3.2% of the DUPIXENT 200 mg every 2 weeks (Q2W) group, and 6.1% of the DUPIXENT 300 mg Q2W group1
In the LIBERTY VENTURE study, the proportion of patients who discontinued treatment due to adverse events was 4% of the placebo group and 1% of the DUPIXENT 300 mg Q2W group3
In the VOYAGE study, the proportion of patients who discontinued treatment due to adverse events was 1.5% of the placebo group and 1.8% of the DUPIXENT Q2W group (100 or 200mg depending on weight)1
Adverse reactions for DUPIXENT in Great Britain1
SYSTEM ORGAN CLASS |
ADVERSE REACTION |
FREQUENCY |
Infections and infestations |
Conjunctivitis*, oral herpes* |
Common (≥1/100 to <1/10) |
Blood and lymphatic system disorders |
Eosinophilia |
Common (≥1/100 to <1/10) |
Immune system disorders |
Serum sickness reaction / serum sickness-like reaction, anaphylactic reaction |
Rare (≥1/10,000 to 1/1,000) |
Angioedema # |
Uncommon (≥1/1,000 to <1/100) |
|
Eye disorders |
Allergic conjunctivitis* |
Common (≥1/100 to <1/10) |
Eye pruritus*†, blepharitis*†, keratitis* #,dry eye*† |
Uncommon (≥1/1,1000 to <1/100) |
|
Ulcerative keratitis*† # |
Rare (≥1/10,000 to <1/1,000) |
|
Skin and subcutaneous tissue disorders |
Facial rash# |
Uncommon (≥1/1,000 to <1/100) |
Musculoskeletal and connective tissue disorders |
Arthralgia# |
Common (≥1/100 to <1/10) |
General disorders and administration site conditions |
Injection site reactions (includes erythema, oedema, pruritus, pain, swelling and bruising) |
Common (≥1/100 to <1/10) |
Adverse reactions for DUPIXENT in Northern Ireland and Republic of Ireland2
SYSTEM ORGAN CLASS |
ADVERSE REACTION |
FREQUENCY |
Infections and infestations |
Conjunctivitis*, oral herpes* |
Common (≥1/100 to <1/10) |
Blood and lymphatic system disorders |
Eosinophilia |
Common (≥1/100 to <1/10) |
Immune system disorders |
Serum sickness reaction / serum sickness-like reaction, anaphylactic reaction |
Rare (≥1/10,000 to <1/1,000 |
Angioedema# |
Uncommon (≥1/1,000 to <1/100) |
|
Eye disorders |
Allergic conjunctivitis* |
Common (≥1/100 to <1/10) |
Eye pruritus*†, blepharitis*†, keratitis*#, dry eye*† |
Uncommon (≥1/1,000 to <1/100) |
|
Ulcerative keratitis*†# |
Rare (≥1/10,000 to <1/1,000) |
|
Skin and subcutaneous tissue disorders |
Facial rash# |
Uncommon (≥1/1,000 to <1/100) |
Musculoskeletal and connective tissue disorders |
Arthralgia# |
Common (≥1/100 to <1/10) |
General disorders and administration site conditions |
Injection site reactions (includes erythema, oedema, pruritus, pain, swelling and bruising) |
Common (≥1/100 to <1/10) |
Adverse reactions for DUPIXENT in children aged 6 to 11 years1
Similar results were observed in children 6 to 11 years of age with moderate-to-severe asthma as in adults and adolescents 12 years and older
The additional adverse reaction of enterobiasis was reported in 1.8 % (5 patients) in the DUPIXENT groups and none in the placebo group
All enterobiasis cases were mild-to-moderate and patients recovered with anti-helminth treatment without DUPIXENT treatment discontinuation
Special warnings1
DUPIXENT should not be used to treat acute asthma symptoms or acute exacerbations
DUPIXENT should not be used to treat acute bronchospasm or status asthmaticus
Systemic, topical, or inhaled corticosteroids (ICS) should not be discontinued abruptly upon initiation of therapy with DUPIXENT
Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician1
Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy1
Biomarkers of Type 2 inflammation may be suppressed by systemic corticosteroid use; this should be taken into consideration to determine the Type 2 status in patients taking oral corticosteroids (OCS)1
-
Traceability1
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded
Traceability1
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded
-
Hypersensitivity1
If a systemic hypersensitivity reaction (immediate or delayed) occurs, administration of DUPIXENT should be discontinued immediately and appropriate therapy initiated
Cases of anaphylactic reaction, angioedema, and serum sickness/serum sickness-like reaction have been reported
Anaphylactic reactions and angioedema have occurred from minutes to up to 7 days after the DUPIXENT injection
Hypersensitivity1
If a systemic hypersensitivity reaction (immediate or delayed) occurs, administration of DUPIXENT should be discontinued immediately and appropriate therapy initiated
Cases of anaphylactic reaction, angioedema, and serum sickness/serum sickness-like reaction have been reported
Anaphylactic reactions and angioedema have occurred from minutes to up to 7 days after the DUPIXENT injection
-
Eosinophilic conditions1
Cases of eosinophilic pneumonia and cases of vasculitis consistent with eosinophilic granulomatosis with polyangiitis (EGPA) have been reported with DUPIXENT in adult patients who participated in the asthma development programme
Cases of vasculitis consistent with EGPA have been reported with DUPIXENT and placebo in adult patients with comorbid asthma in the Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP) development programme
Physicians should be alert to vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients with eosinophilia
Patients being treated for asthma may present with serious systemic eosinophilia sometimes presenting with clinical features of eosinophilic pneumonia or vasculitis consistent with EGPA, conditions which are often treated with systemic corticosteroid therapy
These events usually, but not always, may be associated with the reduction of OCS therapy
Eosinophilic conditions1
Cases of eosinophilic pneumonia and cases of vasculitis consistent with eosinophilic granulomatosis with polyangiitis (EGPA) have been reported with DUPIXENT in adult patients who participated in the asthma development programme
Cases of vasculitis consistent with EGPA have been reported with DUPIXENT and placebo in adult patients with comorbid asthma in the Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP) development programme
Physicians should be alert to vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients with eosinophilia
Patients being treated for asthma may present with serious systemic eosinophilia sometimes presenting with clinical features of eosinophilic pneumonia or vasculitis consistent with EGPA, conditions which are often treated with systemic corticosteroid therapy
These events usually, but not always, may be associated with the reduction of OCS therapy
-
Helminth infections1
Patients with known helminth infections were excluded from participation in clinical studies
DUPIXENT may influence the immune response against helminth infections by inhibiting IL-4/IL-13 signalling
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, treatment with DUPIXENT should be discontinued until the infection resolves
Helminth infections1
Patients with known helminth infections were excluded from participation in clinical studies
DUPIXENT may influence the immune response against helminth infections by inhibiting IL-4/IL-13 signalling
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, treatment with DUPIXENT should be discontinued until the infection resolves
-
Conjunctivitis and keratitis related events1
Conjunctivitis and keratitis related events have been reported with DUPIXENT, predominantly in atopic dermatitis (AD) patients
Some patients reported visual disturbances (e.g. blurred vision) associated with conjunctivitis or keratitis
Patients should be advised to report new onset or worsening eye symptoms to their healthcare provider
Patients treated with DUPIXENT who develop conjunctivitis that does not resolve following standard treatment or signs and symptoms suggestive of keratitis should undergo ophthalmological examination, as appropriate
Conjunctivitis and keratitis related events1
Conjunctivitis and keratitis related events have been reported with DUPIXENT, predominantly in atopic dermatitis (AD) patients
Some patients reported visual disturbances (e.g. blurred vision) associated with conjunctivitis or keratitis
Patients should be advised to report new onset or worsening eye symptoms to their healthcare provider
Patients treated with DUPIXENT who develop conjunctivitis that does not resolve following standard treatment or signs and symptoms suggestive of keratitis should undergo ophthalmological examination, as appropriate
-
AD or CRSwNP patients with comorbid asthma1
Patients on DUPIXENT for moderate-to-severe AD or severe CRSwNP who also have comorbid asthma should not adjust or stop their asthma treatments without consultation with their physician
Patients with comorbid asthma should be monitored carefully following discontinuation of DUPIXENT
AD or CRSwNP patients with comorbid asthma1
Patients on DUPIXENT for moderate-to-severe AD or severe CRSwNP who also have comorbid asthma should not adjust or stop their asthma treatments without consultation with their physician
Patients with comorbid asthma should be monitored carefully following discontinuation of DUPIXENT
-
Vaccinations1
Live and live attenuated vaccines should not be given concurrently with DUPIXENT as clinical safety and efficacy has not been established; immune responses to the tetanus, diphtheria and pertussis (TdaP) vaccine and meningococcal polysaccharide vaccine were assessed
Antibody responses to both the tetanus vaccine and meningococcal polysaccharide vaccine were similar in DUPIXENT-treated and placebo-treated patients. No adverse interactions between either of the non-live vaccines and DUPIXENT were noted in the study. Thus, patients receiving DUPIXENT may receive concurrent inactivated or non-live vaccinations
It is recommended that patients should be brought up to date with live and live attenuated immunisations in agreement with current immunisation guidelines prior to treatment with DUPIXENT
Vaccinations1
Live and live attenuated vaccines should not be given concurrently with DUPIXENT as clinical safety and efficacy has not been established; immune responses to the tetanus, diphtheria and pertussis (TdaP) vaccine and meningococcal polysaccharide vaccine were assessed
Antibody responses to both the tetanus vaccine and meningococcal polysaccharide vaccine were similar in DUPIXENT-treated and placebo-treated patients. No adverse interactions between either of the non-live vaccines and DUPIXENT were noted in the study. Thus, patients receiving DUPIXENT may receive concurrent inactivated or non-live vaccinations
It is recommended that patients should be brought up to date with live and live attenuated immunisations in agreement with current immunisation guidelines prior to treatment with DUPIXENT
-
Sodium content1
This medicinal product contains less than 1 mmol sodium (23 mg) per 300 mg dose, i.e. essentially ‘sodium-free’
Sodium content1
This medicinal product contains less than 1 mmol sodium (23 mg) per 300 mg dose, i.e. essentially ‘sodium-free’
Complexity of Type 2 inflammation
Learn more about the biomarkers involved in Type 2 inflammation.
- DUPIXENT Summary of Product Characteristics, 2023. Date last accessed May 2023.
- DUPIXENT Summary of Product Characteristics. Ireland. 2023. Date last accessed May 2023
- Rabe KF, et al. N Engl J Med. 2018;378(26):2475–2485.
- Wenzel S, et al. Lancet. 2016;388(10039):31–44.
*DRI12544 is a 24-week, (N=776), randomised (1:1:1:1:1), double-blind, placebo-controlled, parallel-group, pivotal, Phase 2b clinical trial in 174 sites across 16 countries or regions. The primary endpoint was the mean change in forced expiratory volume in 1 second (FEV1) from baseline at Week 12.1,2,4
†Eye disorders and oral herpes occurred predominately in AD studies.1,2
‡The frequencies for eye pruritus and blepharitis were common and ulcerative keratitis was uncommon in AD studies.1,2
#From post marketing reporting
AD, atopic dermatitis; CRSwNP, Chronic Rhinosinusitis with Nasal Polyposis; EGPA, eosinophilic granulomatosis with polyangiitis; FEV1, forced expiratory volume in 1 second; ICS, inhaled corticosteroids; IL, interleukin; OCS, oral corticosteroids; Q2W, every 2 weeks; TdaP, tetanus, diphtheria and pertussis.
References
MAT-XU-2204591 (v2.0) | Date of preparation: November 2023