Printed From:

QUESTIONS ABOUT NOVEL CORONAVIRUS?
CLICK HERE.

DUPIXENT has a safety profile in asthma studied up to 1 year1,2

  • The most common adverse reaction was injection site erythema. Anaphylactic reaction has been reported very rarely in the asthma development programme1
  • 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

Safety profile of DUPIXENT in asthma1,2

SYSTEM ORGAN CLASS ADVERSE REACTION FREQUENCY
Immune system disorders Anaphylactic reaction Very rare (0 to <0.0001%)
Angioedema Not known
Eye disorders Keratitis Rare (≥0.010 to <0.10%)
Musculoskeletal and connective tissue disorders Arthralgia Not known
General disorders and administration site conditions Injection site erythema Very common (≥10%)
Injection site oedema Common (≥1% to <10%)
Injection site pain Common (≥1% to <10%)
Injection site pruritus Common (≥1% to <10%)


SYSTEM ORGAN CLASS ADVERSE REACTION FREQUENCY
Infections and infestations Conjunctivitis,oral herpes Common (≥1% to <10%)
Blood and lymphatic system disorders Eosinophilia Common (≥1% to <10%)
Immune system disorders Serum sickness reaction, serum sickness-like reaction, anaphylactic reaction Rare (≥0.01 to <0.1%)
Angioedema Uncommon (≥0.1 to <1%)
Eye disorders Conjunctivitis allergic Common (≥1% to <10%)
Eye pruritus,‡§ blepharitis,‡§ Keratitis Uncommon (≥0.1 to <1%)
Ulcerative keratitis‡§ Rare (≥0.01 to <0.1%)
Musculoskeletal and connective tissue disorders Arthralgia Common (≥1% to <10%)
General disorders and administration site conditions Injection site reactions (includes erythema, oedema, pruritus, pain, and swelling) Common (≥1% to <10%)

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

Precautions for use1

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

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

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

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’

*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 12.1,4
From post-marketing reporting.1
Eye disorders and oral herpes occurred predominately in AD studies.2
§The frequencies for eye pruritus and blepharitis were common and ulcerative keratitis was uncommon in AD studies.2


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

  1. DUPIXENT Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/8553/smpc. Date accessed: July 2021.
  2. DUPIXENT Summary of Product Characteristics Ireland. Available at: https://www.medicines.ie/medicines/dupixent-200-mg-solution-forinjection-in-pre-filled-pen-34950/spc. Date accessed: July 2021.
  3. Rabe KF, et al. N Engl J Med. 2018;378(26):2475–2485.
  4. Wenzel S, et al. Lancet. 2016;388(10039):31–44.