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DEMONSTRATED SAFETY PROFILE IN CSU

Adverse reactions occurring in ≥2% of patients through Week 241
POOLED ACROSS CUPID STUDIES A, B, AND Ca
Adverse
reaction
DUPIXENT
200/300 mg Q2W 
(n=195)
%
Placebo 
(n=197)
%
Injection site
reactionb
10 8

Rate of treatment discontinuation at Week 242,a

Rate of discontinuations due to adverse events vs placebo
1.0% DUPIXENT
vs
2.5% Placebo
  • Patients should discontinue DUPIXENT if a clinically significant hypersensitivity reaction occurs or until a parasitic (helminth) infection resolves in a patient who does not respond to anti-helminth treatment1
  • aPooled safety population from CUPID-A, CUPID-B, and CUPID-C. CUPID-B was an identically designed study that enrolled 108 CSU patients (aged 12 years or older) who were inadequate responders (N=104) to H1 antihistamines and anti-IgE treatments or intolerant (N=4) to anti-IgE therapy. The efficacy of DUPIXENT was based only on CUPID-A and CUPID-C; CUPID-B did not meet the primary endpoint.
  • bInjection site reactions cluster includes injection site dermatitis, injection site erythema, injection site hematoma, injection site induration, injection site pain, injection site pruritus, injection site reaction, and injection site swelling.

Safety profile studied in >8900 patients across
us-approved indications1,c

DUPIXENT Attributes And Considerations

NOT AN
IMMUNOSUPPRESSANT
OR A STEROID1

NO INITIAL LAB
TESTING OR
ONGOING
LAB MONITORING

according to the
Prescribing Information1

NO KNOWN DRUG‑TO‑
DRUG INTERACTIONS1

  • Not metabolized through
    the liver or
    excreted
    through the kidneys

At-home
self-
administration1

  • Train patients and/or
    caregivers on
    proper
    administration prior to use

NO boxed warning1

Please see additional
Warnings and Precautions
in the Prescribing
Information and Important
Safety Information below.

Select important
safety information

WARNINGS AND PRECAUTIONS

  • Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, serum sickness or serum sickness-like reactions, angioedema, generalized urticaria, rash, erythema nodosum, and erythema multiforme, have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue DUPIXENT.
  • cPatient total included patients in AD trials (SOLO 1, SOLO 2, CHRONOS, AD-1021, AD-1526, AD-1652, AD-1539, and AD-HAFT), asthma trials (DRI12544, QUEST, VENTURE, and VOYAGE), CRSwNP trials (SINUS-24 and SINUS-52), EoE trials (EoE-1 and EoE-2), PN trials (PRIME and PRIME2), COPD trials (BOREAS and NOTUS), and CSU trials (CUPID-A, CUPID-B, and CUPID-C).

AD, atopic dermatitis; COPD, chronic obstructive pulmonary disease; CRSwNP, chronic rhinosinusitis with nasal polyps; CSU, chronic spontaneous urticaria; EoE, eosinophilic esophagitis; PN, prurigo nodularis; Q2W, once every 2 weeks.