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Demonstrated safety profile

Adverse reactions occuring in ≥2% of DUPIXENT patients 12+ years of age through Week 24 (pooled across CUPID studies A, B, and C) and greater than placebo1,a
DUPIXENT
200/300 mg Q2W 
(n=195)
%		 Placebo 
(n=197)
%
Injection site reactionb
10 8

The safety of DUPIXENT was assessed in 18 subjects 2-11 years of age who received DUPIXENT based on weight.
No new adverse reactions were identified in pediatric subjects aged 2-11 years who received DUPIXENT.1

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 demonstrated only in CUPID studies A and C. Study B did not meet the primary endpoint.1

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, injection site swelling.

Attributes and considerations

NOT AN
IMMUNOSUPPRESSANT
OR A STEROID1
NO KNOWN DRUG-TO-DRUG INTERACTIONS1

Not metabolized through the liver or
excreted through the kidneys

NO INITIAL LAB TESTING OR ONGOING LAB MONITORING

according to the Prescribing Information1

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, acute generalized exanthematous pustulosis (AGEP), serum sickness or serum sickness-like reactions, angioedema, generalized urticaria, rash, erythema nodosum, and erythema multiforme have been reported. A case of AGEP was reported in an adult subject who participated in the bullous pemphigoid development program. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue DUPIXENT.

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Explore administration
options

CSU, chronic spontaneous urticaria; Q2W, once every 2 weeks.