DEMONSTRATED SAFETY PROFILE UP TO 52 WEEKS1
Adverse reactions occurring in ≥1% of patients taking DUPIXENT and at a
higher rate than placebo

SINUS-24 and SINUS-52 in adults (24-week safety pool)

DUPIXENT 300 mg
Q2W + INCS n=440 n (%)
DUPIXENT 300 mg Q2W + INCS
n=440
n (%)
Injection site reactionsb

28 (6%)

Conjunctivitisc

7 (2%)

Arthralgia

14 (3%)

Gastritis

7 (2%)

Insomnia

6 (1%)

Eosinophilia

5 (1%)

Toothache

5 (1%)

Placebo + INCS n=282 n (%)
Placebo + INCS
n=282
n (%)
Injection site reactionsb

12 (4%)

Conjunctivitisc

2 (1%)

Arthralgia

5 (2%)

Gastritis

2 (1%)

Insomnia

0 (<1%)

Eosinophilia

1 (<1%)

Toothache

1 (<1%)

bInjection site reactions cluster includes injection site reaction, pain, bruising, and swelling.1

cConjunctivitis cluster includes conjunctivitis, allergic conjunctivitis, bacterial conjunctivitis, viral conjunctivitis, giant papillary conjunctivitis, eye irritation, and eye inflammation.1

The safety profile of DUPIXENT through Week 52 was generally consistent with the safety profile observed at Week 24.1

In subjects with CRSwNP, the frequency of conjunctivitis was 2% in the DUPIXENT group compared with 1% in the placebo group in the 24-week safety pool; these subjects recovered. There were no cases of keratitis reported in the CRSwNP development program.1

In SINUS-52 (52 weeks), the frequency of conjunctivitis was 3% in the DUPIXENT group compared with 1% in the placebo group; all of these subjects recovered.1

Rates of discontinuation
due to adverse events
were 2% with
DUPIXENT
and 5% with placebo1

  • 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

DUPIXENT 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
NO BOXED WARNING1
Please see additional Warnings and
Precautions in the Prescribing Information
and Important Safety Information below.
SELECT IMPORTANT SAFETY INFORMATION

WARNING AND PRECAUTION

  • 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

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

CRSwNP, chronic rhinosinusitis with nasal polyps; INCS, intranasal corticosteroids; Q2W, once every 2 weeks.