Slideshows Images Quizzes

Copyright © 2018 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. See additional information.

Dupixent

Last reviewed on RxList: 9/30/2020
Dupixent Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Dupixent?

Dupixent (dupilumab) injection is aninterleukin-4 receptor alpha-antagonist indicated for the treatment of adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent can be used with or without topical corticosteroids.

What Are Side Effects of Dupixent?

Common side effects of Dupixent include:

Dosage for Dupixent

The recommended dose of Dupixent is an initial dose of 600 mg (two 300 mg injections in different injection sites), followed by 300 mg given every other week.

What Drugs, Substances, or Supplements Interact with Dupixent?

Dupixent may interact with:

  • "live" vaccines
  • ,
  • warfarin, or
  • cyclosporine

Tell your doctor all medications and supplements you use and all vaccines you recently received.

Dupixent During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Dupixent; it is unknown how it may affect a fetus. It is unknown if Dupixent passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Dupixent (dupilumab) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Eczema (also atopic eczema or atopic dermatitis) is a general medical term for many types of skin inflammation. See Answer
Dupixent Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail elsewhere in the labeling:

  • Hypersensitivity [see WARNINGS AND PRECAUTIONS]
  • Conjunctivitis and Keratitis [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adults With Atopic Dermatitis

Three randomized, double-blind, placebo-controlled, multicenter trials (Trials 1, 2, and 3) and one dose-ranging trial (Trial 4) evaluated the safety of DUPIXENT in subjects with moderate-tosevere atopic dermatitis. The safety population had a mean age of 38 years; 41% of subjects were female, 67% were white, 24% were Asian, and 6% were black; in terms of co-morbid conditions, 48% of the subjects had asthma, 49% had allergic rhinitis, 37% had food allergy, and 27% had allergic conjunctivitis. In these 4 trials, 1472 subjects were treated with subcutaneous injections of DUPIXENT, with or without concomitant topical corticosteroids (TCS).

A total of 739 subjects were treated with DUPIXENT for at least 1 year in the development program for moderate-to-severe atopic dermatitis.

Trials 1, 2, and 4 compared the safety of DUPIXENT monotherapy to placebo through Week 16. Trial 3 compared the safety of DUPIXENT + TCS to placebo + TCS through Week 52.

Weeks 0 To 16 (Trials 1 To 4)

In DUPIXENT monotherapy trials (Trials 1, 2, and 4) through Week 16, the proportion of subjects who discontinued treatment because of adverse events was 1.9% in both the DUPIXENT 300 mg Q2W and placebo groups. Table 2 summarizes the adverse reactions that occurred at a rate of at least 1% in the DUPIXENT 300 mg Q2W monotherapy groups, and in the DUPIXENT + TCS group, all at a higher rate than in their respective comparator groups during the first 16 weeks of treatment.

Table 2: Adverse Reactions Occurring in ≥1% of the DUPIXENT Monotherapy Group or the DUPIXENT + TCS Group in the Atopic Dermatitis Trials through Week 16

Adverse ReactionDUPIXENT MonotherapyaDUPIXENT + TCSb
DUPIXENT
300 mg Q2Wc
N=529
n (%)
Placebo
N=517
n (%)
DUPIXENT
300 mg Q2Wc + TCS
N=110
n (%)
Placebo + TCS
N=315
n (%)
Injection site reaction51 (10)28 (5)11 (10)18 (6)
Conjunctivitisd51 (10)12 (2)10 (9)15 (5)
Blepharitis2 (<1)1 (<1)5 (5)2 (1)
Oral herpes20 (4)8 (2)3 (3)5 (2)
Keratitise1 (<1)04 (4)0
Eye pruritus3 (1)1 (<1)2 (2)2 (1)
Other herpes simplex virus infectionf10 (2)6 (1)1 (1)1 (<1)
Dry eye1 (<1)02 (2)1 (<1)
a Pooled analysis of Trials 1, 2, and 4.
b Analysis of Trial 3 where subjects were on background TCS therapy.
c DUPIXENT 600 mg at Week 0, followed by 300 mg every two weeks.
d Conjunctivitis cluster includes conjunctivitis, allergic conjunctivitis, bacterial conjunctivitis, viral conjunctivitis, giant papillary conjunctivitis, eye irritation, and eye inflammation.
e Keratitis cluster includes keratitis, ulcerative keratitis, allergic keratitis, atopic keratoconjunctivitis, and ophthalmic herpes simplex.
f Other herpes simplex virus infection cluster includes herpes simplex, genital herpes, herpes simplex otitis externa, and herpes virus infection, but excludes eczema herpeticum.

Safety Through Week 52 (Trial 3)

In the DUPIXENT with concomitant TCS trial (Trial 3) through Week 52, the proportion of subjects who discontinued treatment because of adverse events was 1.8% in DUPIXENT 300 mg Q2W + TCS group and 7.6% in the placebo + TCS group. Two subjects discontinued DUPIXENT because of adverse reactions: atopic dermatitis (1 subject) and exfoliative dermatitis (1 subject).

The safety profile of DUPIXENT + TCS through Week 52 was generally consistent with the safety profile observed at Week 16.

Adolescents With Atopic Dermatitis (12 To 17 Years Of Age)

The safety of DUPIXENT was assessed in a trial of 250 subjects 12 to 17 years of age with moderate-to-severe atopic dermatitis (Trial 6). The safety profile of DUPIXENT in these subjects through Week 16 was similar to the safety profile from studies in adults with atopic dermatitis.

The long-term safety of DUPIXENT was assessed in an open-label extension study in subjects 12 to 17 years of age with moderate-to-severe atopic dermatitis (Trial 7). The safety profile of DUPIXENT in subjects followed through Week 52 was similar to the safety profile observed at Week 16 in Trial 6. The long-term safety profile of DUPIXENT observed in adolescents was consistent with that seen in adults with atopic dermatitis.

Children With Atopic Dermatitis (6 To 11 Years Of Age)

The safety of DUPIXENT with concomitant TCS was assessed in a trial of 367 subjects 6 to 11 years of age with severe atopic dermatitis (Trial 8). The safety profile of DUPIXENT + TCS in these subjects through Week 16 was similar to the safety profile from trials in adults and adolescents with atopic dermatitis.

The long-term safety of DUPIXENT + TCS was assessed in an open-label extension study of 368 subjects 6 to 11 years of age with atopic dermatitis (Trial 7). Among subjects who entered this study, 110 (30%) had moderate and 72 (20%) had severe atopic dermatitis at the time of enrollment in Trial 7. The safety profile of DUPIXENT + TCS in subjects followed through Week 52 was similar to the safety profile observed through Week 16 in Trial 8. The long-term safety profile of DUPIXENT + TCS observed in pediatric subjects was consistent with that seen in adults and adolescents with atopic dermatitis [see Use In Specific Populations].

Asthma

A total of 2888 adult and adolescent subjects with moderate-to-severe asthma (AS) were evaluated in 3 randomized, placebo-controlled, multicenter trials of 24 to 52 weeks duration (AS Trials 1, 2, and 3). Of these, 2678 had a history of 1 or more severe exacerbations in the year prior to enrollment despite regular use of medium to high-dose inhaled corticosteroids plus an additional controller(s) (AS Trials 1 and 2). A total of 210 subjects with oral corticosteroiddependent asthma receiving high-dose inhaled corticosteroids plus up to two additional controllers were enrolled (AS Trial 3). The safety population (AS Trials 1 and 2) was 12-87 years of age, of which 63% were female, and 82% were white. DUPIXENT 200 mg or 300 mg was administered subcutaneously Q2W, following an initial dose of 400 mg or 600 mg, respectively.

In AS Trials 1 and 2, the proportion of subjects who discontinued treatment due to adverse events was 4% of the placebo group, 3% of the DUPIXENT 200 mg Q2W group, and 6% of the DUPIXENT 300 mg Q2W group.

Table 3 summarizes the adverse reactions that occurred at a rate of at least 1% in subjects treated with DUPIXENT and at a higher rate than in their respective comparator groups in Asthma Trials 1 and 2.

Table 3: Adverse Reactions Occurring in ≥1% of the DUPIXENT Groups in Asthma Trials 1 and 2 and Greater than Placebo (6 Month Safety Pool)

Adverse ReactionAS Trials 1 and 2
DUPIXENT
200 mg Q2W
N=779
n (%)
DUPIXENT
300 mg Q2W
N=788
n (%)
Placebo
N=792
n (%)
Injection site reactionsa111 (14%)144 (18%)50 (6%)
Oropharyngeal pain13 (2%)19 (2%)7 (1%)
Eosinophiliab17 (2%)16 (2%)2 (<1%)
a Injection site reactions cluster includes erythema, edema, pruritus, pain, and inflammation.
b Eosinophilia = blood eosinophils ≥3,000 cells/mcL, or deemed by the investigator to be an adverse event. None met the criteria for serious eosinophilic conditions [see WARNINGS AND PRECAUTIONS].

Injection site reactions were most common with the loading (initial) dose.

The safety profile of DUPIXENT through Week 52 was generally consistent with the safety profile observed at Week 24.

Chronic Rhinosinusitis With Nasal Polyposis

A total of 722 adult subjects with chronic rhinosinusitis with nasal polyposis (CRSwNP) were evaluated in 2 randomized, placebo-controlled, multicenter trials of 24 to 52 weeks duration (CSNP Trials 1 and 2). The safety pool consisted of data from the first 24 weeks of treatment from both studies.

In the safety pool, the proportion of subjects who discontinued treatment due to adverse events was 5% of the placebo group and 2% of the DUPIXENT 300 mg Q2W group.

Table 4 summarizes the adverse reactions that occurred at a rate of at least 1% in subjects treated with DUPIXENT and at a higher rate than in their respective comparator group in CSNP Trials 1 and 2.

Table 4: Adverse Reactions Occurring in ≥1% of the DUPIXENT Group in CRSwNP Trials 1 and 2 and Greater than Placebo (24 Week Safety Pool)

Adverse ReactionCSNP Trials 1 and 2
DUPIXENT 300 mg Q2W
N=440
n (%)
Placebo
N=282
n (%)
Injection site reactionsa28 (6%)12 (4%)
Conjunctivitisb7 (2%)2 (1%)
Arthralgia14 (3%)5 (2%)
Gastritis7 (2%)2 (1%)
Insomnia6 (1%)0 (<1%)
Eosinophilia5 (1%)1 (<1%)
Toothache5 (1%)1 (<1%)
a Injection site reactions cluster includes injection site reaction, pain, bruising and swelling.
b Conjunctivitis cluster includes conjunctivitis, allergic conjunctivitis, bacterial conjunctivitis, viral conjunctivitis, giant papillary conjunctivitis, eye irritation, and eye inflammation.

Specific Adverse Reactions

Conjunctivitis and Keratitis

During the 52-week treatment period of concomitant therapy atopic dermatitis trial (Trial 3), conjunctivitis was reported in 16% of the DUPIXENT 300 mg Q2W + TCS group (20 per 100 subject-years) and in 9% of the placebo + TCS group (10 per 100 subject-years). In DUPIXENT atopic dermatitis monotherapy trials (Trials 1, 2, and 4) through Week 16, keratitis was reported in <1% of the DUPIXENT group (1 per 100 subject-years) and in 0% of the placebo group (0 per 100 subject-years). In the 52-week atopic dermatitis DUPIXENT + topical corticosteroids (TCS) atopic dermatitis trial (Trial 3), keratitis was reported in 4% of the DUPIXENT + TCS group (12 per 100 subject-years) and in 0% of the placebo + TCS group (0 per 100 subject-years). Most subjects with conjunctivitis or keratitis recovered or were recovering during the treatment period. Among asthma subjects, the frequency of conjunctivitis was similar between DUPIXENT and placebo. In the 52-week CRSwNP study (CSNP Trial 2), the frequency of conjunctivitis was 3% in the DUPIXENT subjects and 1% in the placebo subjects; all of these subjects recovered. [see WARNINGS AND PRECAUTIONS].

Eczema Herpeticum and Herpes Zoster

The rate of eczema herpeticum was similar in the placebo and DUPIXENT groups in the atopic dermatitis trials.

Herpes zoster was reported in <0.1% of the DUPIXENT groups (<1 per 100 subject-years) and in <1% of the placebo group (1 per 100 subject-years) in the 16-week atopic dermatitis monotherapy trials. In the 52-week DUPIXENT + TCS atopic dermatitis trial, herpes zoster was reported in 1% of the DUPIXENT + TCS group (1 per 100 subject-years) and 2% of the placebo + TCS group (2 per 100 subject-years). Among asthma subjects the frequency of herpes zoster was similar between DUPIXENT and placebo. Among CRSwNP subjects there were no reported cases of herpes zoster or eczema herpeticum.

Hypersensitivity Reactions

Hypersensitivity reactions were reported in <1% of DUPIXENT-treated subjects. These included serum sickness reaction, serum sickness-like reaction, generalized urticaria, rash, erythema nodosum, and anaphylaxis [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, and Immunogenicity].

Eosinophils

DUPIXENT-treated subjects had a greater initial increase from baseline in blood eosinophil count compared to subjects treated with placebo. In subjects with atopic dermatitis, the mean and median increases in blood eosinophils from baseline to Week 4 were 100 and 0 cells/mcL respectively. In subjects with asthma, the mean and median increases in blood eosinophils from baseline to Week 4 were 130 and 10 cells/mcL respectively. In subjects with CRSwNP, the mean and median increases in blood eosinophils from baseline to Week 16 were 150 and 50 cells/mcL, respectively.

Across all indications, the incidence of treatment-emergent eosinophilia (≥500 cells/mcL) was similar in DUPIXENT and placebo groups. Treatment-emergent eosinophilia (≥5,000 cells/mcL) was reported in <2% of DUPIXENT-treated patients and <0.5% in placebo-treated patients. Blood eosinophil counts declined to near baseline levels during study treatment [see WARNINGS AND PRECAUTIONS].

Cardiovascular

In the 1-year placebo controlled trial in subjects with asthma (AS Trial 2), cardiovascular thromboembolic events (cardiovascular deaths, non-fatal myocardial infarctions, and non-fatal strokes) were reported in 1 (0.2%) of the DUPIXENT 200 mg Q2W group, 4 (0.6%) of the DUPIXENT 300 mg Q2W group, and 2 (0.3%) of the placebo group.

In the 1-year placebo controlled trial in subjects with atopic dermatitis (Trial 3), cardiovascular thromboembolic events (cardiovascular deaths, non-fatal myocardial infarctions, and non-fatal strokes) were reported in 1 (0.9%) of the DUPIXENT + TCS 300 mg Q2W group, 0 (0.0%) of the DUPIXENT + TCS 300 mg QW group, and 1 (0.3%) of the placebo + TCS group.

In the 24-week placebo controlled trial in subjects with CRSwNP (CSNP Trial 1), cardiovascular thromboembolic events (cardiovascular deaths, non-fatal myocardial infarctions, and non-fatal strokes) were reported in 1 (0.7%) of the DUPIXENT group and 0 (0.0%) of the placebo group. In the 1-year placebo controlled trial in subjects with CRSwNP (CSNP Trial 2), there were no cases of cardiovascular thromboembolic events (cardiovascular deaths, non-fatal myocardial infarctions, and non-fatal strokes) reported in any treatment arm.

Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to dupilumab in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.

Approximately 5% of subjects with atopic dermatitis, asthma, or CRSwNP who received DUPIXENT 300 mg Q2W for 52 weeks developed antibodies to dupilumab; approximately 2% exhibited persistent ADA responses, and approximately 2% had neutralizing antibodies. Similar results were observed in pediatric subjects (6 to 11 years of age) with atopic dermatitis who received DUPIXENT 200 mg Q2W or 300 mg Q4W for 16 weeks.

Approximately 16% of adolescent subjects with atopic dermatitis who received DUPIXENT 300 mg or 200 mg Q2W for 16 weeks developed antibodies to dupilumab; approximately 3% exhibited persistent ADA responses, and approximately 5% had neutralizing antibodies.

Approximately 9% of subjects with asthma who received DUPIXENT 200 mg Q2W for 52 weeks developed antibodies to dupilumab; approximately 4% exhibited persistent ADA responses, and approximately 4% had neutralizing antibodies.

Regardless of age or population, approximately 2% to 4% of subjects in placebo groups were positive for antibodies to DUPIXENT; approximately 2% exhibited persistent ADA responses, and approximately 1% had neutralizing antibodies.

The antibody titers detected in both DUPIXENT and placebo subjects were mostly low. In subjects who received DUPIXENT, development of high titer antibodies to dupilumab was associated with lower serum dupilumab concentrations [see CLINICAL PHARMACOLOGY].

Two adult subjects who experienced high titer antibody responses developed serum sickness or serum sickness-like reactions during DUPIXENT therapy [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Dupixent (Dupilumab Injection)

SLIDESHOW

Rosacea, Acne, Shingles, Covid-19 Rashes: Common Adult Skin Diseases See Slideshow
Related Resources for Dupixent

© Dupixent Patient Information is supplied by Cerner Multum, Inc. and Dupixent Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Health Solutions From Our Sponsors

CONTINUE SCROLLING FOR RELATED SLIDESHOW