DUPIXENT® in inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP)
Patients aged 12+ years
HELPING PATIENTS
ACHIEVE AND MAINTAIN CONTROL OF THE UNDERLYING INFLAMMATION IN CRSwNP1
DUPIXENT WAS STUDIED IN THE LARGEST CLINICAL TRIAL PROGRAM CONDUCTED FOR ADULTS WITH CRSwNP*
Adults aged ≥18 years2
Patients enrolled were continued on background INCS throughout the duration of both trials
*Valid as of October 2023.
Efficacy in CRSwNP
Use of DUPIXENT for this indication in patients aged 12-17 years is supported by evidence from studies of DUPIXENT as add-on maintenance treatment in adults with inadequately controlled CRSwNP. The data that will be reviewed on this page will be from studies conducted in adults. Clinical studies have not been conducted in pediatric patients aged 12 years and older with CRSwNP.
In inadequately controlled CRSwNP, DUPIXENT demonstrated an ability to improve nasal polyp burden, sinus opacification, and nasal congestion score in adults.3
Nasal polyp burden and sinus opacification (as measured by LMK-CT in adults)3
aNPS, the sum of right and left nostril scores (range 0 to 4 for each nostril, range 0 to 8 in total) as evaluated by nasal endoscopy; a reduced score indicates improvement.
bWeek 24 in SINUS-24 (coprimary endpoint). LSM difference between DUPIXENT 300 mg Q2W + INCS (n=143) and placebo + INCS (n=133): -2.06 (95% CI: -2.43, -1.69) (-1.89 from a baseline score of 5.64 vs 0.17 from a baseline score of 5.86, respectively).
cAt Week 24 in SINUS-52 (coprimary endpoint). LSM difference between DUPIXENT 300 mg Q2W + INCS (n=295, pooled arms) vs placebo + INCS (n=153): -1.80 (95% CI: -2.10, -1.51) (-1.71 from a baseline score of 6.18 vs 0.10 from a baseline score of 5.96) (P<0.0001).
dLMK-CT score (range 0 to 24); a reduced score indicates improvement.
eWeek 52 in SINUS-52 (other secondary endpoint). LSM difference between DUPIXENT 300 mg Q2W + INCS (n=150) vs placebo + INCS (n=153): -6.94 (95% CI: -7.87, 6.01) (-6.83 from a baseline score of 18.42 vs 0.11 from a baseline score of 17.65, respectively).
Nasal congestion score in adults3
aWeek 24 in SINUS-24. LSM difference between DUPIXENT 300 mg Q2W + INCS (n=143) and placebo + INCS (n=133): -0.89 (95% CI: -1.07, -0.71) (-1.34 from a baseline score of 2.26 vs -0.45 from a baseline score of 2.45, respectively).
bNC score (range 0-3); a reduced score indicates improvement.
cAt Week 24 in SINUS-52. LSM difference between DUPIXENT 300 mg Q2W + INCS (n=295, pooled arms) and placebo + INCS (n=153): -0.87 (95% CI: -1.03, -0.71) (-1.25 from a baseline score of 2.46 vs -0.38 from a baseline score of 2.38, respectively) (P<0.0001).
Relieved symptoms in adults3
aLSM difference between DUPIXENT 300 mg Q2W + INCS (n=438) and placebo + INCS (n=286): -0.07 (95% CI: -0.13, -0.01).
bWeek 52 in SINUS-52 (key secondary endpoint). LSM difference between DUPIXENT 300 mg Q2W + INCS (n=150) and placebo + INCS (n=153): -0.98 (95% CI: -1.17, -0.79) (-1.35 from a baseline score of 2.48 vs -0.37 from a baseline score of 2.38, respectively) (P<0.0001).
cLSM difference between DUPIXENT 300 mg Q2W + INCS (n=438) and placebo + INCS (n=286): -0.07 (95% CI: -0.12, -0.02). Patient-reported loss of smell score.
dWeek 24 in SINUS-52 (key secondary endpoint). LSM difference between DUPIXENT 300 mg Q2W + INCS (n=295, pooled arms) and placebo + INCS (n=153): -0.98 (95% CI: -1.15, -0.81) (-1.21 from a baseline score of 2.77 vs -0.23 from a baseline score of 2.72, respectively).
eWeek 52 in SINUS-52 (other secondary endpoint). LSM difference between DUPIXENT 300 mg Q2W + INCS (n=150) and placebo + INCS (n=153): 10.30 (95% CI: 8.50, 12.10) (9.53 from a baseline score of 13.46 vs -0.77 from a baseline score of 13.78, respectively).11
fWeek 24 in SINUS-52 (key secondary endpoint). LSM difference between DUPIXENT 300 mg Q2W + INCS (n=150) and placebo + INCS (n=153): 10.77 (95% CI: 8.98, 12.56) (9.96 from a baseline score of 13.46 vs -0.81 from a baseline score of 13.78, respectively).
Reduced surgery need and/or SCS use in adults1
aIn SINUS-24 and SINUS-52, DUPIXENT (Day 0: n=438; Week 24: n=376; Week 52: n=100); placebo (Day 0: n=286; Week 24: n=187; Week 52: n=61).
CI, confidence interval; HR, hazard ratio; INCS, intranasal corticosteroid; LMK-CT, Lund-Mackay computed tomography; LSM, least squares mean; NC, nasal congestion/obstruction; NPS, nasal polyp score; Q2W, once every 2 weeks; SCS, systemic corticosteroid; UPSIT, University of Pennsylvania Smell Identification Test.
Safety profile in adults with CRSwNP1
Use of DUPIXENT for this indication in patients aged 12-17 years is supported by evidence from studies of DUPIXENT as add-on maintenance treatment in adults with inadequately controlled CRSwNP. Clinical studies have not been conducted in pediatric patients aged 12 years and older with CRSwNP.
Use of DUPIXENT for this indication is also supported by the following additional data:
- Pharmacokinetic (PK) data from adult and pediatric patients aged 12 years and older with moderate-to-severe asthma and adult patients with inadequately controlled CRSwNP
- Safety data in pediatric patients aged 12 years and older with moderate-to-severe asthma
DUPIXENT has a demonstrated safety profile for up to 52 weeks
SINUS-24 AND SINUS-52 (24-WEEK SAFETY POOL)
| ADVERSE REACTIONS OCCURRING IN ≥1% OF PATIENTS TAKING DUPIXENT AND AT A HIGHER RATE THAN PLACEBO | DUPIXENT 300 mg Q2W + INCS | PLACEBO + INCS |
| Injection site reactionsa | 28% (6%) | 12 (4%) |
| Conjunctivitisb | 7 (2%) | 2 (1%) |
| Arthralgia | 14 (3%) | 5 (2%) |
| Gastritis | 7 (2%) | 2 (1%) |
| Insomnia | 6 (1%) | 0 (<1%) |
| Eosinophilia | 5 (1%) | 1 (<1%) |
| Toothache | 5 (1%) | 1 (<1%) |
The safety profile of DUPIXENT Q2W through Week 52 was generally consistent with the safety profile observed at Week 24.
In patients 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 patients recovered. No cases of keratitis were reported in the CRSwNP development program.
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 patients recovered.
aInjection site reactions cluster includes injection site reaction, pain, bruising, and swelling.
bConjunctivitis cluster includes conjunctivitis, allergic conjunctivitis, bacterial conjunctivitis, viral conjunctivitis, giant papillary conjunctivitis, eye irritation, and eye inflammation.
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Explore the other indications of DUPIXENT
Moderate-to-severe eosinophilic or OCS-dependent asthma
(aged 6+ years)
References: 1. DUPIXENT. Prescribing information. Regeneron Pharmaceuticals, Inc.; 2024. 2. Bachert C, Han JK, Desrosiers M, et al. Efficacy and safety of dupilumab in patients with severe chronic rhinosinusitis with nasal polyps (LIBERTY NP SINUS-24 and LIBERTY NP SINUS-52): results from two multicentre, randomised, double-blind, placebo-controlled, parallel-group phase 3 trials [published correction appears in Lancet. 2019;394(10209):1618]. Lancet. 2019;394(10209):1638-1650. doi:10.1016/S0140-6736(19)31881-1 3. Data on file. Sanofi US.
INDICATIONS
Atopic Dermatitis: DUPIXENT is indicated for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis (AD) 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.
Asthma: DUPIXENT is indicated as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma. Limitations of Use: DUPIXENT is not indicated for the relief of acute bronchospasm or status asthmaticus.
Chronic Rhinosinusitis with Nasal Polyps: DUPIXENT is indicated as an add-on maintenance treatment in adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).
Eosinophilic Esophagitis: DUPIXENT is indicated for the treatment of adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (EoE).
Prurigo Nodularis: DUPIXENT is indicated for the treatment of adult patients with prurigo nodularis (PN).
Chronic Obstructive Pulmonary Disease: DUPIXENT is indicated as an add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. Limitations of Use: DUPIXENT is not indicated for the relief of acute bronchospasm.
CONTRAINDICATION
DUPIXENT is contraindicated in patients with known hypersensitivity to dupilumab or any of its excipients.
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.
Conjunctivitis and Keratitis: Conjunctivitis and keratitis occurred more frequently in AD subjects who received DUPIXENT versus placebo, with conjunctivitis being the most frequently reported eye disorder. Conjunctivitis also occurred more frequently in adult CRSwNP subjects, PN subjects, and COPD subjects who received DUPIXENT compared to those who received placebo. Conjunctivitis and keratitis have been reported with DUPIXENT in postmarketing settings, predominantly in AD patients. Some patients reported visual disturbances (e.g., blurred vision) associated with conjunctivitis or keratitis. Advise patients or their caregivers to report new onset or worsening eye symptoms to their healthcare provider. Consider ophthalmological examination for patients who develop conjunctivitis that does not resolve following standard treatment or signs and symptoms suggestive of keratitis, as appropriate.
Eosinophilic Conditions: Patients being treated for asthma may present with serious systemic eosinophilia sometimes presenting with clinical features of eosinophilic pneumonia or vasculitis consistent with eosinophilic granulomatosis with polyangiitis (EGPA), conditions which are often treated with systemic corticosteroid therapy. These events may be associated with the reduction of oral corticosteroid therapy. Healthcare providers should be alert to vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients with eosinophilia. Cases of eosinophilic pneumonia were reported in adult subjects who participated in the asthma development program and cases of vasculitis consistent with EGPA have been reported with DUPIXENT in adult subjects who participated in the asthma development program as well as in adult subjects with co-morbid asthma in the CRSwNP development program. A causal association between DUPIXENT and these conditions has not been established.
Acute Symptoms of Asthma or Chronic Obstructive Pulmonary Disease or Acute Deteriorating Disease: Do not use DUPIXENT to treat acute symptoms or acute exacerbations of asthma or COPD, acute bronchospasm, or status asthmaticus. Patients should seek medical advice if their asthma or COPD remains uncontrolled or worsens after initiation of DUPIXENT.
Risk Associated with Abrupt Reduction of Corticosteroid Dosage: Do not discontinue systemic, topical, or inhaled corticosteroids abruptly upon initiation of DUPIXENT. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a healthcare provider. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.
Patients with Co-morbid Asthma: Advise patients with co-morbid asthma not to adjust or stop their asthma treatments without consultation with their physicians.
Arthralgia: Arthralgia has been reported with the use of DUPIXENT with some patients reporting gait disturbances or decreased mobility associated with joint symptoms; some cases resulted in hospitalization. Advise patients to report new onset or worsening joint symptoms. If symptoms persist or worsen, consider rheumatological evaluation and/or discontinuation of DUPIXENT.
Parasitic (Helminth) Infections: It is unknown if DUPIXENT will influence the immune response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with DUPIXENT. If patients become infected while receiving treatment with DUPIXENT and do not respond to anti-helminth treatment, discontinue treatment with DUPIXENT until the infection resolves. Helminth infections (5 cases of enterobiasis and 1 case of ascariasis) were reported in pediatric patients 6 to 11 years old in the pediatric asthma development program.
Vaccinations: Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating DUPIXENT. Avoid use of live vaccines during treatment with DUPIXENT.
ADVERSE REACTIONS
Most common adverse reactions are:
- Atopic Dermatitis (incidence ≥1%): injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, and eosinophilia. The safety profile in pediatric patients through Week 16 was similar to that of adults with AD. In an open-label extension study, the long-term safety profile of DUPIXENT ± TCS in pediatric patients observed through Week 52 was consistent with that seen in adults with AD, with hand-foot-and-mouth disease and skin papilloma (incidence ≥2%) reported in patients 6 months to 5 years of age. These cases did not lead to study drug discontinuation.
- Asthma (incidence ≥1%): injection site reactions, oropharyngeal pain, and eosinophilia.
- Chronic Rhinosinusitis with Nasal Polyps (incidence ≥1% in adult patients): injection site reactions, eosinophilia, insomnia, toothache, gastritis, arthralgia, and conjunctivitis.
- Eosinophilic Esophagitis (incidence ≥2%): injection site reactions, upper respiratory tract infections, arthralgia, and herpes viral infections.
- Prurigo Nodularis (incidence ≥2%): nasopharyngitis, conjunctivitis, herpes infection, dizziness, myalgia, and diarrhea.
- Chronic Obstructive Pulmonary Disease (incidence ≥2%): viral infection, headache, nasopharyngitis, back pain, diarrhea, arthralgia, urinary tract infection, local administration reactions, rhinitis, eosinophilia, toothache, and gastritis.
USE IN SPECIFIC POPULATIONS
- Pregnancy: A pregnancy exposure registry monitors pregnancy outcomes in women exposed to DUPIXENT during pregnancy. To enroll or obtain information call 1‑877‑311‑8972 or go to https://mothertobaby.org/ongoing-study/dupixent/. Available data from case reports and case series with DUPIXENT use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Human IgG antibodies are known to cross the placental barrier; therefore, DUPIXENT may be transmitted from the mother to the developing fetus.
- Lactation: There are no data on the presence of DUPIXENT in human milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for DUPIXENT and any potential adverse effects on the breastfed child from DUPIXENT or from the underlying maternal condition.
Please see accompanying full Prescribing Information
INDICATIONS
Atopic Dermatitis: DUPIXENT is indicated for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis (AD) 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.
Asthma: DUPIXENT is indicated as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma. Limitations of Use: DUPIXENT is not indicated for the relief of acute bronchospasm or status asthmaticus.
Chronic Rhinosinusitis with Nasal Polyps: DUPIXENT is indicated as an add-on maintenance treatment in adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).
Eosinophilic Esophagitis: DUPIXENT is indicated for the treatment of adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (EoE).
Prurigo Nodularis: DUPIXENT is indicated for the treatment of adult patients with prurigo nodularis (PN).
Chronic Obstructive Pulmonary Disease: DUPIXENT is indicated as an add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. Limitations of Use: DUPIXENT is not indicated for the relief of acute bronchospasm.
CONTRAINDICATION
DUPIXENT is contraindicated in patients with known hypersensitivity to dupilumab or any of its excipients.
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.
Conjunctivitis and Keratitis: Conjunctivitis and keratitis occurred more frequently in AD subjects who received DUPIXENT versus placebo, with conjunctivitis being the most frequently reported eye disorder. Conjunctivitis also occurred more frequently in adult CRSwNP subjects, PN subjects, and COPD subjects who received DUPIXENT compared to those who received placebo. Conjunctivitis and keratitis have been reported with DUPIXENT in postmarketing settings, predominantly in AD patients. Some patients reported visual disturbances (e.g., blurred vision) associated with conjunctivitis or keratitis. Advise patients or their caregivers to report new onset or worsening eye symptoms to their healthcare provider. Consider ophthalmological examination for patients who develop conjunctivitis that does not resolve following standard treatment or signs and symptoms suggestive of keratitis, as appropriate.
Eosinophilic Conditions: Patients being treated for asthma may present with serious systemic eosinophilia sometimes presenting with clinical features of eosinophilic pneumonia or vasculitis consistent with eosinophilic granulomatosis with polyangiitis (EGPA), conditions which are often treated with systemic corticosteroid therapy. These events may be associated with the reduction of oral corticosteroid therapy. Healthcare providers should be alert to vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients with eosinophilia. Cases of eosinophilic pneumonia were reported in adult subjects who participated in the asthma development program and cases of vasculitis consistent with EGPA have been reported with DUPIXENT in adult subjects who participated in the asthma development program as well as in adult subjects with co-morbid asthma in the CRSwNP development program. A causal association between DUPIXENT and these conditions has not been established.
Acute Symptoms of Asthma or Chronic Obstructive Pulmonary Disease or Acute Deteriorating Disease: Do not use DUPIXENT to treat acute symptoms or acute exacerbations of asthma or COPD, acute bronchospasm, or status asthmaticus. Patients should seek medical advice if their asthma or COPD remains uncontrolled or worsens after initiation of DUPIXENT.
Risk Associated with Abrupt Reduction of Corticosteroid Dosage: Do not discontinue systemic, topical, or inhaled corticosteroids abruptly upon initiation of DUPIXENT. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a healthcare provider. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.
Patients with Co-morbid Asthma: Advise patients with co-morbid asthma not to adjust or stop their asthma treatments without consultation with their physicians.
Arthralgia: Arthralgia has been reported with the use of DUPIXENT with some patients reporting gait disturbances or decreased mobility associated with joint symptoms; some cases resulted in hospitalization. Advise patients to report new onset or worsening joint symptoms. If symptoms persist or worsen, consider rheumatological evaluation and/or discontinuation of DUPIXENT.
Parasitic (Helminth) Infections: It is unknown if DUPIXENT will influence the immune response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with DUPIXENT. If patients become infected while receiving treatment with DUPIXENT and do not respond to anti-helminth treatment, discontinue treatment with DUPIXENT until the infection resolves. Helminth infections (5 cases of enterobiasis and 1 case of ascariasis) were reported in pediatric patients 6 to 11 years old in the pediatric asthma development program.
Vaccinations: Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating DUPIXENT. Avoid use of live vaccines during treatment with DUPIXENT.
ADVERSE REACTIONS
Most common adverse reactions are:
- Atopic Dermatitis (incidence ≥1%): injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, and eosinophilia. The safety profile in pediatric patients through Week 16 was similar to that of adults with AD. In an open-label extension study, the long-term safety profile of DUPIXENT ± TCS in pediatric patients observed through Week 52 was consistent with that seen in adults with AD, with hand-foot-and-mouth disease and skin papilloma (incidence ≥2%) reported in patients 6 months to 5 years of age. These cases did not lead to study drug discontinuation.
- Asthma (incidence ≥1%): injection site reactions, oropharyngeal pain, and eosinophilia.
- Chronic Rhinosinusitis with Nasal Polyps (incidence ≥1% in adult patients): injection site reactions, eosinophilia, insomnia, toothache, gastritis, arthralgia, and conjunctivitis.
- Eosinophilic Esophagitis (incidence ≥2%): injection site reactions, upper respiratory tract infections, arthralgia, and herpes viral infections.
- Prurigo Nodularis (incidence ≥2%): nasopharyngitis, conjunctivitis, herpes infection, dizziness, myalgia, and diarrhea.
- Chronic Obstructive Pulmonary Disease (incidence ≥2%): viral infection, headache, nasopharyngitis, back pain, diarrhea, arthralgia, urinary tract infection, local administration reactions, rhinitis, eosinophilia, toothache, and gastritis.
USE IN SPECIFIC POPULATIONS
- Pregnancy: A pregnancy exposure registry monitors pregnancy outcomes in women exposed to DUPIXENT during pregnancy. To enroll or obtain information call 1‑877‑311‑8972 or go to https://mothertobaby.org/ongoing-study/dupixent/. Available data from case reports and case series with DUPIXENT use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Human IgG antibodies are known to cross the placental barrier; therefore, DUPIXENT may be transmitted from the mother to the developing fetus.
- Lactation: There are no data on the presence of DUPIXENT in human milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for DUPIXENT and any potential adverse effects on the breastfed child from DUPIXENT or from the underlying maternal condition.
Please see accompanying full Prescribing Information
INDICATIONS
Atopic Dermatitis: DUPIXENT is indicated for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis (AD) 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.
Asthma: DUPIXENT is indicated as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma. Limitations of Use: DUPIXENT is not indicated for the relief of acute bronchospasm or status asthmaticus.
Chronic Rhinosinusitis with Nasal Polyps: DUPIXENT is indicated as an add-on maintenance treatment in adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).
Eosinophilic Esophagitis: DUPIXENT is indicated for the treatment of adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (EoE).
Prurigo Nodularis: DUPIXENT is indicated for the treatment of adult patients with prurigo nodularis (PN).
Chronic Obstructive Pulmonary Disease: DUPIXENT is indicated as an add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. Limitations of Use: DUPIXENT is not indicated for the relief of acute bronchospasm.
CONTRAINDICATION
DUPIXENT is contraindicated in patients with known hypersensitivity to dupilumab or any of its excipients.
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.
Conjunctivitis and Keratitis: Conjunctivitis and keratitis occurred more frequently in AD subjects who received DUPIXENT versus placebo, with conjunctivitis being the most frequently reported eye disorder. Conjunctivitis also occurred more frequently in adult CRSwNP subjects, PN subjects, and COPD subjects who received DUPIXENT compared to those who received placebo. Conjunctivitis and keratitis have been reported with DUPIXENT in postmarketing settings, predominantly in AD patients. Some patients reported visual disturbances (e.g., blurred vision) associated with conjunctivitis or keratitis. Advise patients or their caregivers to report new onset or worsening eye symptoms to their healthcare provider. Consider ophthalmological examination for patients who develop conjunctivitis that does not resolve following standard treatment or signs and symptoms suggestive of keratitis, as appropriate.
Eosinophilic Conditions: Patients being treated for asthma may present with serious systemic eosinophilia sometimes presenting with clinical features of eosinophilic pneumonia or vasculitis consistent with eosinophilic granulomatosis with polyangiitis (EGPA), conditions which are often treated with systemic corticosteroid therapy. These events may be associated with the reduction of oral corticosteroid therapy. Healthcare providers should be alert to vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients with eosinophilia. Cases of eosinophilic pneumonia were reported in adult subjects who participated in the asthma development program and cases of vasculitis consistent with EGPA have been reported with DUPIXENT in adult subjects who participated in the asthma development program as well as in adult subjects with co-morbid asthma in the CRSwNP development program. A causal association between DUPIXENT and these conditions has not been established.
Acute Symptoms of Asthma or Chronic Obstructive Pulmonary Disease or Acute Deteriorating Disease: Do not use DUPIXENT to treat acute symptoms or acute exacerbations of asthma or COPD, acute bronchospasm, or status asthmaticus. Patients should seek medical advice if their asthma or COPD remains uncontrolled or worsens after initiation of DUPIXENT.
Risk Associated with Abrupt Reduction of Corticosteroid Dosage: Do not discontinue systemic, topical, or inhaled corticosteroids abruptly upon initiation of DUPIXENT. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a healthcare provider. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.
Patients with Co-morbid Asthma: Advise patients with co-morbid asthma not to adjust or stop their asthma treatments without consultation with their physicians.
Arthralgia: Arthralgia has been reported with the use of DUPIXENT with some patients reporting gait disturbances or decreased mobility associated with joint symptoms; some cases resulted in hospitalization. Advise patients to report new onset or worsening joint symptoms. If symptoms persist or worsen, consider rheumatological evaluation and/or discontinuation of DUPIXENT.
Parasitic (Helminth) Infections: It is unknown if DUPIXENT will influence the immune response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with DUPIXENT. If patients become infected while receiving treatment with DUPIXENT and do not respond to anti-helminth treatment, discontinue treatment with DUPIXENT until the infection resolves. Helminth infections (5 cases of enterobiasis and 1 case of ascariasis) were reported in pediatric patients 6 to 11 years old in the pediatric asthma development program.
Vaccinations: Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating DUPIXENT. Avoid use of live vaccines during treatment with DUPIXENT.
ADVERSE REACTIONS
Most common adverse reactions are:
- Atopic Dermatitis (incidence ≥1%): injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, and eosinophilia. The safety profile in pediatric patients through Week 16 was similar to that of adults with AD. In an open-label extension study, the long-term safety profile of DUPIXENT ± TCS in pediatric patients observed through Week 52 was consistent with that seen in adults with AD, with hand-foot-and-mouth disease and skin papilloma (incidence ≥2%) reported in patients 6 months to 5 years of age. These cases did not lead to study drug discontinuation.
- Asthma (incidence ≥1%): injection site reactions, oropharyngeal pain, and eosinophilia.
- Chronic Rhinosinusitis with Nasal Polyps (incidence ≥1% in adult patients): injection site reactions, eosinophilia, insomnia, toothache, gastritis, arthralgia, and conjunctivitis.
- Eosinophilic Esophagitis (incidence ≥2%): injection site reactions, upper respiratory tract infections, arthralgia, and herpes viral infections.
- Prurigo Nodularis (incidence ≥2%): nasopharyngitis, conjunctivitis, herpes infection, dizziness, myalgia, and diarrhea.
- Chronic Obstructive Pulmonary Disease (incidence ≥2%): viral infection, headache, nasopharyngitis, back pain, diarrhea, arthralgia, urinary tract infection, local administration reactions, rhinitis, eosinophilia, toothache, and gastritis.
USE IN SPECIFIC POPULATIONS
- Pregnancy: A pregnancy exposure registry monitors pregnancy outcomes in women exposed to DUPIXENT during pregnancy. To enroll or obtain information call 1‑877‑311‑8972 or go to https://mothertobaby.org/ongoing-study/dupixent/. Available data from case reports and case series with DUPIXENT use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Human IgG antibodies are known to cross the placental barrier; therefore, DUPIXENT may be transmitted from the mother to the developing fetus.
- Lactation: There are no data on the presence of DUPIXENT in human milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for DUPIXENT and any potential adverse effects on the breastfed child from DUPIXENT or from the underlying maternal condition.
Please see accompanying full Prescribing Information
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