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DUPIXENT Basics

DUPIXENT is an add-on maintenance treatment for adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP). It is the first biologic FDA-approved in CRSwNP. DUPIXENT targets inflammation underlying the disease by inhibiting IL-4 and IL-13 signaling and is not an immunosuppressant.1

See how DUPIXENT works

DUPIXENT is the first and only dual inhibitor of IL-4 and IL-13 signaling, addressing Type 2 inflammation that contributes to CRSwNP. DUPIXENT is not a steroid. DUPIXENT inhibits IL-4 and IL-13 cytokine-induced inflammatory responses and cell signaling that contribute to IgE production, mast cell activation, eosinophil activation and trafficking, epithelial barrier dysfunction, and Th2 cell activation.1,2

View the unique Mechanism of Action of DUPIXENT

DUPIXENT is indicated as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP).

Some examples of CRSwNP patients who may be appropriate for DUPIXENT are:

  • Patients who are uncontrolled despite use of systemic corticosteroids or previous sino-nasal surgery
  • Patients who are surgery naive
  • Patients with a history of asthma
  • Patients with comorbid NSAID-ERD

CRSwNP, chronic rhinosinusitis with nasal polyposis; NSAID-ERD, nonsteroidal anti-inflammatory drug–exacerbated respiratory disease.

Explore patient types appropriate for DUPIXENT

DUPIXENT is not a steroid. DUPIXENT is a biologic and can help reduce your patient’s use of systemic corticosteroids. In Trials 1 and 2, 74% fewer patients required SCS use at Week 52 with DUPIXENT 300 mg Q2W + INCS compared to placebo + INCS (HR: 0.26 [95% CI: 0.18, 0.38]). In those same trials, SCS courses were reduced by 75% per year (RR: 0.25 [95% CI: 0.17, 0.37]).1

DUPIXENT provided a 76% reduction in SCS use or CRSwNP surgery at Week 52 with DUPIXENT 300 mg Q2W + INCS vs placebo + INCS (HR: 0.24 [95% CI: 0.17, 0.35]).

Individually, SCS reduction was not a multiplicity-adjusted endpoint.
HR, hazard ratio; INCS, intranasal corticosteroids; Q2W, once every 2 weeks; RR, risk ratio; SCS, systemic corticosteroid.

Learn more about how DUPIXENT can reduce steroid use

DUPIXENT is the first biologic FDA approved in CRSwNP and is not an immunosuppressant.

CRSwNP, chronic rhinosinusitis with nasal polyposis; FDA, US Food and Drug Administration.

Explore the Mechanism of
Action

Type 2 inflammation is the underlying cause of CRSwNP in 80% of patients. CRSwNP is predominantly characterized by
Type 2 inflammation of the nose and paranasal sinuses and is frequently associated with comorbidities of the lower airway.
By inhibiting IL-4 and IL-13 signaling, DUPIXENT targets both upper and lower airway inflammation in CRSwNP and asthma.2-5,a

DUPIXENT is indicated as an add-on maintenance treatment in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid dependent asthma. Limitation of Use: DUPIXENT is not indicated for the relief of acute bronchospasm or status asthmaticus.

a In Western countries.

CRSwNP, chronic rhinosinusitis with nasal polyposis.

Explore the upper and lower airway

In addition to moderate-to-severe CRSwNP, DUPIXENT is also indicated in 2 other disease states.

learn more

DUPIXENT Clinical Data

In Trial 2, 67% of total improvement in sense of smell was seen after the first dose of DUPIXENT, as measured at Week 2 (LSM difference vs placebo: 5.36 [95% CI: 3.62, 7.10]). That improvement was sustained through Week 52 in the same study, increasing to 71% with DUPIXENT (baseline score 13.46) vs 6% worsening with placebo (baseline score 13.78) (LSM difference: 10.30 [95% CI: 8.50, 12.10]) (other secondary endpoint).7,a

Improvement in sense of smell was investigated in 2 measures: UPSIT score and daily loss of smell score.

a Analysis of change at Week 52 was not multiplicity controlled; result is descriptive.

University of Pennsylvania Smell Identification Test (UPSIT) score (range 0 to 40): higher score indicates improvement; LSM, least squares mean; SNOT-22, 22-item Sino-Nasal Outcome Test.

Learn more about how quickly DUPIXENT can improve sense of smell

DUPIXENT improved nasal congestion and obstruction as early as Week 4 as measured by NC score in Trial 2: -0.52 with DUPIXENT 300 mg Q2W + INCS (n=295, pooled DUPIXENT arms) vs -0.16 with placebo + INCS (n=153) (LSM difference vs placebo: -0.37 [95% CI: -0.46, -0.27]).1,7

At Week 24 in the same study, patients experienced a 51% improvement in their NC score with DUPIXENT 300 mg Q2W + INCS (n=295, pooled DUPIXENT arms) (-1.25 from a baseline score of 2.46) vs 16% improvement with placebo + INCS (n=153) (-0.38 from a baseline score of 2.38) (LSM difference vs placebo: -0.87 [95% CI: -1.03, -0.71]).1

Nasal congestion/obstruction (NC) score (range 0 to 3): reduced score indicates improvement; INCS, intranasal corticosteroids; LSM, least squares mean; Q2W, once every 2 weeks.

See the full data on nasal congestion and obstruction

In DUPIXENT’s SINUS-52 trial, 59% of patients had 1 or more surgeries. With DUPIXENT, 83% fewer patients required sino-nasal surgery with DUPIXENT 300 mg Q2W + INCS (HR: 0.17 [95% CI: 0.07, 0.46]).1,a

DUPIXENT provided a 76% reduction in SCS use or CRSwNP surgery at Week 52 with DUPIXENT 300 mg Q2W + INCS vs placebo + INCS (HR: 0.24 [95% CI: 0.17, 0.35]).

a Individually, need for sino-nasal surgery was not a multiplicity-adjusted endpoint.7
CRSwNP, chronic rhinosinusitis with nasal polyposis; HR, hazard ratio; INCS, intranasal corticosteroids; Q2W, once every 2 weeks.

Learn more about sino-nasal surgery reduction

DUPIXENT significantly decreased LMK-CT score vs placebo at Week 24 (key secondary endpoint) with sustained improvement through Week 52 (other secondary endpoint) in Trial 2.

DUPIXENT (300 mg + SOC) demonstrated 29% improvement at Week 24 from a baseline score of 18.12 (LSM difference vs placebo: -5.13 [95% CI: -5.80, -4.46]) and 37% improvement at Week 52 from a baseline score of 18.42 (LSM difference vs placebo: -6.94 [95% CI: -7.87, -6.01]). DUPIXENT demonstrated statistically significant reductions in opacification across all sinuses at Week 24.

aAnalysis of change at Week 52 was not multiplicity controlled; result is descriptive.7

LMK-CT, Lund-Mackay computed tomography.

See the full data on sinus opacification

DUPIXENT reduced polyp burden as early as Week 4 (LSM difference vs placebo: -1.15 [95% CI: -1.40, -0.91]) in Trial 2.7

In the same study, patients saw a significant reduction in the size of nasal polyps, as measured by NPS:

  • -1.71 improvement in NPS at Week 24 with DUPIXENT 300 mg Q2W + INCS (n=295, pooled DUPIXENT arms) (baseline score 6.18) vs 0.10 worsening with placebo + INCS (n=153) (baseline score 5.96) (LSM difference vs placebo: -1.80 [95% CI: -2.10, -1.51]) (coprimary endpoint)1
  • -2.24 improvement in NPS at Week 52 with DUPIXENT 300 mg Q2W + INCS (n=150) (baseline score 6.07) vs 0.15 worsening with placebo + INCS (n=153) (baseline score 5.96) (LSM difference vs placebo: -2.40 [95% CI: -2.77, -2.02]) (key secondary endpoint)

Nasal polyps score (NPS) is the sum of right and left nostril scores (range 0 to 8) as evaluated by nasal endoscopy: reduced score indicates improvement, LMS, least square mean; Q2W, once every 2 weeks; INCS, intranasal corticosteroids.

See what polyp reduction looks like with DUPIXENT

Patients experienced rapid and sustained relief of symptoms and improved quality of life, as measured by SNOT-22. Improvement began as early as Week 4 and was maintained through Weeks 24 and 52 with DUPIXENT 300 mg Q2W + INCS (n=295, pooled DUPIXENT arms) (key secondary endpoints).7,a

a22-item Sino-Nasal Outcome Test (SNOT-22) score (range 0 to 110): reduced score indicates improvement.1

SNOT-22 includes 22 items assessing symptoms and symptom impact associated with CRSwNP.

SNOT-22 had a 2-week recall period. The meaningful clinically important difference is 8.9.7

Q2W, once every 2 weeks; INCS, intranasal corticosteroids.

See more about how DUPIXENT can improve symptoms & quality of life

The most common adverse reactions reported in Trials 1 and 2 were injection site reactions, conjunctivitis, arthralgia, gastritis, insomnia, eosinophilia, and toothache. These adverse reactions occurred in ≥1% of patients on DUPIXENT 300 mg Q2W + INCS and at a higher rate than placebo + INCS in a 24-week safety pool.1

Q2W, once every 2 weeks; INCS, intranasal corticosteroids.

view the safety data

DUPIXENT was studied in the largest clinical trial program to date for CRSwNP. 724 total participants; Trial 1: 276, Trial 2: 448, Combined: 724. Adults (≥18 years) on background INCSa with CRSwNP were included despite prior sino-nasal surgery or prior treatment with, or who were ineligible to receive or were intolerant to, systemic corticosteroids in the past 2 years were enrolled in the clinical trials.

In both Trials 1 and 2, 73% to 90% of subjects had opacification of all sinuses. Prior surgery patients had a mean of 2.0 prior surgeries, and SCS use patients had 1.6 SCS courses in the previous 2 years. ~79% of patients enrolled in both trials had atopic diseases. 60% of patients had history of asthma, and 27% had NSAID-ERD.

Patients with chronic rhinosinusitis without nasal polyposis were not included in these trials. Rescue with systemic corticosteroids or surgery was allowed at investigators’ discretion. The total population of patients in Trials 1 and 2 was unrestricted by minimum baseline blood eosinophil count.1

aAll patients in the placebo and DUPIXENT arms were on a background therapy of INCS, mometasone furoate nasal spray.8

CRSwNP, chronic rhinosinusitis with nasal polyposis; INCS, intranasal corticosteroids; SCS, systemic corticosteroid; NSAID-ERD, nonsteroidal anti-inflammatory drug-exacerbated respiratory disease.

view the study designs

Using DUPIXENT

DUPIXENT is an injectable medicine that is administered by subcutaneous injection. You may decide whether patients self-administer DUPIXENT at home, or you administer in office.

DUPIXENT is intended for use under the guidance of a healthcare provider. A patient may self-inject DUPIXENT after receiving training in subcutaneous injection technique using the 300 mg pre-filled syringe or 300 mg pre-filled pen. No loading dose is required for the pre-filled syringe or pre-filled pen.

Provide proper training to patients and/or caregivers on the preparation and administration of DUPIXENT prior to use according to the Instructions for Use.1

Learn more about dosing for DUPIXENT

If an every-other-week dose is missed, instruct the patient to administer the injection within 7 days from the missed dose and then resume their original schedule. If the missed dose is not administered within 7 days, instruct the patient to wait until the next dose on the original schedule.1

Learn more about dosing for DUPIXENT

DUPIXENT should be refrigerated at 36 °F to 46 °F (2 °C to 8 °C) in the original carton to protect from light. However, before DUPIXENT is injected, it must be removed from the refrigerator and allowed to reach room temperature without removing the needle cap.

  • For the 300 mg/2 mL pre-filled pen or syringe, allow 45 minutes for DUPIXENT to reach room temperature
SEE INFORMATION ON PREPARATION FOR USE, STORAGE, AND HANDLING FOR DUPIXENT

Administer the subcutaneous injection into the thigh or abdomen, except for the 2 inches (5 cm) around the navel. The upper arm can also be used if a caregiver administers the injection. Rotate the injection site with each injection. DO NOT inject DUPIXENT into skin that is tender, damaged, bruised, or scarred.1

See the Instructions for Use for more details Learn more about dosing for DUPIXENT

The pre-filled syringe and pre-filled pen each come with their own set of specific instructions and guidelines for administration. After choosing your preferred method of treatment, you and your patient should go through the Instructions for Use to ensure each step is followed correctly. No loading dose is required.

Download the full Instructions for Use

Pre-filled Pen Instructions for Use – 300 mg Pre-filled Syringe Instructions for Use – 300 mg

DUPIXENT Access and Support

DUPIXENT MyWay is a patient support program that can help enable access to DUPIXENT through benefits verification and assistance navigating the insurance process. It also offers financial assistance for eligible patients, one-on-one nursing support, and more. Our team can provide assistance during the insurance approval process. Support begins when your patients enroll in DUPIXENT MyWay.

DUPIXENT® and DUPIXENT MyWay® are registered trademarks of Sanofi Biotechnology. LEARN MORE ABOUT THE SUPPORT OFFERED BY DUPIXENT MyWay

When filling out the DUPIXENT MyWay Enrollment Form, both you and your patient will be required to supply information, such as the patient’s insurance, diagnosis, and prescription. You can download and begin filling out the enrollment forms below.

Download DUPIXENT MyWay enrollment forms

english form

spanish form

Overall, 93% of commercial patients nationally are covered for DUPIXENT. By using the DUPIXENT formulary status tool, you can see which insurance plans offer coverage for DUPIXENT in your area. Contact the health plan or DUPIXENT MyWay® to verify coverage for a specific patient. Coverage varies by type and plan9

USE THE DUPIXENT FORMULARY STATUS TOOL

Patients may be eligible for the DUPIXENT MyWay® Copay Card if they have commercial insurance, have a DUPIXENT prescription for an FDA-approved condition, and are a resident of the 50 United States, the District of Columbia, or Puerto Rico. The patient or caregiver must be aged 18 years or older to be eligible.

Eligible patients covered by commercial health insurance may pay as little as $0a copay per fill of DUPIXENT (maximum of $13,000 per patient per calendar year).

aTHIS IS NOT INSURANCE. Program has an annual maximum of $13,000. Not valid for prescriptions paid, in whole or in part, by Medicaid, Medicare, VA, DoD, TRICARE, or other federal or state programs including any state pharmaceutical programs. This program is not valid where prohibited by law, taxed, or restricted. DUPIXENT MyWay reserves the right to rescind, revoke, terminate, or amend this offer, eligibility, and terms of use at any time without notice. Additional terms and conditions apply.

COPAY CARD ONLINE OFFER

References:

  1. DUPIXENT Prescribing Information.
  2. Gandhi NA, Bennett BL, Graham NMH, Pirozzi G, Stahl N, Yancopoulos GD. Targeting key proximal drivers of type 2 inflammation in disease. Nat Rev Drug Discov. 2016;15(1):35-50.
  3. Stevens WW, Peters AT, Hirsch AG, et al. Clinical characteristics of patients with chronic rhinosinusitis with nasal polyps, asthma, and aspirin-exacerbated respiratory disease. J Allergy Clin Immunol Prat. 2017;5(4):1061-1070.e3. doi:10.1016/j.jaip.2016.12.027
  4. Langdon C, Mullol J. Nasal polyps in patients with asthma: prevalence, impact, and management challenges. J Asthma Allergy. 2016;9:45-53.
  5. Chaaban MR, Walsh EM, Woodworth BA. Epidemiology and differential diagnosis of nasal polyps. Am J Rhinol Allergy. 2013;27(6):473-478.
  6. Castro M, Corren J, Pavord ID, et al. Dupilumab efficacy and safety in moderate-to-severe uncontrolled asthma. N Engl J Med. 2018;378(26):2486-2496.
  7. Data on file, Sanofi US. LIBERTY NP SINUS-52, CSR. 2018.
  8. Data on file, Sanofi US. Clinical overview (chronic rhinosinusitis with nasal polyposis). 2018.
  9. The Dedham Group Quality of Access Tracking Report. February 2021.

Important Safety
Information and Indication

CONTRAINDICATION: DUPIXENT is contraindicated in patients with known hypersensitivity to dupilumab or any of its excipients.

WARNINGS AND PRECAUTIONS

Hypersensitivity: Hypersensitivity reactions, including generalized urticaria, rash, erythema nodosum, anaphylaxis and serum sickness or serum sickness-like reactions, were reported in <1% of subjects who received DUPIXENT in clinical trials. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue DUPIXENT.

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. Physicians 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 patients who participated in the asthma development program and cases of vasculitis consistent with EGPA have been reported with DUPIXENT in adult patients who participated in the asthma development program as well as in adult patients with co-morbid asthma in the chronic rhinosinusitis with nasal polyposis development program. A causal association between DUPIXENT and these conditions has not been established.

Acute Asthma Symptoms or Deteriorating Disease: Do not use DUPIXENT to treat acute asthma symptoms, acute exacerbations, acute bronchospasm or status asthmaticus. Patients should seek medical advice if their asthma remains uncontrolled or worsens after initiation of DUPIXENT.

Reduction of Corticosteroid Dosage: Do not discontinue systemic, topical, or inhaled corticosteroids abruptly upon initiation with DUPIXENT. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

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.

ADVERSE REACTIONS: The most common adverse reactions (incidence ≥1%) in patients with asthma are injection site reactions, oropharyngeal pain, and eosinophilia.

DRUG INTERACTIONS: Avoid use of live vaccines in patients treated with DUPIXENT.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to DUPIXENT during pregnancy. Healthcare providers and patients may call 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/ to enroll in or obtain information about the registry. 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.


Indication

DUPIXENT is indicated as an add-on maintenance treatment in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid dependent asthma. Limitation of Use: DUPIXENT is not indicated for the relief of acute bronchospasm or status asthmaticus.