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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 two of the sources of inflammation underlying the disease by inhibiting IL-4 and IL-13 signaling and is not an immunosuppressant or steroid.1,a

FDA, US Food and Drug Administration.

aThe mechanism of dupilumab action has not been definitively established.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.1-3,a DUPIXENT is not a steroid.1 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.1-4

aThe mechanism of dupilumab action has not been definitively established.1

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).1

Some examples of CRSwNP patients who may be appropriate for DUPIXENT are1:

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

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 patients’ use of systemic steroids.1

In the SINUS-24 and SINUS-52 trials, there was an 83% reduction in the need for sinus surgery with DUPIXENT 300 mg Q2W + INCS vs placebo + INCS through Week 52 (HR: 0.17 [95% CI: 0.07, 0.46]).1,a 

DUPIXENT 300 mg Q2W + INCS provided a 74% reduction in the need for SCS use through Week 52 vs placebo + INCS (HR: 0.26 [95% CI: 0.18, 0.38]).1

DUPIXENT 300 mg Q2W + INCS provided a 76% reduction in the need for SCS use and/or sinus surgery through Week 52 vs placebo + INCS (HR: 0.24 [95% CI: 0.17, 0.35]).1,4,a,b

aIndividually, SCS reduction and need for sinus surgery were not multiplicity-adjusted endpoints.1,4

b In SINUS-24 and SINUS-52, DUPIXENT 300 mg + INCS (Day 0: n=438; Week 24: n=376; Week 52: n=100); placebo + INCS (Day 0: n=286; Week 24: n=187; Week 52: n=61).1

HR, hazard ratio; INCS, intranasal corticosteroid; Q2W, once every 2 weeks; 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.1

FDA, US Food and Drug Administration.

Explore the Mechanism
of Action

Up to 87% of CRSwNP patients have evidence of type 2 inflammation.5

Learn about the cycle of recurrence in CRSwNP

In addition to inadequately controlled CRSwNP, DUPIXENT is also indicated for other disease states.1

See other disease
states for which
DUPIXENT is indicated

DUPIXENT Clinical Data

SINUS-24 and SINUS-52

Improvement in sense of smell was investigated in 2 measures: UPSIT score and Daily LoS score.4

UPSIT: Week 24 in SINUS-52 (key secondary endpoint). LSM difference between DUPIXENT 300 mg Q2W + INCS (n=295, pooled arms) and placebo + INCS (n=153): 10.52 (95% CI: 8.98, 12.07) (9.71 from a baseline score of 13.53 vs -0.81 from a baseline score of 13.78, respectively).4

Rapid improvement in LoS was observed as early as Day 3.6,a,b (Patient-reported outcome. Results are descriptive. Post hoc analysis. Definitive conclusions cannot be made.)6,a

aLSM difference between DUPIXENT 300 mg Q2W + INCS (n=438) and placebo + INCS (n=286): -0.07 (95% CI: -0.12, -0.02).6,8

bWeek 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) (P<0.0001).4

University of Pennsylvania Smell Identification Test (UPSIT) score (range 0 to 40): higher score indicates improvement.4

Loss of Smell (LoS) score (range 0-3): reduced score indicates improvement.1

INCS, intranasal corticosteroid; LSM, least squares mean; Q2W, once every 2 weeks.

Learn more about how quickly DUPIXENT can improve sense of smell

SINUS-24 and SINUS-52

In SINUS-52, 51% total improvement in NC score with DUPIXENT 300 mg Q2W + INCS was seen at Week 24 (n=295, pooled DUPIXENT arms) (-1.25 from a baseline score of 2.46) vs 15% 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]) (coprimary endpoint) (P<0.0001).1,4

Week 24 in SINUS-24 (coprimary endpoint). 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) (P<0.0001).1,4

Rapid relief in nasal congestion was seen as early as Day 2.6,a (Post hoc analysis. Results are descriptive. Definitive conclusions cannot be made.)6

aLSM difference between DUPIXENT 300 mg Q2W + INCS (n=438) and placebo + INCS (n=286): -0.07 (95% CI: -0.13, -0.01).6,8

Nasal congestion/obstruction (NC) score (range 0 to 3): reduced score indicates improvement.1

NCS, intranasal corticosteroid; LSM, least squares mean; Q2W, once every 2 weeks.

See the full data on nasal congestion and obstruction

SINUS-24 and SINUS-52

In the SINUS-24 and SINUS-52 trials, there was an 83% reduction in the need for sinus surgery with DUPIXENT vs placebo through Week 52 (HR: 0.17 [95% CI: 0.07, 0.46]).1,a

DUPIXENT provided a 76% reduction in the need for SCS use and/or sinus surgery through Week 52 vs placebo (HR: 0.24 [95% CI: 0.17, 0.35]).1,4

a Individually, need for sinus surgery was not a multiplicity-adjusted endpoint.1,4

HR, hazard ratio; SCS, systemic corticosteroid.

Learn more about SINUS surgery reduction

SINUS-52

DUPIXENT 300 mg Q2W + INCS significantly decreased sinus opacification vs placebo + INCS, as measured by LMK-CT at Week 24 (key secondary endpoint), with sustained improvement through Week 52 (other secondary endpoint) in SINUS-52.4

Week 24 in SINUS-52. LSM difference between DUPIXENT 300 mg Q2W + INCS (n=295, pooled arms) and placebo + INCS (n=153): -5.13 (95% CI: -5.80, -4.46) (-5.21 from a baseline score of 18.12 vs -0.09 from a baseline score of 17.65, respectively) (P<0.0001).4

Week 52 in SINUS-52. LSM difference between DUPIXENT 300 mg Q2W + INCS (n=150) and 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).4

Analysis of change at Week 52 was not multiplicity controlled; result is descriptive.4

Lund-Mackay computed tomography (LMK-CT) score (range 0-24): reduced score indicates improvement.1

INCS, intranasal corticosteroid; LSM, least squares mean; Q2W, once every 2 weeks.

See the full data on sinus opacification

SINUS-24 SINUS-52

DUPIXENT (300 mg Q2W + INCS) reduced polyp burden as early as Week 4, sustained through Week 52 in SINUS-52 as compared to placebo.4

There was a reduction in bilateral NPS as follows:

  • Week 4 in SINUS-52. LSM difference between DUPIXENT 300 mg Q2W + INCS (n=150) and placebo + INCS (n=153): -1.18 (95% CI: -1.47, -0.90) (-1.13 from a baseline score of 6.07 vs 0.05 from a baseline score of 5.96, respectively)4
  • Week 24 in SINUS-52 (coprimary endpoint). LSM difference between DUPIXENT 300 mg Q2W + INCS (n=295, pooled arms) and 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, respectively) (P<0.0001)1,4
  • Week 52 in SINUS-52 (key secondary endpoint). LSM difference between DUPIXENT 300 mg Q2W + INCS (n=150) and placebo + INCS (n=153): -2.40 (95% CI: -2.77, -2.02) (-2.24 from a baseline score of 6.07 vs 0.15 from a baseline score of 5.96, respectively) (P<0.0001)4
  • Week 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) (P<0.0001)1,4

Nasal polyp score (NPS), 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: reduced score indicates improvement.1

INCS, intranasal corticosteroid; LSM, least squares mean; Q2W, once every 2 weeks.

See what polyp reduction looks like with DUPIXENT

SINUS-52

Patients experienced improvement in QoL, as measured by SNOT-22, as follows:

  • Week 4 in SINUS-52. LSM difference between DUPIXENT 300 mg Q2W + INCS (n=150) vs placebo + INCS (n=153): -10.57 (95% CI: -14.47, -6.66) (-18.97 from a baseline score of 50.16 vs -8.40 from a baseline score of 53.48, respectively)4
  • Week 24 in SINUS-52. LSM difference between DUPIXENT 300 mg Q2W + INCS (n=150) vs placebo + INCS (n=153): -16.76 (95% CI: -20.85, -12.67) (-27.08 from a baseline score of 50.16 vs -10.32 from a baseline score of 53.48, respectively)4
  • Week 52 in SINUS-52. LSM difference between DUPIXENT 300 mg Q2W + INCS (n=150) vs placebo + INCS (n=153): -20.96 (95% CI: -25.03, -16.89) (-29.84 from a baseline score of 50.16 vs -8.88 from a baseline score of 53.48, respectively)4
  • Week 24 in SINUS-52 (key secondary endpoint). LSM difference between DUPIXENT 300 mg Q2W + INCS (n=295, pooled arms) and placebo + INCS (n=153): -17.36 (95% CI: -20.87, -13.85) (-27.77 from a baseline score of 51.02 vs -10.40 from a baseline score of 53.48, respectively) (P<0.0001)4

The SNOT-22 score is calculated from a patient questionnaire in which 22 symptoms are rated from 0 (“no problem”) to 5 (“as bad is it can be”) based on the severity and frequency of each particular item.1,9

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

INCS, intranasal corticosteroid; LSM, least squares mean; Q2W, once every 2 weeks.

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

SINUS-24 and SINUS-52

The most common adverse reactions reported in SINUS-24 and SINUS-52 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

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

view the safety data

SINUS-24 and SINUS-52

DUPIXENT was studied in the largest CRSwNP biologics trial program to date.1,4,a There were 724 total participants: 276 in SINUS-24 and 448 in SINUS-52. Adults (≥18 years) on background INCSb with CRSwNP despite prior sinus surgery or prior treatment with (unless ineligible to receive or intolerant to) SCS in the past 2 years were enrolled in the clinical trials.1

In both SINUS-24 and SINUS-52, 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.1

Patients with chronic rhinosinusitis without nasal polyposis were not included in these trials. Rescue with SCS or surgery was allowed at investigators’ discretion. The total population of patients in SINUS-24 and SINUS-52 was unrestricted by minimum baseline blood eosinophil count.1

aValid as of February 2024

bAll patients in the placebo and DUPIXENT arms were on a background therapy of INCS, mometasone furoate nasal spray.4

INCS, intranasal corticosteroid; SCS, systemic corticosteroid.

view the study designs

Using DUPIXENT

DUPIXENT is a medicine that is administered by subcutaneous injection. You may decide whether patients self-administer DUPIXENT at home or you administer in office.1

DUPIXENT is intended for use under the guidance of a healthcare provider. A patient may self-inject DUPIXENT—or a caregiver may administer DUPIXENT—after training has been provided by a healthcare provider on proper subcutaneous injection technique using the 300 mg pre-filled syringe or the 300 mg pre-filled pen. No loading dose is required for the pre-filled syringe or pre-filled pen for CRSwNP patients.1

It is important to 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

Advise patients to follow sharps disposal recommendations after administration.

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. If necessary, DUPIXENT may be kept at room temperature up to 77 °F (25 °C) for a maximum of 14 days. Do not store above 77 °F (25 °C). After removal from the refrigerator, DUPIXENT must be used within 14 days or discarded.1

Do not expose DUPIXENT to heat or direct sunlight.1

Do NOT freeze. Do NOT shake.1

  • For the 300 mg/2 mL pre-filled pen or syringe, allow 45 minutes for DUPIXENT to reach room temperature before injecting
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

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 for CRSwNP patients.1

Download the full Instructions for Use

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 provide information such as insurance information, patient diagnosis, and prescription information. You can email or print the enrollment forms below.

DUPIXENT MyWay ENROLLMENT FORMS

English Enrollment Form
Spanish Enrollment Form

Overall, ~99% of commercially insured patients nationally are covered for DUPIXENT.10,a,b 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.

aFUN Documents, MMIT, and Policy Reporter as of December 8, 2023.

bCoverage varies by type and plan.8,a,b

USE THE DUPIXENT FORMULARY STATUS TOOL

Patients may be eligible for the DUPIXENT MyWay Copay Card if they have commercial health insurance, have a DUPIXENT prescription for an FDA-approved condition, and are a resident of the 50 United States, District of Columbia, Puerto Rico, Guam or the USVI. 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 $13,000b per patient per calendar year).

aApproval is not guaranteed. Program has an annual maximum of $13,000.b THIS IS NOT INSURANCE. 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 assistance 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. Any savings provided by the program may vary depending on patients' out-of-pocket costs. The program is intended to help patients afford DUPIXENT. Patients may have insurance plans that attempt to dilute the impact of the assistance available under the program. In those situations, the program may change its terms. Additional terms and conditions apply.

bAnnual maximum subject to change.