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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

FDA, US Food and Drug Administration.

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.^1-4,a

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

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 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.

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

CRSwNP, chronic rhinosinusitis with nasal polyposis.

Up to 87% of CRSwNP patients in the United States have evidence of type 2 inflammation.⁵

CRSwNP, chronic rhinosinusitis with nasal polyposis.

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

CRSwNP, chronic rhinosinusitis with nasal polyposis.

SINUS-52

UPSIT: Week 24 (key secondary endpoint). LSM difference between DUPIXENT 300 mg Q2W + INCS (n=295, pooled DUPIXENT arms) and placebo + INCS (n=153): 10.52 (95% CI: 8.98, 12.07).⁴

Loss of Smell score (results are descriptive, definitive conclusions cannot be made as this was a post hoc analysis; data prior to Week 24 were not multiplicity controlled); rapid improvement in patient-reported loss of smell was observed as early as Day 3.^6,a

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

^aLSM difference between DUPIXENT 300 mg Q2W + INCS (n=438) and placebo + INCS (n=286): -0.07 (95% CI: -0.12, -0.02).⁷

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): -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.⁴

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

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

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

SINUS-24 and SINUS-52

In SINUS-52, 51% total improvement in NC score vs 15% improvement with placebo was seen at Week 24 (coprimary endpoint) (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]).^1,4

In SINUS-24, -1.34 improvement in NC score with DUPIXENT vs -0.45 improvement with placebo was seen at Week 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).¹

Rapid relief in nasal congestion was seen as early as Day 2.^6,a (results are descriptive, definitive conclusions cannot be made as this was a post hoc analysis; data prior to Week 24 were not multiplicity controlled).

^aLSM difference between DUPIXENT 300 mg Q2W + INCS (n=438) and placebo + INCS (n=286): -0.07 (95% CI: -0.13, -0.01).^6,7

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

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

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

CI, confidence interval; CRSwNP, chronic rhinosinusitis with nasal polyposis; HR, hazard ratio; SCS, systemic corticosteroid.

SINUS-52

DUPIXENT significantly decreased sinus opacification vs placebo, as measured by LMK-CT score at Week 24 (key secondary endpoint) with sustained improvement through Week 52 (other secondary endpoint) in SINUS-52.^4,a

DUPIXENT (300 mg Q2W + INCS) demonstrated a 27% improvement at Week 24 from a baseline score of 18.12 (n=295, pooled arms) vs 1% improvement with placebo from a baseline score of 17.65 (n=153) (LSM difference vs placebo: -5.13 [95% CI: -5.80, -4.46]) and 38% improvement at Week 52 from a baseline score of 18.42 (n=150) vs 2% worsening with placebo from a baseline score of 17.65 (n=153) (LSM difference vs placebo: -6.94 [95% CI: -7.87, -6.01]). DUPIXENT demonstrated statistically significant reductions in opacification across all sinuses at Week 24.⁴

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

CI, confidence interval; INCS, intranasal corticosteroid; LMK-CT, Lund-Mackay computed tomography; LSM, least squares mean; Q2W, once every 2 weeks.

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 nasal polyp score as follows:

• Week 4 (SINUS-52): 18% improvement in NPS with DUPIXENT vs 1% worsening with placebo⁴
• Week 24 (SINUS-52): 27% improvement in NPS with DUPIXENT (pooled arms) vs 4% worsening with placebo; LSM difference vs placebo -1.80 (95% CI: -2.10, -1.51) (coprimary endpoint)⁴
• Week 52 (SINUS-52): 39% improvement in NPS with DUPIXENT vs 4% worsening with placebo⁴

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

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

SINUS-52

Patients experienced relief of symptoms and improvement in quality of life, 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,a
• 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,a
• Week 52 in SINUS-52 (key secondary endpoint). 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,a

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

The SNOT-22 score is calculated from a patient questionnaire where 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.⁴

CI, confidence interval; CRSwNP, chronic rhinosinusitis with nasal polyposis; INCS, intranasal corticosteroid; LSM, least squares mean; Q2W, once every 2 weeks.

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.

SINUS-24 and SINUS-52

DUPIXENT was studied in the largest CRSwNP Biologics Trial Program. There were 724 total participants: 276 in SINUS-24 and 448 in SINUS-52. Adults (≥18 years) on background INCS^a with CRSwNP were included despite prior sinus 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.^1,4

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 systemic corticosteroids 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

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

CRSwNP, chronic rhinosinusitis with nasal polyposis; INCS, intranasal corticosteroid; SCS, systemic corticosteroid.

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

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.

Do NOT freeze. Do NOT shake.

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

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.

Download the full Instructions for Use

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.

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.

Overall, ~98% of commercially insured 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 plan.^8,a,b

^aFUN Documents, MMIT, and Policy Reporter; data through July 12, 2023.

^bCoverage varies by type and plan.

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 $0^a copay per fill of DUPIXENT (maximum of $13,000 per patient per calendar year).

^aApproval is not guaranteed. Program has an annual maximum of $13,000. 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.

Copay card online offer