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DUPIXENT Basics

DUPIXENT has a unique mechanism of action. It is the first and only dual inhibitor of IL-4 and IL-13 signaling, inhibiting two key sources of Type 2 inflammation in asthma. IL-4 and IL-13 signaling impact Type 2 inflammation both locally and systemically. DUPIXENT is not an immunosuppressant. The mechanism of action of dupilumab in asthma has not been definitively established.1-3

Watch a video on how DUPIXENT targets IL-4 and IL-13 signaling

DUPIXENT is indicated as add-on maintenance treatment for patients (12+ years) with moderate-to-severe asthma with an eosinophilic phenotype, or with OCS-dependent asthma. Limitation of Use: DUPIXENT is not indicated for the relief of acute bronchospasm or status asthmaticus.1

See EXAMPLES OF APPROPRIATE PATIENT TYPES FOR DUPIXENT

Type 2 inflammation is present in up to 84% of adult asthma patients and can be both local and systemic. DUPIXENT targets both IL-4 and IL-13 signaling, inhibiting two key sources of Type 2 inflammation in asthma. The mechanism of action of dupilumab in asthma has not been definitively established.

DUPIXENT is indicated as an add-on 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.1-5

Learn more about patients who may be affected by Type 2 inflammation

DUPIXENT is the first and only dual inhibitor of IL-4 and IL-13 signaling. It is the only biologic indicated for an OCS-dependent asthma population. The mechanism of action of dupilumab in asthma has not been definitively established.1

WATCH A VIDEO ON THE UNIQUE MOA OF DUPIXENT

Yes. DUPIXENT treatment decreased FeNO (up to 35% reduction from baseline) and circulating concentrations of eotaxin-3, total IgE (up to 70% reduction from baseline), allergen-specific IgE, TARC, and periostin in asthma subjects relative to placebo. DUPIXENT decreased these markers of airway inflammation and sustained the effects throughout treatment. In addition, there was an impact on eosinophil activation and trafficking. These results are based on pharmacodynamic data from Trials 1 (24 weeks) and 2 (52 weeks). The mechanism of action of dupilumab in asthma has not been definitively established.1,6-8

Explore the role these biomarkers have in the pathogenesis of asthma

In addition to moderate-to-severe asthma, DUPIXENT is also indicated in 2 other disease states.1

LEARN MORE

DUPIXENT Clinical Data

DUPIXENT offers rapid breathing relief patients can feel, as early as Week 2. Approximately 72% of the total FEV1 improvement (470 mL improvement at Week 52 compared to baseline FEV1 of 1.78 L) was seen at Week 2 in patients in Trial 2 with baseline blood EOS ≥300 cells/μL taking DUPIXENT 200 mg + SOC (n=264) (secondary endpoint).

Primary endpoint: 320 mL improvement from baseline in pre-bronchodilator FEV1 at Week 12 with DUPIXENT 200 mg + SOC (n=631) vs 180 mL with placebo + SOC (n=317) (LSM difference: 140 mL [95% CI: 80, 190 mL]) (Trial 2, ITT population). In Trial 2, a significant difference from placebo + SOC was not observed at 12 weeks in change in pre-bronchodilator FEV1 in patients with baseline blood eosinophil levels <150 cells/μL taking DUPIXENT 200 mg + SOC.1,9

Explore the lung function data

Patients with baseline blood EOS ≥300 cells/μL in Trial 2 experienced sustained breathing relief at Week 52: a 470 mL improvement from baseline in pre-bronchodilator FEV1 with DUPIXENT 200 mg + SOC (n=264) vs 170 mL with placebo + SOC (n=148) (secondary endpoint).1,9

Explore the lung function data

DUPIXENT reduced severe exacerbations by up to 81% in subjects with EOS ≥300 cells/μL with DUPIXENT 300 mg + SOC (n=64) vs placebo + SOC (n=68) (0.20 vs 1.04; rate ratio: 0.19 [95% CI: 0.07, 0.56] (secondary endpoint) in Trial 1.

In addition, DUPIXENT demonstrated a 60% reduction in severe exacerbations in subjects with EOS ≥150 cells/µL with DUPIXENT 300 mg + SOC (n=452) vs placebo + SOC (n=237) (rate ratio: 0.40 [95% CI: 0.31, 0.53]) (secondary endpoint) in Trial 2.

DUPIXENT also reduced severe exacerbations by 46% in patients with no biomarker requirement (ITT population) with DUPIXENT 300 mg + SOC (n=633) vs placebo + SOC (n=321) (rate ratio: 0.54 [95% CI: 0.43, 0.68]) (primary endpoint) in Trial 2.

No statistically significant differences were observed during the 52-week treatment period in patients with baseline blood eosinophils <150 cells/μL taking DUPIXENT 200 mg or 300 mg + SOC and in the ≥150 to <300 cells/μL eosinophil subgroup treated with DUPIXENT 200 mg + SOC vs matching placebo + SOC.1,10

View the exacerbation data

In Trial 3 in the ITT population, 86% of OCS-dependent asthma patients reduced or eliminated their OCS dose at Week 24 with DUPIXENT 300 mg + SOC (n=103) vs 68% with placebo + SOC (n=107). Overall, more than half of patients receiving DUPIXENT 300 mg + SOC (n=103) in the ITT population in Trial 3 completely eliminated OCS use at Week 24 vs 29% with placebo + SOC (n=107) (secondary endpoints).

70% significant reduction in OCS dose (median 100%) from baseline at Week 24 with DUPIXENT 300 mg + SOC (n=103) (95% CI: 60%, 80%) vs 42% (median 50%) with placebo + SOC (n=107) (primary endpoint).1,11

Learn more about how DUPIXENT MAY IMPACT OCS use

DUPIXENT simultaneously improved asthma control (ie, reducing severe exacerbations, improving lung function) while reducing or eliminating steroid use in the ITT population at Week 24 (Trial 3, no biomarker requirement, secondary endpoints).

  • 86% of OCS-dependent asthma patients reduced or eliminated their OCS dose at Week 24 with DUPIXENT 300 mg + SOC (n=103) vs 68% with placebo + SOC (n=107)
    • 70% significant reduction in OCS dose (median 100%) from baseline at Week 24 with DUPIXENT 300 mg + SOC (n=103) (95% CI: 60%, 80%) vs 42% (median 50%) with placebo + SOC (n=107) (primary endpoint)
  • 59% reduction in severe exacerbations at Week 24 with DUPIXENT 300 mg + SOC (n=103) vs placebo + SOC (n=107) (0.65 vs 1.60; rate ratio: 0.41 [95% CI: 0.26, 0.63])
  • 220 mL improvement in lung function at Week 24 with DUPIXENT 300 mg + SOC (n=103) vs 10 mL with placebo + SOC (n=107) (LSM difference: 220 mL [95% CI: 90, 340 mL])1,11

Learn more about how DUPIXENT may impact OCS use

The most common adverse reactions from the DUPIXENT asthma trials were injection site reactions, oropharyngeal pain, and eosinophilia. These adverse reactions occurred in ≥1% of patients receiving DUPIXENT + SOC and at a higher rate than in patients receiving placebo + SOC in Trials 1 and 2 (6-month safety pool).1

View the Full Safety Data

Subjects enrolled in Trials 1 and 2 were required to have a history of at least 1 severe asthma exacerbation in the year prior to trial entry. A severe asthma exacerbation was defined as deterioration of asthma requiring the use of systemic corticosteroids for at least 3 days or asthma-related hospitalization or emergency department visit requiring systemic corticosteroids.

Whereas subjects who enrolled in Trials 1 and 2 were receiving the standard of care for their moderate-to-severe asthma, those enrolled in Trial 3 required dependence on daily oral corticosteroids in addition to regular use of high-dose inhaled corticosteroids plus a minimum of 1 and up to 2 additional controller medications as standard of care for their asthma. In all 3 trials, enrollment was unrestricted by minimum baseline blood eosinophil count. In Trials 2 and 3, subjects with screening blood eosinophil levels >1500 cells/μL (<1.3%) were excluded.1,11

View the full study designs

Using DUPIXENT

DUPIXENT is an injectable medicine that is administered by subcutaneous injection. DUPIXENT is intended for use under the guidance of a healthcare provider. However, a patient may self-inject DUPIXENT after receiving training in subcutaneous injection technique using the pre-filled syringe or pen. In adolescents 12 years of age and older, it is recommended that DUPIXENT be administered by or under the supervision of an adult.1

LEARN MORE ABOUT DOSING INSTRUCTIONS, SCHEDULES, AND RECOMMENDATIONS

As add-on maintenance treatment for patients (12+ years) with moderate-to-severe asthma with an eosinophilic phenotype, or with OCS-dependent asthma. DUPIXENT is available in a 200 mg and 300 mg dose. The 200 mg treatment, given every 2 weeks, has an initial loading dose of 400 mg (2 x 200 mg pre-filled syringes), and the 300 mg treatment, given every 2 weeks, has an initial loading dose of 600 mg (2 x 300 mg pre-filled pens or syringes).

If your patient has OCS-dependent asthma or comorbid moderate-to-severe atopic dermatitis for which DUPIXENT is indicated, the recommended dose is an initial dose of 600 mg followed by 300 mg given every 2 weeks.1

LEARN MORE ABOUT DOSING INSTRUCTIONS, SCHEDULES, AND RECOMMENDATIONS

You should avoid the use of live vaccines in patients being treated with DUPIXENT.

Immune responses to non-live vaccines were assessed in a study in which adult subjects with atopic dermatitis were treated once weekly for 16 weeks with 300 mg of dupilumab (twice the recommended dosing frequency). After 12 weeks of DUPIXENT administration, subjects were vaccinated with a Tdap vaccine (Adacel®) and a meningococcal polysaccharide vaccine (Menomune®). Antibody responses to tetanus toxoid and serogroup C meningococcal polysaccharide were assessed 4 weeks later. Antibody responses to both tetanus vaccine and meningococcal polysaccharide vaccine were similar in dupilumab-treated and placebo-treated subjects. Immune responses to the other active components of the Adacel and Menomune vaccines were not assessed.1

The pre-filled syringe and the pre-filled pen each come with their own set of specific instructions and guidelines for administration. After choosing your preferred method of treatment, it is important to provide proper training to patients and/or caregivers on the preparation and administration of DUPIXENT prior to use to ensure each step is followed correctly. In adolescents 12 years of age and older, it is recommended that DUPIXENT be administered by or under the supervision of an adult.

Advise patients to follow sharps disposal recommendations after administration of DUPIXENT. Patients and/or caregivers should read the Instructions for Use—either 200 mg or 300 mg—prior to injecting.1

Download the full Instructions for Use below.

Pre-filled Pen Instructions for Use – 300 mg Pre-filled Syringe Instructions for Use – 200 mg Pre-filled Syringe Instructions for Use – 300 mg

If a dose is missed, instruct the patient to administer the injection within 7 days from the missed dose and then resume the patient’s 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 INSTRUCTIONS, SCHEDULES, AND RECOMMENDATIONS

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
  • For the 200 mg/1.14 mL pre-filled syringe, allow 30 minutes1
SEE INFORMATION ON PREPARATION FOR USE, STORAGE, AND HANDLING FOR DUPIXENT

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.

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 below.

ENGLISH FORM

SPANISH FORM

Overall, 98% of commercially insured patients nationally are covered for DUPIXENT (MMIT Lives as of April 2021). Coverage varies by type and plan.

With 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.12

USE THE DUPIXENT FORMULARY STATUS TOOL

Patients may be eligible for the DUPIXENT MyWay Copay Card if:

  • They have commercial insurance
  • They have a DUPIXENT prescription for an FDA-approved condition
  • They are a resident of the 50 United States, the District of Columbia, or Puerto Rico
  • The patient or caregiver is aged 18 years or older

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

a THIS 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 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. Additional terms and conditions apply.

COPAY CARD ONLINE SIGN-UP

EOS, eosinophils; FeNO, fractional exhaled nitric oxide; FEV1, forced expiratory volume in 1 second; ITT, intention-to-treat; LSM, least squares mean; OCS, oral corticosteroid; SOC, standard of care; TARC, thymus and activation-regulated chemokine.

References:

  1. DUPIXENT Prescribing Information.
  2. Corren J. Role of interleukin-13 in asthma. Curr Allergy Asthma Rep. 2013;13(5):415-420.
  3. 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.
  4. Seys SF, Scheers H, Van den Brande P, et al. Cluster analysis of sputum cytokine-high profiles reveals diversity in T(h)2-high asthma patients. Respir Res. 2017;18(1):39. doi:10.1186/s12931-017-0524-y
  5. Jackson DJ, Aljamil N, Roxas C, et al. The ‘T2-low’ asthma phenotype: could it just be T2-high asthma treated with corticosteroids? Thorax. 2018;73(suppl 4):A124-A125. Abstract P48.
  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. Robinson D, Humbert M, Buhl R, et al. Revisiting type 2-high and type 2-low airway inflammation in asthma: current knowledge and therapeutic implications. Clin Exp Allergy. 2017;47(2):161-175.
  8. Ravensberg AJ, Ricciardolo FLM, van Schadewijk A, et al. Eotaxin-2 and eotaxin-3 expression is associated with persistent eosinophilic bronchial inflammation in patients with asthma after allergen challenge. J Allergy Clin Immunol. 2005;115(4):779-785.
  9. Santanello NC, Zhang J, Seidenberg B, Reiss TF, Barber BL. What are minimal important changes for asthma measures in a clinical trial? Eur Respir J. 1999;14(1):23-27.
  10. Data on file, Sanofi US. QUEST CSR, 2017.
  11. Rabe KF, Nair P, Brusselle G, et al. Efficacy and safety of dupilumab in glucocorticoid-dependent severe asthma. N Engl J Med. 2018;378(26):2475-2485.
  12. The Dedham Group Quality of Access Tracking Report. March 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.