PARTNER
IN ASTHMA
CARE

PARTNER
IN ASTHMA
RELIEF

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. Limitation of Use: DUPIXENT is not indicated for the relief of acute bronchospasm or status asthmaticus.

APPROVED IN CHILDREN WITH
ASTHMA AS YOUNG AS 6 YEARS
EXPLORE THE RESULTS
IDENTIFYING PATIENTS
Your eosinophilic or OCS-dependent asthma patients may be appropriate for DUPIXENT if they present with the following:
  • Exacerbation requiring hospitalization/ED visit in the past year
  • 2 courses of oral corticosteroids (OCS) in the past year despite maximum inhaler therapy
  • Still uncontrolled on medium- or high-dose inhaled corticosteroids (ICS) + LABA
  • Elevated EOS with or without elevated lgE/FeNO
  • Impaired lung function and decreased quality of life

IDENTIFY YOUR PATIENT

DUPIXENT IS NOT A STEROID OR AN IMMUNOSUPPRESSANT.1,a

aDupilumab is a dual inhibitor of IL-4 and IL-13 signaling. The mechanism of dupilumab action has not been definitively established.

DUPIXENT MAY OFFER
ASTHMA SYMPTOM RELIEF
TO YOUR APPROPRIATE
PATIENTS, INCLUDING:

Allergic asthma patients with elevated
eosinophils

OCS-dependent asthma patients—
DUPIXENT is the only biologic indicated for
this patient population1

Children (6+ years) with moderate-to-
severe uncontrolled asthma

Patients with coexisting diseases, such
as atopic dermatitis or chronic
rhinosinusitis with nasal polyposis1,2

EXPLORE PATIENT TYPES

CLINICAL TRIAL & REAL-WORLD EXPERIENCE
Extensive clinical trial and real-world experience across indications
>6900 patients studied
and
>360K patients on therapy 1,3,b,c

VIEW OTHER INDICATIONS

DUPIXENT has proven efficacy and a demonstrated safety profile in nearly 3000 patients with moderate-to-severe asthma1

Exacerbation reduction1

SEE THE DATA

OCS reduction4

SEE THE DATA

Rapid and sustained
breathing relief1,5,d

SEE THE DATA

Demonstrated
safety profile1

SEE SAFETY DATA

Asthma control
and quality of life1

SEE THE DATA

At-home or in-office
administration1,e

SEE OPTIONS

bNew adult and pediatric patients (6+ months of age) with uncontrolled moderate-to-severe atopic dermatitis; new adult and pediatric patients (6+ years of age) with moderate-to-severe asthma (eosinophilic/OCS-dependent); new adult patients with CRSwNP; new adult and pediatric patients (12+ years of age), weighing at least 40 kg, with EoE; and new adult patients with prurigo nodularis.

cUS DUPIXENT Patients on Therapy; data calculated based on application of in-network monthly discontinuation and restart rates to total projected patient starts through June 2023.

d~72% of the total FEV1 improvement was seen at Week 2 with DUPIXENT 200 mg + SOC (n=264). Up to 470 mL improvement from baseline in pre-bronchodilator FEV1 at Week 52 with DUPIXENT 200 mg + SOC (n=264) vs 170 mL with placebo + SOC (n=148) (QUEST, EOS ≥300 cells/µL, secondary 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]) (QUEST, ITT population, primary endpoint). In QUEST, 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

eA patient or caregiver may inject DUPIXENT after training in subcutaneous injection technique.1

Most Common
Adverse Reactions

The most common adverse reactions (incidence ≥1%) in patients with asthma were injection site reactions, oropharyngeal pain, and
eosinophilia. In DRI12544 and QUEST, the proportion of subjects who discontinued treatment due to adverse events was 4% of the placebo + SOC
group, 3% of the DUPIXENT 200 mg Q2W + SOC group, and 6% of the DUPIXENT 300 mg Q2W + SOC group.1

Trial Designs and Results

PATIENT SYMPTOM
EVALUATION
QUESTIONNAIRE

Download the questionnaire for helpful questions
when evaluating your patients' asthma severity,
control, and referral eligibility.

DOWNLOAD THE questionnaire

Contact a Field Representative

Connect with a DUPIXENT Field Representative to get answers to your product-related questions.

FAQs

Frequently asked questions about DUPIXENT

DUPIXENT is a biologic therapy and has a unique mechanism of action. DUPIXENT is the first and only dual inhibitor of IL-4 and IL-13 signaling, inhibiting two key sources of type 2 inflammation in asthma. DUPIXENT is not an immunosuppressant or a steroid. The mechanism of dupilumab action has not been definitively established.1

SEE HOW DUPIXENT WORKS

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. Limitation of Use: DUPIXENT is not indicated for the relief of acute bronchospasm or status asthmaticus.1

SEE THE EFFICACY AND SAFETY DATA OF DUPIXENT EXPLORE APPROPRIATE PATIENT TYPES

DUPIXENT is typically prescribed by an asthma specialist, such as an allergist or a pulmonologist. If you have patients 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma who you think might be appropriate for DUPIXENT, consider referring them to an asthma specialist.1

For help finding a
specialist in your area,
use the HeaLthgrades® tool

Overall, ~98% of commercially insured patients nationally are covered for DUPIXENT.7,i 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.

iFUN Documents, MMIT, and Policy Reporter as of July 2023.

CHECK FORMULARY
STATUS FOR DUPIXENT
IN YOUR AREA

For patients with a valid prescription for DUPIXENT, support is available through the DUPIXENT MyWay® patient support program. Patients who enroll can receive:

  • Insightful tips and tools to help them along the way
  • Supplemental injection training virtually or over the phone
  • Financial assistance for eligible patients
  • Assistance with insurance questions
  • Assistance locating a specialty pharmacy that can dispense DUPIXENT
LEARN MORE ABOUT THE SUPPORT OFFERED BY DUPIXENT MyWay

DUPIXENT can be administered at home or in the office.

DUPIXENT is an injectable medicine that is administered by subcutaneous injection. DUPIXENT is intended for use under the guidance of a healthcare provider. However, patients 12 years of age and older may self-inject DUPIXENT at home after receiving training in subcutaneous injection technique using the pre-filled syringe or pen. It is recommended that pediatric patients 12 to 17 years of age administer DUPIXENT under the supervision of an adult. In pediatric patients 6 to less than 12 years of age, DUPIXENT should be given by a caregiver.1

LEARN MORE ABOUT DOSAGES

Severe asthma management by an allergist or a pulmonologist may involve:

  • Evaluation of OCS use and asthma attack history and reconfirmation of asthma diagnosis
  • Assessment of biomarkers of type 2 inflammation
  • Allergy testing
  • Pulmonary function tests
  • Evaluation of coexisting T2 inflammatory diseases and degree of control
  • Consideration of add-on biologic therapies
CONTACT A REP
COST & COVERAGE

DUPIXENT provides eligible patients with access supportk-m

Overall, ~98% of commercially insured patients nationally are covered for DUPIXENT.7,k

Coverage varies by type and plan.

Explore COST & COVERAGE

kFUN Documents, MMIT, and Policy Reporter as of July 2023.

lEligible patients subject to program restrictions.

mApproval 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.

FIND AN ASTHMA SPECIALIST

Refer your appropriate asthma patients
to a specialist today

Partner with an asthma specialist to help
your patients. Use the Healthgrades®
tool
to easily find nearby specialists.

Sanofi US and Regeneron neither endorse nor recommend any
particular physician, and
search results do not include a
comprehensive list of doctors in your area.

IMPORTANT SAFETY
INFORMATION AND INDICATIONS

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 atopic dermatitis subjects who received DUPIXENT versus placebo, with conjunctivitis being the most frequently reported eye disorder. Conjunctivitis also occurred more frequently in chronic rhinosinusitis with nasal polyposis subjects and prurigo nodularis 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 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.

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:
  • Atopic Dermatitis: The most common adverse reactions (incidence ≥1%) in patients are 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 atopic dermatitis. 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 atopic dermatitis, 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: The most common adverse reactions (incidence ≥1%) are injection site reactions, oropharyngeal pain, and eosinophilia.
  • Chronic Rhinosinusitis with Nasal Polyposis: The most common adverse reactions (incidence ≥1%) are injection site reactions, eosinophilia, insomnia, toothache, gastritis, arthralgia, and conjunctivitis.
  • Eosinophilic Esophagitis: The most common adverse reactions (incidence ≥2%) are injection site reactions, upper respiratory tract infections, arthralgia, and herpes viral infections.
  • Prurigo Nodularis: The most common adverse reactions (incidence ≥2%) are nasopharyngitis, conjunctivitis, herpes infection, dizziness, myalgia, and diarrhea.
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

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. Limitation of Use: DUPIXENT is not indicated for the relief of acute bronchospasm or status asthmaticus.

Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP): DUPIXENT is indicated as an add-on maintenance treatment in adult patients with inadequately controlled CRSwNP.

Atopic Dermatitis: DUPIXENT is indicated for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis 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.

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).

CRSwNP, chronic rhinosinusitis with nasal polyposis; ED, emergency department; EoE, eosinophilic esophagitis; EOS, eosinophils; FeNO, fractional exhaled nitric oxide; FEV1, forced expiratory volume in one second: ITT, intention-to-treat; LABA, long-acting beta agonist; LSM, least squares mean; Q2W, once every 2 weeks; SOC, standard of care.

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. Data on file, Sanofi US. IQVIA Sanofi Integrated DUPIXENT Platform; data through June 2023.
  4. 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.
  5. 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.
  6. Wang E, Wechsler ME, Tran TN, et al. Characterization of severe asthma worldwide: data from the International Severe Asthma Registry. Chest. 2020;157(4):790-804.
  7. FUN Documents, MMIT, and Policy Reporter; data through July, 2023.