Control the Signs and Symptoms of Moderate‑to‑Severe Atopic Dermatitis With Every‑Other‑Week Dosing

DUPIXENT is an injectable medicine that is administered by subcutaneous injection and is intended for use under the guidance of a healthcare provider. Patients may self‑inject DUPIXENT, or a caregiver may administer DUPIXENT, after training has been provided by a healthcare provider on proper subcutaneous injection technique. 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 and full Prescribing Information. Patients and/or caregivers should read the Instructions for Use–either 200 mg or 300 mg—prior to injecting.1

Weight-Based Dosing Regimen For Adolescents1

TwoWeeksMobile

Preparation for Use1

  • Before injection, instruct patients and/or caregivers to remove the DUPIXENT pre‑filled syringe from the refrigerator and allow DUPIXENT to reach room temperature (45 minutes for the 300 mg/2 mL pre‑filled syringe and 30 minutes for the 200 mg/1.14 mL pre‑filled syringe) without removing the needle cap
  • Patients and/or caregivers should inspect DUPIXENT for particulate matter and discoloration prior to administration
  • Patients and/or caregivers should not use the pre‑filled syringe if the liquid contains visible particulate matter, or is discolored or cloudy (other than clear to slightly opalescent, colorless to pale yellow)
  • Patients and/or caregivers should discard any unused product remaining in the pre‑filled syringe in accordance with local requirements

Important Administration Instructions1

  • Patients and/or caregivers should read the Instructions for Use prior to injecting
  • Instruct patients and/or caregivers to administer 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
  • It is important to rotate the injection site with each injection. DO NOT inject
    DUPIXENT into skin that is tender, damaged, bruised, or scarred
  • For the initial dose, patients and/or caregivers should administer each
    DUPIXENT injection at a different injection site
  • In adolescents aged 12 years and older, it is recommended that DUPIXENT be administered by or under the supervision of an adult
 
 

Dosage Forms and Strengths1

DUPIXENT is a clear to slightly opalescent, colorless to
pale yellow solution available as:

  • Injection: 300 mg/2 mL in a single‑dose, pre‑filled syringe with needle shield
  • Injection: 200 mg/1.4 mL in a single-dose, pre‑filled syringe with needle shield

How It's Supplied1

DUPIXENT is available in cartons containing 2 pre‑filled syringes with needle shields. Syringes can deliver 300 mg/2 mL or 200 mg/1.4 mL.

Storage and Handling1

  • DUPIXENT is sterile and preservative‑free. Patients and/or caregivers should discard any unused portion
  • Patients and/or caregivers should store DUPIXENT by refrigerating at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light
  • If necessary, pre‑filled syringes may be kept at room temperature up to 77°F (25°C) for a maximum of 14 days. DUPIXENT should not be stored above 77°F (25°C). After removal from the refrigerator, DUPIXENT must be used within 14 days or discarded
  • The syringe should not be exposed to heat or direct sunlight
  • Any unused medicinal product or waste material should be disposed of in accordance with local requirements
  • Do NOT freeze. Do NOT expose to heat. Do NOT shake

Patient Counseling Information

Advise patients and/or caregivers to read the FDA‑approved patient labeling (Patient Information and Instructions for Use ‑ 200 mg or Instructions for Use ‑ 300 mg) before the patient starts using DUPIXENT and each time the prescription is renewed as there may be new information they need to know.

Pregnancy Registry: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to DUPIXENT during pregnancy. Encourage participation in the registry.

Administration Instructions: Provide proper training to patients and/or caregivers on proper subcutaneous injection technique, including aseptic technique, and the preparation and administration of DUPIXENT prior to use.

Advise patients to follow sharps disposal recommendations.

Hypersensitivity:Advise patients to discontinue DUPIXENT and to seek immediate medical attention if they experience any symptoms of systemic hypersensitivity reactions.

Conjunctivitis and Keratitis:Advise patients to consult their healthcare provider if new onset or worsening eye symptoms develop.

Reduction in Corticosteroid Dosage: Inform patients to not discontinue systemic or inhaled corticosteroids except under the direct supervision of a physician. Inform patients that reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

Comorbid Asthma:Advise patients with comorbid asthma not to adjust or stop their asthma treatment without talking to their physicians.

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EASI, Eczema Area and Surface Index; IGA, Investigator’s Global Assessment; NRS, numerical rating scale; Q2W, once every 2 weeks; TCS, topical corticosteroids.

Reference:
References:
  1. DUPIXENT Prescribing Information.
  2. Simpson EL, Bieber T, Guttman‑Yassky E, et al; SOLO 1 and SOLO 2 Investigators. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis. N Engl J Med. 2016;375(24):2335‑2348.
  3. Blauvelt A, de Bruin‑Weller M, Gooderham M, et al. Long‑term management of moderate‑to‑severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1‑year, randomised, double‑blinded, placebo‑controlled, phase 3 trial. Lancet. 2017;389(10086):2287‑2303.
  4. Data on file, Regeneron Pharmaceuticals, Inc.
  5. Gittler JK, Shemer A, Suárez‑Fariñas M, et al. Progressive activation of TH2/TH22 cytokines and selective epidermal proteins characterizes acute and chronic atopic dermatitis. J Allergy Clin Immunol. 2012:130(6):1344‑1354.
  6. DUPIXENT Prescribing Information.
  7. Wei W, Anderson P, Gadkari A, et al. Extent and consequences of inadequate disease control among adults with a history of moderate‑to‑severe atopic dermatitis. J Dermatol. 2018;45(2):150‑157.
  8. DUPIXENT Prescribing Information.
  9. DUPIXENT Prescribing Information.
  10. Hanifin JM, Thurston M, Omoto M, Cherill R, Tofte SJ, Graeber M; the EASI Evaluator Group. The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. Exp Dermatol. 2001;10(1):11‑18.
  11. Data on file, Regeneron Pharmaceuticals, Inc.
  12. Blauvelt A, de Bruin‑Weller M, Gooderham M, et al. Long‑term management of moderate‑to‑severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1‑year, randomised, double‑blinded, placebo‑controlled, phase 3 trial. Lancet. 2017;389(10086):2287‑2303.
  13. Simpson EL, Bieber T, Guttman‑Yassky E, et al; SOLO 1 and SOLO 2 Investigators. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis. N Engl J Med. 2016;375(24):2335‑2348.
  14. Blauvelt A, Rosmarin D, Bieber T, et al. Improvement of atopic dermatitis with dupilumab occurs equally well across different anatomic regions: data from phase 3 clinical trials [published online February 4, 2019]. Br J Dermatol. doi:10.1111/bjd.17703
  15. EASI User Guide. HOME‑Harmonising Outcome Measures for Eczema website. http://www.homeforeczema.org/documents/easi-user-guide-jan-2017-v3.pdf. Accessed January 4, 2019.
  16. DUPIXENT Prescribing Information.
  17. Data on file, Regeneron Pharmaceuticals, Inc.
  18. Blauvelt A, de Bruin‑Weller M, Gooderham M, et al. Long‑term management of moderate‑to‑severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1‑year, randomised, double‑blinded, placebo‑controlled, phase 3 trial. Lancet. 2017;389(10086):2287‑2303.
  19. Simpson EL, Bieber T, Guttman‑Yassky E, et al; SOLO 1 and SOLO 2 Investigators. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis. N Engl J Med. 2016;375(24):2335‑2348.
  20. DUPIXENT Prescribing Information.
  21. Blauvelt A, de Bruin‑Weller M, Gooderham M, et al. Long‑term management of moderate‑to‑severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1‑year, randomised, double‑blinded, placebo‑controlled, phase 3 trial. Lancet. 2017;389(10086):2287‑2303.
  22. Phan NQ, Blome C, Fritz F, et al. Assessment of pruritus intensity: prospective study on validity and reliability of the visual analogue scale, numerical rating scale and verbal rating scale in 471 patients with chronic pruritus. Acta Derm Venereol. 2012;92(5):502‑507.
  23. Data on file, Regeneron Pharmaceuticals, Inc.
  24. Simpson EL, Bieber T, Guttman‑Yassky E, et al; SOLO 1 and SOLO 2 Investigators. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis. N Engl J Med. 2016;375(24):2335‑2348.
  25. Blauvelt A, de Bruin‑Weller M, Szepietowski JC, et al. Efficacy and safety of dupilumab with concomitant topical corticosteroids in moderate‑to‑severe atopic dermatitis over 1‑year as assessed by baseline characteristics. Presented at: 26th European Academy of Dermatology and Venereology Congress; September 13‑17, 2017; Geneva, Switzerland.
  26. Pariser DM, Lockshin BN, Griffiths CEM. Dupilumab and concomitant topical corticosteroids in the long‑term management of moderate‑to‑severe atopic dermatitis: analysis of clinical outcomes by race (LIBERTY AD CHRONOS). Presented at: 10th Annual Skin of Color Seminar Series; May 5‑6, 2018; New York, New York.
  27. DUPIXENT Prescribing Information.
  28. Data on file, Regeneron Pharmaceuticals, Inc.
  29. DUPIXENT Prescribing Information.
  30. Data on file, Regeneron Pharmaceuticals, Inc.
  31. Blauvelt A, Simpson EL, Tyring SK, et al. Dupilumab does not affect correlates of vaccine‑induced immunity: a randomised, placebo‑controlled trial in adults with moderate‑to‑severe atopic dermatitis. J Am Acad Dermatol. 2019;80(1):158‑167.
  32. DUPIXENT Prescribing Information.
  33. Boguniewicz M, Alexis AF, Beck LA, et al. Expert perspectives on management of moderate‑to‑severe atopic dermatitis: a multidisciplinary consensus addressing current and emerging therapies. J Allergy Clin Immumol Pract. 2017;5(6):1519‑1531.
  34. DUPIXENT Prescribing Information.
  35. Data on file. Regeneron Pharmaceuticals, Inc.
  36. DUPIXENT Prescribing Information.
  37. Data on file, Regeneron Pharmaceuticals, Inc.
  38. Blauvelt A, de Bruin‑Weller M, Gooderham M, et al. Long‑term management of moderate‑to‑severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1‑year, randomised, double‑blinded, placebo‑controlled, phase 3 trial. Lancet. 2017;389(10086):2287‑2303.
  39. DUPIXENT Prescribing Information.
  40. 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.
  41. Guttman‑Yassky E, Nograles KE, Krueger JG. Contrasting pathogenesis of atopic dermatitis and psoriasis—part II: immune cell subsets and therapeutic concepts. J Allergy Clin Immunol. 2011;127(3):1420‑1432.
  42. DUPIXENT Prescribing Information.
  43. DUPIXENT Prescribing Information.
  44. Data on file, Regeneron Pharmaceuticals, Inc.
  45. DUPIXENT Prescribing Information.
  46. Data on file, Regeneron Pharmaceuticals, Inc.
  47. DUPIXENT Prescribing Information.
  48. Blauvelt A, Simpson EL, Tyring SK, et al. Dupilumab does not affect correlates of vaccine‑induced immunity: a randomised, placebo‑controlled trial in adults with moderate‑to‑severe atopic dermatitis. J Am Acad Dermatol. 2019;80(1):158‑167.
  49. DUPIXENT Prescribing Information.
  50. Data on file, Regeneron Pharmaceuticals, Inc.
  51. Phan NQ, Blome C, Fritz F, et al. Assessment of pruritus intensity: prospective study on validity and reliability of the visual analogue scale, numerical rating scale and verbal rating scale in 471 patients with chronic pruritus. Acta Derm Venereol. 2012;92(5):502‑507.
  52. DUPIXENT Prescribing Information.
  53. Data on file, Regeneron Pharmaceuticals, Inc.
  54. Hanifin JM, Thurston M, Omoto M, Cherill R, Tofte SJ, Graeber M; the EASI evaluator group. The eczema area and severity (EASI): assessment of reliability in atopic dermatitis. Exp Dermatol. 2001;10(1):11‑18.
  55. EASI User Guide. HOME–Harmonising Outcome Measures for Eczema website. http://www.homeforeczema.org/documents/easi-user-guide-jan-2017-v3.pdf. Accessed January 4, 2019.
  56. DUPIXENT Prescribing Information.
  57. Data on file, Regeneron Pharmaceuticals, Inc.