Illustrations represent an EASI-75 response. See DUPIXENT clinical study responses. Individual patient responses may vary.

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 should read the Instructions for Use prior to injecting.

DUPIXENT Dosing Schedule

Initial dose 600 mg (two 300 mg
pre-filled syringes)
2 weeks later
Every-other-week-dosing 300 mg pre-filled syringe thereafter at different injection sites
  • Patients may either self-inject DUPIXENT, or a caregiver may administer DUPIXENT, after training has been provided by a healthcare professional on proper subcutaneous injection technique according to the Instructions for Use and Prescribing Information1
  • Patients can use DUPIXENT with or without topical corticosteroids. Topical calcineurin inhibitors may be used, but should be reserved for problem areas only, such as the face, neck, and intertriginous and genital areas1
  • 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 schedule1

Preparation for Use

  • Before injection, instruct patients to remove the DUPIXENT pre-filled syringe from the refrigerator and allow DUPIXENT to reach room temperature (45 minutes) without removing the needle cap1
  • Patients should inspect DUPIXENT for particulate matter and discoloration prior to administration1
  • Patients 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)1
  • Patients should discard any unused product remaining in the pre-filled syringe in accordance with local requirements1

Important Administration Instructions

  • Patients 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 navel1
  • The upper arm can also be used if a caregiver administers the injection1
  • It is important to rotate the injection site with each injection. DO NOT
    inject DUPIXENT into skin that is tender, damaged, bruised, or scarred1
  • For the initial 600 mg dose, patients and/or caregivers should administer
    each DUPIXENT 300 mg injections at a different injection site1
 
 

Dosage Forms and Strengths

DUPIXENT is a clear to slightly opalescent, colorless
to pale yellow solution available as1:

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

How It's Supplied

DUPIXENT is available in cartons containing 2 pre-filled syringes with needle shields, and each syringe is designed to deliver 300 mg of DUPIXENT in a 2 mL solution.1



Storage and Handling

  • DUPIXENT is sterile and preservative-free. Patients should discard any unused portion.1
  • Patients should store DUPIXENT by refrigerating at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light.1
  • 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.1
  • The syringe should not be exposed to heat or direct sunlight.1
  • Any unused medicinal product or waste material should be disposed of in accordance with local requirements.1
  • Do NOT freeze. Do NOT expose to heat. Do NOT shake.1

Patient Counseling Information

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

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 [see Instructions for Use].

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.

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

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Reference:
References:
  1. DUPIXENT Prescribing Information. March 2017.
  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. Data on file, Regeneron Pharmaceuticals, Inc.
  4. DUPIXENT Prescribing Information. March 2017.
  5. Data on file, Regeneron Pharmaceuticals, Inc.
  6. 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.
  7. 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.
  8. Brandt EB, Sivaprasad U. Th2 cytokines and atopic dermatitis. J Clin Cell Immunol. 2011;2(3):1-25. doi:10.4172/2155-9899:100011
  9. Noda S, Krueger JG, Guttman-Yassky E. The translational revolution and use of biologics in patients with inflammatory skin diseases. J Allergy Clin Immunol. 2015;135(2):324-336.
  10. 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(6):1420-1432.
  11. Guttman-Yassky E, Dhingra N, Leung DY. New era of biological therapeutics in atopic dermatitis. Expert Opin Biol Ther. 2013;13(4):549-561.
  12. Data on file, Regeneron Pharmaceuticals, Inc.
  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. Leshem YA, Hajar T, Hanifin JM, Simpson EL. What the Eczema Area and Severity Index score tells us about the severity of atopic dermatitis: an interpretability study. Br J Dermatol. 2015;172(5):1353-1357.
  15. DUPIXENT Prescribing Information. March 2017.
  16. 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 [published May 4, 2017]. Lancet. 2017;389(10086):2287-2303.
  17. DUPIXENT Prescribing Information. March 2017.
  18. Data on file, Regeneron Pharmaceuticals, Inc.
  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. March 2017.
  21. Data on file, Regeneron Pharmaceuticals, Inc.
  22. 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.
  23. 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.
  24. DUPIXENT Prescribing Information. March 2017.
  25. Data on file, Regeneron Pharmaceuticals, Inc.
  26. DUPIXENT Prescribing Information. March 2017.
  27. Data on file, Regeneron Pharmaceuticals, Inc.
  28. DUPIXENT Prescribing Information. March 2017.
  29. Data on file, Regeneron Pharmaceuticals, Inc.
  30. Leshem YA, Hajar T, Hanifin JM, Simpson EL. What the Eczema Area and Severity Index score tells us about the severity of atopic dermatitis: an interpretability study. Br J Dermatol. 2015;172(5):1353-1357.
  31. EASI User Guide. HOME—Harmonising Outcome Measures for Eczema website. http://www.homeforeczema.org/documents/easi-user-guide-jan-2017-v3.pdf. Accessed January 11, 2017.
  32. 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.
  33. Hanifin JM, Thurston M, Omoto M, Cherill R, Tofte SJ, Graeber M. The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. Exp Dermatol. 2001;10(1):11-18.
  34. DUPIXENT Prescribing Information. March 2017.
  35. Data on file, Regeneron Pharmaceuticals, Inc.
  36. Torrelo A, Ortiz J, Alomar A, Ros S, Pedrosa E, Cuervo J. Health-related quality of life, patient satisfaction, and adherence to treatment in patients with moderate or severe atopic dermatitis on maintenance therapy: the CONDA-SAT study. Actas Dermosifiliogr. 2013;104(5):409-417.
  37. 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.
  38. DUPIXENT Prescribing Information. March 2017.