Dosing Schedule and Weight-Tiered Dosage Regimen

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. In adolescents 12 years of age and older, it is recommended that DUPIXENT be administered by or under the supervision of an adult. In children younger than 12 years of age, DUPIXENT should be given by a caregiver. 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

One Dosage Regimen For Adults1


Weight-tiered Dosage Regimen For Pediatric Patients (6-17 Years)1,a

a15 kg is equal to 33 lb; 30 kg is equal to 66 lb; 60 kg is equal to 132 lb.

NOW APPROVED
The DUPIXENT 300 mg Pre-filled Pen will be available by late August 2020 for appropriate patients aged 12 years and older.
DUP.20.05.0265

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 12 years of age and older, it is recommended that DUPIXENT be administered by or under the supervision of an adult. In children younger than 12 years of age, DUPIXENT should be administered by a caregiver

See How to Inject DUPIXENT

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/1.14 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.

Pre-filled syringes can deliver 300 mg/2 mL or 200 mg/1.14 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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Reference:
  1. DUPIXENT Prescribing Information.