Dosing and Administration

Real patient treated with DUPIXENT.
Individual results may vary.

DUPIXENT does not require initial lab testing or ongoing lab monitoring, according to the Prescribing Information1

DUPIXENT is an injectable medicine that is administered by subcutaneous injection and is intended for use under the guidance of a healthcare provider.1
  • 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 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
    • 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
  • After administration, advise patients to follow sharps disposal recommendations
  • Patients and/or caregivers should read the Instructions for Use—either 200 mg or 300 mg—prior to injecting

Adult patients (18+ years)1

One dosing regimen

Pediatric patients
(6-17 Years)1,a

Weight-tiered dosing regimenb

aThe DUPIXENT 300 mg Pre-filled Pen is approved for patients aged 12+ years.

b15 kg is equal to 33 lb; 30 kg is equal to 66 lb; 60 kg is equal to 132 lb.

Choice of administration with the 300 mg pre-filled pen for patients aged 12+ years or 200 mg or 300 mg pre-filled syringe1


At-home or in-office administration options

Pre-Filled Pen (12+ years)
  • Subcutaneous autoinjector with hidden needle
  • Needle cap is not made with natural rubber latex
  • Visual and audible feedback
  • Available in 300 mg
  • Available for patients aged 12+ years
Pre-Filled Syringe
  • Subcutaneous injection with needle shield
  • Needle cap is not made with natural rubber latex
  • Includes finger grip
  • Available in 300 mg and 200 mg

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 the Instructions for Use for more detailed instructions on the preparation and administration of DUPIXENT
Pre-Filled Pen
Instructions for Use - 300 mg
Pre-Filled Syringe
Instructions for Use - 200 mg
Instructions for Use - 300 mg
Supplemental Injection Training
VIEW PATIENT VIDEOS

Outer
Upper Arms

Abdomen

Thighs

Injection by caregiver only

Self-injection or by caregiver

Preparation for use1

Before injection, instruct patients and/or caregivers to remove the DUPIXENT pre‑filled pen or syringe from the refrigerator and allow DUPIXENT to reach room temperature without removing the needle cap.

  • 45 minutes for the 300 mg/2 mL pre‑filled pen or syringe
  • 30 minutes for the 200 mg/1.14 mL pre‑filled syringe

Patients and/or caregivers should not use the pre-filled pen or 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 pen or syringe in accordance with local requirements

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 pen or 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 pens or syringes with needle shields. Each pre-filled pen delivers 300 mg/2 mL. Each pre-filled syringe delivers either 300 mg/2 mL or 200 mg/1.14 mL, depending on the prescribed dose.

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 pens or 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 pen or 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

Reference:

  1. DUPIXENT Prescribing Information.

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.

Conjunctivitis and Keratitis: Conjunctivitis and keratitis occurred more frequently in atopic dermatitis subjects who received DUPIXENT. Conjunctivitis was the most frequently reported eye disorder. Most subjects with conjunctivitis or keratitis recovered or were recovering during the treatment period. Advise patients to report new onset or worsening eye symptoms to their healthcare provider.

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.

Atopic Dermatitis Patients with Comorbid Asthma: Advise patients not to adjust or stop their asthma treatments without consultation with their physicians.

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% at Week 16) in adult patients with atopic dermatitis are injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, and dry eye. The safety profile in children and adolescents 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 in adolescents and children observed through Week 52 was consistent with that seen in adults with atopic dermatitis.

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 for the treatment of patients aged 6 years 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.