Dosing and Administration

YOU DECIDE:
PATIENTS ADMINISTER AT HOME OR
YOU ADMINISTER IN OFFICE

NOW AVAILABLE
200 mg PRE-FILLED PEN

DUPIXENT is available in a pre-filled pen (12 years and older) or pre-filled syringe; both are available in 200 mg and 300 mg doses.

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
  • 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

Dosing for Moderate-to-Severe Asthma1

For patients with moderate-to-severe asthma with an eosinophilic phenotype

12+ years

Loading dose
600 mg
2 x 300 mgapre-filled pens or syringes
Every 2 weeks
300 mg
1 pre-filled
pen or syringe
OR
 
400 mg
2 x 200 mgbpre-filled pens or syringes
Every 2 weeks
200 mg
1 pre-filled
pen or syringe

OCS-dependent asthma patients or patients with comorbid moderate‑to‑severe atopic dermatitis for which DUPIXENT is indicated1

12+ years

Loading dose
600 mg
2 x 300 mgapre-filled pens or syringes
Every 2 weeks
300 mg
1 pre-filled
pen or syringe

a 300 mg=2 mL solution.
b 200 mg=1.14 mL solution.

At-home or In-office Administration Options



Important Administration Instructions1

  • For the initial dose, administer each of the 2 injections at different injection sites
  • Administer the 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
  • Rotate the injection site with each injection. DO NOT inject DUPIXENT into skin that is tender, damaged, bruised, or scarred

See the Instructions for Use for more detailed instructions on the preparation and administration of DUPIXENT.

Pre-filled Pen
Instructions for Use - 200 mg
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 injection
by caregiver

Preparation for Use1

Before injection, instruct patients and/or caregivers to remove DUPIXENT 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 syringe or pre-filled pen
  • 30 minutes for the 200 mg/1.14 mL pre‑filled syringe or pre-filled pen

Patients and/or caregivers should inspect DUPIXENT for particulate matter and discoloration prior to administration.

  • Do not use 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 or pre-filled pen in accordance with local requirements.

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, DUPIXENT 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
  • DUPIXENT 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 shake
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References:

  1. DUPIXENT Prescribing Information.
  2. DUPIXENT 200 mg/300 mg Pre-filled Pen Instructions for Use.
  3. DUPIXENT 200 mg/300 mg Pre-filled Syringe Instructions for Use.

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.

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. Physicians 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 patients who participated in the asthma development program and cases of vasculitis consistent with EGPA have been reported with DUPIXENT in adult patients who participated in the asthma development program as well as in adult patients with co-morbid asthma in the chronic rhinosinusitis with nasal polyposis 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.

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.

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%) in patients with asthma are injection site reactions, oropharyngeal pain, and eosinophilia.

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 as an add-on maintenance treatment in patients with moderate-to-severe asthma aged 12 years and older with 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.