DUPIXENT® (dupilumab) Injection by Regeneron and Sanofi Genzyme


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Indications & Usage

 

INDICATIONS AND USAGE

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.


Please see full Prescribing Information

Dosage & Administration

DOSAGE AND ADMINISTRATION

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 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

 

DOSING FOR MODERATE-TO-SEVERE ASTHMA

·         For patients 12 years of age and older with moderate-to-severe asthma with an eosinophilic phenotype

o   Loading dose of 600 mg (2 x 300 mg pre-filled pens or syringes) followed by 300 mg (1 pre-filled pen or syringe) given every 2 weeks or

o   Loading dose of 400 mg (2 x 200 mg pre-filled syringes) followed by 200 mg (1 pre-filled syringe) given every 2 weeks

·         For patients 12 years of age and older with OCS-dependent asthma patients or with comorbid moderate‑to‑severe atopic dermatitis for which DUPIXENT is indicated

o   Loading dose of 600 mg (2 x 300 mg pre-filled pens or syringes) followed by 300 mg (1 pre-filled pen or syringe) given every 2 weeks

 

ADMINISTRATION FORMS

  • Subcutaneous Injection: 300 mg/2 mL solution in a single-dose pre-filled pen
  • Subcutaneous Injection: 300 mg/2 mL solution in a single-dose pre-filled syringe
  • Subcutaneous Injection: 200 mg/1.14 mL solution in a single-dose pre-filled syringe



Please see full Prescribing Information



© 2021 Sanofi and Regeneron Pharmaceuticals, Inc. All Rights Reserved.
DUPIXENT® and DUPIXENT MyWay® are registered trademarks of Sanofi Biotechnology.
DUP.21.03.0303  May 2021



Please see full Prescribing Information for all indications

Indication and Important Safety 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.

IMPORTANT SAFETY INFORMATION

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.