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Patient Access Support - Indications & Usage
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INDICATIONS AND USAGE
DUPIXENT is indicated as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by 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
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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 12 years of age and older 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 children 6 to less than 12 years of age, DUPIXENT should be given by a caregiver. DUPIXENT can be administered in the office under the guidance of a healthcare provider if the caregiver is not an appropriate candidate for administration.
DOSAGE FOR MODERATE-TO-SEVERE ASTHMA
- For patients 12 years of age and older with moderate-to-severe asthma with an eosinophilic phenotype
- Loading dose of 600 mg (2x 300 mg pre-filled pens or syringes) followed by 300 mg (1 pre-filled pen or syringe) given every 2 weeks or
- Loading dose of 400 mg (2x 200 mg pre-filled pens or syringes) followed by 200 mg (1 pre-filled pen or syringe) given every 2 weeks
- For patients 12 years of age and older with OCS-dependent asthma or with comorbid moderate-to-severe atopic dermatitis or adults with co-morbid chronic rhinosinusitis with nasal polyposis
- Loading dose of 600 mg (2x 300 mg pre-filled pens or syringes) followed by 300 mg (1 pre-filled pen or syringe) given every 2 weeks
- For patients 6-11 years of age with moderate-to-severe asthma
- 30 kg or morea: 200 mg (1x 200 mg pre-filled pen or syringe) given every 2 weeks
- 15 kg to <30 kgb: 100 mg (1x 100 mg pre-filled syringe) given every 2 weeks OR 300 mg (1x 300 mg pre-filled pen or syringe) given every 4 weeks
- No loading dose
- For patients 6-11 years of age with asthma and comorbid moderate-to-severe atopic dermatitis, follow the recommended dosage for atopic dermatitis, which includes an initial loading dose
a30 kg is equal to 66 lb.
b15 kg is equal to 33 lb.
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 pen
- Subcutaneous Injection: 200 mg/1.14 mL solution in a single-dose pre-filled syringe
- Subcutaneous Injection: 100 mg/0.67 mL solution in a single-dose pre-filled syringe
Please see full Prescribing Information. - For patients 12 years of age and older with moderate-to-severe asthma with an eosinophilic phenotype
© 2023 Sanofi and Regeneron Pharmaceuticals, Inc. All Rights Reserved.
DUPIXENT ® and DUPIXENT MyWay ® are registered trademarks of Sanofi Biotechnology.
DUP.22.12.0060 January 2023
Please see full Prescribing Information for all indications
Indication and Important Safety Information
INDICATION
DUPIXENT is indicated as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by 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.
CONTRAINDICATION: DUPIXENT is contraindicated in patients with known hypersensitivity to dupilumab or any of its excipients.
WARNINGS AND PRECAUTIONS
Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, serum sickness or serum sickness-like reactions, angioedema, generalized urticaria, rash, erythema nodosum, and erythema multiforme have been reported. 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. Healthcare providers 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 subjects who participated in the asthma development program and cases of vasculitis consistent with EGPA have been reported with DUPIXENT in adult subjects who participated in the asthma development program as well as in adult subjects 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.
Risk Associated with Abrupt Reduction of Corticosteroid Dosage: Do not discontinue systemic, topical, or inhaled corticosteroids abruptly upon initiation of DUPIXENT. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a healthcare provider. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.
Arthralgia: Arthralgia has been reported with use of DUPIXENT with some patients reporting gait disturbances or decreased mobility associated with joint symptoms; some cases resulted in hospitalization. Advise patients to report new onset or worsening joint symptoms. If the symptoms persist or worsen, consider rheumatological evaluation and/or discontinuation of DUPIXENT.
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. Helminth infections (5 cases of enterobiasis and 1 case of ascariasis) were reported in pediatric patients 6 to 11 years old in the pediatric asthma development program.
Vaccinations: Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating DUPIXENT. Avoid use of live vaccines in patients treated with DUPIXENT.
ADVERSE REACTIONS: The most common adverse reactions (incidence ≥1%) in patients with asthma are injection site reactions, oropharyngeal pain, and eosinophilia.
- Pregnancy: A pregnancy exposure registry monitors pregnancy outcomes in women exposed to DUPIXENT during pregnancy. To enroll or obtain information call 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/. 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.