Dosing for moderate-to-severe asthma
Adults/adolescents (12+ years)¹

MODERATE-TO-SEVERE ASTHMA WITH AN EOSINOPHILIC PHENOTYPE

OCS-DEPENDENT ASTHMA PATIENTS, OR PATIENTS WITH COMORBID MODERATE-TO-SEVERE ATOPIC DERMATITIS, FOR WHOM DUPIXENT IS INDICATED

Initial dose is 600 mg (two 300 mg pre-filled pens or syringes) followed by
every-2-week dosing of a 300 mg pre-filled pen or syringe

DUPIXENT is intended for use under the guidance of a healthcare provider. A patient may self-inject DUPIXENT after receiving training in subcutaneous injection technique using the pre-filled syringe or pre-filled pen. In adolescents 12 years of age and older, it is recommended that DUPIXENT be administered by or under the supervision of an adult. Provide proper training to patients and/or caregivers on the preparation and administration of DUPIXENT prior to use according to the Instructions for Use.

DUPIXENT can be administered in the office under the guidance of a healthcare provider if the patient is not an appropriate candidate for at-home administration.

If an every-other-week dose is missed, instruct the patient to administer the injection within 7 days from the missed dose and then resume their original schedule. If the missed dose is not administered within 7 days, instruct the patient to wait until the next dose on the original schedule.

Important Administration Instructions

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.

^a 300 mg=2 mL solution.

^b 200 mg=1.14 mL solution.

At-home or in-office administration options

NEW PRE-FILLED PEN (AGES 12+ YEARS)^1,2

Subcutaneous autoinjector with hidden needle
Needle cap is not made with natural rubber latex
Visual and audible feedback
Available in 300 mg

PRE-FILLED SYRINGE^1,3

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 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.

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

Dosing for moderate-to-severe asthma
Adults/adolescents (12+ years)¹

At-home or in-office administration options

Safety

Contact a Rep

DUPIXENT MyWay^®

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

Dosing for moderate-to-severe asthma Adults/adolescents (12+ years)1

At-home or in-office administration options

Safety

Contact a Rep

DUPIXENT MyWay®

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

Dosing for moderate-to-severe asthma
Adults/adolescents (12+ years)¹

DUPIXENT MyWay^®