Dosing Information | DUPIXENT® (dupilumab)

DUPIXENT can be administered at home

DUPIXENT is intended for use under the guidance of a healthcare provider. A patient may self-inject DUPIXENT after training in subcutaneous injection technique using the pre-filled syringe. 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 self-administration.

Recommended dosing

INTIAL DOSE 2 WEEKS LATER EVERY-OTHER-WEEK DOSING

400 mg (two 200 mg^a
pre-filled syringes) 200 mg pre-filled syringe OR 600 mg (two 300 mg^b
pre-filled syringes) 300 mg pre-filled syringe

OCS-dependent asthma:

Initial dose is 600 mg (two 300 mg pre-filled syringes) followed 2 weeks later by every-other-week dosing of 300 mg pre-filled syringe

In patients with comorbid moderate-to-severe atopic dermatitis for which DUPIXENT is indicated:

Initial dose is 600 mg (two 300 mg pre-filled syringes) followed 2 weeks later by every-other-week dosing of 300 mg pre-filled syringe

DUPIXENT is also indicated for the treatment of adult patients 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

Important administration instructions

Patients 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

For the initial 400 or 600 mg dose in moderate-to-severe asthma patients, patients and/or caregivers should administer each of the two DUPIXENT 200 mg (for 400 mg initial dose) or 300 mg (for 600 mg initial dose) injections at a different injection site

It is important to rotate the injection site with each injection. DO NOT inject DUPIXENT into skin that is tender, damaged, bruised, or scarred

If a dose is missed, instruct the patient to administer the injection within 7 days from the missed dose and then resume the patient's 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

^a200 mg=1.14 mL solution.

^b300 mg=2 mL solution.

Important Safety Information and Indications

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 in these patients. Among asthma subjects the frequency of conjunctivitis and keratitis was similar between DUPIXENT and placebo. Advise patients to report new onset or worsening eye symptoms to their healthcare provider.

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. Be alert to vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in patients with eosinophilia, which may be associated with a reduction of oral corticosteroids. Cases of eosinophilic pneumonia and of vasculitis consistent with eosinophilic granulomatosis with polyangiitis have been reported in adult patients who participated in the asthma 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.

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:

Atopic Dermatitis: The most common adverse reactions (incidence ≥1%) are injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, and dry eye.
Asthma: The most common adverse reactions (incidence ≥1%) 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: 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.

Indications

Atopic Dermatitis: DUPIXENT is indicated for the treatment of adult patients 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.

Asthma: 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.

Dosing & Administration

DUPIXENT can be administered at home

Recommended dosing

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