dosage and administration

You decide: Patients administer at home or you administer in office1

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 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 pediatric patients 12 years of age and older, it is recommended that DUPIXENT be administered 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 appropriate Instructions for Use

Dosing for Adults/Pediatric Patients (12+ Years) With 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 or adults with comorbid chronic rhinosinusitis with nasal polyposis1

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.

Dosing for Pediatric Patients (6-11 Years) With Moderate-to-Severe Asthma1

30 kg
or
morec

200 mg
1 pre-filled syringe
Every 2 weeks

15 kg
to
<30 kgd

Every 2 weeks
100 mge
1 pre-filled syringe
Or
Every 4 weeks
300 mg
1 pre-filled syringe

No loading dose.
For pediatric patients (6‑11 years) with asthma and comorbid moderate-to-severe atopic dermatitis, follow the recommended dosage for atopic dermatitis, which includes an initial loading dose.

c30 kg is equal to 66 lb.
d15 kg is equal to 33 lb.
e100 mg=0.67 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 - 100 mg
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
  • 30 minutes for the 100 mg/0.67 mL pre-filled syringe

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

References:

  1. DUPIXENT Prescribing Information.
  2. DUPIXENT 200 mg/300 mg Pre-filled Pen Instructions for Use.
  3. DUPIXENT 100 mg/200 mg/300 mg Pre-filled Syringe Instructions for Use.

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 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.

Conjunctivitis and Keratitis: Conjunctivitis and keratitis occurred more frequently in atopic dermatitis subjects who received DUPIXENT compared to those who received placebo, with conjunctivitis being the most frequently reported eye disorder. Conjunctivitis also occurred more frequently in chronic rhinosinusitis with nasal polyposis subjects who received DUPIXENT compared to those who received placebo. Conjunctivitis and keratitis have been reported with DUPIXENT in postmarketing settings, predominantly in atopic dermatitis patients. Some patients reported visual disturbances (e.g. blurred vision) associated with conjunctivitis or keratitis. Advise patients to report new onset or worsening eye symptoms to their healthcare provider. Consider ophthalmological examination for patients who develop conjunctivitis that does not resolve following standard treatment or signs and symptoms suggestive of keratitis, as appropriate.

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 CRSwNP 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.

Patients with Co-morbid Asthma: Advise patients with atopic dermatitis or CRSwNP who have co-morbid asthma not to adjust or stop their asthma treatments without consultation with their physicians.

Arthralgia: Arthralgia has been reported with the 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 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:

  • Atopic dermatitis: The most common adverse reactions (incidence ≥1% at Week 16) in adult patients are injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, and dry eye. The safety profile in children and adolescents through Week 16 was similar to that of adults with atopic dermatitis. In an open-label extension study, the long-term safety profile of DUPIXENT in adolescents and children observed through Week 52 was consistent with that seen in adults with atopic dermatitis.
  • Asthma: The most common adverse reactions (incidence ≥1%) are injection site reactions, oropharyngeal pain, and eosinophilia.
  • Chronic rhinosinusitis with nasal polyposis: The most common adverse reactions (incidence ≥1%) are injection site reactions, eosinophilia, insomnia, toothache, gastritis, arthralgia, and conjunctivitis.

USE IN SPECIFIC POPULATIONS

  • 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.

Indications

Asthma: 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.

Chronic rhinosinusitis with nasal polyposis (CRSwNP): DUPIXENT is indicated as an add-on maintenance treatment in adult patients with inadequately controlled CRSwNP.

Atopic Dermatitis: DUPIXENT is indicated for the treatment of adult and pediatric patients aged 6 years and older 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.