DOSAGE and AdministRAtion

TYLER, AGE 14
LIVING WITH SEVERE AD SINCE INFANCY
Real patient being treated with DUPIXENT.
Individual results may vary.

DUPIXENT does not require initial lab testing or ongoing lab monitoring, according to the Prescribing Information1

Available in a 200 mg or 300 mg pre-filled pen
(for patients 12+ years of age) or pre-filled
syringe for subcutaneous injection

DUPIXENT is an injectable medicine that is administered by subcutaneous injection and is intended for use under the guidance of a healthcare provider.1
  • A patient 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 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
    • In children 6-11 years of age, the DUPIXENT pre-filled syringe should be given by a caregiver
  • 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 Instructions for Use—either 200 mg or 300 mg pre-filled pen or pre-filled syringe—prior to injecting
  • Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating treatment with DUPIXENT


One dose of DUPIXENT every 2 or 4 weeks (based on age and weight) after initial loading dose1

Adult patients (18+ years)1

One dosing regimen


Pediatric patients
(6-17 years)1,a

Weight-tiered dosing regimenb

aThe DUPIXENT 200 mg and 300 mg pre-filled pens are approved for patients aged 12+ years.

b15 kg is equal to 33 lb; 30 kg is equal to 66 lb; 60 kg is equal to 132 lb.

At-home or in-office administration options

Important administration instructions1

  • Patients and/or caregivers 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
  • It is important to rotate the injection site with each injection. DO NOT inject DUPIXENT into skin that is tender, damaged, bruised, or scarred
  • For the initial dose, patients and/or caregivers should administer each DUPIXENT injection at a different injection site
  • In adolescents 12 years of age and older, it is recommended that DUPIXENT be administered by or under the supervision of an adult. In children younger than 12 years of age, DUPIXENT should be administered by a caregiver

See the Instructions for Use for more detailed instructions on the preparation and administration of DUPIXENT

Outer
Upper Arms

Abdomen

Thighs

Injection by caregiver only

Self-injection or by caregiver

Preparation for use1

Before injection, instruct patients and/or caregivers to remove the DUPIXENT pre-filled pen or syringe 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 pen or syringe
  • 30 minutes for the 200 mg/1.14 mL pre-filled pen or syringe

Patients and/or caregivers should not use the pre-filled pen or syringe 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 pen or syringe in accordance with local requirements.

Dosage forms and strengths1

DUPIXENT is a clear to slightly opalescent, colorless to pale yellow solution available as:

  • Injection: 300 mg/2 mL in a single-dose, pre-filled pen with hidden needle or syringe with needle shield
  • Injection: 200 mg/1.14 mL in a single-dose, pre-filled pen with hidden needle or syringe with needle shield

How it's supplied1

DUPIXENT is available in cartons containing 2 pre-filled pens or syringes with needle shields. Each 300 mg pre-filled syringe or pre-filled pen delivers 300 mg/2 mL. Each 200 mg pre-filled syringe or pre-filled pen delivers 200 mg/1.14 mL.

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, pre-filled pens or syringes 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
  • The pen or syringe 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 expose to heat. Do NOT shake

Reference:

  1. DUPIXENT Prescribing Information.
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

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.

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.