dupilumab

REMS

Moderate to severe atopic dermatitis not controlled by other prescription therapies or when these therapies cannot be used (with or without topical corticosteroids).
Add-on maintenance treatment of moderate to severe asthma that is of an eosinophilic phenotype or that is dependent on oral corticosteroids.
Add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps.
Eosinophilic esophagitis.
Prurigo nodularis.
Patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype (as add-on maintenance treatment).

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Acute bronchospasm or status asthmaticus.

Use Cautiously in:

Pre-existing helminth infections;
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Safety and effectiveness not established in children <6 mo (atopic dermatitis), <1 yr (eosinophilic esophagitis), <6 yr (asthma), <12 yr (chronic rhinosinusitis with nasal polyps), or <18 yr (COPD or prurigo nodularis).

Adv. Reactions/Side Effects ⬆ ⬇

CV: vasculitis

EENT: conjunctivitis, keratitis

Hemat: eosinophilia

MS: arthralgia

Resp: eosinophilic pneumonia

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS), injection site reactions

Interactions ⬆ ⬇

Drug-drug:

Avoid use of live vaccines.

Availability ⬆ ⬇

Solution for injection (prefilled syringes or pens): 200 mg/1.14 mL; 300 mg/2 mL

Route/Dosage ⬆ ⬇

Atopic Dermatitis

SC (Adults and Children ≥6 yr and ≥60 kg): 600 mg (given as two 300-mg injections) initially; then 300 mg in 2 wk; then 300 mg every 2 wk.
SC (Children ≥6 yr and 30–<60 kg): 400 mg (given as two 200-mg injections) initially; then 200 mg in 2 wk; then 200 mg every 2 wk.
SC (Children ≥6 yr and 15–<30 kg): 600 mg (given as two 300-mg injections) initially; then 300 mg in 4 wk; then 300 mg every 4 wk.
SC (Children 6 mo–5 yr and 15–<30 kg): 300 mg every 4 wk.
SC (Children 6 mo–5 yr and 5–<15 kg): 200 mg every 4 wk.

Asthma

SC (Adults ): 400 mg (given as two 200-mg injections) initially; then 200 mg in 2 wk; then 200 mg every 2 wk or 600 mg (given as two 300-mg injections) initially; then 300 mg in 2 wk; then 300 mg every 2 wk. Patients with oral corticosteroid-dependent asthma, concomitant moderate to severe atopic dermatitis, or concomitant chronic rhinosinusitis with nasal polyps: 600 mg (given as two 300-mg injections) initially; then 300 mg in 2 wk; then 300 mg every 2 wk.
SC (Children ≥12 yr): 400 mg (given as two 200-mg injections) initially; then 200 mg in 2 wk; then 200 mg every 2 wk or 600 mg (given as two 300-mg injections) initially; then 300 mg in 2 wk; then 300 mg every 2 wk. Patients with oral corticosteroid-dependent asthma or concomitant moderate to severe atopic dermatitis: 600 mg (given as two 300-mg injections) initially; then 300 mg in 2 wk; then 300 mg every 2 wk.
SC (Children 6–11 yr and ≥30 kg): 200 mg every 2 wk. Patients with concomitant moderate to severe atopic dermatitis: 400 mg (given as two 200-mg injections) initially; then 200 mg in 2 wk; then 200 mg every 2 wk.
SC (Children 6–11 yr and 15–<30 kg): 300 mg every 4 wk. Patients with concomitant moderate to severe atopic dermatitis: 600 mg (given as two 300-mg injections) initially; then 300 mg in 4 wk; then 300 mg every 4 wk.

Chronic Rhinosinusitis with Nasal Polyps

SC (Adults and Children ≥12 yr): 300 mg every 2 wk.

Eosinophilic Esophagitis

SC (Adults and Children ≥1 yr and ≥40 kg): 300 mg every wk.
SC (Adults and Children ≥1 yr and 30–<40 kg): 300 mg every 2 wk.
SC (Adults and Children ≥1 yr and 15–<30 kg): 200 mg every 2 wk.

Prurigo Nodularis

SC (Adults ): 600 mg (given as two 300-mg injections) initially; then 300 mg in 2 wk; then 300 mg every 2 wk.

Chronic Obstructive Pulmonary Disease

SC (Adults ): 300 mg every 2 wk.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Monoclonal antibody that inhibits interleukin-4 (IL-4) and IL-13, which inhibits cytokine-induced inflammatory responses. Mechanism in asthma not fully established.

Therapeutic effects:

Decreased severity of atopic dermatitis.
Decreased incidence of asthma and COPD exacerbations.
Reduction in nasal polyps and nasal congestion.
Achievement of remission and reduction in dysphagia in eosinophilic esophagitis.
Reduction in itching associated with prurigo nodularis.

Classifications ⬆ ⬇

Therapeutic Classification: anti-inflammatories, antiasthmatics

Pharmacologic Classification: interleukin antagonists

Pharmacokinetics ⬆ ⬇

Absorption: 61–64% absorbed following SUBQ administration.

Distribution: Minimally distributed to tissues.

Metabolism/Excretion: Degraded by proteolytic enzymes located throughout the body.

Half-Life: Unknown.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
SUBQ	unknown	1 wk	unknown

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy. Instruct patient and caregiver in correct injection technique and disposal of equipment. If a weekly dose is missed, administer dose as soon as possible, and start a new weekly schedule from the date of the last administered dose. If every-other-wk dose is missed, administer as soon as remembered if within 7 days; then resume original schedule. If >7 days, skip dose and resume with next scheduled dose. If every-4-wk dose is missed, administer injection within 7 days from missed dose and resume original schedule. If missed dose is not administered within 7 days, administer dose and start a new schedule based on this date.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other Rx, OTC, or herbal products.
Inform patient that dupilumab is not used for acute asthma symptoms or acute COPD exacerbations. Instruct patient to notify health care professional if asthma/COPD symptoms remain uncontrolled or worsen after starting therapy.
Advise patient to notify health care professional if new onset or worsening eye symptoms occur.
Advise patient to avoid live vaccines during therapy.
Advise patient to have helminth infections treated before starting therapy. If patient becomes infected while receiving treatment with dupilumab and does not respond to antihelminth treatment, discontinue treatment with dupilumab until infection resolves.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Inform patient of pregnancy exposure registry that monitors pregnancy outcomes in women exposed to dupilumab during pregnancy. Health care professionals and patients may call 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/ to enroll in or to obtain information about the registry.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

0024- sanofi-aventis U.S. LLC
- 0024-5914- Dupixent
  - 0024-5914-01- 2 SYRINGE, GLASS in 1 CARTON (0024-5914-01) > 2 mL in 1 SYRINGE, GLASS

0024- sanofi-aventis U.S. LLC
- 0024-5914- Dupixent
  - 0024-5914-02- 2 SYRINGE, GLASS in 1 CARTON (0024-5914-02) > 2 mL in 1 SYRINGE, GLASS

0024- sanofi-aventis U.S. LLC
- 0024-5916- Dupixent
  - 0024-5916-01- 2 SYRINGE, GLASS in 1 CARTON (0024-5916-01) > 2 mL in 1 SYRINGE, GLASS

0024- sanofi-aventis U.S. LLC
- 0024-5918- Dupixent
  - 0024-5918-01- 2 SYRINGE, GLASS in 1 CARTON (0024-5918-01) > 1.14 mL in 1 SYRINGE, GLASS

0024- sanofi-aventis U.S. LLC
- 0024-5918- Dupixent
  - 0024-5918-02- 2 SYRINGE, GLASS in 1 CARTON (0024-5918-02) > 1.14 mL in 1 SYRINGE, GLASS

section name header

Indications ⬇