Dupilumab

Dupilumab uses moderate-to-severe atopic dermatitis, moderate-to-severe asthma, severe chronic rhinosinusitis with nasal polyps.

Dupilumab is available under the following different brand names: Dupixent.

Dosages of Dupilumab:

Adult and Pediatric Dosage Forms and Strengths

Solution for Injection

• 300 mg/2mL
• 200 mg/1.14mL
• Available as a single-dose prefilled syringe

Dosage Considerations – Should be Given as Follows:

Moderate-to-Severe Atopic Dermatitis

• Indicated when dermatitis is not adequately controlled with topical prescription therapies or when those therapies are not advisable
• Adults: 600 mg (i.e., two 300-mg injections) subcutaneously (SC) once, and then 300 mg SC every other week
• Can be used with or without topical corticosteroids

Children 12 years and older:

• 60 kg or greater: 600 mg (i.e., two 300-mg injections) SC once, and then 300 mg SC every other week
• Less than 60 kg: 400 mg (i.e., two 200-mg injections) SC once, and then 200 mg SC every other week
• It may be used with or without topical corticosteroids

Children under 12 years: Safety and efficacy not established.

Moderate-to-Severe Asthma

Indicated as add-on maintenance treatment for patients with an eosinophilic phenotype or orally corticosteroid dependent asthma/

Adults and children 12 years and older:

• 400 mg SC once, then 200 mg every 2 weeks, OR
• 600 mg SC once, then 300 mg every 2 weeks
• 600 mg initial, then 300 mg every 2 weeks for patients with orally corticosteroid-dependent asthma or comorbid moderate-to-severe atopic dermatitis (for which dupilumab is indicated)

Children under 12 years: Safety and efficacy not established

Severe Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

• Indicated as add-on maintenance treatment
• Adults: 300 mg SC every 2 Weeks

Dosing Considerations

• Topical calcineurin inhibitors may be used, for topical dermatitis, but should be reserved for problem areas only (e.g., face, neck, intertriginous, and genital areas)
• Not indicated for acute bronchospasm or status asthmaticus

Side effects of Dupilumab include:

• Injection site reactions
• Conjunctivitis
• Puffy eyelids
• Oral herpes
• Keratitis
• Immunogenicity, neutralizing
• Eye itching
• Other herpes simplex virus infection
• Dry eye
• Eosinophilia

Postmarketing side effects of dupilumab reported include:

• Chronic rhinosinusitis with nasal polyposis

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Serious interactions of dupilumab include::
  • adenovirus types 4 and 7 live, oral
  • BCG vaccine live
  • cholera vaccine
  • influenza virus vaccine quadrivalent, intranasal
  • measles mumps and rubella vaccine, live
  • smallpox (vaccinia) vaccine, live
  • typhoid polysaccharide vaccine
  • typhoid vaccine live
  • yellow fever vaccine
  • zoster vaccine live
• Moderate interactions of dupilumab include:
  • carbamazepine
  • clonidine
  • cyclosporine
  • dengue vaccine
  • disopyramide
  • fosphenytoin
  • phenobarbital
  • phenytoin
  • primidone
  • quinidine
  • quinine
  • sirolimus
  • tacrolimus
  • theophylline
  • valproic acid
  • warfarin

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

• This medication contains dupilumab. Do not take Dupixent if you are allergic to dupilumab or any ingredients contained in this drug.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Known hypersensitivity to dupilumab or its excipients

Effects of Drug Abuse

• No information is available.

Short-Term Effects

• See "What Are Side Effects Associated with Using Dupilumab?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Dupilumab?"

Cautions

• Hypersensitivity reactions, including anaphylaxis, generalized hives, rash, erythema nodosum, and serum sickness or serum sickness-like reactions, reported; if a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue dupilumab
• Conjunctivitis and keratitis were reported more frequently in the treatment group during clinical trials for atopic dermatitis and CRSwNP; however, when treating asthma, the incidence was similar to placebo
• Patients with asthma may present with serious systemic eosinophilia, including clinical features of eosinophilic pneumonia or vasculitis consistent with eosinophilic granulomatosis with polyangiitis; these events may be associated with reduction of PO corticosteroids; monitor for rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy in patients with eosinophilia
• Do not use to treat acute bronchospasm or status asthmaticus
• Do not abruptly discontinue corticosteroid therapy upon initiation; reduce corticosteroid doses gradually, if appropriate, under physician supervision
• Instruct patients with atopic dermatitis or CRSwNP who have comorbid asthma not to adjust or stop their asthma therapy without consulting their physician
• Patients with pre-existing helminth infections were excluded from clinical trials; treat infections before initiating; if the patient becomes infected and is unresponsive to anthelmintic, discontinue dupilumab until the infection resolves

Drug interaction overview

• Avoid coadministration with live vaccines
• CYP450 substrates
  • The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (e.g., interleukin [IL]-1, IL-6, IL-10, TNF-alpha, IFN) during chronic inflammation
  • Dupilumab may modulate serum levels of some cytokines
  • Therefore, upon initiating or discontinuing dupilumab in patients who are receiving concomitant drugs that are CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for effect (e.g., for warfarin) or drug concentration (e.g., for cyclosporine) and consider dosage modification of the CYP450 substrate

Pregnancy and Lactation

• Available data from case reports and case series on the use of dupilumab 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, dupilumab may be transmitted from mother to developing fetus. There are adverse effects on maternal and fetal outcomes associated with asthma in pregnancy. In women with poorly or moderately controlled asthma, evidence demonstrates there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. The level of asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control.
• There are no data on the presence of dupilumab in human milk, its effects on breastfed infants, or milk production. Maternal IgG is known to be present in human milk; its effects of local gastrointestinal exposure and limited systemic exposure to dupilumab on breastfed infants are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on a breastfed child from dupilumab or the underlying maternal condition.