Formulary
Dupilumab: Indications, Dosing, Side Effects and Interactions
Dupilumab is a recombinant human monoclonal antibody that inhibits interleukin-4 and interleukin-13 signaling.
MedNext Academy | 6 min read
Dupilumab: Indications, Dosing, Side Effects and Interactions
Dupilumab is a recombinant human monoclonal antibody that inhibits interleukin-4 and interleukin-13 signaling.
Drug action
Dupilumab is a recombinant human monoclonal antibody that inhibits interleukin-4 and interleukin-13 signaling.
Indications and dose
**Moderate-to-severe atopic eczema (initiated by a specialist)**
- **Adult** (By Subcutaneous Injection): Initially 600 mg, to be administered as two consecutive 300 mg injections at different injection sites, followed by 300 mg every 2 weeks, review treatment if no response after 16 weeks.
**Severe asthma with type 2 inflammation [add-on maintenance therapy] (initiated by a specialist)**
- **Adult** (By Subcutaneous Injection): Initially 400 mg, to be administered as two consecutive 200 mg injections at different injection sites, followed by 200 mg every 2 weeks, review need for treatment yearly.
**Severe asthma with type 2 inflammation [add-on maintenance therapy**
- **Adult** (By Subcutaneous Injection): for patients currently treated with oral corticosteroids or patients with co-morbid moderate-to-severe atopic eczema or patients with co-morbid severe chronic rhinosinusitis with nasal polyps] (initiated by a specialist) Initially 600 mg, to be administered as two consecutive 300 mg injections at different injection sites, followed by 300 mg every 2 weeks, review need for treatment yearly.
**Uncontrolled chronic obstructive pulmonary disease [add-on maintenance therapy] (initiated by a specialist)**
- **Adult** (By Subcutaneous Injection): 300 mg every 2 weeks, review treatment if no response after 52 weeks.
**Severe chronic rhinosinusitis with nasal polyps [add-on therapy] (initiated by a specialist)**
- **Adult** (By Subcutaneous Injection): Initially 300 mg, followed by 300 mg every 2 weeks, review treatment if no response after 24 weeks.
**Eosinophilic oesophagitis (initiated by a specialist)**
- **Adult** (By Subcutaneous Injection): (body-weight 40 kg and above) 300 mg once weekly.
**Moderate-to-severe prurigo nodularis (initiated by a specialist)**
- **Adult** (By Subcutaneous Injection): Initially 600 mg, to be administered as two consecutive 300 mg injections at different injection sites, followed by 300 mg every 2 weeks, review treatment if no response after 24 weeks.
**Moderate-to-severe atopic eczema (initiated by a specialist) for dupilumab**
- **Child 12-17 years (body-weight 15-59 kg)** (By subcutaneous injection): Initially 400 mg, to be administered as two consecutive 200 mg injections at different injection sites, followed by 200 mg every 2 weeks, review treatment if no response after 16 weeks.
- **Child 12-17 years (body-weight 60 kg and above)** (By subcutaneous injection): Initially 600 mg, to be administered as two consecutive 300 mg injections at different injection sites, followed by 300 mg every 2 weeks, review treatment if no response after 16 weeks.
**Severe atopic eczema (initiated by a specialist) for dupilumab**
- **Child 6 months-5 years (body-weight 5-14 kg)** (By subcutaneous injection): Initially 200 mg, followed by 200 mg every 4 weeks, review treatment if no response after 16 weeks.
- **Child 6 months-5 years (body-weight 15-29 kg)** (By subcutaneous injection): Initially 300 mg, followed by 300 mg every 4 weeks, review treatment if no response after 16 weeks.
- **Child 6-11 years (body-weight 15-59 kg)** (By subcutaneous injection): Initially 300 mg on day 1, then 300 mg on day 15, followed by 300 mg every 4 weeks, dose may be increased to 200 mg every 2 weeks based on clinical judgement, review treatment if no response after 16 weeks.
- **Child 6-11 years (body-weight 60 kg and above)** (By subcutaneous injection): Initially 600 mg, to be administered as two consecutive 300 mg injections at different injection sites, followed by 300 mg every 2 weeks, review treatment if no response after 16 weeks.
**Severe asthma with type 2 inflammation [add-on maintenance therapy] (initiated by a specialist) for dupilumab**
- **Child 6-11 years (body-weight 15-29 kg)** (By subcutaneous injection): 100 mg every 2 weeks, review need for treatment yearly, alternatively 300 mg every 4 weeks, review need for treatment yearly.
- **Child 6-11 years (body-weight 30-59 kg)** (By subcutaneous injection): 200 mg every 2 weeks, review need for treatment yearly, alternatively 300 mg every 4 weeks, review need for treatment yearly.
- **Child 6-11 years (body-weight 60 kg and above)** (By subcutaneous injection): 200 mg every 2 weeks, review need for treatment yearly.
- **Child 12-17 years** (By subcutaneous injection): Initially 400 mg, to be administered as two consecutive 200 mg injections at different injection sites, followed by 200 mg every 2 weeks, review need for treatment yearly.
**Severe asthma with type 2 inflammation [add-on maintenance therapy for patients with co-morbid severe atopic eczema] (initiated by a specialist) for dupilumab**
- **Child 6-11 years (body-weight 15-59 kg)** (By subcutaneous injection): Initially 300 mg on day 1, then 300 mg on day 15, followed by 300 mg every 4 weeks, dose may be increased to 200 mg every 2 weeks based on clinical judgement, review need for treatment yearly.
- **Child 6-11 years (body-weight 60 kg and above)** (By subcutaneous injection): Initially 600 mg, to be administered as two consecutive 300 mg injections at different injection sites, followed by 300 mg every 2 weeks, review need for treatment yearly.
**Severe asthma with type 2 inflammation [add-on maintenance therapy for patients currently treated with oral corticosteroids or patients with co-morbid moderate-to-severe atopic eczema] (initiated by a specialist) for dupilumab**
- **Child 12-17 years** (By subcutaneous injection): Initially 600 mg, to be administered as two consecutive 300 mg injections at different injection sites, followed by 300 mg every 2 weeks, review need for treatment yearly.
**Eosinophilic oesophagitis (initiated by a specialist) for dupilumab**
- **Child 1-17 years (body-weight 15-29 kg)** (By subcutaneous injection): 200 mg every 2 weeks.
- **Child 1-17 years (body-weight 30-39 kg)** (By subcutaneous injection): 300 mg every 2 weeks.
- **Child 1-17 years (body-weight 40 kg and above)** (By subcutaneous injection): 300 mg once weekly.
Cautions
Helminth infection Cautions, further information Risk of infection Dupilumab may influence the immune response to helminth infections. Resolve pre-existing infection before initiating treatment; suspend treatment if resistant infection develops during therapy. Manufacturer advises patients should be brought up-to-date with live and live attenuated vaccines before initiating treatment.
Side effects
Common or very common Arthralgia; dry eye; eosinophilia; eye inflammation; eye pruritus; increased risk of infection Uncommon Angioedema; facial rash Rare or very rare Hypersensitivity Frequency not known Pneumonia eosinophilic; vasculitis Side-effects, further information Eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome) Churg-Strauss syndrome has occurred in adult patients given dupilumab; the reaction may be associated with the reduction of oral corticosteroid therapy. Churg-Strauss syndrome can present as vasculitic rash, cardiac complications, worsening pulmonary symptoms, or peripheral neuropathy in patients with eosinophilia. Hypersensitivity Anaphylactic reactions and angioedema have occurred from minutes to up to seven days after the dupilumab injection.
Interactions
**Severe interactions:**
- Based on the population analysis, commonly co-administered medicinal products had no effect on dupilumab pharmacokinetics on patients with moderate to severe asthma.
**Other interactions (6):**
- Immune responses to vaccination were assessed in a study in which patients with atopic dermatitis were treated once weekly for 16 weeks with 300 mg of dupilumab.
- After 12 weeks of dupilumab administration, patients were vaccinated with a Tdap vaccine (T cell-dependent), and a meningococcal polysaccharide vaccine (T cell-independent) and immune responses were...
- No adverse interactions between either of the non-live vaccines and dupilumab were noted in the study.
- Therefore, patients receiving dupilumab may receive concurrent inactivated or non-live vaccinations.
- In a clinical study of atopic dermatitis patients, the effects of dupilumab on the pharmacokinetics (PK) of CYP substrates were evaluated.
- The data gathered from this study did not indicate clinically relevant effects of dupilumab on CYP1A2, CYP3A, CYP2C19, CYP2D6, or CYP2C9 activity.
Pregnancy
Manufacturer advises use only if potential benefit outweighs risk-limited information available.
Breast feeding
Manufacturer advises avoid-no information available.
Medicinal forms
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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