DUPIXENT
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DUPIXENT (DUPIXENT).
Dupilumab is a fully human monoclonal antibody that binds to the alpha subunit of the interleukin-4 receptor (IL-4Rα), inhibiting signaling of both IL-4 and IL-13, key cytokines in type 2 inflammation.
| Metabolism | Dupilumab is a monoclonal antibody, degraded into small peptides and amino acids via general protein catabolism; not metabolized by cytochrome P450 enzymes. |
| Excretion | Dupilumab is degraded into small peptides and amino acids via general protein catabolism; no specific elimination studies conducted. No renal or biliary excretion of intact antibody. |
| Half-life | 26.6 days (range 21-31 days) in patients; supports every 2-4 week dosing. |
| Protein binding | Monoclonal antibody; not bound to specific serum proteins; negligible protein binding. |
| Volume of Distribution | 4.4 L (0.06 L/kg) in typical 70 kg adult; indicates limited extravascular distribution consistent with a large antibody. |
| Bioavailability | Subcutaneous: 64% (range 59-71%). |
| Onset of Action | Subcutaneous: Clinical improvement in atopic dermatitis and asthma signs/symptoms observed as early as 2 weeks after first dose. |
| Duration of Action | Sustained effect over 16 weeks; dosing interval 2-4 weeks maintains therapeutic concentrations. |
600 mg subcutaneously initially, then 300 mg every 2 weeks for adults with moderate-to-severe atopic dermatitis; 300 mg every 2 weeks for adults with asthma or chronic rhinosinusitis with nasal polyposis.
| Dosage form | INJECTABLE |
| Renal impairment | No dosage adjustment required for any degree of renal impairment, including end-stage renal disease. |
| Liver impairment | No dosage adjustment required for mild to moderate hepatic impairment (Child-Pugh A or B); not studied in severe hepatic impairment (Child-Pugh C). |
| Pediatric use | Age 6 months to <6 years: 200 mg subcutaneously if weight 5-<15 kg, 300 mg if 15-<30 kg on day 1, then 200 mg every 4 weeks (5-<15 kg) or 300 mg every 4 weeks (15-<30 kg). Age 6 to <18 years: 300 mg day 1, then 300 mg every 4 weeks (weight 15-<60 kg) or 300 mg every 2 weeks (weight ≥60 kg) for atopic dermatitis; for asthma age ≥6 years: weight <30 kg: 200 mg every 2 weeks; weight ≥30 kg: 300 mg every 2 weeks. |
| Geriatric use | No specific dose adjustment recommended; limited data in patients ≥65 years, but no evidence of altered pharmacokinetics or safety based on age. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DUPIXENT (DUPIXENT).
| Breastfeeding | It is unknown whether dupilumab is excreted in human milk. Human IgG is present in breast milk, but the extent of absorption by the infant is limited. The M/P ratio is not established. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for dupilumab and any potential adverse effects on the breastfed child from the drug or underlying maternal condition. |
| Teratogenic Risk | Dupilumab is a human monoclonal IgG4 antibody. IgG molecules are actively transported across the placenta during the third trimester. No adequate and well-controlled studies exist in pregnant women. In animal studies, no evidence of fetal harm was observed in cynomolgus monkeys at exposures up to 100 times the maximum recommended human dose. However, due to the potential for placental transfer in the third trimester, fetal risk cannot be excluded. |
■ FDA Black Box Warning
No black box warning.
| Serious Effects |
["Known hypersensitivity to dupilumab or any excipients"]
| Precautions | ["Hypersensitivity reactions (serious)","Conjunctivitis and keratitis","Eosinophilic conditions (eosinophilic pneumonia, vasculitis)","Parasitic (helminth) infections: treat before initiation","Do not discontinue systemic or inhaled corticosteroids abruptly","Vaccination: avoid live vaccines during treatment"] |
| Food/Dietary | No food interactions have been identified. |
| Clinical Pearls |
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| Fetal Monitoring | No specific fetal monitoring required. Monitor maternal response to therapy and for potential infections. Pregnancy registries are recommended to collect data on outcomes. |
| Fertility Effects | No human data on fertility effects. Animal studies in cynomolgus monkeys showed no effects on fertility or reproductive function at exposures up to 100 times the MRHD. |
| Dupilumab is a fully human monoclonal antibody that blocks IL-4 and IL-13 signaling. It is administered subcutaneously. Live vaccines should not be given concurrently. Monitor for injection site reactions, conjunctivitis, and eosinophilia. In atopic dermatitis, assess for facial redness or worsening eczema. In asthma, evaluate for new-onset or worsening eosinophilic conditions. Dose adjustments not required for renal or hepatic impairment. |
| Patient Advice | Do not use if you have an allergy to dupilumab or any ingredients. · Inform your doctor if you have a parasitic infection or are on immunosuppressants. · Seek medical attention for signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing). · Rotate injection sites and do not inject into tender, bruised, or scarred skin. · Report new or worsening eye symptoms (redness, itching, swelling). · Avoid live vaccines during treatment. · Store in refrigerator at 2-8°C; do not freeze. Protect from light. · If a dose is missed, administer within 7 days; otherwise skip and resume regular schedule. |