Dupixent
Dupixent
Generic Name
Dupixent
Mechanism
- Dupixent (dupilumab) is a fully human monoclonal antibody that binds the α‑subunit of the interleukin‑4 receptor (IL‑4Rα), blocking signaling of IL‑4 and IL‑13.
- Inhibition of these cytokines down‑regulates Th2‑mediated inflammation, central to the pathophysiology of atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, and eosinophilic esophagitis.
- Results in reduced IgE production, lower eosinophil recruitment, and improved epithelial barrier integrity.
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Pharmacokinetics
| Parameter | Typical Value (Adults) | Comments |
| Absorption | Subcutaneous; rapid absorption with peak serum concentration 3–5 days post‑dose. | Bioavailability ~80 % vs IV. |
| Volume of Distribution | ~14–20 L | Reflects binding to IL‑4Rα. |
| Half‑life | 13–15 days | Allows bi‑weekly or monthly dosing. |
| Clearance | 0.31 mL/day/kg | Linear; no accumulation with steady‑state dosing. |
| Metabolism | Proteolytic catabolism to peptides and amino acids. | Not a CYP substrate. |
| Excretion | Renal and biliary routes; minimal unchanged drug in urine. | Renal impairment does not alter exposure. |
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Indications
- Moderate‑to‑severe atopic dermatitis (AD) in adults and adolescents ≥12 y and in children ≥6 y (≥12 kg).
- Moderate‑to‑severe asthma with an eosinophilic phenotype or inadequate control on high‑dose inhaled corticosteroids + LABA.
- Chronic rhinosinusitis with nasal polyps (CRSwNP).
- Eosinophilic esophagitis (under review; pending label expansion).
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Contraindications
| Category | Key Points |
| Contraindications | Known hypersensitivity to dupilumab or excipients. |
| Warnings |
• Ophthalmic reactions (conjunctivitis, blepharitis). • Injection‑site reactions (pain, erythema, pruritus). • Hypersensitivity/anaphylaxis rare; severe reactions require immediate cessation. |
| Precautions |
• Concurrent biologics: avoid overlap due to immunosuppression. • Infections: monitor for bacterial, viral, and fungal infections. • Pregnancy/Lactation: Use only if clearly needed; limited safety data. |
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Dosing
| Indication | Loading Dose | Maintenance | Administration |
| Atopic Dermatitis | 600 mg (two 300 mg SC injections) | 300 mg SC every 2 weeks | Subcutaneous 30 mL syringe; pre‑filled pen or in‑house dispenser. |
| Asthma | 400 mg IV (single infusion) or 600 mg SC | 200 mg SC every 2 weeks (or 300 mg monthly if 200 mg suboptimal) | SC injection; no pre‑medication required. |
| CRSwNP | 300 mg SC | 300 mg SC every 2 weeks | SC route as above. |
• Route: Subcutaneous injection (30 min for SC).
• Administration timing: Non‑fasting or fasting does not affect absorption.
• Special populations: Dose adjustments unnecessary for renal or hepatic impairment; weight‑based dosing not required.
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Monitoring
| Parameter | Frequency | Rationale |
| Eczema Area Severity Index (EASI) / Paediatric EASI | Baseline, 4 wk, 12 wk, then quarterly | Assess therapeutic response. |
| Blood eosinophil count | Baseline, every 4–8 weeks | Detect eosinophil flare or rebound. |
| Serum IgE | Baseline, annually | Not clinically required but may guide asthma therapy. |
| Liver function tests | Baseline, annually | Rare hepatic complications. |
| Ophthalmologic exam | Baseline, 12 wk, as needed | Early detection of conjunctivitis. |
| Infection surveillance | Ongoing (pulmonary, sinus, urinary) | Detect opportunistic infections early. |
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Clinical Pearls
- Conjunctivitis as an Early Warning: Conjunctivitis frequently precedes injection‑site reactions; early ophthalmic assessment can prevent progression to vision‑threatening inflammation.
- Switching from Omalizumab to Dupixent in Severe Asthma: Rapidly improve eosinophilic asthma control when ≥ 400 cells/µL and inadequate on omalizumab; maintain asthma‑control score > 5 points at 12 wk.
- Weight‑based dosing not necessary: Unlike other biologics, dupilumab dosing is flat; pediatric dosing does not rely on weight categories.
- Drug‑Drug Interactions: Dupixent is not a CYP substrate or inducer; minimal interaction risk, allowing concurrent use with inhaled corticosteroids and LABAs without dose adjustment.
- Vaccinations: Live vaccines contraindicated during dupilumab therapy; inactivated vaccines safe. Consider pausing therapy for 1–2 weeks around high‑dose influenza vaccination if patient is immunocompromised.
- Tapering Strategy for Atopic Dermatitis: After sustained response (> 6 months), consider reducing dosing interval to monthly; monitor EASI, as 30–40 % of patients may relapse on monthly dosing.
- Patient Education: Emphasize self‑injection techniques, rotating sites, and prompt reporting of ocular symptoms; provide a contact hotline for acute ocular complaints.
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• *All information reflects current FDA‑approved labeling and major peer‑reviewed sources as of 2026. For patient‑specific decisions, always refer to the most recent prescribing information and institutional protocols.*