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ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS › IMMUNOSUPPRESSANTS › IMMUNOSUPPRESSANTS › Interleukin inhibitors
levilimab
L04AC25
Forms & Strengths
- Subcutaneous injection: 160 mg / 1.14 mL in pre-filled syringe
Adult Dosing
- Moderate to severe rheumatoid arthritis: 160 mg subcutaneously once every 2 weeks (in combination with methotrexate or as monotherapy)
- Severe COVID-19 cytokine release syndrome: 160 mg single subcutaneous dose (may repeat if clinically indicated)
Pediatric Dosing
- Safety and efficacy in pediatric patients under 18 years of age have not been established
Indications
- Treatment of moderate to severe rheumatoid arthritis in adults who have had an inadequate response to disease-modifying antirheumatic drugs (DMARDs)
- Management of severe COVID-19 associated cytokine release syndrome
Mechanism of Action
- Recombinant humanized monoclonal antibody (IgG1) that acts as an interleukin-6 (IL-6) receptor antagonist
- Binds to both soluble and membrane-bound IL-6 receptors, inhibiting IL-6-mediated pro-inflammatory signaling pathways
Contraindications
- Hypersensitivity to levilimab or any of its excipients
- Active severe infections, including latent or active tuberculosis
- Severe hepatic impairment (ALT or AST > 5 times the upper limit of normal)
- Baseline absolute neutrophil count < 0.5 x 10^9/L or platelet count < 50 x 10^9/L
Adverse Reactions
- Upper respiratory tract infections and nasopharyngitis
- Elevated liver transaminases (ALT/AST)
- Neutropenia and leukopenia
- Hyperlipidemia (elevated LDL and total cholesterol)
- Injection site reactions
- Increased risk of serious bacterial, fungal, and viral infections
Drug Interactions
- CYP450 substrates: IL-6 downregulation can normalize CYP450 enzyme activity, potentially decreasing exposure of co-administered CYP substrates (e.g., warfarin, atorvastatin, oral contraceptives)
- Live vaccines: Avoid concomitant administration during levilimab therapy
- Immunosuppressive agents: Increased risk of severe immunosuppression and infection when combined with other potent immunosuppressants or biologic DMARDs
Curated Content: Needs Vetting Before Put to Clinical Use