COSENTYX
Clinical safety rating: caution
Comprehensive clinical and safety monograph for COSENTYX (COSENTYX).
Secukinumab is a human IgG1/κ monoclonal antibody that selectively binds to the interleukin-17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. This neutralizes the activity of IL-17A, a key pro-inflammatory cytokine involved in the pathogenesis of psoriasis, psoriatic arthritis, and ankylosing spondylitis.
| Metabolism | Secukinumab is a monoclonal antibody that is degraded into small peptides and amino acids via general protein catabolic pathways; no specific metabolic enzymes are involved. |
| Excretion | Secukinumab is degraded into small peptides and amino acids; no significant renal or biliary excretion of intact drug. Elimination is primarily via intracellular catabolism. |
| Half-life | Terminal elimination half-life approximately 27 days (range 18-46 days), supporting monthly subcutaneous dosing. |
| Protein binding | Approximately 90% bound to serum albumin; no specific binding proteins identified. |
| Volume of Distribution | Volume of distribution approximately 7-10 L, indicating limited extravascular distribution; not reported in L/kg. |
| Bioavailability | Subcutaneous administration: absolute bioavailability estimated at 60-80%. |
| Onset of Action | Clinical improvement in plaque psoriasis may be observed as early as 2 weeks after the first subcutaneous dose. |
| Duration of Action | Therapeutic effect persists for approximately 4-6 months after discontinuation, with gradual loss of response. Maintenance dosing every 4 weeks sustains efficacy. |
300 mg subcutaneously at weeks 0, 1, 2, 3, 4, then every 4 weeks. For psoriatic arthritis and ankylosing spondylitis, 150 mg subcutaneously at weeks 0, 1, 2, 3, 4, then every 4 weeks; may increase to 300 mg every 4 weeks if needed.
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment required for any degree of renal impairment, including end-stage renal disease. |
| Liver impairment | No dose adjustment required for mild to severe hepatic impairment (Child-Pugh A, B, C). |
| Pediatric use | For pediatric patients weighing ≥50 kg with moderate to severe plaque psoriasis: 300 mg subcutaneously at weeks 0, 1, 2, 3, 4, then every 4 weeks. For those <50 kg: 75 mg subcutaneously at weeks 0, 1, 2, 3, 4, then every 4 weeks. For pediatric enthesitis-related arthritis and juvenile psoriatic arthritis (≥2 years old, weight-based): 15 kg to <50 kg: 75 mg; ≥50 kg: 150 mg; administered subcutaneously at weeks 0, 1, 2, 3, 4, then every 4 weeks. |
| Geriatric use | No specific geriatric dose adjustment required; however, consider higher infection risk and monitor closely for adverse reactions. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for COSENTYX (COSENTYX).
| Breastfeeding | Safety in lactation: Unknown if secreted in human milk. Human IgG is present in breast milk; secukinumab is a human IgG1 monoclonal antibody. M/P ratio not established. Effects on nursing infant potential for immunosuppression. Use caution; consider developmental and health benefits of breastfeeding along with mother's clinical need. |
| Teratogenic Risk | Teratogenic risk: Limited human data; in animal studies, no evidence of teratogenicity at doses up to 30 mg/kg IV (maternal toxicity). First trimester: Insufficient data; theoretical risk of IgG transport across placenta minimal in early gestation. Second/third trimester: IgG1 monoclonal antibodies are actively transported across placenta; potential fetal exposure increases with gestational age. No known embryo-fetal toxicity. Use only if benefit outweighs risk. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Known serious hypersensitivity reaction to secukinumab or any of its excipients"]
| Precautions | ["Increased risk of serious infections (e.g., tuberculosis, invasive fungal infections, bacterial, viral, and opportunistic infections); screen for latent TB prior to initiation and during therapy","Exacerbation of inflammatory bowel disease (Crohn's disease, ulcerative colitis) has been reported; monitor for new or worsening symptoms","Hypersensitivity reactions including anaphylaxis and angioedema; discontinue if occurs","Avoid use with live vaccines; complete all age-appropriate vaccinations before starting therapy"] |
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| Fetal Monitoring | Monitor for maternal infections including tuberculosis reactivation. Assess fetal growth via ultrasound due to limited safety data. Monitor newborn for infections if exposed in utero; live vaccines contraindicated in infant for 5 months after last maternal dose. No specific fetal monitoring required beyond standard prenatal care. |
| Fertility Effects | No human data on fertility effects. In animal studies, no impairment of male or female fertility at doses up to 150 mg/kg SC. Clinical relevance unknown; theoretical potential for hormonal disruption not established. |