Partial
Partially Aligned
Patient Risk:
Moderate
Summary
Some statements are supported (e.g., TB contraindication/precautions, hypersensitivity reactions, live vaccine avoidance, limited pregnancy/lactation data), but there are multiple unsupported/over-specific claims (e.g., infection types and malignancy risk, breastfeeding/pregnancy 'caution' framing) and potential omissions/inaccurate generalizations (e.g., routine CBC/LFT monitoring not supported).
Category Scores
Accurate Statements
Cosentyx is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or any excipients in COSENTYX.
Label section 4 (CONTRAINDICATIONS): 'previous serious hypersensitivity reaction to secukinumab or any excipients'; and 5.2 notes serious hypersensitivity (anaphylaxis/angioedema/urticaria).
Cosentyx should not be initiated in patients with active TB infection; latent TB treatment should be initiated prior to starting COSENTYX.
Label section 2.1 (Testing and Procedures Prior to Treatment Initiation): 'Evaluate for active or latent tuberculosis… not recommended in patients with active TB infection… Initiate treatment of latent TB prior to initiation.'
Cosentyx may increase the risk of infections.
Label section 5.1 (Infections): 'COSENTYX may increase the risk of infections… including… opportunistic infections… some fatal infections.'
Cosentyx may cause serious hypersensitivity reactions including anaphylaxis, angioedema, and urticaria.
Label section 5.2 (Hypersensitivity Reactions): 'Serious hypersensitivity reactions including anaphylaxis, angioedema, and urticaria.' and 4 notes reports of anaphylaxis/angioedema.
Avoid use of live vaccines in patients treated with COSENTYX.
Label section 5.7 (Immunizations): 'Avoid use of live vaccines in patients treated with COSENTYX.'
Patients should report symptoms of infections or allergic reactions while taking Cosentyx.
Supported indirectly by label safety instructions: 5.1 (monitor for signs/symptoms of active TB during and after; discontinue for serious infection), 5.2 (immediately discontinue for anaphylactic/serious allergic reaction). (No exact 'report' phrasing found in provided excerpts, but label includes monitoring/response instructions for infections and serious allergic reactions.)
There is limited available human data regarding pregnancy.
Label section 8.1 (Pregnancy): 'Limited available human data… insufficient…'
There is limited information on the use of Cosentyx in breastfeeding women.
Label section 8.2 (Lactation): 'It is not known whether secukinumab is excreted in human milk…'
The safety and efficacy of Cosentyx in children have not been established.
Partially supported: label section 8.4 (Pediatric Use) states safety/effectiveness established for multiple indications with age/weight constraints; however some pediatric age groups/indications are not established (not fully specified in excerpts).
Cosentyx may cause injection site reactions.
Supported generally: label section 6 includes skin/subcutaneous adverse reactions; however the provided excerpts do not explicitly say 'injection site reactions' in the lines shown.
Unsupported Statements
Cosentyx is contraindicated in patients with latent or active tuberculosis.
Label states evaluation prior to treatment and 'not recommended in patients with active TB infection' and 'Initiate treatment of latent TB prior to initiation' (section 2.1) and 'Avoid in active TB infection' (5.3). The provided label excerpts do not state 'contraindicated' for latent TB specifically.
Cosentyx may increase the risk of reactivating latent or active tuberculosis.
Provided label excerpts include 'Monitor for signs/symptoms of active TB during and after' and latent TB treatment prior to initiation, but do not explicitly state a risk of reactivation of latent or active TB.
Patients with a history of tuberculosis should be evaluated and treated before starting Cosentyx.
Label requires evaluating for active or latent TB and initiating treatment of latent TB prior to starting, but does not explicitly state 'history of tuberculosis' phrasing (provided excerpts do not include that wording).
Cosentyx should be used with caution during pregnancy.
Label pregnancy excerpt provided says limited data/insufficient; it does not explicitly state 'use with caution during pregnancy.'
Cosentyx should be used with caution during breastfeeding.
Label lactation excerpt provided says 'not known whether secukinumab is excreted in human milk' but does not explicitly state 'use with caution during breastfeeding.'
Cosentyx may increase the risk of infections, including upper respiratory tract infections.
Label 5.1 indicates increased risk of infections generally; provided excerpts do not specifically list upper respiratory tract infections as an example.
Cosentyx may increase the risk of infections, including bronchitis.
Provided excerpts do not specifically identify bronchitis as an infection example.
Cosentyx may increase the risk of infections, including urinary tract infections.
Provided excerpts do not specifically identify urinary tract infections as an infection example.
There is a potential increased risk of malignancies, including lymphoma, associated with Cosentyx.
No malignancy/lymphoma risk language appears in the provided label excerpts (sections reviewed do not mention malignancy).
There is a potential increased risk of malignancies, including skin cancer, associated with Cosentyx.
No malignancy/skin cancer risk language appears in the provided label excerpts.
Avoiding live vaccines while taking Cosentyx is recommended because it may reduce vaccine effectiveness.
Label excerpt 5.7 says avoid live vaccines but does not state a rationale about reducing vaccine effectiveness.
Cosentyx may increase the risk of infections when used with immunosuppressants.
Label excerpts provided discuss infections generally and caution/discontinue for serious infections, but do not provide specific interaction language about immunosuppressants increasing infection risk.
Patients taking other biologics, such as TNF inhibitors, may have increased risks of infections and other adverse effects when taking Cosentyx.
Provided drug interaction section (7) excerpt is about CYP450 substrate monitoring; no TNF inhibitor co-therapy infection/adverse effect interaction language appears in the provided excerpts.
Patients should adhere to the recommended dosing schedule and administration instructions for Cosentyx.
General adherence advice is not explicitly stated in the provided label excerpts. While administration instructions exist, the claim is generic rather than label-referenced.
Patients may need regular laboratory tests, including complete blood counts, to monitor for potential side effects with Cosentyx.
Provided label excerpts do not mention routine CBC monitoring.
Patients may need regular laboratory tests, including liver function tests, to monitor for potential side effects with Cosentyx.
Provided label excerpts do not mention routine liver function test monitoring.
Cosentyx may cause injection site reactions.
The provided excerpts include 'Skin/subcutaneous' adverse reactions and 'eczema/eceematous eruptions' but do not explicitly confirm injection site reactions wording.
The most common side effects of Cosentyx include upper respiratory tract infections.
The provided excerpts do not list 'most common' side effects or specific frequency comparisons.
The most common side effects of Cosentyx include fatigue.
The provided excerpts do not list fatigue as a most common side effect or provide frequency data.
Contradictions
Low
AI Statement
Cosentyx is contraindicated in patients with latent or active tuberculosis.
Label Reference
Label 2.1 and 5.3 describe 'not recommended/avoid in active TB' and 'initiate treatment of latent TB prior to initiation,' not 'contraindicated' for latent TB.
Important Omissions
IV vs subcutaneous administration limitations (e.g., IV infusion only by healthcare professional; IV regimen in adults with specific indications; pediatric self-administration restrictions).
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Moderate
Overstated contraindication for latent TB and unsupported infection/malignancy specificity could mislead risk framing; however, major contraindication/warning themes (serious hypersensitivity, active TB avoidance, live vaccine avoidance) are generally aligned.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Medium |
Recommendation
Partially Aligned
Primary Issue
Several safety claims are either unsupported by the provided label excerpts (e.g., TB reactivation risk language, specific infection types, malignancy risk, 'caution' in pregnancy/lactation, routine CBC/LFT monitoring, rationale for live vaccines) or overreach (latent TB labeled as contraindicated).
Suggested Improvement
Restrict TB statements to label-supported language (active TB avoidance/not recommended and latent TB treatment prior to initiation; include monitoring). Remove unsupported specifics (infection subtypes, malignancy/lymphoma/skin cancer, routine CBC/LFT monitoring, vaccine effectiveness rationale) unless directly supported in the provided label text. Align pregnancy/lactation wording to 'limited/insufficient data' without adding explicit 'use with caution' unless present in the label.