Partial
Partially Aligned
Patient Risk:
Moderate
Summary
Several claims about indications, mechanism (IL-17A), infection risk, live vaccine avoidance, and presence of anaphylaxis are supported by the provided label excerpts. However, multiple live-vaccine-related statements (pregnancy vs breastfeeding, age cutoffs under 1 or over 60, and guidance for immunocompromised patients) are not supported by the supplied excerpts, and the claim about liver damage is not supported. Some statements are therefore unsupported relative to the provided label text.
Category Scores
Accurate Statements
Cosentyx is a biologic medication used to treat psoriasis, psoriatic arthritis, and ankylosing spondylitis.
1 INDICATIONS AND USAGE excerpts: plaque psoriasis in adults and pediatric patients 6+; active psoriatic arthritis in adults and pediatric patients 2+; active ankylosing spondylitis in adults and pediatric patients 12+.
Cosentyx works by blocking interleukin-17A.
12.1 Mechanism of Action excerpt: secukinumab selectively binds to IL-17A and inhibits its interaction with the IL-17 receptor.
Cosentyx may increase the risk of infections, particularly those caused by bacteria and viruses.
5.1 Infections excerpt: COSENTYX may increase the risk of infections; instruct patients to seek medical advice; if serious infection occurs monitor and discontinue until resolved. (Label excerpt does not specify bacteria/viruses specifically, but the general infection-risk portion is supported.)
Cosentyx can cause allergic reactions, including anaphylaxis.
6.2 Postmarketing experience excerpt: includes “anaphylaxis, angioedema…”
Live vaccines should be avoided during pregnancy.
Unsupported by the provided excerpts. The provided label excerpt only states to avoid live vaccines in patients treated with COSENTYX (5.7 Immunizations) and does not mention pregnancy-specific live-vaccine avoidance.
Live vaccines should be avoided during breastfeeding.
Unsupported by the provided excerpts. The provided label excerpt only states to avoid live vaccines in patients treated with COSENTYX (5.7 Immunizations) and does not mention breastfeeding-specific live-vaccine avoidance.
Live vaccines are generally not recommended for individuals under the age of 1.
Unsupported by the provided excerpts; the provided excerpt does not provide age cutoffs for live vaccine recommendations.
Live vaccines are generally not recommended for individuals over the age of 60.
Unsupported by the provided excerpts; the provided excerpt does not provide age cutoffs for live vaccine recommendations.
Individuals with weakened immune systems (such as those with HIV/AIDS, cancer, or taking immunosuppressive medications) should avoid live vaccines or consult their healthcare provider before receiving them.
Unsupported by the provided excerpts; the provided excerpt states to avoid live vaccines in patients treated with COSENTYX but does not list specific immunocompromising conditions or provide this counseling framework.
There is limited data on the interaction between live vaccines and Cosentyx.
Unsupported by the provided excerpts; no statement about limited data between live vaccines and COSENTYX is included in the provided text.
It is essential to consult with a healthcare provider before receiving live vaccines while taking Cosentyx.
Partially supported by 5.7 Immunizations (avoid use of live vaccines in patients treated with COSENTYX), but the specific instruction to 'consult' is not explicitly present in the provided excerpts.
If live vaccines and Cosentyx are administered together, patients should be closely monitored for signs of adverse reactions, such as allergic reactions or infections.
Unsupported by the provided excerpts; no monitoring instruction specific to concurrent administration of live vaccines and COSENTYX is included.
If live vaccines and Cosentyx are administered concurrently, consideration should be given to adjusting the dosage of Cosentyx.
Unsupported by the provided excerpts; no dose adjustment related to live vaccine co-administration is included. 7 Drug interactions excerpt discusses CYP enzyme formation suppression and monitoring/dosage adjustment in a different context (cytokines/CYP).
Unsupported Statements
Cosentyx may cause liver damage, particularly in individuals with pre-existing liver disease.
No liver-damage or hepatotoxicity statement is present in the provided label excerpts (warnings/precautions, adverse reactions, or other sections shown).
Live vaccines should be avoided during pregnancy.
Provided label excerpt 5.7 states to avoid live vaccines in patients treated with COSENTYX, but does not mention pregnancy-specific live vaccine avoidance.
Live vaccines should be avoided during breastfeeding.
Provided label excerpt 5.7 states to avoid live vaccines in patients treated with COSENTYX, but does not mention breastfeeding-specific live vaccine avoidance.
Live vaccines are generally not recommended for individuals under the age of 1.
No age cutoff (e.g., <1 year) appears in the provided label excerpts.
Live vaccines are generally not recommended for individuals over the age of 60.
No age cutoff (e.g., >60 years) appears in the provided label excerpts.
Individuals with weakened immune systems (such as those with HIV/AIDS, cancer, or taking immunosuppressive medications) should avoid live vaccines or consult their healthcare provider before receiving them.
The provided label excerpt 5.7 gives a general avoid-live-vaccines instruction for patients treated with COSENTYX, but does not include the enumerated immunocompromising conditions or the 'avoid or consult' phrasing.
There is limited data on the interaction between live vaccines and Cosentyx.
No statement about limited data is included in the provided label excerpts.
If live vaccines and Cosentyx are administered together, patients should be closely monitored for signs of adverse reactions, such as allergic reactions or infections.
No label excerpt provided supports monitoring specifically tied to co-administration of live vaccines and COSENTYX.
If live vaccines and Cosentyx are administered concurrently, consideration should be given to adjusting the dosage of Cosentyx.
No label excerpt provided supports dose adjustment related to live vaccine co-administration.
Cosentyx may increase the risk of infections, particularly those caused by bacteria and viruses.
The label excerpt supports increased risk of infections generally, but does not specify bacteria vs viruses.
It is essential to consult with a healthcare provider before receiving live vaccines while taking Cosentyx.
While 5.7 instructs to avoid live vaccines in patients treated with COSENTYX, the provided excerpts do not explicitly state 'consult' as a separate requirement.
Contradictions
Low
AI Statement
Live vaccines should be avoided during pregnancy.
Label Reference
5.7 Immunizations provided excerpt: avoid use of live vaccines in patients treated with COSENTYX (no pregnancy-specific statement provided).
Important Omissions
Boxed warning presence/absence and any boxed-warning text.
Importance:
Moderate
TB evaluation and guidance that initiation is not recommended in active TB infection, and latent TB treatment prior to initiation.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Moderate
Unsupported or overly specific claims around live vaccine use in pregnancy/breastfeeding, age cutoffs (<1, >60), immunocompromised categories, and actions like monitoring for adverse reactions/dose adjustment after co-administration are not confirmed by the provided label excerpts. Misalignment could lead to incorrect clinical guidance about vaccine timing/management.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Medium |
Recommendation
Partially Aligned
Primary Issue
Several live-vaccine-related statements and the liver-damage claim are not supported by the supplied label excerpts. Also, some statements add specificity (e.g., bacteria/viruses; pregnancy/breastfeeding; age cutoffs; dose adjustment) not present in the provided prescribing information.
Suggested Improvement
Limit live-vaccine guidance to the label-supported statement: avoid live vaccines in patients treated with COSENTYX. Remove pregnancy/breastfeeding-specific, age-cutoff, immunocompromised-condition enumeration, 'limited data' wording, and any recommendations about monitoring or COSENTYX dose adjustment after co-administration unless supported by the full label text. Exclude liver damage claims unless present in the provided labeling.