Poor
Not Aligned
Patient Risk:
Moderate
Summary
Several vaccine-related claims are not supported by the provided label excerpts (e.g., flu/shingles/MMR being specifically live-attenuated, vaccination-related symptom/risk statements, and explicit post-vaccination timing). Some general guidance on avoiding live vaccines during COSENTYX treatment is supported.
Category Scores
Accurate Statements
Cosentyx works by blocking the action of interleukin-17A (IL-17A).
12.1 Mechanism of Action: secukinumab binds IL-17A and inhibits its interaction with the IL-17 receptor.
Cosentyx may increase the risk of infections.
5.1 Infections: COSENTYX may increase the risk of infections; higher infection rates vs placebo.
COSENTYX may alter a patient's immune response to live vaccines.
5.7 Immunizations: COSENTYX may alter immune response to live vaccines.
Avoid use of live vaccines in patients treated with COSENTYX.
5.7 Immunizations: Avoid use of live vaccines in patients treated with COSENTYX.
Cosentyx patients should inform the healthcare practitioner that they are taking COSENTYX prior to a potential vaccination.
17 Patient Counseling Information under Immunization: instruct patients to inform the healthcare practitioner that they are taking COSENTYX prior to a potential vaccination.
Unsupported Statements
The flu vaccine is a live, attenuated vaccine.
No supporting content for identifying a specific flu vaccine type appears in the provided label excerpts.
Receiving the flu vaccine can increase the risk of flu-like symptoms in Cosentyx users.
No such vaccine-specific symptom or risk statement appears in the provided label excerpts.
The shingles vaccine (Zostavax) is a live, attenuated vaccine.
No label excerpt provided that identifies Zostavax (or shingles vaccine) as live, attenuated.
Receiving the shingles vaccine can increase the risk of shingles in Cosentyx users.
No label excerpt provided describing increased shingles risk after vaccination in COSENTYX-treated patients.
The MMR vaccine is a live, attenuated vaccine.
No label excerpt provided identifying MMR as live, attenuated.
Receiving the MMR vaccine can increase the risk of measles, mumps, and rubella in Cosentyx users.
No label excerpt provided describing such risks after vaccination in COSENTYX-treated patients.
Inactivated vaccines are safe for Cosentyx users.
The provided label excerpts explicitly address avoiding live vaccines; they do not explicitly state inactivated vaccines are safe.
Inactivated vaccines such as the pneumococcal conjugate vaccine are safe for Cosentyx users.
No pneumococcal conjugate vaccine discussion is present in the provided label excerpts.
Inactivated vaccines such as the HPV vaccine are safe for Cosentyx users.
No HPV vaccine discussion is present in the provided label excerpts.
Subunit vaccines are safe for Cosentyx users.
No subunit vaccine safety statement is present in the provided label excerpts.
Subunit vaccines such as the hepatitis B vaccine are safe for Cosentyx users.
No hepatitis B vaccine or subunit vaccine safety statement is present in the provided label excerpts.
Cosentyx users should wait at least 4 weeks after receiving a vaccine before taking Cosentyx.
No dosing-vaccination timing interval (e.g., 4 weeks) is stated in the provided label excerpts.
Cosentyx users should monitor for side effects after receiving a vaccine.
The provided label excerpt on immunization guidance does not include post-vaccination side-effect monitoring instructions.
Cosentyx users should report side effects to their doctor.
The provided label excerpt on immunization does not specifically tie side-effect reporting to vaccination.
Contradictions
Important Omissions
Live vaccine avoidance is supported, but the AI claims identify specific vaccines (flu/shingles/MMR) and specific adverse outcomes; the label excerpt only provides general live vaccine avoidance and immune response alteration. The AI did not reflect the label’s lack of specificity about particular vaccine products or named risks.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Moderate
Unsupported specificity (named vaccines, vaccine-specific risks, and inactivated/subunit vaccine safety declarations) could mislead decision-making beyond the label excerpt. However, the core instruction to avoid live vaccines during COSENTYX treatment is supported.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Medium |
Recommendation
Not Aligned
Primary Issue
Multiple vaccine-type and vaccine-outcome claims are not supported by the provided label excerpts, including explicit identification of flu/shingles/MMR as live-attenuated and specific post-vaccination risk or symptom statements, plus an unsupported 4-week timing interval and unsupported statements about inactivated/subunit vaccine safety.
Suggested Improvement
Restrict vaccine counseling to label-supported statements provided here: consider completion of age-appropriate immunizations prior to initiating therapy; COSENTYX may alter immune response to live vaccines; avoid use of live vaccines in patients treated with COSENTYX; instruct patients to inform the healthcare practitioner they are taking COSENTYX prior to potential vaccination; and follow label infection precautions (seek medical advice for infection signs).