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drugs_cystic_fibrosis [2026/08/03 10:53] – [Ocular Complications of Elexacaftor/Tezacaftor/Ivacaftor (Trikafta)] Scott Larsondrugs_cystic_fibrosis [2026/08/03 11:13] (current) – [References] Scott Larson
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   * this class of drugs regular transmembrane conductance   * this class of drugs regular transmembrane conductance
    
-==== Cataracts with Lumacaftor/Ivacaftor ====+==== Cataracts with Lumacaftor/Ivacaftor (Orkambi) ====
   * Cataracts were found in juvenile rats in pre-clinical toxicology studies   * Cataracts were found in juvenile rats in pre-clinical toxicology studies
   * Cataracts have been discovered in a few children taking this drug. The concomitant use of steroids or other pre-existing coniditions could not be excluded.    * Cataracts have been discovered in a few children taking this drug. The concomitant use of steroids or other pre-existing coniditions could not be excluded. 
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 ==== Practical Monitoring Approach ==== ==== Practical Monitoring Approach ====
 +<WRAP round box 85%>
 ^ Element ^ Recommendation ^ ^ Element ^ Recommendation ^
 | Baseline eye exam | Recommended in pediatric patients before/at initiation of ETI | | Baseline eye exam | Recommended in pediatric patients before/at initiation of ETI |
-| Follow-up exams | Follow-up ophthalmologic examinations recommended in pediatric patients; commonly operationalized as annual exams through age|+| Follow-up exams | Follow-up ophthalmologic examinations recommended in pediatric patients; yearly exams most common|
 | Adults | No routine screening exam mandated by label; evaluate symptom-driven| | Adults | No routine screening exam mandated by label; evaluate symptom-driven|
 | New headache or visual disturbance (any age) | Interrupt drug; urgent evaluation including fundoscopy for papilledema; consider vitamin A level | | New headache or visual disturbance (any age) | Interrupt drug; urgent evaluation including fundoscopy for papilledema; consider vitamin A level |
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 The recommended exam should include **slit-lamp assessment for lens opacities and fundoscopy**. The label does not specify a fixed interval beyond "baseline and follow-up"; annual examination during childhood is the convention derived from review guidance.[3] The recommended exam should include **slit-lamp assessment for lens opacities and fundoscopy**. The label does not specify a fixed interval beyond "baseline and follow-up"; annual examination during childhood is the convention derived from review guidance.[3]
 +</WRAP>
 =====References===== =====References=====
  
   - [[https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212273s004lbl.pdf|Trikafta. Food and Drug Administration. Updated date: 2026-06-22]]   - [[https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212273s004lbl.pdf|Trikafta. Food and Drug Administration. Updated date: 2026-06-22]]
   - [[https://www.nejm.org/doi/10.1056/NEJMra2216474|Cystic Fibrosis. Grasemann H, Ratjen F. The New England Journal of Medicine. 2023;389(18):1693-1707]]   - [[https://www.nejm.org/doi/10.1056/NEJMra2216474|Cystic Fibrosis. Grasemann H, Ratjen F. The New England Journal of Medicine. 2023;389(18):1693-1707]]
-  - Cystic Fibrosis. Ong T, Ramsey BW. JAMA. 2023;329(21):1859-1871. doi:10.1001/jama.2023.8120 +  - [[https://pubmed.ncbi.nlm.nih.gov/37278811/|Cystic Fibrosis. Ong T, Ramsey BW. JAMA. 2023;329(21):1859-1871]] 
-  - Heterogeneity in Reported Side Effects Following Initiation of Elexacaftor‐Tezacaftor‐Ivacaftor: Experiences at a Quaternary CF Care Center. Papadakis L, Stander T, Mombourquette J, et al. Pediatric Pulmonology. 2025;60(1):e27382. doi:10.1002/ppul.27382. +  - [[https://pubmed.ncbi.nlm.nih.gov/39503182/|Heterogeneity in Reported Side Effects Following Initiation of Elexacaftor‐Tezacaftor‐Ivacaftor: Experiences at a Quaternary CF Care Center. Papadakis L, Stander T, Mombourquette J, et al. Pediatric Pulmonology. 2025;60(1):e27382]] 
-  - [[https://www-bmj-com.proxy.lib.uiowa.edu/content/361/bmj.k1783|Review Article]]+  - [[https://pmc.ncbi.nlm.nih.gov/articles/PMC2137053/|Cystic Fibrosis. Davies JC et al. BMJ 2007;335(7632):1255–1259]]
  
 {{tag>drugs}} {{tag>drugs}}