OJEMDA: selected primary-label renal guidance and limits
What matters first
Product: OJEMDA for labeled BRAF-altered relapsed/refractory pediatric low-grade glioma, age >=6 months; preserve age-appropriate renal estimation and formulation.
- Renal action / finding
- eGFR >=30 mL/min/1.73 m2: no renal adjustment.
- Evidence or dialysis limit
- eGFR <30 not studied; no dialysis regimen established.
- Monitoring / application
- Use age-appropriate Schwartz/MDRD interpretation and the labeled oncology regimen.
- Product / population
- OJEMDA for labeled BRAF-altered relapsed/refractory pediatric low-grade glioma, age >=6 months; preserve age-appropriate renal estimation and formulation.
- Renal measure
- Indexed eGFR, mL/min/1.73 m2, calculated by Schwartz or MDRD as stated in the label
- Source revision
- Revision date not captured in selected review; retrieval date is not revision date.
- Retrieved
- 2026-11-07 (not the revision date)
eGFR <30 not studied; no dialysis regimen established.
Selected renal section, not a complete prescribing monograph. A label and its mirror are not independent evidence.
Section 8.7
No dose adjustment is recommended for mild-to-moderate impairment with eGFR >=30 mL/min/1.73 m2 using Schwartz or MDRD. Severe impairment below 30 has not been studied. No dialysis regimen is supplied. Use the labeled pediatric oncology indication, BSA-based regimen and appropriate oral presentation; the renal statement does not provide a complete treatment protocol.
Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ea3a9631-3a66-6a7c-e053-2995a90ae2ad
