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Independent clinical review is pending. Confirm indication, exact formulation/route, population, renal measure and units, kidney-function stability, dialysis prescription, interacting drugs, monitoring and source revision. An RX mirror and its original label are not independent corroboration. Missing disagreement notes do not certify agreement.
Record caution: Renal endpoint needs clarification at exactly 15 mL/min; section 8.7 and the PK population use different inequality wording.
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Suzetrigine (JOURNAVX, adults)
Product / population
Adult oral JOURNAVX acute pain; exact Vertex label; not pediatric or dialysis dosing.
Renal method
BSA-adjusted CKD-EPI eGFR in mL/min; section 8.7 >15 versus PK >=15 boundary
Source revision
January 2026
Retrieved
2026-09-07
Local review status
Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph.
Documented differences and cautions on this drug
All record notes are retained here, including notes about sources not selected in this review.
Exactly 15 is written differently in the dosing and PK sections
Section 8.7 uses below 15 for avoidance and above 15 for usual dosing; the PK analysis includes at least 15. Exactly 15 is therefore not consistently assigned across the selected sections.
What to reconcile: Seek exact-label clarification at this endpoint. Do not round, silently change an inequality, or apply indexed eGFR when the source uses a BSA-adjusted measure.
DailyMed / Vertex Pharmaceuticals Incorporated · Adult oral JOURNAVX acute pain; exact Vertex label; not pediatric or dialysis dosing.
Renal method: BSA-adjusted CKD-EPI eGFR in mL/min; section 8.7 >15 versus PK >=15 boundary Source date: January 2026 Retrieved: 2026-09-07
Dose or interval guidance. Use only the product, indication, renal metric and population described in this source.
Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph.
Renal dosing, restrictions and evidence limits
Avoid JOURNAVX at eGFR below 15 mL/min; that population was not studied. Section 8.7 states usual dosing above 15, whereas the PK analysis includes eGFR at least 15 using CKD-EPI adjusted for body surface area. Exactly 15 therefore needs boundary clarification; no automatic choice is made. For eligible adults with acute pain, the usual regimen is 100 mg initially on an empty stomach, then 50 mg every 12 hours starting 12 hours later. Use beyond 14 days was not studied. Strong CYP3A inhibitors are contraindicated; moderate inhibitors and hepatic impairment require separate adjustments. This is not a dialysis-specific regimen.
This reference does not select a regimen. Complete the indication, measured/estimated renal function and trend, dialysis setting, source rationale, monitoring and reassessment plan in your institution's approved documentation system. Confirm the complete current source before adopting its regimen.
GlobalRPh v6.6 | RDM66-DIRECT-PHP-20260911 | Local library date 2026-09-11. Selected-card identity does not imply clinical verification.