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2 additional source qualifications - review before use
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.
Before applying: 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.
The official recheck retains the same greater-than versus greater-than-or-equal boundary distinction seen in the mirror.
Before applying: Do not assign exact 15 from the PK paragraph or change absolute mL/min to indexed units. Obtain product-specific clarification.
Also check: Exactly 15 is written differently in the dosing and PK sections; Exact eGFR boundary remains unresolved in both sources
Official source
JOURNAVX - official renal boundary and measure recheck
Product / population
JOURNAVX - official renal boundary and measure recheck; selected renal passages, not a complete prescribing monograph.
Renal measure
CKD-EPI eGFR adjusted for body surface area, mL/min in the PK paragraph. Exact 15 boundary not explicitly assigned in section 8.7.
Renal dosing, restrictions and evidence limits
The January 2026 prescribing information retains avoidance below eGFR 15 mL/min and a same-dose statement above 15. Its PK analysis includes values >=15 using CKD-EPI adjusted for body surface area. The exact value 15 is not explicitly assigned by the renal dosing paragraph, so this recheck does not fill that boundary. The wording occurs in the official label as well as the RX mirror. Preserve the absolute mL/min measure, the distinction between PK and dose instructions, and the unresolved boundary.
Source revision: Prescribing information revised January 2026. | Retrieved: 2026-09-09. Retrieval date is not the revision date.
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Evidence sources and renal implications
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JOURNAVX - official renal boundary and measure recheck
Restriction or avoidance guidance. Read the specific threshold, age, formulation and dialysis exclusions; do not generalize across products.
JOURNAVX - official renal boundary and measure recheck; selected renal passages, not a complete prescribing monograph.
Renal method: CKD-EPI eGFR adjusted for body surface area, mL/min in the PK paragraph. Exact 15 boundary not explicitly assigned in section 8.7. Retrieved: 2026-09-09
Important product / source limitation: Renal endpoint needs clarification at exactly 15 mL/min; section 8.7 and the PK population use different inequality wording.
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Renal-context checklist: population, kidney trend and dialysis
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These are specific issues found during source review, not an automated judgment that one source is universally correct. A label mirror and its original label are not independent evidence.
ambiguous threshold
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.
How to use this: 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.
Choose a source, then jump to its renal or dialysis section. These links locate stored text; they do not merge regimens or certify that sources agree.
New source summary - independent clinical review pending. Summaries of the identified label sections are included locally. Source import and numeric transcription checks are not independent two-reference validation. Do not treat this card as an approved institutional dosing protocol.
Official source
Suzetrigine (JOURNAVX, adults)
Adult oral JOURNAVX acute pain; exact Vertex label; not pediatric or dialysis dosing.
Method: BSA-adjusted CKD-EPI eGFR in mL/min; section 8.7 >15 versus PK >=15 boundary
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Exact product and population matter. This added page contains locally stored, source-specific clinical summaries. Historical handbook information, when present, is identified separately and may conflict with U.S. labeling. Confirm indication, population, kidney-function method, monitoring and the full prescribing information before applying a regimen.
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.
DailyMed / Vertex Pharmaceuticals Incorporated · JOURNAVX - official renal boundary and measure recheck; selected renal passages, not a complete prescribing monograph.
Renal method: CKD-EPI eGFR adjusted for body surface area, mL/min in the PK paragraph. Exact 15 boundary not explicitly assigned in section 8.7. Source date: Prescribing information revised January 2026. Retrieved: 2026-09-09
Restriction or avoidance guidance. Read the specific threshold, age, formulation and dialysis exclusions; do not generalize across products.
Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph.
Renal dosing, restrictions and evidence limits
The January 2026 prescribing information retains avoidance below eGFR 15 mL/min and a same-dose statement above 15. Its PK analysis includes values >=15 using CKD-EPI adjusted for body surface area. The exact value 15 is not explicitly assigned by the renal dosing paragraph, so this recheck does not fill that boundary. The wording occurs in the official label as well as the RX mirror. Preserve the absolute mL/min measure, the distinction between PK and dose instructions, and the unresolved boundary.
RDM53-official-suzetrigine-journavx-90f3d04d76-C1 · Source locator: Sections 8.7 and 12.3; label header and prescribing-information revision.
GlobalRPh-hosted RX List · Suzetrigine - JOURNAVX adult oral tablets; selected renal passages, not a complete prescribing monograph.
Renal method: CKD-EPI eGFR adjusted for body surface area, mL/min in the PK paragraph; source boundary wording requires reconciliation. Source date: Source revision date not established in selected retrieval. Retrieved: 2026-09-09
Label mirror, not independent corroboration. This is selected locally stored RX List content. Full monograph import and current official-label review are not implied.
Restriction or avoidance guidance. Read the specific threshold, age, formulation and dialysis exclusions; do not generalize across products.
Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph.
Renal dosing, restrictions and evidence limits
The mirror advises avoiding JOURNAVX below eGFR 15 mL/min and uses >15 for its same-dose instruction. Its PK paragraph instead includes >=15, using CKD-EPI adjusted for body surface area. The exact value 15 is therefore not silently assigned to a dosing band by this summary. Keep the body-surface-area-adjusted mL/min measure distinct from indexed mL/min/1.73 m2, and reconcile the boundary against the official source before applying it.
RDM53-rxlist-suzetrigine-journavx-5a78bd04c2-C1 · Source locator: Renal impairment; clinical pharmacology: specific populations.
Source-specific limits
Boundary wording and units are preserved. No inferred dialysis recommendation.
Additional summaries stored on this page: 2 official-label, 1 RX List, 0 professional, 0 handbook. Empty additional-source groups are not shown. A missing layer is not a no-adjustment recommendation.
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This page is an additional exact-product entry, not a recovered GlobalRPh monograph. Its primary scope text and separately attributed clinical summaries are locally included.