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SUZETRIGINE TAB,ORAL

Clinical Criteria Summary

Document 740: Suzetrigine JOURNAVX Criteria June 2026

Exclusion Criteria

  • Use for >14 days for any episode of care
  • Severe Renal Impairment (eGFR <15 mL/min – CKD-EPI body surface area adjusted)
  • Severe Liver Disease (Child-Pugh class C, kinetics unknown)
  • Unmanageable drug-drug interactions (e.g. CYP3A4 strong inhibitor or inducer)
  • Patients with current arrhythmia
  • Known pregnancy

Inclusion Criteria

  • Patients undergoing surgical procedure with or expected to have moderate-to-severe pain
  • Patients unable to use or with insufficient response to systemic NSAIDs or acetaminophen as part of Enhanced Recovery After Surgery (ERAS) protocol
  • Patient not candidate for short-term opioid use, opioid minimization is clinically indicated OR patient declines use of short term opioids as part of shared decision making

Pregnancy & Contraception Requirements

  • Pregnancy must be excluded prior to receiving suzetrigine
  • If taking contraceptives containing progestins other than levonorgestrel and norethindrone, use additional nonhormonal contraceptives (e.g. condoms) or alternative contraceptives during suzetrigine therapy and for 28 days after the last dose

Dosing & Interaction Adjustments

  • In patients with moderate hepatic illness (Child-Pugh B) or taking moderate CYP3A4 inhibitors, reduce dose frequency to once every 24 hours after 4 doses (start of day 3)
  • Avoid use in patients on strong or moderate CYP3A4 inducers

Opioid Co-Administration Considerations

  • May be considered when post-operative opioids will be used, but opioid minimization is particularly important (e.g., thoracic and abdominal surgery)
  • Opioids should not be withheld from patients who truly need them for post-operative pain management, even with a history of OUD or dependence; use cautiously with assistance from addiction/pain specialists
  • Not specifically studied in patients with OUD/opioid dependence or SUD

Document 746: MON Suzetrigine JOURNAVX Monograph MAY 2025

Indication

  • Treatment of moderate to severe acute pain in adults

Dosage & Administration

  • Tablet for oral use
  • Loading dose: 100 mg on empty stomach
  • Maintenance dose: 50 mg every 12 hours, initiated 12 hours after loading dose start

Contraindications & Warnings

  • Concomitant use with strong CYP3A4 inhibitors is contraindicated
  • Patients using contraceptives containing progestins other than levonorgestrel and norethindrone require additional nonhormonal contraception (e.g., condoms) or alternative contraceptives during suzetrigine therapy and for 28 days after the last dose

Clinical Evidence & VHA Population Considerations

  • Currently indicated only as a treatment for acute pain
  • Demonstrates modest reduction in pain with a small effect size that is numerically better than placebo; clinical significance of this difference is uncertain (e.g., similar request for rescue medication)
  • Did not perform better than low-dose opioid therapy (e.g., 20 MEDD)
  • Not studied in context of usual post-operative pain protocols
  • Studied primarily in middle-aged females; generalizability to how a VHA Veteran population would respond to treatment is unclear
  • No evidence demonstrates it performs better than treatment options commonly used postoperatively and already on formulary (e.g., NSAIDs, intravenous APAP, opioids, local and regional blocks)

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