SUZETRIGINE TAB,ORAL

Clinical Criteria Summary

Use for >5 days for any episode of care (treatment not to exceed 14 days may be considered case-by-case)
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., CYP 3A4 strong inhibitor or inducer)
Patients with pre-operative, long-term pain management already utilizing daily use of pain medications (e.g., NSAIDs or opioids)
Patients with a history (or current) arrhythmia or abnormal findings on EKG
Known pregnancy

Patients undergoing surgical procedure expected to result in 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 unable to use opioids or use of opioids, including buprenorphine, is inadvisable

For females who can become pregnant: Pregnancy must be excluded prior to receiving suzetrigine
For females who can become pregnant on contraceptives containing progestins other than levonorgestrel and norethindrone: Counseling provided on potential risks vs benefits of treatment and the use of alternative contraception during therapy

Moderate hepatic illness (Child-Pugh B) or taking moderate CYP3A4 inhibitors: After 4 doses (start of day 3), reduce dose frequency to once every 24 hours; avoid use in patients on strong or moderate CYP3A4 inducers

Pre-operative/long-term pain management: Efficacy unknown for patients already on pre-surgical pain therapy that can be continued or titrated; use can be considered case-by-case
Opioid minimization: When use of opioids is appropriate, such use should not be avoided purely for the sake of opioid minimization; with appropriate monitoring and risk mitigation, opioids can be a component of a multi-modal pain management strategy even in high-risk patients
Combination with opioids: Not studied in combination with opioids, but may be considered case-by-case when post-operative opioids will be used and opioid minimization is particularly important (e.g., abdominal surgery)

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

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

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)