Most of the safety data for suzetrigine was based on pooled, double-blind, placebo- and active-controlled trials of patient post-surgery (n=874), with supportive safety data from a single-arm, open-label study in patients (n=256) with different acute pain conditions. The most common adverse reactions include itching, muscle spasms, increased creatine phosphokinase blood levels, and rash. No serious adverse events were reported in clinical trials.
Suzetrigine Use
Suzetrigine is available as 50 mg tablets. The recommended starting dose is 100 mg taken on an empty stomach at least one hour before or two hours after eating. Clear liquids may be consumed during this interval. At 12 hours after the starting dose, 50 mg of suzetrigine can be taken orally and administered every 12 hours with or without food. The medication should be taken for the shortest duration possible that is consistent with individual patient treatment goals. Suzetrigine for this indication has not been studied beyond 14 days of use.4
Suzetrigine is contraindicated for concomitant use with strong or moderate CYP3A inhibitors, such as fluconazole and itraconazole. It should be avoided with strong and moderate CYP3A inducers, such as rifampin, efavirenz and Saint John’s wort. Patients should avoid food or drink containing grapefruit when taking suzetrigine.
Also, patients taking suzetrigine while using hormonal contraceptives containing progestins other than levonorgestrel and norethindrone should use a back-up contraceptive method (i.e., additional non-hormonal contraceptives) or alternative contraceptives (i.e., a combined oral contraceptive containing ethinyl estradiol as the estrogen and levonorgestrel or norethindrone as the progestin, or an intrauterine system). These additional contraceptive methods should be used throughout suzetrigine treatment and for 28 days after suzetrigine discontinuation.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
References
- FDA approves novel non-opioid treatment for moderate to severe acute pain [news release]. U.S. Food & Drug Administration. 2025 Jan 30.
- Vertex announces FDA acceptance of new drug application for suzetrigine for the treatment of moderate to severe acute pain [news release]. Vertex Pharmaceuticals Inc. 2024 Jul 30.
- Vertex announces positive results from the VX-548 phase 3 program for the treatment of moderate to severe acute pain [news release]. Vertex Pharmaceuticals Inc. 2024 Jan 30.
- Highlights of prescribing information: Journavx (suzetrigine) tablets. U.S. Food & Drug Administration. 2025 Jan 30.
