Version July 2025
Acute pain, moderate to severe: Oral:
Loading dose: 100 mg once on an empty stomach.
Subsequent doses: 12 hours after the loading dose, start maintenance dose of 50 mg every 12 hours.
Missed doses: If one dose is missed, take the missed dose as soon as possible, then take the next scheduled dose at the recommended time. If ≥2 doses are missed, take 100 mg once, and then take the next scheduled dose at the recommended time.
Duration of therapy: Use for the shortest duration consistent with patient treatment goals; use beyond 14 days has not been evaluated.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
eGFR >15 mL/minute: No dosage adjustments necessary.
eGFR ≤15 mL/minute: Avoid use (has not been studied).
Child-Turcotte-Pugh class A: No dosage adjustments necessary.
Child-Turcotte-Pugh class B:
Loading dose: 100 mg once on an empty stomach.
Doses 2, 3, and 4: 12 hours after the initial dose, administer 50 mg every 12 hours for 3 doses.
Dose 5 and subsequent doses: 12 hours after dose 4, administer 50 mg every 24 hours.
Missed doses: If a dose is missed, administer the missed dose as soon as possible. If the next scheduled dose is within 6 hours, skip the next scheduled dose and administer subsequent doses at the recommended time.
Child-Turcotte-Pugh class C: Avoid use (has not been studied).
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported in adults.
1% to 10%:
Dermatologic: Skin rash (1%)
Neuromuscular & skeletal: Increased creatine phosphokinase in blood specimen (1% to 3%), muscle spasm (1%)
Renal: Decreased estimated GFR (eGFR) (3%)
Concomitant use with strong CYP3A inhibitors.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Journavx: 50 mg [contains fd&c blue #2 (indigo carm) aluminum lake]
No
Tablets (Journavx Oral)
50 mg (per each): $18.60
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Oral: Swallow tablets whole; do not crush or chew. Administer the loading dose on an empty stomach at least 1 hour before or 2 hours after food (clear liquids may be consumed during this time). Subsequent doses may be administered with or without food.
Acute pain, moderate to severe: Treatment of moderate to severe acute pain in adults.
Substrate of CYP3A4 (Major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential; Induces CYP3A4 (Weak);
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Atogepant: CYP3A4 Inducers (Weak) may decrease serum concentration of Atogepant. Management: For treatment of episodic migraine, the recommended dose of atogepant is 30 mg once daily or 60 mg once daily when combined with CYP3A4 inducers. When used for treatment of chronic migraine, use of atogepant with CYP3A4 inducers should be avoided. Risk D: Consider Therapy Modification
Clofazimine: May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor
CloZAPine: CYP3A4 Inducers (Weak) may decrease serum concentration of CloZAPine. Risk C: Monitor
CYP3A4 Inducers (Moderate): May decrease serum concentration of Suzetrigine. Risk X: Avoid
CYP3A4 Inducers (Strong): May decrease serum concentration of Suzetrigine. Risk X: Avoid
CYP3A4 Inhibitors (Moderate): May increase serum concentration of Suzetrigine. Management: Reduce suzetrigine dose as follows: initiate with 100 mg for 1 dose; then 12 hours after first dose, give 50 mg every 12 hours for doses 2, 3, and 4; then 50 mg every 24 hours for dose 5 and thereafter. Risk D: Consider Therapy Modification
CYP3A4 Inhibitors (Strong): May increase serum concentration of Suzetrigine. Risk X: Avoid
Fusidic Acid (Systemic): May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Consider avoiding this combination if possible. If required, monitor patients closely for increased adverse effects of the CYP3A4 substrate. Risk D: Consider Therapy Modification
Grapefruit Juice: May increase serum concentration of Suzetrigine. Risk X: Avoid
Hormonal Contraceptives: Suzetrigine may decrease serum concentration of Hormonal Contraceptives. Management: Patients should use a nonhormonal contraceptive, an intrauterine system, or ethinyl estradiol and norethindrone or levonorgestrel for the duration of treatment with suzetrigine and for 28 days after stopping suzetrigine. Risk D: Consider Therapy Modification
NiMODipine: CYP3A4 Inducers (Weak) may decrease serum concentration of NiMODipine. Risk C: Monitor
Selpercatinib: CYP3A4 Inducers (Weak) may decrease serum concentration of Selpercatinib. Risk C: Monitor
Sirolimus (Conventional): CYP3A4 Inducers (Weak) may decrease serum concentration of Sirolimus (Conventional). Risk C: Monitor
Sirolimus (Protein Bound): CYP3A4 Inducers (Weak) may decrease serum concentration of Sirolimus (Protein Bound). Risk C: Monitor
Tacrolimus (Systemic): CYP3A4 Inducers (Weak) may decrease serum concentration of Tacrolimus (Systemic). Risk C: Monitor
Ubrogepant: CYP3A4 Inducers (Weak) may decrease serum concentration of Ubrogepant. Management: Use an initial ubrogepant dose of 100 mg and second dose (if needed) of 100 mg when used with a weak CYP3A4 inducer. Risk D: Consider Therapy Modification
Food: Administration of suzetrigine 100 mg with a meal resulted in decreased initial concentration of suzetrigine and M6-SUZ (active metabolite) compared to a fasted state. Pharmacokinetics of suzetrigine 50 mg doses are not affected by meal conditions. Management: Administer the first dose of suzetrigine (100 mg) on an empty stomach (at least 1 hour before or 2 hours after food).
Grapefruit: Concomitant use of strong CYP3A4 inhibitors with suzetrigine (CYP3A4 substrate) increases exposure to suzetrigine and its active metabolite and may cause adverse reactions. Management: Avoid food or drinks containing grapefruit during suzetrigine treatment.
Suzetrigine may interact with some hormonal contraceptives. Patients using contraceptives containing progestins other than levonorgestrel and norethindrone require additional nonhormonal contraception (eg, condoms) or alternative contraceptives during suzetrigine therapy and for 28 days after the last dose. Consult drug interactions database for more detailed information related to the use of suzetrigine and specific contraceptives.
Based on animal toxicology studies, suzetrigine may reversibly impact female fertility; data are lacking on possible fertility effects in humans.
Based on data from animal reproduction studies, in utero exposure to suzetrigine may cause fetal harm. Increased post implantation loss, reduced gestational length, and increased pup mortality were observed in some studies following oral administration of suzetrigine to rats in doses up to 2.2 times the maximum recommended human dose (based on AUC).
It is not known if suzetrigine is present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Suzetrigine is a selective blocker of the NaV 1.8 voltage-gated sodium channel, compared to other known voltage-gated sodium channels (NaV 1.1 through 1.9). NaV 1.8 is expressed in peripheral sensory neurons, including dorsal root ganglion neurons, where its role is to transmit pain signals (action potentials). By selectively inhibiting NaV 1.8 channels, suzetrigine inhibits transmission of pain signals from peripheral sensory neurons to the spinal cord and brain. M6-SUZ, a major active metabolite, is a less potent inhibitor of Na V 1.8 than suzetrigine by 3.7-fold.
Distribution: Vd: 495 L.
Protein binding: 99% (suzetrigine); 96% (M6-SUZ active metabolite).
Metabolism: Primarily CYP3A.
Half-life elimination: 23.6 hours (suzetrigine); 33 hours (M6-SUZ active metabolite).
Time to peak: Median: 3 hours (suzetrigine); median: 10 hours (M6-SUZ active metabolite).
Excretion: Feces: 49.9% (9.1% as unchanged drug); urine: 44% (primarily as metabolites).
Clearance: 13.9 L/hour.
Hepatic impairment: In patients with Child-Pugh class B liver impairment, suzetrigine AUC and Cmax increased by 1.5- and 1.3-fold, respectively, and M6-SUZ AUC and Cmax both increased by 1.2 fold. The effect of Child-Pugh class C liver impairment on suzetrigine pharmacokinetics was not studied.
