General MedicationsORALHigh Alert

JOURNAVX

SUZETRIGINE

Standard Dose

2 DOSAGE AND ADMINISTRATION Swallow JOURNAVX tablets whole and do not chew or crush. ( 2.1 ) Recommended starting JOURNAVX oral dose is 100 mg. Take the starting dose on an empty stomach at least 1 hour before or 2 hours after food. Clear liquids may be consumed during this time (e.g., water, apple juice, vegetable broth, tea, black coffee). ( 2.1 ) Starting 12 hours after the starting dose, take 50 mg of JOURNAVX orally every 12 hours. Take these doses with or without food. ( 2.1 ) Use JOURNAVX for the shortest duration, consistent with individual patient treatment goals. Use of JOURNAVX for the treatment of acute pain has not been studied beyond 14 days. ( 2.1 ) See the full prescribing information for the recommended dosage in patients with hepatic impairment ( 2.2 ), for JOURNAVX dosage modifications with concomitant use of CYP3A inhibitors ( 2.3 ), and recommendations regarding missed dose(s). ( 2.4 ) Avoid food or drink containing grapefruit during treatment with JOURNAVX. ( 2.3 ) 2.1 Recommended Dosage and Administration Instructions Swallow JOURNAVX tablets whole and do not chew or crush. The recommended starting dose of JOURNAVX is 100 mg orally. Take the starting dose on an empty stomach at least 1 hour before or 2 hours after food to avoid delay in onset of action [see Clinical Pharmacology (12.3) ]. Clear liquids may be consumed during this time (e.g., water, apple juice, vegetable broth, tea, black coffee). Starting 12 hours after the initial dose, take 50 mg of JOURNAVX orally every 12 hours. Take these doses with or without food [see Clinical Pharmacology (12.3) ]. Avoid food or drink containing grapefruit during treatment with JOURNAVX [see Dosage and Administration (2.3) ]. Use JOURNAVX for the shortest duration, consistent with individual patient treatment goals. Use of JOURNAVX for the treatment of moderate to severe acute pain has not been studied beyond 14 days. 2.2 Recommended Dosage in Patients with Hepatic Impairment The recommended dosage of JOURNAVX in patients with hepatic impairment is described in Table 1. Table 1: Recommended JOURNAVX Dosage in Patients with Hepatic Impairment Degree of Hepatic Impairment (HI) Recommended Dosage Severe HI (Child-Pugh Class C) Avoid use [see Use in Specific Populations (8.6) ]. Moderate HI (Child-Pugh Class B) Dose 1 : The recommended starting dose of JOURNAVX is 100 mg taken orally. Take the starting dose on an empty stomach at least 1 hour before or 2 hours after food [see Clinical Pharmacology (12.3) ]. Clear liquids may be consumed during this time (e.g., water, apple juice, vegetable broth, tea, black coffee). Doses 2, 3, and 4 : Starting 12 hours after the initial dose, take 50 mg of JOURNAVX orally every 12 hours. Take these doses with or without food [see Clinical Pharmacology (12.3) ]. Dose 5 and Subsequent Doses : Starting 12 hours after Dose 4, take 50 mg of JOURNAVX orally every 24 hours. Take these dose(s) with or without food [see Clinical Pharmacology (12.3) ]. Mild HI (Child-Pugh Class A) The recommended dosage is the same as in those with normal hepatic function [see Dosage and Administration (2.1) ]. 2.3 Dosage Modifications for CYP3A Inhibitors JOURNAVX is contraindicated in patients taking strong CYP3A inhibitors. When JOURNAVX is administered to patients taking moderate CYP3A inhibitors reduce the JOURNAVX dose, as described below: Dose 1 : The recommended starting dose of JOURNAVX is 100 mg orally. Take the starting dose on an empty stomach at least 1 hour before or 2 hours after food [see Clinical Pharmacology (12.3) ]. Clear liquids may be consumed during this time (e.g., water, apple juice, vegetable broth, tea, black coffee). Doses 2, 3, and 4 : Starting 12 hours after the initial dose, take 50 mg of JOURNAVX orally every 12 hours. Take these doses with or without food [see Clinical Pharmacology (12.3) ]. Dose 5 and Subsequent Doses : Starting 12 hours after Dose 4, take 50 mg of JOURNAVX orally every 24 hours. Take these dose(s) with or without food [see Clinical Pharmacology (12.3) ]. Avoid food or drink containing grapefruit during treatment with JOURNAVX [see Drug Interactions (7.1) , Clinical Pharmacology (12.3) ]. 2.4 Recommendations Regarding Missed Dose(s) For patients on the standard recommended dosing schedule [see Dosage and Administration (2.1) ] : If a dose is missed, take the missed dose as soon as possible and then take the next scheduled dose at the recommended time. If two or more doses are missed, take 100 mg and then take the next scheduled dose at the recommended time. For patients with moderate hepatic impairment or patients taking moderate CYP3A inhibitors [see Dosage and Administration (2.2 , 2.3) ] , if a dose is missed, take the missed dose as soon as possible. If the next scheduled dose is within 6 hours, skip the next scheduled dose, and take the subsequent doses at the recommended time.

Max Dose

See official label

Primary Use

1 INDICATIONS AND USAGE JOURNAVX is indicated for the treatment of moderate to severe acute pain, including postoperative pain, in adults.

Summary

Indications and usage 1 INDICATIONS AND USAGE JOURNAVX is indicated for the treatment of moderate to severe acute pain, including postoperative pain, in adults.

JOURNAVX is a sodium channel blocker indicated for the treatment of moderate to severe acute pain, including postoperative pain, in adults. ( 1 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION Swallow JOURNAVX tablets whole and do not chew or crush. ( 2.1 ) Recommended starting JOURNAVX oral dose is 100 mg.

Structured Monograph

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE JOURNAVX is indicated for the treatment of moderate to severe acute pain, including postoperative pain, in adults. JOURNAVX is a sodium channel blocker indicated for the treatment of moderate to severe acute pain, including postoperative pain, in adults. ( 1 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION Swallow JOURNAVX tablets whole and do not chew or crush. ( 2.1 ) Recommended starting JOURNAVX oral dose is 100 mg. Take the starting dose on an empty stomach at least 1 hour before or 2 hours after food. Clear liquids may be consumed during this time (e.g., water, apple juice, vegetable broth, tea, black coffee). ( 2.1 ) Starting 12 hours after the starting dose, take 50 mg of JOURNAVX orally every 12 hours. Take these doses with or without food. ( 2.1 ) Use JOURNAVX for the shortest duration, consistent with individual patient treatment goals. Use of JOURNAVX for the treatment of acute pain has not been studied beyond 14 days. ( 2.1 ) See the full prescribing information for the recommended dosage in patients with hepatic impairment ( 2.2 ), for JOURNAVX dosage modifications with concomitant use of CYP3A inhibitors ( 2.3 ), and recommendations regarding missed dose(s). ( 2.4 ) Avoid food or drink containing grapefruit during treatment with JOURNAVX. ( 2.3 ) 2.1 Recommended Dosage and Administration Instructions Swallow JOURNAVX tablets whole and do not chew or crush. The recommended starting dose of JOURNAVX is 100 mg orally. Take the starting dose on an empty stomach at least 1 hour before or 2 hours after food to avoid delay in onset of action [see Clinical Pharmacology (12.3) ]. Clear liquids may be consumed during this time (e.g., water, apple juice, vegetable broth, tea, black coffee). Starting 12 hours after the initial dose, take 50 mg of JOURNAVX orally every 12 hours. Take these doses with or without food [see Clinical Pharmacology (12.3) ]. Avoid food or drink containing grapefruit during treatment with JOURNAVX [see Dosage and Administration (2.3) ]. Use JOURNAVX for the shortest duration, consistent with individual patient treatment goals. Use of JOURNAVX for the treatment of moderate to severe acute pain has not been studied beyond 14 days. 2.2 Recommended Dosage in Patients with Hepatic Impairment The recommended dosage of JOURNAVX in patients with hepatic impairment is described in Table 1. Table 1: Recommended JOURNAVX Dosage in Patients with Hepatic Impairment Degree of Hepatic Impairment (HI) Recommended Dosage Severe HI (Child-Pugh Class C) Avoid use [see Use in Specific Populations (8.6) ]. Moderate HI (Child-Pugh Class B) Dose 1 : The recommended starting dose of JOURNAVX is 100 mg taken orally. Take the starting dose on an empty stomach at least 1 hour before or 2 hours after food [see Clinical Pharmacology (12.3) ]. Clear liquids may be consumed during this time (e.g., water, apple juice, vegetable broth, tea, black coffee). Doses 2, 3, and 4 : Starting 12 hours after the initial dose, take 50 mg of JOURNAVX orally every 12 hours. Take these doses with or without food [see Clinical Pharmacology (12.3) ]. Dose 5 and Subsequent Doses : Starting 12 hours after Dose 4, take 50 mg of JOURNAVX orally every 24 hours. Take these dose(s) with or without food [see Clinical Pharmacology (12.3) ]. Mild HI (Child-Pugh Class A) The recommended dosage is the same as in those with normal hepatic function [see Dosage and Administration (2.1) ]. 2.3 Dosage Modifications for CYP3A Inhibitors JOURNAVX is contraindicated in patients taking strong CYP3A inhibitors. When JOURNAVX is administered to patients taking moderate CYP3A inhibitors reduce the JOURNAVX dose, as described below: Dose 1 : The recommended starting dose of JOURNAVX is 100 mg orally. Take the starting dose on an empty stomach at least 1 hour before or 2 hours after food [see Clinical Pharmacology (12.3) ]. Clear liquids may be consumed during this time (e.g., water, apple juice, vegetable broth, tea, black coffee). Doses 2, 3, and 4 : Starting 12 hours after the initial dose, take 50 mg of JOURNAVX orally every 12 hours. Take these doses with or without food [see Clinical Pharmacology (12.3) ]. Dose 5 and Subsequent Doses : Starting 12 hours after Dose 4, take 50 mg of JOURNAVX orally every 24 hours. Take these dose(s) with or without food [see Clinical Pharmacology (12.3) ]. Avoid food or drink containing grapefruit during treatment with JOURNAVX [see Drug Interactions (7.1) , Clinical Pharmacology (12.3) ]. 2.4 Recommendations Regarding Missed Dose(s) For patients on the standard recommended dosing schedule [see Dosage and Administration (2.1) ] : If a dose is missed, take the missed dose as soon as possible and then take the next scheduled dose at the recommended time. If two or more doses are missed, take 100 mg and then take the next scheduled dose at the recommended time. For patients with moderate hepatic impairment or patients taking moderate CYP3A inhibitors [see Dosage an

Monitoring

• 5 WARNINGS AND PRECAUTIONS Moderate and Severe Hepatic Impairment : Avoid use in patients with severe hepatic impairment (Child-Pugh Class C).
• Use in patients with moderate hepatic impairment may increase the risk of adverse reactions.
• The recommended dosage is lower in patients with moderate hepatic impairment (Child-Pugh Class B) than those with normal hepatic function.
• ( 5.4 ) 5.1 Increased Risk of Adverse Reactions with Concomitant Use with Strong or Moderate CYP3A Inhibitors Strong and moderate CYP3A inhibitors increase suzetrigine and M6-SUZ (active metabolite) exposures which may cause JOURNAVX adverse reactions.

Interaction Notes

• 7 DRUG INTERACTIONS Strong and Moderate CYP3A inhibitors : Concomitant use with strong CYP3A inhibitors is contraindicated.
• Reduce the JOURNAVX dose when used concomitantly with moderate CYP3A inhibitors.
• Avoid food or drink containing grapefruit.
• ( 2.3 , 7.1 , 12.3 ) Strong and Moderate CYP3A inducers : Avoid JOURNAVX use with strong or moderate CYP3A inducers.