Journavx

JOURNAVX is indicated for the treatment of moderate to severe acute pain in adults.

• Swallow JOURNAVX tablets whole and do not chew or crush. (
  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.
  )
• 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 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.
  )
• 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 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.
  )
• 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 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.
  )
• See the full prescribing information for the recommended dosage in patients with hepatic impairment (
  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)].
  ), for JOURNAVX dosage modifications with concomitant use of CYP3A inhibitors (
  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)].
  ), and recommendations regarding missed dose(s). (
  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.
  )
• Avoid food or drink containing grapefruit during treatment with JOURNAVX. (
  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)].
  )

Tablets: 50 mg, blue, film-coated, oblong tablets debossed with "VX50" on one side and plain on the other.

Risk Summary

There are no available data on the use of JOURNAVX during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.

In animal reproduction studies in rats, effects on implantation and maintenance of pregnancy occurred at oral suzetrigine doses of ≥ 2.2-times the maximum recommended human dose (MRHD) when administered during early embryonic development or throughout organogenesis. In a pre- and postnatal development study, reduced mean gestation length and increased postnatal pup mortality were observed at maternal rat exposures of 1.6-times the MRHD and decreased rat pup body weights were observed during the period of birth to weaning at maternal exposures of 2.2-times the MRHD. No malformations were observed when suzetrigine was administered orally to rats and rabbits during the period of organogenesis at doses up to 2.2- and 5.9-times, respectively, the MRHD. The clinical relevance of these findings is unclear.

The background risk of major birth defects and miscarriage in patients with moderate to severe acute pain is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.