Twice-daily oral dosing for your adult patients1,a
Twice-daily oral dosing for your adult patients1,a
Twice-daily oral dosing for your adult patients1,a
a Loading dose is two (2) 50 mg tablets; subsequent doses are 1 tablet.
a Loading dose is two (2) 50 mg tablets; subsequent doses are 1 tablet.
a Loading dose is two (2) 50 mg tablets; subsequent doses are 1 tablet.
Dosing adjustments may be required for patients with moderate hepatic impairment or taking moderate CYP3A inhibitors.
Dosing adjustments may be required for patients with moderate hepatic impairment or taking moderate CYP3A inhibitors.
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RECOMMENDED DOSING
RECOMMENDED DOSING
RECOMMENDED DOSING
Recommended dosage for adult patients with moderate-to-severe acute pain
Loading dose:
Two 50 mg tablets
Followed by:
One 50 mg tablet every 12 hours beginning 12 hours after loading dose
Use JOURNAVXTM 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.
How to administer
How to administer
How to administer
Patients should take the first
dose of JOURNAVX on an
empty stomach at least 1 hour
before or 2 hours after food to
avoid delay in onset of action.
Clear liquids may be consumed
during this time (such as water,
apple juice, vegetable broth,
tea, or black coffee)
Patients should take the first
dose of JOURNAVX on an
empty stomach at least 1 hour
before or 2 hours after food to
avoid delay in onset of action.
Clear liquids may be consumed
during this time (such as water,
apple juice, vegetable broth,
tea, or black coffee)
Patients should take the first dose of JOURNAVX on an empty stomach at least 1 hour before or 2 hours after food to avoid delay in onset of action. Clear liquids may be consumed during this time (such as water, apple juice, vegetable broth, tea, or black coffee)
May be taken with or without
food after initial administration of
loading dose
May be taken with or without
food after initial administration of
loading dose
May be taken with or without food after initial administration of loading dose
Oral use: Tablets should be
swallowed whole and not
chewed or crushed
Oral use: Tablets should be
swallowed whole and not
chewed or crushed
Oral use: Tablets should be swallowed whole and not chewed or crushed
Food or drink containing
grapefruit should be avoided
during treatment with JOURNAVX
Food or drink containing
grapefruit should be avoided
during treatment with JOURNAVX
Food or drink containing grapefruit should be avoided during treatment with JOURNAVX
SPECIFIC POPULATIONS
SPECIFIC POPULATIONS
SPECIFIC POPULATIONS
Recommended
dosage for
patients with
hepatic
impairment
Recommended
dosage for
patients with
hepatic
impairment
Recommended
dosage for patients
with hepatic
impairment
In patients with severe hepatic impairment (Child-Pugh Class C) | AVOID USE JOURNAVX has not been studied in patients with severe hepatic impairment |
In patients with moderate hepatic impairment (Child-Pugh Class B) | REDUCE DOSE Dose 1b: Doses 2, 3, and 4c (starting 12 hours after Dose 1): Dose 5 and subsequent dosesc (starting 12 hours after Dose 4): |
In patients with mild hepatic impairment (Child-Pugh Class A) | NO DOSE ADJUSTMENT The recommended dosage is the same as in those with normal hepatic function |
bPatients should take the first dose of JOURNAVX on an empty stomach at least 1 hour before or 2 hours after food. Clear liquids may be consumed during this time (such as water, apple juice, vegetable broth, tea, or black coffee).
c May be taken with or without food.
Other administration notes
Contraceptives
Patients using hormonal contraceptives containing progestins other than levonorgestrel and norethindrone should use additional nonhormonal contraceptives (such as condoms), or use alternative contraceptives (such as a combined oral contraceptive containing ethinyl estradiol as the estrogen and levonorgestrel or norethindrone as the progestin, or an intrauterine system) during treatment with JOURNAVX and for 28 days after discontinuation of JOURNAVX.
Infertility
JOURNAVX may reversibly impact the likelihood of females of reproductive potential to become pregnant while on treatment. Patients using contraceptives should continue to use contraceptives.
Pregnancy
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.
Lactation
There is no information regarding the presence of JOURNAVX or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. In animal studies, JOURNAVX was present in animal milk, suggesting that JOURNAVX is likely to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for JOURNAVX and any potential adverse effects on the breastfed child from JOURNAVX or from the underlying maternal condition.
Pediatric use
The safety and effectiveness of JOURNAVX has not been established in pediatric patients.
Geriatric use
Clinical studies of JOURNAVX did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients. However, based on population pharmacokinetic analyses in patients with ages ranging from 18 to 75 years, age does not have a clinically relevant impact on suzetrigine exposure.
Renal impairment
No dose adjustment is required in patients with renal impairment of eGFR >15 mL/min. JOURNAVX has not been studied in patients with renal impairment of eGFR <15 mL/min and use should be avoided in these patients.
DRUG INTERACTIONS
DRUG INTERACTIONS
DRUG INTERACTIONS
Recommended
dosage for
patients taking
CYP3A inhibitors
or inducers
Recommended
dosage for
patients taking
CYP3A inhibitors
or inducers
Recommended dosage
for patients taking CYP3A
inhibitors or inducers
Strong CYP3A inhibitorsd (such as itraconazole) | SHOULD NOT BE COADMINISTERED Concomitant use of JOURNAVX with strong CYP3A inhibitors is contraindicated |
Moderate CYP3A inhibitorsd (such as fluconazole) | REDUCE DOSE Dose 1f: Doses 2, 3, and 4g (starting 12 hours after Dose 1): Dose 5 and subsequent dosesg (starting 12 hours after Dose 4): |
Strong CYP3A inducerse (such as rifampin) | SHOULD NOT BE COADMINISTERED Avoid concomitant use of JOURNAVX with strong and moderate CYP3A inducers |
d Strong and moderate CYP3A inhibitors increase suzetrigine and M6-SUZ exposures, which may cause JOURNAVX adverse reactions.
e Concomitant use of strong or moderate CYP3A inducers results in reduced exposures of suzetrigine and M6-SUZ, which may result in reduced JOURNAVX efficacy.
f Patients should take the first dose of JOURNAVX on an empty stomach at least 1 hour before or 2 hours after food. Clear liquids may be consumed during this time (such as water, apple juice, vegetable broth, tea, or black coffee).
g May be taken with or without food.
Dose adjustment of concomitant CYP3A substrates may be required when initiating or discontinuing JOURNAVX
Suzetrigine is an inducer of CYP3A
Concomitant use with JOURNAVX may reduce the exposure of sensitive CYP3A substrates (such as midazolam), which may decrease the efficacy of these substrates
Discontinuation of JOURNAVX may increase the exposure of sensitive CYP3A substrates
Refer to the prescribing information of sensitive CYP3A substrates, or of CYP3A substrates where minimal concentration changes may lead to loss of efficacy, for dosing instructions if used concomitantly with JOURNAVX
MISSED DOSES
MISSED DOSES
MISSED DOSES
Guidance regarding missed doses
If a dose is missed, patients should 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, patients should 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: If a dose is missed, patients should take the missed dose as soon as possible. If the next scheduled dose is within 6 hours, they should skip the next scheduled dose, and take the subsequent doses at the recommended time
Reference: 1. JOURNAVX [prescribing information]. Vertex Pharmaceuticals Incorporated. Boston, MA; January 2025.
INDICATION
JOURNAVX is indicated for the treatment of moderate-to-severe acute pain in adults.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Concomitant use of JOURNAVX with strong CYP3A inhibitors is contraindicated.
WARNINGS AND PRECAUTIONS
INDICATION
JOURNAVX is indicated for the treatment of moderate-to-severe acute pain in adults.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Concomitant use of JOURNAVX with strong CYP3A inhibitors is contraindicated.
WARNINGS AND PRECAUTIONS
Increased Risk of Adverse Reactions With Concomitant Use With Strong and Moderate CYP3A Inhibitors: Strong and moderate CYP3A inhibitors increase suzetrigine and its active metabolite exposures, which may cause adverse reactions with JOURNAVX.
Risk of Drug Interactions With Certain CYP3A Substrates: Suzetrigine is an inducer of CYP3A. If JOURNAVX is used concomitantly with sensitive CYP3A substrates or CYP3A substrates where minimal concentration changes may lead to loss of efficacy, refer to the Prescribing Information for the CYP3A substrates for dosing instructions. Dosage adjustment of the concomitant CYP3A substrates may be required when initiating or discontinuing JOURNAVX.
Risk of Drug Interactions With Certain Hormonal Contraceptives: Patients treated with JOURNAVX who are taking concomitant hormonal contraceptives containing progestins other than levonorgestrel and norethindrone should use additional nonhormonal contraceptives (such as condoms) or use alternative contraceptives during JOURNAVX treatment and for 28 days after discontinuation of JOURNAVX.
Risk of Adverse Reactions in Patients With Moderate and Severe Hepatic Impairment: Patients with moderate hepatic impairment have higher systemic exposures of suzetrigine and its active metabolite than those with normal hepatic function, which may increase the risk of JOURNAVX-related adverse reactions.
ADVERSE REACTIONS
Pooled adverse reactions from Trials 1 and 2 that occurred in ≥1% of patients treated with JOURNAVX and at a greater rate than patients treated with placebo were pruritus, muscle spasms, increased blood creatine phosphokinase, and rash. The safety profile of JOURNAVX in Trial 3 was consistent with that observed in Trials 1 and 2.
DRUG INTERACTIONS
Effect of Other Drugs on JOURNAVX
CYP3A Inhibitors: A reduced dose is recommended when coadministered with moderate CYP3A inhibitors. Avoid food or drink containing grapefruit.
Strong and Moderate CYP3A Inducers: Avoid concomitant use of JOURNAVX with strong and moderate CYP3A inducers. Concomitant use of strong or moderate CYP3A inducers results in reduced exposures of suzetrigine and its active metabolite, which may result in reduced JOURNAVX efficacy.
Effect of JOURNAVX on Other Drugs
CYP3A Substrates: Dose adjustment of the concomitant CYP3A substrates may be required when initiating or discontinuing JOURNAVX. Discontinuation of JOURNAVX may increase the exposure of sensitive CYP3A substrates.
USE IN SPECIFIC POPULATIONS
Pregnancy
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.
Lactation
There are no data on the presence of suzetrigine or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for JOURNAVX and any potential adverse effects on the breastfed child from JOURNAVX or from the underlying maternal condition.
Infertility
JOURNAVX may reversibly impact the likelihood of females of reproductive potential to become pregnant while on treatment. Patients using contraceptives should continue to use contraceptives.
Geriatric Use
Based on population pharmacokinetic analyses in patients with ages ranging from 18 to 75 years, age does not have a clinically relevant impact on suzetrigine exposure.
Hepatic Impairment
The recommended JOURNAVX dosage is lower in patients with moderate hepatic impairment (Child‑Pugh Class B) than those with normal hepatic function. Avoid use of JOURNAVX in patients with severe hepatic impairment (Child‑Pugh Class C).
Renal Impairment
Avoid use of JOURNAVX in patients with renal impairment of eGFR <15 mL/min.
Please see full Prescribing Information for JOURNAVX.