JOURNAVXTM was generally well tolerated across all Phase 3 pivotal trials1
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ADVERSE REACTIONS
Adverse reactions from Trials 1 and 2 (pooled)1
JOURNAVX safety data were collected from 2 pooled, double-blind, placebo- and HB/APAP–controlled trials that enrolled 874 patients with moderate-to-severe acute pain following full abdominoplasty (Trial 1) and bunionectomy (Trial 2).
There were no serious adverse events related to JOURNAVX in the pivotal trials.2
Adverse reactions reported in ≥1% of patients treated with JOURNAVX and greater than rate of placebo1
ADVERSE REACTIONS | JOURNAVX | PLACEBO | HB/APAPa |
|---|---|---|---|
Pruritus | 18 (2.1) | 7 (1.6) | 30 (3.4) |
Muscle spasms | 11 (1.3) | 2 (0.5) | 6 (0.7) |
Increased blood creatine phosphokinase | 10 (1.1) | 2 (0.5) | 7 (0.8) |
Rash | 10 (1.1) | 2 (0.5) | 6 (0.7) |
a Patients received 5 mg/325 mg of oral hydrocodone bitartrate/acetaminophen (HB/APAP) every 6 hours.
Discontinuation due to adverse events in Trials 1 and 2 was 0.6% in the JOURNAVX group, 0.2% in the placebo group, and 0.6% in the HB/APAP group.1
No adverse reactions occurred in patients treated with JOURNAVX at a frequency higher than placebo by ≥1%.1,2
Secondary Endpoint:
Nausea or Vomiting
Incidence of nausea or vomiting vs placebo and HB/APAP1
TRIAL 1: ABDOMINOPLASTY | TRIAL 2: BUNIONECTOMY | |
|---|---|---|
JOURNAVX | 20% | 9% |
Placebo | 25% | 12% |
HB/ABAP | 33% | 16% |
References: 1. JOURNAVX [prescribing information]. Vertex Pharmaceuticals Incorporated. Boston, MA; January 2025. 2. Data on file. Vertex Pharmaceuticals Incorporated. Boston, MA. REF-28506 (v1.0); 2024.
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.