Suzetrigene
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Anum Ijaz M.B.B.S., M.D.[2]
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Overview
Suzetrigene is a sodium channel blocker that is FDA approved for the treatment of of moderate to severe pain acute pain, including postoperative pain, in adults.. Common adverse reactions include pruritus, muscle spasms, increased creatine phosphokinase, and rash.
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Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Adult Indications. JOURNAVX is indicated for the treatment of moderate to severe acute pain, including postoperative pain, in adults. 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 Dosage and Administration:
- 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.
- 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.
- Avoid food or drink containing grapefruit during treatment with JOURNAVX.
Dosage Form.
- Tablets: 50 mg, blue, film-coated, oblong tablets debossed with "VX50" on one side and plain on the other.
Recommedations regarding Missed Doses. For patients on the standard recommended dosing schedule:
- 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.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Suzetrigene in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Suzetrigene in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding indications and dosage of Suzetrigene in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Suzetrigene in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Suzetrigene in pediatric patients.
Contraindications
- 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. 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.
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.
Avoid food or drink containing grapefruit during treatment with JOURNAVX.
Warnings
FDA reported warnings and precautions associated with the JOURNAVX are as follows:
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. Concomitant use of JOURNAVX with strong CYP3A inhibitors is contraindicated. Reduce the JOURNAVX dosage with moderate CYP3A inhibitors.
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 JOURNAVX-treated patients taking concomitant hormonal contraceptives containing progestins other than levonorgestrel and norethindrone should use additional nonhormonal contraceptives (such as condoms) or use alternative contraceptives (e.g., a combined oral contraceptive containing ethinyl estradiol as the estrogen and levonorgestrel or norethindrone as the progestin, an intrauterine system) 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 M6-SUZ (active metabolite) than those with normal hepatic function which may increase the risk of JOURNAVX related adverse reactions.Avoid use of JOURNAVX in patients with severe hepatic impairment (Child-Pugh Class C). The recommended JOURNAVX dosage is lower in patients with moderate hepatic impairment (Child-Pugh Class B) than those with normal hepatic function.
Adverse Reactions
Clinical Trials Experience
The safety profile of JOURNAVX is primarily based on data from the pooled, double-blind, placebo- and active-controlled trials in 874 adult patients with moderate to severe acute pain following full abdominoplasty (Trial 1) and bunionectomy (Trial 2), with supportive safety data from one single arm trial in 256 adult patients with moderate to severe acute pain in a broad range of acute pain conditions (Trial 3).
Nausea and Vomiting
In Trial 1, the incidence of patients who experienced either nausea or vomiting was 20% in JOURNAVX-treated patients, 33% in HB/APAP-treated patients, and 25% in placebo-treated patients. In Trial 2, the incidence of patients who experienced either nausea or vomiting was 9% in JOURNAVX-treated patients, 16% in HB/APAP-treated patients, and 12% in placebo-treated patients.
Laboratory Abnormalities
Creatine Phosphokinase Elevations: In Trials 1 and 2, 2.9% of JOURNAVX-treated patients and 1.2% of placebo-treated patients had a creatine phosphokinase (CPK) level > 3 times the upper limit of normal. The incidence of increased blood CPK was 1.1% in JOURNAVX-treated patients and 0.5% in placebo-treated patients. All reports of CPK elevations occurred in the post-surgical setting. There were no associated signs or symptoms, no serious adverse reactions, and no patients required treatment discontinuation or interruption.
Decreased Estimated Glomerular Filtration Rate: In Trials 1 and 2, 2.5% of JOURNAVX-treated patients and 0.9% of placebo-treated patients had a decrease in estimated glomerular filtration rate (eGFR) of ≥ 25% but < 50%. Follow-up eGFR data for these controlled trials was not available after treatment discontinuation. Similar decreases in eGFR also occurred in Trial 3 (the open-label Phase 3 study) and appeared to resolve to baseline by the final safety follow-up visit. There was no control arm for comparison. There were no adverse reactions of eGFR decrease in JOURNAVX-treated patients.
Adverse Reactions from the Open-Label Study (Trial 3)
- In an open-label study of patients with moderate to severe acute pain following a surgical procedure or nonsurgical condition [NCT05661734], a total of 256 adult patients received at least one dose of JOURNAVX. Patients received 100 mg as a first dose, then 50 mg every 12 hours and continued to receive JOURNAVX for up to 14 days or until their pain resolved. Rescue medication of 650 mg of acetaminophen and 400 mg of ibuprofen together every 6 hours was permitted as needed for pain relief. The patients' perceptions of pain control was captured by patient global assessment (PGA). The mean duration of treatment with JOURNAVX was 9.6 days. The majority of patients were female (68%), and the median age was 43 years (range: 18 to 78).
- In Trial 3, a total of 222 (87%) patients received JOURNAVX for post-surgical pain; orthopedic surgery was the most common (e.g., ligament operation, arthrodesis), followed by plastic surgery (e.g., liposuction, mammoplasty), otorhinolaryngologic surgery (e.g., nasal septal operation, turbinoplasty), and general and urologic surgery (e.g., inguinal hernia repair). Thirty-four (13%) patients received JOURNAVX for non-surgical pain (e.g., arthralgias, limb pain, and sprains/strains).
- The proportion of patients who discontinued study drug prematurely was 2% due to adverse events (arrhythmia [0.4%], nausea [0.4%], somnolence [0.4%], rash [0.4%]) and 1.6% due to lack of efficacy.
- The safety profile of JOURNAVX in Trial 3 was consistent with that observed in Trials 1 and 2.
Postmarketing Experience
There is limited information regarding Suzetrigene Postmarketing Experience in the drug label.
Drug Interactions
Effect of Other Drugs on JOURNAVX
- Food or drink containing grapefruit should be avoided during treatment with JOURNAVX.
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Effect of JOURNAVX on Other Drugs
CYP3A Substrates
- 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 modification of the concomitant CYP3A substrates may be required when initiating or discontinuing JOURNAVX.
Hormonal Contraceptives
- JOURNAVX-treated 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.
- JOURNAVX did not result in clinically significant changes in the pharmacokinetics of ethinyl estradiol and levonorgestrel when used concomitantly with an oral contraceptive containing ethinyl estradiol and levonorgestrel.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA): 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.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Suzetrigene in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Suzetrigene during labor and delivery.
Nursing Mothers
Risk Summary
- 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.
- Suzetrigine is present in animal milk. When a drug is present in animal milk, it is likely that the drug will 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.
Geriatic Use
- Of the total 1130 patients with moderate to severe acute pain who received JOURNAVX in the Phase 3 studies, 71 patients (6.3%) were 65 years of age and older.
- 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.
Gender
There is no FDA guidance on the use of Suzetrigene with respect to specific gender populations.
Race
There is no FDA guidance on the use of Suzetrigene with respect to specific racial populations.
Renal Impairment
- JOURNAVX has not been studied in patients with renal impairment of eGFR < 15 mL/min.
- Avoid use of JOURNAVX in patients with renal impairment of eGFR < 15 mL/min.
- The recommended dosage in patients with eGFR > 15 mL/min is the same as those with normal kidney function.
Hepatic Impairment
- Avoid use of JOURNAVX in patients with severe hepatic impairment (Child-Pugh Class C.
- The recommended JOURNAVX dosage is lower in patients with moderate hepatic impairment (Child-Pugh Class B) than those with normal hepatic function.
- The recommended dosage in patients with mild hepatic impairment (Child-Pugh Class A) is the same as those with normal hepatic function.
- Patients with moderate hepatic impairment had greater suzetrigine and M6-SUZ (the active metabolite) exposure than those with normal hepatic function, which may increase the risk of suzetrigine adverse reactions.
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Females of Reproductive Potential and Males
Contraception
- Advise patients using hormonal contraceptives containing progestins other than levonorgestrel and norethindrone to use an additional nonhormonal contraceptive or to use alternative contraceptives during JOURNAVX treatment and for 28 days after discontinuation of JOURNAVX.
Infertility
- In a female fertility study in rats, increased pre-implantation loss was observed at oral suzetrigine doses of ≥ 2.2-times the MRHD when administered prior to mating and through Gestation Day 7.
- Following discontinuation of suzetrigine for 4 weeks, the increased pre-implantation loss in rats was not observed.
- The finding in rats may be explained by the effect of suzetrigine on the rat progesterone receptor, which was more sensitive to suzetrigine than the human progesterone receptor based on in vitro studies.
- 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.
Immunocompromised Patients
There is no FDA guidance one the use of Suzetrigene in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Suzetrigene Administration in the drug label.
Monitoring
There is limited information regarding Suzetrigene Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Suzetrigene and IV administrations.
Overdosage
- No specific antidote is available for overdose with JOURNAVX. Treatment of overdose consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
Pharmacology
There is limited information regarding Suzetrigene Pharmacology in the drug label.
Mechanism of Action
Suzetrigine is a selective blocker of the NaV1.8 voltage-gated sodium channel, compared to other known voltage-gated sodium channels (NaV1.1 through 1.9). NaV1.8 is expressed in peripheral sensory neurons including dorsal root ganglion neurons, where its role is to transmit pain signals (action potentials). By selectively inhibiting NaV1.8 channels, suzetrigine inhibits transmission of pain signals to the spinal cord and brain. M6-SUZ, a major active metabolite, is a less potent inhibitor of NaV1.8 than suzetrigine by 3.7-fold.
Structure
The active ingredient in JOURNAVX (suzetrigine) tablets is suzetrigine, a sodium channel blocker, which has the following chemical name:
4-[(2R,3S,4S,5R)-3-(3,4-difluoro-2-methoxyphenyl)-4,5-dimethyl-5-(trifluoromethyl)oxolane-2-amido]pyridine-2-carboxamide. Its molecular formula is C21H20F5N3O4.
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Pharmacodynamics
Cardiac Electrophysiology
At 2 times the exposure of the maximum recommended JOURNAVX dose, clinically significant QTc prolongation was not observed.
Pharmacokinetics
There is limited information regarding Suzetrigene Pharmacokinetics in the drug label.
Nonclinical Toxicology
Carcinogenesis
- Long-term animal studies have not been completed to evaluate the carcinogenic potential of suzetrigine.
Mutagenesis
- Suzetrigine was not mutagenic in the bacterial reverse mutation assay (Ames test), or clastogenic in the in vitro micronucleus assay with a human TK6 lymphoblastoid cell line, or in the in vivo rat bone marrow micronucleus assay.
Impairment of Fertility
- In a female fertility study, female rats were treated orally with suzetrigine at 5, 10, and 15 mg/kg/day for a minimum of 14 days prior to mating, throughout mating, and through Gestation Day 7. These doses are approximately 0.57, 1.6, and 2.2-times the steady state MRHD exposure based on AUC. Increased pre-implantation loss was observed at 15 mg/kg (approximately 2.2-times the MRHD based on AUC).
- In a male fertility study, male rats were treated orally with suzetrigine at 200, 600, and 1000 mg/kg/day for a minimum of 28 days prior to mating and through mating. These doses are 3.6, 9.7, and 13.8-times the steady state MRHD exposure based on AUC, respectively. Suzetrigine had no effects on sperm parameters (motility, concentration, or morphology), reproductive performance or uterine parameters (number of implants, viable implants, pre-implantation loss, early resorptions, and post-implantation loss) at any dose.
Clinical Studies
Overview of Clinical Studies
- The efficacy of JOURNAVX in the treatment of moderate to severe acute pain in adults was established in two randomized, double-blind, placebo and active-controlled trials of acute pain, one following full abdominoplasty (Trial 1) [see Clinical Studies (14.2)] and the other following bunionectomy (Trial 2) [see Clinical Studies (14.3)].
- In each trial, pain intensity was measured using a patient-reported 11-point numeric pain rating scale (NPRS), ranging from 0 to 10, where zero corresponds to no pain and 10 corresponds to the worst pain imaginable.
- Patients were eligible for study participation if they had moderate to severe pain on the verbal categorical rating system (VRS) and a pain score of ≥ 4 on the NPRS, within 4 hours of the abdominoplasty completion (Trial 1) or during the 9-hour period after discontinuation of regional anesthesia following bunionectomy (Trial 2).
- Once eligible, patients were randomized to receive oral JOURNAVX, placebo, or hydrocodone bitartrate/acetaminophen (HB/APAP) for a duration of 48 hours.
- For the JOURNAVX treatment regimen, patients received an initial loading dose of 100 mg JOURNAVX, followed by 50 mg every 12 hours.
- For the HB/APAP-control regimen, patients received 5 mg/325 mg every 6 hours. * For both studies, 400 mg of ibuprofen every 6 hours, as needed for pain relief, was permitted as a rescue medication.
Moderate to Severe Acute Pain Following Full Abdominoplasty
- Trial 1 [NCT05558410] evaluated the efficacy of JOURNAVX over 48 hours in 1,118 adult patients with moderate to severe acute pain following a full abdominoplasty procedure (JOURNAVX n = 447, placebo n = 223, and hydrocodone bitartrate/acetaminophen (HB/APAP) n = 448).
- The majority of patients were female (98%), and the mean age was 42 years (range: 18 to 69).
- The study population consisted of 70% White participants, 27% Black or African American participants, 1% Asian participants, 0.8% Native Hawaiian or other Pacific Islander participants, 0.5% American Indian or Alaska Native participants, and 0.9% Other or Multiracial participants, among which 34% identified as Hispanic or Latino. The mean pain score at baseline was 7.4 (range: 4 to 10).
- All baseline characteristics, including NPRS, VRS, and BMI were generally balanced across treatment arms.
- In Trial 1, 89% of patients in the JOURNAVX group completed the treatment period (compared to 75% of patients in the placebo group and 85% of patients in the HB/APAP group), and 9% of patients in the JOURNAVX group discontinued due to lack of efficacy (compared to 22% of patients in the placebo group and 13% of patients in the HB/APAP group).
- Efficacy was evaluated by the time-weighted sum of the pain intensity difference from 0 to 48 hours (SPID48) in the JOURNAVX group compared to the placebo group and then to the HB/APAP group. Treatment with JOURNAVX demonstrated statistically significant superior reduction in pain compared to treatment with placebo.
- The median time to meaningful pain relief (defined as a ≥ 2-point reduction in NPRS) was 119 minutes for patients in the JOURNAVX group and 480 minutes for patients in the placebo group. The median time to onset of perceptible pain relief (defined as a ≥ 1-point reduction in NPRS) for patients in the JOURNAVX group was 34 minutes.
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Moderate to Severe Acute Pain Following Bunionectomy
- Trial 2 [NCT05553366] evaluated the efficacy of JOURNAVX over 48 hours in 1,073 adult patients with moderate to severe acute pain following bunionectomy (JOURNAVX n = 426, placebo n = 216, and HB/APAP n = 431).
- The majority of patients were female (85%), and the mean age was 48 years (range: 18 to 75).
- The study population consisted of 71% White participants, 24% Black or African American participants, 2% Asian participants, 0.2% Native Hawaiian or other Pacific Islander participants, 1% American Indian or Alaska Native participants, and 1% Other or Multiracial participants, and 0.3% with race missing, among which 34% identified as Hispanic or Latino.
- The mean pain score at baseline was 6.8 (range: 4 to 10). All baseline characteristics, including NPRS, VRS, and BMI were generally balanced across treatment arms.
- In Trial 2, 87% of patients in the JOURNAVX group completed the treatment period (compared to 82% of patients in the placebo group and 90% of patients in the HB/APAP group), and 12% of patients in the JOURNAVX group discontinued due to lack of efficacy (compared to 16% of patients in the placebo group and 8% of patients in the HB/APAP group).
- Efficacy was evaluated by the time-weighted sum of the pain intensity difference from 0 to 48 hours (SPID48) in the JOURNAVX group compared to the placebo group and then to the HB/APAP group.
- In an exploratory analysis, the time-weighted sum of the pain intensity difference from 0 to 24 hours (SPID24) reported using the least square mean was 30.6 in the JOURNAVX group and 19.8 in the placebo group.
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Time to Onset of Pain Relief
The median time to meaningful pain relief (defined as ≥ 2-point reduction in NPRS) was 240 minutes for patients in the JOURNAVX group and 480 minutes in the placebo group. The median time to onset of perceptible pain relief (defined as a ≥ 1-point reduction in NPRS) for patients in the JOURNAVX group was 60 minutes.
How Supplied
JOURNAVX (suzetrigine) tablets are supplied as blue, film-coated, oblong tablets containing 50 mg of suzetrigine. Each tablet is debossed with the characters "VX50" on one side and plain on the other, and is packaged as follows:
- 30-count bottle NDC 51167-548-30
- 100-count bottle NDC 51167-548-31
- 100-count Hospital Unit Dose Carton (10 blister cards, each containing 10 tablets) NDC 51167-548-34
Storage
- Store at 68°F to 77°F (20°C to 25°C); excursions permitted to 59°F to 86°F (15°C to 30°C).
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Patient Counseling Information
Drug Interactions
- Ask patients to tell you all the medications they are taking, including any herbal supplements or vitamins.
- Food or drink containing grapefruit should be avoided.
- When used concomitantly with hormonal contraceptives containing a progestin other than levonorgestrel or norethindrone, advise patients to use an additional nonhormonal contraceptive (such as condoms) or use alternative contraceptives during JOURNAVX treatment and for 28 days after discontinuation of JOURNAVX.
Females of Reproductive Potential
- Advise females of reproductive potential that JOURNAVX may reversibly impact the likelihood to become pregnant while on treatment.
- Patients using contraceptives should continue to use contraceptives.
Use in Patients with Hepatic Impairment
- Inquire and/or assess whether patients have hepatic impairment.
Administration Instructions
- Advise patients to take the starting 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 (such as water, apple juice, vegetable broth, tea, or black coffee) during this time.
- Avoid food or drink containing grapefruit during treatment with JOURNAVX.
- Subsequent doses of JOURNAVX can be taken with or without food.
- Patients should be instructed to swallow JOURNAVX tablets whole (do not chew or crush).
- Inform patients about what to do in the event they miss a dose of JOURNAVX.
Precautions with Alcohol
Alcohol-Suzetrigene interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
JOURNAVX
Look-Alike Drug Names
There is limited information regarding Look-Alike Drug Names to JOURNAVX.
Price
References
The contents of this FDA label are provided by the National Library of Medicine.