JOURNAVX is an oral nonopioid 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.