Who Should Not Take Suzetrigine? Contraindications and Warnings

October 10, 2025 •

3 min read

Approved by the FDA in January 2025, suzetrigine (brand name Journavx) offers a non-opioid alternative for acute pain relief. However, like all medications, it is not suitable for everyone. Understanding who should not take suzetrigine is crucial for patient safety and preventing serious adverse effects.

Quick Summary

Suzetrigine is contraindicated in individuals with severe liver or kidney problems and those on strong CYP3A inhibitors. Patients must also avoid grapefruit and be aware of interactions with certain hormonal contraceptives, pregnancy, and breastfeeding considerations.

Key Points

Severe Liver or Kidney Impairment: Patients with severe hepatic (Child-Pugh Class C) or renal (eGFR < 15 mL/min) impairment should not take suzetrigine due to increased risk of adverse effects.
Strong CYP3A Inhibitors: Use of suzetrigine is contraindicated with potent CYP3A inhibitors like itraconazole, as these can dangerously increase suzetrigine levels.
Grapefruit Products: Avoid grapefruit and grapefruit juice, which can inhibit the CYP3A enzyme and raise the risk of side effects.
Hormonal Contraceptives: Suzetrigine can decrease the effectiveness of certain hormonal birth control methods.
Pregnancy and Breastfeeding: The safety of suzetrigine has not been established in pregnant or breastfeeding women, and its use should be discussed with a healthcare provider.
Pediatric Patients: Safety and efficacy have not been established in pediatric patients; therefore, suzetrigine is not recommended for children.
Short-Term Use: Suzetrigine is intended only for short-term (acute) pain management, typically for up to 14 days, not for chronic pain.

Suzetrigine, marketed as Journavx, is a non-opioid pain reliever for moderate to severe acute pain in adults. It targets pain by blocking sodium channels in peripheral nerves. This mechanism helps avoid the addiction risks of opioids, but it comes with specific contraindications and drug interactions. A thorough review of a patient's medical history is essential before prescribing suzetrigine.

Key Contraindications and Warnings

Severe Hepatic Impairment: The Liver's Role

Due to the liver's role in drug metabolism, suzetrigine is not advised for patients with severe liver impairment (Child-Pugh Class C). For those with moderate hepatic impairment (Child-Pugh Class B), a lower dose may be necessary and requires close monitoring by a healthcare provider. Patients with mild impairment (Child-Pugh Class A) can typically receive the standard dose.

Strong CYP3A Inhibitors and Inducers

Suzetrigine is metabolized by the liver enzyme CYP3A. Medications affecting this enzyme's activity can cause harmful drug interactions.

Strong CYP3A inhibitors: Concomitant use with strong CYP3A inhibitors is contraindicated. These drugs increase suzetrigine levels, heightening the risk of adverse effects. Examples include itraconazole, clarithromycin, and certain HIV protease inhibitors like ritonavir.

Moderate CYP3A inhibitors: A reduced suzetrigine dose is needed when taken with moderate CYP3A inhibitors.

CYP3A inducers: Drugs that increase CYP3A activity should also be avoided as they can reduce suzetrigine's effectiveness. Examples include rifampin, carbamazepine, phenytoin, and St. John's Wort.

Grapefruit and grapefruit juice can also inhibit CYP3A, increasing suzetrigine levels, and should be avoided.

Severe Renal Impairment

The safety and efficacy of suzetrigine have not been assessed in patients with severe kidney problems (eGFR < 15 mL/min), and its use is not recommended in this group. While the dosage for moderate impairment (eGFR > 15 mL/min) is not typically adjusted, further research is needed for patients with advanced chronic kidney disease.

Special Population Considerations

Pregnancy and Breastfeeding

Limited data exists on suzetrigine use during pregnancy and breastfeeding. Animal studies at high doses showed potential adverse effects. Given the unknown effects on human pregnancy and lactation, healthcare providers should discuss potential risks and benefits with patients. It is not known if the drug is present in human breast milk.

Hormonal Contraceptives

Suzetrigine may temporarily decrease the chance of pregnancy and can reduce the effectiveness of hormonal contraceptives containing progestins other than levonorgestrel and norethindrone. Women using these contraceptives should use an alternative nonhormonal method (like condoms) during treatment and for 28 days afterward.

Pediatric Patients

Suzetrigine is not recommended for children as its safety and effectiveness in this age group have not been established.

Elderly Patients

While population analysis suggests age doesn't significantly impact drug exposure, clinical trials lacked sufficient data on adults 65 and older to fully assess differences in response. {Link: Drugs.com https://www.drugs.com/journavx.html}

Comparison of Suzetrigine with Other Analgesics

For a comparison of suzetrigine with other pain relievers, including mechanism, addiction potential, common side effects, duration of use, and key contraindications, please refer to {Link: Drugs.com https://www.drugs.com/journavx.html}.

Conclusion

Suzetrigine offers a valuable non-opioid option for acute pain management. However, individuals with severe liver or kidney issues and those on strong CYP3A inhibitors should not take it due to safety risks and potential interactions. Always consult with a healthcare provider to ensure suzetrigine is a safe and appropriate choice.

When to Consult a Doctor Immediately

Seek immediate medical attention if you experience severe allergic reactions or other serious symptoms. For additional details on suzetrigine, including side effects and usage, consult the {Link: MedlinePlus https://medlineplus.gov/druginfo/meds/a625039.html}.

Frequently Asked Questions

If you have severe liver impairment (Child-Pugh Class C), you should not take suzetrigine. For moderate liver impairment (Child-Pugh Class B), a dose reduction is required, and your healthcare provider will need to closely monitor you.

Use of suzetrigine is not recommended for patients with an eGFR less than 15 mL/min because its safety in this population has not been studied. For those with less severe kidney impairment (eGFR > 15 mL/min), the standard dose is typically used, but caution and monitoring are advised.

You should not take suzetrigine with strong CYP3A inhibitors, such as itraconazole or clarithromycin. You should also avoid strong and moderate CYP3A inducers like rifampin and St. John's Wort. Always inform your doctor of all other medications, vitamins, and supplements you are taking.

No, you should avoid grapefruit and grapefruit juice while taking suzetrigine. Grapefruit can inhibit the CYP3A enzyme, potentially increasing the concentration of suzetrigine in your body and raising the risk of side effects.

If your hormonal contraceptive contains a progestin other than levonorgestrel or norethindrone, its effectiveness may be reduced while taking suzetrigine. You will need to use a backup nonhormonal method of birth control for the duration of treatment and for 28 days after your last dose.

The safety and efficacy of suzetrigine have not been established in pediatric patients, and it is not approved for use in children.

No, suzetrigine is only indicated for the short-term (acute) treatment of moderate to severe pain. Its safety and efficacy for longer-term, chronic pain have not been studied.