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Journavx: Package Insert / Prescribing Info: Highlights of Prescribing Information

JOURNAVX (suzetrigine) is a sodium channel blocker indicated for treating moderate to severe acute pain in adults, with an initial U.S. approval in 2025. The recommended starting dose is 100 mg taken on an empty stomach, followed by 50 mg every 12 hours, and it should not be used for more than 14 days. Contraindications include use with strong CYP3A inhibitors, and common side effects include pruritus, muscle spasms, and rash.

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106 views3 pages

Journavx: Package Insert / Prescribing Info: Highlights of Prescribing Information

JOURNAVX (suzetrigine) is a sodium channel blocker indicated for treating moderate to severe acute pain in adults, with an initial U.S. approval in 2025. The recommended starting dose is 100 mg taken on an empty stomach, followed by 50 mg every 12 hours, and it should not be used for more than 14 days. Contraindications include use with strong CYP3A inhibitors, and common side effects include pruritus, muscle spasms, and rash.

Uploaded by

quyenthuftu59
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Journavx: Package Insert /

Prescribing Info
Package insert / product label
Generic name: suzetrigine
Dosage form: tablet, film coated
Medically reviewed by Drugs.com. Last updated on Feb 11, 2025.

On This Page

Indications and Usage


Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
Adverse Reactions/Side Effects
Drug Interactions
Use In Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
Clinical Studies
How Supplied/Storage and Handling
Storage and Handling
Patient Counseling Information

Highlights of Prescribing Information

These highlights do not include all the information needed to use


JOURNAVX safely and effectively. See full prescribing information for
JOURNAVX.

JOURNAVX (suzetrigine) tablets, for oral use

Initial U.S. Approval: 2025


Indications and Usage for Journavx

JOURNAVX is a sodium channel blocker indicated for the treatment of


moderate to severe acute pain in adults. (1)

Journavx Dosage and Administration

● Swallow JOURNAVX tablets whole and do not chew or crush. (2.1)


● Recommended starting JOURNAVX oral dose is 100 mg. 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). (2.1)
● Starting 12 hours after the starting dose, take 50 mg of JOURNAVX
orally every 12 hours. Take these doses with or without food. (2.1)
● Use JOURNAVX for the shortest duration, consistent with
individual patient treatment goals. Use of JOURNAVX for the
treatment of acute pain has not been studied beyond 14 days. (2.1)
● See the full prescribing information for the recommended dosage
in patients with hepatic impairment (2.2), for JOURNAVX dosage
modifications with concomitant use of CYP3A inhibitors (2.3), and
recommendations regarding missed dose(s). (2.4)
● Avoid food or drink containing grapefruit during treatment with
JOURNAVX. (2.3)

Dosage Forms and Strengths

Tablets: 50 mg (3)

Contraindications

● Concomitant use with strong CYP3A inhibitors is contraindicated.


(4)

Warnings and Precautions


Moderate and Severe Hepatic Impairment: Avoid use in patients with severe
hepatic impairment (Child-Pugh Class C). Use in patients with moderate
hepatic impairment may increase the risk of adverse reactions. The
recommended dosage is lower in patients with moderate hepatic impairment
(Child-Pugh Class B) than those with normal hepatic function. (5.4)

Adverse Reactions/Side Effects

The most common adverse reactions (greater incidence in JOURNAVX-


treated patients compared to placebo-treated patients) were pruritus,
muscle spasms, increased creatine phosphokinase, and rash. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Vertex


Pharmaceuticals Incorporated at 1-877-634-8789 or FDA at 1-800-FDA-
1088 or www.fda.gov/medwatch.

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