Suzetrigine
Generic Name: suzetrigine
Brand Names:
Journavx
11 DESCRIPTION The active ingredient in JOURNAVX (suzetrigine) tablets is suzetrigine, a sodium channel blocker, which has the following chemical name: 4-[(2 R ,3 S ,4 S ,5 R )-3-(3,4-difluoro-2-methoxyphenyl)-4,5-dimethyl-5-(trifluoromethyl)oxolane-2-amido]pyridine-2-carboxamide. Its molecular formula is C 21 H 20 F 5 N 3 O 4 . Suzetrigine's molecular weight is 473.39 g/mol.
Overview
11 DESCRIPTION The active ingredient in JOURNAVX (suzetrigine) tablets is suzetrigine, a sodium channel blocker, which has the following chemical name: 4-[(2 R ,3 S ,4 S ,5 R )-3-(3,4-difluoro-2-methoxyphenyl)-4,5-dimethyl-5-(trifluoromethyl)oxolane-2-amido]pyridine-2-carboxamide. Its molecular formula is C 21 H 20 F 5 N 3 O 4 . Suzetrigine's molecular weight is 473.39 g/mol.
Uses
1 INDICATIONS AND USAGE JOURNAVX is indicated for the treatment of moderate to severe acute pain, including postoperative pain, in adults. JOURNAVX is a sodium channel blocker indicated for the treatment of moderate to severe acute pain, including postoperative pain, in adults. ( 1 )
Dosage
2 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.
Side Effects
6 ADVERSE REACTIONS 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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Interactions
7 DRUG INTERACTIONS Strong and Moderate CYP3A inhibitors : Concomitant use with strong CYP3A inhibitors is contraindicated. Reduce the JOURNAVX dose when used concomitantly with moderate CYP3A inhibitors. Avoid food or drink containing grapefruit. ( 2.3 , 7.1 , 12.3 ) Strong and Moderate CYP3A inducers : Avoid JOURNAVX use with strong or moderate CYP3A inducers. ( 7.1 , 12.3 ) 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.
Warnings
5 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 ) 5.1 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 [see Drug Interactions (7.1) , Clinical Pharmacology (12.3) ] . 4 CONTRAINDICATIONS Concomitant use of JOURNAVX with strong CYP3A inhibitors is contraindicated [see Warnings and Precautions (5.1) , Drug Interactions (7.1) ] . Concomitant use with strong CYP3A inhibitors is contraindicated. ( 4 )
Pregnancy
8.1 Pregnancy 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.
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) [see USP Controlled Room Temperature].
Frequently Asked Questions
What is Suzetrigine used for?▼
1 INDICATIONS AND USAGE JOURNAVX is indicated for the treatment of moderate to severe acute pain, including postoperative pain, in adults. JOURNAVX is a sodium channel blocker indicated for the treatment of moderate to severe acute pain, including postoperative pain, in adults. ( 1 )
What are the side effects of Suzetrigine?▼
6 ADVERSE REACTIONS 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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Can I take Suzetrigine during pregnancy?▼
8.1 Pregnancy 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.
What are the important warnings for Suzetrigine?▼
5 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 ) 5.1 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 [see Drug Interactions (7.1) , Clinical Pharmacology (12.3) ] . 4 CONTRAINDICATIONS Concomitant use of JOURNAVX with strong CYP3A inhibitors is contraindicated [see Warnings and Precautions (5.1) , Drug Interactions (7.1) ] . Concomitant use with strong CYP3A inhibitors is contraindicated. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.