Suzetrigine

Suzetrigine is a prescription medication indicated for the treatment of moderate-to-severe acute pain.

• Suzetrigine is available under the following different brand names: Journavx

Common side effects of Suzetrigine include:

• itching
• muscle spasms
• increased blood level of creatine phosphokinase
• rash

Serious side effects of Suzetrigine include:

• not available

Rare side effects of Suzetrigine include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Tablet

• 50 mg

Acute pain

Adult dosage

Initial dose

• 100 mg orally
• Take on an empty stomach at least 1 hour before or 2 hours after food to avoid delay in the onset of action
• Clear liquids may be consumed during this time (eg, water, apple juice, vegetable broth, tea, black coffee)

Subsequent doses

• Start 12 hours after the initial dose
• 50 mg orally every 12 hours
• May take these doses with or without food
• Use for the shortest duration consistent with individual patient treatment goals
• Use not studied beyond 14 days

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Suzetrigine has no noted severe interactions with any other drugs
• Suzetrigine has no noted serious interactions with any other drugs
• Suzetrigine has no noted moderate interactions with any other drugs
• Suzetrigine has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Coadministration with strong CYP3A inhibitors

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Suzetrigine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Suzetrigine?”

Cautions

• Hepatic impairment
• Moderate (Child-Pugh B)
  • Higher systemic exposures of suzetrigine and M6-SUZ (active metabolite) compared with normal hepatic function
  • May increase the risk of adverse effects
  • Lower doses recommended
• Severe (Child-Pugh C)
  • Avoid use
  • Drug interaction overview
  • Suzetrigine: Moderately sensitive CYP3A substate
  • M6-SUZ (active metabolite): Moderately sensitive CYP3A substrate
• Strong CYP3A inhibitors
  • Contraindicated
  • Coadministration increases suzetrigine and M6-SUZ exposure by 4.8-fold and 4.4-fold, respectively
• Moderate CYP3A inhibitors
• Modify dose
  • Reduce Suzetrigine dose
  • Coadministration may increase the risk of suzetrigine adverse effects
• Strong or moderate CYP3A inducers
• Avoid
  • Coadministration reduces exposures of suzetrigine and M6-SUZ, which may result in reduced efficacy
• Sensitive CYP3A substrates
  • Suzetrigine may reduce systemic exposure of sensitive CYP3A substrates
  • Follow substrate recommendations for use with weak CYP3A inducers
• Hormonal contraceptives
• Modify dose
  • Coadministration may reduce systemic exposure to hormonal contraceptives
  • Advise patients using hormonal contraceptives containing progestins (other than levonorgestrel and norethindrone) to use additional nonhormonal contraceptives (e.g, condoms), or
  • Use alternative contraceptives (e.g., combined oral contraceptive containing ethinyl estradiol and levonorgestrel or norethindrone, or an intrauterine system) during treatment with Suzetrigine and for 28 days after discontinuing

Pregnancy and Lactation

• Data are unavailable regarding use during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes
• 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 suzetrigine treatment and for 28 days after discontinuing
• Infertility
• May reversibly impact the likelihood of females of reproductive potential becoming pregnant while on treatment
• Patients using contraceptives should continue to use contraceptives
• Animal studies
  • In a female fertility study in rats, increased preimplantation loss was observed at oral suzetrigine doses of 2.2x the MRHD and greater when administered before mating and through gestation day 7
  • After suzetrigine was discontinued for 4 weeks, increased preimplantation loss in rats was not observed
  • Findings in rats may be explained by the suzetrigine effect on rat progesterone receptors, which are more sensitive to suzetrigine than humans based on in vitro studies
  • These findings are of uncertain relevance to humans
• Lactation
  • Data are unavailable regarding the presence of suzetrigine or its metabolites in human milk, its effects on breastfed infants, or milk production
  • Suzetrigine is present in animal milk