lacosamide

lacosamide

(la-kose-a-mide) ,

Vimpat

(trade name)

Classification

Therapeutic: anticonvulsants
Pregnancy Category: C

Indications

Adjunctive therapy of partial-onset seizures.

Action

Mechanism is not known, but may involve enhancement of slow inactivation of sodium channels with resultant membrane stabilization

Therapeutic effects

Decreased incidence and severity of partial-onset seizures.

Pharmacokinetics

Absorption: 100% absorbed following oral administration; IV administration results in complete bioavailability.
Distribution: Unknown.
Protein Binding: <15%.
Metabolism and Excretion: Partially metabolized by the liver; 40% excreted in urine as unchanged drug, 30% as a metabolite.
Half-life: 13 hr.

Time/action profile (blood levels)

ROUTEONSETPEAKDURATION
POunknown1–4 hr 12 hr
IVunknownend of infusion12 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity;Severe hepatic impairment; Lactation: Lactation.
Use Cautiously in: CCr <30 mL/min (use lower daily dose);All patients (may ↑ risk of suicidal thoughts/behaviors);Hepatic or renal impairment and taking strong inhibitor of CYP3A4 or CYP2C9 (dose ↓ may be needed)Mild to moderate hepatic impairment; titrate dose carefully, use lower daily dose;Known cardiac conduction problems or severe cardiac disease (heart block or sick sinus syndrome without a pacemaker, Brugada syndrome, MI or HF);Diabetic neuropathy or cardiac disease (↑ risk for atrial fibrillation/flutter) Obstetric: Use only if potential benefit justifies risk to the fetus; Pediatric: Children <17 yr (limited data available); Geriatric: Titrate dose carefully.

Adverse Reactions/Side Effects

Central nervous system

  • suicidal thoughts (life-threatening)
  • dizziness (most frequent)
  • headache (most frequent)
  • hallucinations
  • syncope
  • vertigo

Ear, Eye, Nose, Throat

  • diplopia (most frequent)

Cardiovascular

  • atrial fibrillation/flutter
  • bradycardia
  • PR interval prolongation

Dermatologic

  • drug reaction with eosinophilia and systemic symptoms (life-threatening)
  • stevens-johnson syndrome (life-threatening)
  • toxic epidermal necrolysis (life-threatening)
  • rash

Gastrointestinal

  • nausea (most frequent)
  • vomiting

Hematologic

  • agranulocytosis (life-threatening)

Neurologic

  • ataxia

Miscellaneous

  • physical dependence
  • psychological dependence
  • multiorgan hypersensitivity reactions (Drug Reaction with Eosinophilia and Systemic Symptoms—DRESS)

Interactions

Drug-Drug interaction

Use cautiously with other drugs that affect cardiac conduction.

Route/Dosage

Oral Intravenous (Adults) 50 mg twice daily; may be ↑ weekly by 100 mg/day in two divided doses up to a maintenance dose of 200–400 mg/day given in two divided doses.
Oral (Children 3–16 yr) 1 mg/kg/day divided BID initially (maximum dose: 50 mg); may be ↑ weekly by 1 mg/kg/day up to a maintenance dose of 10 mg/kg/day (maximum dose: 400 mg/day).

Hepatic/Renal Impairment

Oral Intravenous (Adults) CCr ≤30 mL/min or mild to moderate hepatic impairment—daily dose should not exceed 300 mg.

Availability

Tablets: 50 mg, 100 mg, 150 mg, 200 mg
Solution for injection: 10 mg/mL
Oral solution: 10 mg/mL

Nursing implications

Nursing assessment

  • Assess location, duration, and characteristics of seizure activity. Institute seizure precautions.
  • Monitor closely for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.
  • Assess ECG prior to therapy in patients with pre-existing cardiac disease.
  • Assess patient for skin rash frequently during therapy. Discontinue at first sign of rash; may be life-threatening. Stevens-Johnson syndrome may develop. Treat symptomatically; may recur once treatment is stopped.
  • Lab Test Considerations: May cause ↑ALT, which may return to normal without treatment.
    • Monitor CBC and platelets periodically during therapy.

Potential Nursing Diagnoses

Risk for injury (Indications)

Implementation

  • IV administration is indicated for short term replacement when PO administration is not feasible. When switching from PO to IV, initial total daily dose should be equivalent to total daily dose and frequency of PO therapy. At end of IV period, may switch to PO at equivalent daily dose and frequency of IV therapy.
  • Oral: May be administered with or without food.
    • Use a calibrated measuring device for accurate dosing of oral solution; household measures are not accurate.
  • Intravenous Administration
  • Intermittent Infusion: Diluent: May be administered undiluted or diluted with 0.9% NaCl, D5W, or LR.Concentration: 10 mg/mL. Solution is clear and colorless; do not administer solutions that are discolored or contain a precipitate. Solution is stable for 24 hr at room temperature. Discard unused portion.
  • Rate: Infuse over 30–60 min.

Patient/Family Teaching

  • Instruct patient to take lacosamide around the clock, as directed. Medication should be gradually discontinued over at least 1 wk to prevent seizures. Advise patient to read the Medication Guide before starting therapy and with each Rx refill.
  • May cause dizziness, ataxia, and syncope. Caution patient to avoid driving or other activities requiring alertness until response to medication is known. Tell patient not to resume driving until physician gives clearance based on control of seizure disorder. If syncope occurs, advise patient to lay down with legs raised until recovered and notify health care professional.
  • Inform patients and families of risk of suicidal thoughts and behavior and advise that behavioral changes, emergency or worsening signs and symptoms of depression, unusual changes in mood, or emergence of suicidal thoughts, behavior, or thoughts of self-harm should be reported to health care professional immediately.
  • Instruct patient to notify health care professional if signs of multiorgan hypersensitivity reactions (fever, rash, fatigue, jaundice, dark urine) occur.
  • Advise patient to consult health care professional before taking other Rx, OTC, or herbal preparation and to avoid taking alcohol or other CNS depressants concurrently with lacosamide.
  • Advise female patients to notify health care professional if pregnancy is planned or suspected or if breast feeding. Encourage pregnant patients to enroll in the pregnancy registry by calling 1-888-537-7734.

Evaluation/Desired Outcomes

  • Decreased seizure activity.
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References in periodicals archive ?
Contract notice: Conclusion of a non-exclusive rebate agreement pursuant to section 130a (8) sgb v on the active substance lacosamide, Atc code: N03ax18, For the period from 1.10.2019 to 30.9.2021
Release date- 25072019 - In January 2019, Vimpat (lacosamide) was approved in Japan for the treatment of partial onset seizures in children 4 years of age and older.
Under neurology's care, lacosamide is added for treatment of Mr.
The data presented in the poster are as follows:188 patients were randomized, 186 were analyzed for efficacy, and 174 completed STAR 1; 171 patients continued into STAR 2; As of December 12, 2017, 95 patients remained in the STAR 2 study; Patients were taking a wide range of antiepileptic drugs, the most common of which are levetiracetam, carbamazepine, lamotrigine, lacosamide, and valproate.
This means children who have the condition, and who are between the ages of four and 15, will now have access to lacosamide (Vimpat(r)) as adjunctive therapy in the treatment of partial-onset seizures, even if the partial seizure spreads across the brain.
M2 EQUITYBITES-March 26, 2018-AWMSG approves lacosamide as adjunctive therapy for children with epilepsy
M2 PHARMA-March 26, 2018-AWMSG approves lacosamide as adjunctive therapy for children with epilepsy
The agents of choice are phenytoin (PHT)/fosphenytoin, valproic acid (VPA), levetiracetam (LEV), and lacosamide (LCM) [68].
Lacosamide (LCM) is a novel agent that has been approved by the US Food and Drug Administration for individuals aged 4 years and older for partial-onset seizures as monotherapy or adjunctive therapy.
He was started on lacosamide 200 mg twice daily in addition to the ongoing levetiracetam increased now to 1 gm three times daily.
Twenty-four hours after propofol was stopped, the seizure suppression continued, so the ketamine infusion was gradually decreased to 75 mcg/kg/min while continuing her maintenance AED regimen, which included LEV 3000 mg q8h, ZNS 300 mg bid, oxcarbazepine 300 mg bid, and lacosamide 200 mg bid.
has gained FDA approval for a label extension of Vimpat CV (lacosamide), its anti-epileptic drag, as an oral option for the treatment of partial-onset seizures in children age 4 and older.