lacosamide

(redirected from Vimpat)

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 ?
UCB's Vimpat, on the market for just over three years, captures 8 percent patient share -- on par with more established AEDs, such as Novartis' Trileptal, UCB's Keppra XR and Abbott's Depakote.
SeeNews) - Nov 5, 2013 - Belgian biopharmaceuticals firm UCB (EBR:UCB) said Monday the US Food and Drug Administration (FDA) had accepted a supplemental new drug application (sNDA) for Vimpat as monotherapy for partial-onset seizures in adults with epilepsy.
According to UCB, the result was boosted by new products like Cimzia, Vimpat and Neupro, and also by its established product portfolio.
The findings also reveal that several third-generation AEDs--particularly UCB's Vimpat, Sunovion/Bial/Eisai's Zebinix/Stedesa, GlaxoSmithKline/Valeant's Potiga/Trobalt, Eisai's perampanel and UCB's Rikelta--have and will continue to offer new therapeutic options to epilepsy patients as adjunctive agents.
New indication and administration options broaden the clinical application of VIMPAT, making it available to more adults in the U.
The decline was, however, almost fully offset by 27% higher sales toA EUR 847 million of the group's core medicinesA Cimzia, Vimpat and Neupro.
UCB itself has three blockbusters -- Cimzia, Vimpat and Neupro -- which are expected to generate EUR 3.
The epilepsy market has become increasingly competitive following the launch of Vimpat (lacosamide; UCB) in the US in May 2009 and patent expiries of the top four second-generation anticonvulsant drugs over 2008-09.
Net sales of the anti-epileptic drug Keppra decreased by 23% to EUR 171 million in the first three months of 2013 but were partly offset by the solid growth of Cimzia, Vimpat and Neupro.
Vimpat and Fentora are some of the pipeline candidates in the regulatory filing stage for approval.
Cimzia, Vimpat and Neupro generated combined net sales of EUR 433 million, while anti-epilepticA drugA Keppra reached EUR 190 million.
By the pharmaceutical company for all medicines called Vimpat with lacosamide (discount drugs) for the period 1.