lacosamide (Rx)

Brand and Other Names:Vimpat
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet: Schedule V

  • 50mg
  • 100mg
  • 150mg
  • 200mg

injectable solution: Schedule V

  • 200mg/20mL

oral solution: Schedule V

  • 10mg/mL
more...

Partial Onset Seizures

Indicated as monotherapy or adjunctive therapy for partial onset seizures in adults and children aged ≥4 years

Monotherapy

  • 100 mg PO/IV q12hr initially, THEN, based on response and tolerability, increase dose at weekly intervals by 50 mg PO/IV BID; up to a recommended dose of 150-200 mg BID (300-400 mg/day)
  • Alternate loading dose schedule: 200 mg PO/IV as a single loading dose, followed 12 hr later by 100 mg PO/IV BID; THEN increase dose at weekly intervals by 50 mg BID; up to a recommended dose of 150-200 mg BID (300-400 mg/day)
  • In patients already taking an antiepileptic drug (AED), maintain lacosamide at recommended maintenance dose of 150-200 mg PO BID for at least 3 days before initiating withdrawal of the previous AED

Adjunctive therapy

  • Initial: 50 mg PO/IV q12hr
  • Based on response and tolerability, increase dose at weekly intervals by 50 mg PO/IV BID; up to a recommended dose of 100-200 mg BID (200-400 mg/day)

Dosage Modifications

Renal impairment

  • Mild-to-moderate: no dose adjustment required
  • Severe (CrCl <30 mL/min) or ESRD: Reduce maximum dosage by 25%
  • Hemodialysis: Consider supplementing with up to 50% of dose after 4-hr dialysis session
  • Coadministration with strong CYP3A4 or CYP2C9 inhibitors: Lacosamide systemic exposure may increase; consider dose reduction

Hepatic impairment

  • Mild-to-moderate: No dose adjustment required
  • Severe: Not recommended
  • Coadministration with strong CYP3A4 or CYP2C9 inhibitors: Lacosamide systemic exposure may increase; consider dose reduction

Dosing Considerations

IV administration indicated as short-term replacement (up to 5 consecutive days) when PO administration is not feasible

Conversion from singe AED to lacosamide monotherapy

  • Patients currently treated with a single antiepileptic (AED) who will convert to lacosamide monotherapy, withdrawal of the concomitant AED should not occur until the therapeutic dosage of lacosamide is achieved and has been administered for at least 3 days
  • Gradual withdrawal of the initial AED over at least 6 weeks is recommended
  • When discontinuing lacosamide, gradually withdraw treatment over at least 1 week is recommended

Dosage Forms & Strengths

tablet: Schedule V

  • 50mg
  • 100mg
  • 150mg
  • 200mg

oral solution: Schedule V

  • 10mg/mL
more...

Partial Onset Seizures

Tabletsa and oral solution indicated as monotherapy or adjunctive therapy for partial onset seizures in children aged ≥4 years; IV administration is not indicated in children aged <17 years

<4 years: Safety and efficacy not established

4-17 years

  • 11 to <30 kg: 1 mg/kg PO BID, THEN, based on response and tolerability, increase dose at weekly intervals by 1 mg/kg PO BID; up to a recommended 3-6 mg/kg PO BID (6-12 mg/kg/day)
  • 30 to <50 kg: 1 mg/kg PO BID, THEN, based on response and tolerability, increase dose at weekly intervals by 1 mg/kg PO BID; up to a recommended 2-4 mg/kg PO BID (4-8 mg/kg/day)
  • ≥50 kg: 50 mg PO BID, THEN, based on response and tolerability, increase dose at weekly intervals by 50 mg PO BID; up to a recommended 150-200 mg PO BID (300-400 mg/day)

Dosage Modifications

Renal impairment

  • Mild-to-moderate: no dose adjustment required
  • Severe (CrCl <30 mL/min) or ESRD: Reduce maximum dosage by 25%
  • Hemodialysis: Consider supplementing with up to 50% of dose after 4-hr dialysis session
  • Coadministration with strong CYP3A4 or CYP2C9 inhibitors: Lacosamide systemic exposure may increase; consider dose reduction

Hepatic impairment

  • Mild-to-moderate: No dose adjustment required
  • Severe: Not recommended
  • Coadministration with strong CYP3A4 or CYP2C9 inhibitors: Lacosamide systemic exposure may increase; consider dose reduction

Dosing Considerations

IV administration indicated as short-term replacement (up to 5 consecutive days) when PO administration is not feasible

Conversion from singe AED to lacosamide monotherapy

  • Patients currently treated with a single antiepileptic (AED) who will convert to lacosamide monotherapy, withdrawal of the concomitant AED should not occur until the therapeutic dosage of lacosamide is achieved and has been administered for at least 3 days
  • Gradual withdrawal of the initial AED over at least 6 weeks is recommended
  • When discontinuing lacosamide, gradually withdraw treatment over at least 1 week is recommended
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Interactions

Interaction Checker

and lacosamide

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Tablets and oral solution

            • Dizziness (16-53%)
            • Diplopia (6-16%)
            • Blurred vision (2-16%)
            • Nausea (7-17%)
            • Vomiting (6-16%)
            • Fatigue (7-15%)
            • Ataxia (11-14%)
            • Nystagmus (2-10%)

            IV

            • Fatigue (20-63%)
            • Somnolence (26-34%)
            • Headache (4-16%)
            • Diplopia (4-20%)
            • Nausea (14-24%)
            • Dry mouth (6-12%)
            • Vomiting (4-12%)
            • Fatigue (12-18%)
            • Chest pain (3-12%)

            1-10%

            Tablets and oral solution

            • Nystagmus (2-10%)
            • Memory impairment (1-6%)
            • Balance disorder (1-6%)
            • Diarrhea (3-5%)
            • Gait disturbance (<1-4%)
            • Asthenia (1-3%)
            • Vertigo (1-4%)
            • Pruritus (2-3%)
            • Depression (2%)

            IV

            • Oral paresthesia (4-8%)
            • Oral hypoesthesia (5-8%)
            • Diarrhea (4-8%)
            • Paresthesia (4-8%)
            • Gait disturbance (2-8%)
            • Hyperhidrosis (2-8%)
            • Tremor (4-6%)
            • Abnormal coordination (3-6%)
            • Pruritus (4-6%)

            Frequency Not Reported

            Blood and lymphatic system disorders: Neutropenia, anemia

            Cardiac disorders: Palpitations Ear and labyrinth disorders: Tinnitus

            Gastrointestinal disorders: Constipation, dyspepsia, dry mouth, oral hypoaesthesia

            General disorders and administration site conditions: Irritability, pyrexia, feeling drunk

            Injury, poisoning, and procedural complications: Fall

            Musculoskeletal and connective tissue disorders: Muscle spasms

            Nervous system disorders: Paresthesia, cognitive disorder, hypesthesia, dysarthria, disturbance in attention, cerebellar syndrome

            Psychiatric disorders: Confusional state, mood altered, depressed mood

            Postmarketing Reports

            Blood and lymphatic system disorders: Agranulocytosis

            Psychiatric disorders: Aggression, agitation, hallucination, insomnia, psychotic disorder

            Skin and subcutaneous tissue disorders: Angioedema, rash, urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis

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            Warnings

            Contraindications

            None

            Cautions

            Increase the risk of suicidal thoughts or behavior; monitor for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior

            Dizziness and ataxia reported; may impair ability to perform hazardous tasks

            Dose-dependent prolongations in PR interval observed in clinical studies in patients and in healthy volunteers; caution in patients with known conduction problems (eg, marked first-degree AV block, second-degree or higher AV block, and sick sinus syndrome without pacemaker), sodium channelopathies (eg, Brugada Syndrome), on concomitant medications that prolong PR interval, or with severe cardiac disease (eg, myocardial ischemia, heart failure, or structural heart disease)

            Increased incidence of syncope in patients with diabetic neuropathy

            Blurred vision and diplopia may occur during therapy; consider increased monitoring in patients with preexisting ocular conditions or vision-related issues

            Oral solution contains aspartame, a source of phenylalanine; 200 mg dose (20 mL) contains 0.32 mg of phenylalanine

            Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multi-organ hypersensitivity, reported with antiepileptic drugs; some of these events have been fatal or life- threatening; monitor for signs and symptoms of possible disparate manifestations associated with lymphatic hepatic, renal, and/or hematologic organ systems; may require gradual discontinuation and conversion to alternate therapy

            Use caution in renal and hepatic impairment; dosage adjustments may be required

            Withdraw gradually over 1 week; do not discontinue abruptly because of risk for increased frequency of seizures

            Drug interactions overview

            • Patients with renal or hepatic impairment who are taking strong CYP3A4 and CYP2C9 inhibitors may have a significant increase in exposure to lacosamide; dose reduction may be necessary
            • Concomitant medications that prolong PR interval
              • Caution if coadministered with medications that prolong PR interval because of risk for AV block or bradycardia, (eg, beta-blockers, calcium channel blockers)
              • Obtain an ECG before initiating and after titrated to steady-state; additionally, monitor closely if administered IV
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            Pregnancy & Lactation

            Pregnancy

            There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs); to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/

            There are no adequate data on the developmental risks associated with lacosamide use in pregnant women

            Lacosamide produced developmental toxicity (increased embryofetal and perinatal mortality, growth deficit) in rats following administration during pregnancy

            Developmental neurotoxicity was observed in rats following administration during a period of postnatal development corresponding to the third trimester of human pregnancy

            Lactation

            There are no data on the presence of lacosamide in human milk, the effects on the breastfed infant, or the effects on milk production

            Studies in lactating rats have shown excretion of lacosamide and/or its metabolites in milk

            Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for lacosamide and any potential adverse effects on the breastfed infant from lacosamide or from the underlying maternal condition

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Antiepileptic effects unknown; may slowly inactivate voltage-gated Na channels

            Binds to collapsin response mediator protein-2 (CRMP-2), a phosphoprotein that is expressed mainly in the nervous system and is involved in neuronal differentiation and control of axonal outgrowth

            Absorption

            Bioavailability: ~100%

            Peak plasma time: 1-4 hr

            Distribution

            Protein bound: <15%

            Vd: 0.6 L/kg

            Metabolism

            Predominantly by CYP isoenzymes 3A4 and 2C9; also 2C19

            Major metabolite: O-desmethyl-lacosamide (inactive)

            Elimination

            Half-life: 13 hr

            Primarily eliminated by renal excretion and biotransformation

            Excretion: 95% urine; <5% feces

            Dialyzable: Yes (hemodialysis)

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            Administration

            IV Compatibility

            0.9% NaCl, D5W, LR

            IV Preparation

            May be administered without dilution or diluted in compatible solutions; (see IV Compatibility)

            Visually inspect for particulate matter and discoloration prior to administration, whenever solution and container permit

            Product with particulate matter or discoloration should not be used

            Vials is for single-dose only; discard any unused portion of lacosamide injection

            IV Administration

            Infuse IV over 15-60 min; 30-60 min preferable, and should be used when a 15 min administration is not required

            IV lacosamide may cause bradycardia or AV bock in patients with underlying cardiac disease

            Monitor infusion closely patients with known cardiac conduction problems, on concomitant medications that prolong PR interval, or with severe cardiac disease (eg, myocardial ischemia, heart failure)

            Oral Administration

            Tablets or oral solution: Take with or without food

            Oral solution

            • Use calibrated measuring device to measure and deliver the prescribed dose accurately
            • May be administered using a nasogastric tube or gastrostomy tube; discard any unused lacosamide oral solution remaining after 7 weeks of first opening the bottle

            Storage

            Tablet: Store at room temperature, 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F); do not freeze lacosamide oral solution

            Oral solution: Store at room temperature, 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F); do not freeze lacosamide oral solution; discard any unused oral solution remaining after 7 weeks of first opening the bottle

            Injection: Store at room temperature, 20-25°C (68-77°F); excursions are permitted between 15-30°C (59-86°F); do not freeze

            Diluted IV solution: Store at room temperature, 20-25°C (68-77°F); for up to 4 hr

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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