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

Partial Onset Seizures

Indicated as monotherapy or adjunctive therapy for partial onset seizures

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) OR
  • Alternate initial 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)

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)

Conversion from single AED to lacosamide monotherapy

  • Maintain lacosamide at recommended maintenance dose for at least 3 days before initiating withdrawal of the previous AED
  • 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

Primary Generalized Tonic-Clonic Seizures

Indicated as adjunctive therapy for primary generalized tonic-clonic seizures

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

Dosage Forms & Strengths

tablet: Schedule V

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

injectable solution: Schedule V

  • 200mg/20mL

oral solution: Schedule V

  • 10mg/mL

Partial Onset Seizures

Indicated as monotherapy or adjunctive therapy for partial-onset seizures in children aged ≥1 month

<1 month: Safety and efficacy not established

1 month to 17 years

  • <6 kg:

    • Intravenous: 0.66 mg/kg TID, THEN, based on response and tolerability, increase dose at weekly intervals by 0.66 mg/kg TID; up to a recommended 2.5-5 mg/kg TID (7.5-15 mg/kg/day)
    • Oral: 1 mg/kg BID (2 mg/kg/day), THEN, based on response and tolerability, increase dose at weekly intervals by 1 mg/kg BID (2 mg/kg/day), up to 3.75-7.5 mg/kg BID (7.5-15 mg/kg/day)
  • 6 to <30 kg: 1 mg/kg PO/IV BID, THEN, based on response and tolerability, increase dose at weekly intervals by 1 mg/kg PO/IV BID, up to recommended 3-6 mg/kg PO/IV BID (6-12 mg/kg/day)
  • 30 to <50 kg: 1 mg/kg PO/IV BID, THEN, based on response and tolerability, increase dose at weekly intervals by 1 mg/kg PO/IV BID, up to recommended 2-4 mg/kg PO BID (4-8 mg/kg/day)
  • ≥50 kg: 50 mg PO/IV BID, THEN, based on response and tolerability, increase dose at weekly intervals by 50 mg PO/IV BID, up to recommended 150-200 mg PO/IV BID (300-400 mg/day) for monotherapy or 100-200 mg PO/IV BID (200-400 mg/day) for adjunctive therapy

Conversion from single AED to lacosamide monotherapy

  • Maintain lacosamide at recommended maintenance dose for at least 3 days before initiating withdrawal of the previous AED
  • 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

Primary Generalized Tonic-Clonic Seizures

Indicated as adjunctive therapy for primary generalized tonic-clonic seizures in patients aged ≥4 years with idiopathic generalized epilepsy

<4 years: Safety and efficacy not established

4-17 years

  • 11 to <30 kg: 1 mg/kg PO/IV BID, THEN, based on response and tolerability, increase dose at weekly intervals by 1 mg/kg PO/IV BID, up to recommended 3-6 mg/kg PO/IV BID (6-12 mg/kg/day)
  • 30 to <50 kg: 1 mg/kg PO/IV BID, THEN, based on response and tolerability, increase dose at weekly intervals by 1 mg/kg PO/IV BID, up to recommended 2-4 mg/kg PO/IV BID (4-8 mg/kg/day)
  • ≥50 kg: 50 mg PO/IV BID, THEN, based on response and tolerability, increase dose at weekly intervals by 50 mg PO/IV BID, up to recommended 150-200 mg PO/IV BID (300-400 mg/day) for monotherapy or 100-200 mg PO/IV BID (200-400 mg/day) for adjunctive therapy

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

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Interactions

Interaction Checker

and lacosamide

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            Contraindicated (0)

              Serious - Use Alternative (8)

              • abametapir

                abametapir will increase the level or effect of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For 2 weeks after abametapir application, avoid taking drugs that are CYP3A4 substrates. If not feasible, avoid use of abametapir.

              • apalutamide

                apalutamide will decrease the level or effect of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible. Evaluate for loss of therapeutic effect if medication must be coadministered. Adjust dose according to prescribing information if needed.

              • fexinidazole

                fexinidazole will increase the level or effect of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Fexinidazole inhibits CYP3A4. Coadministration may increase risk for adverse effects of CYP3A4 substrates.

              • idelalisib

                idelalisib will increase the level or effect of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Idelalisib is a strong CYP3A inhibitor; avoid coadministration with sensitive CYP3A substrates

              • ivosidenib

                ivosidenib will decrease the level or effect of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of sensitive CYP2C9 substrates with ivosidenib or replace with alternate therapies. If coadministration is unavoidable, monitor patients for loss of therapeutic effect of these drugs.

              • metoclopramide intranasal

                lacosamide, metoclopramide intranasal. Either increases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Avoid use of metoclopramide intranasal or interacting drug, depending on importance of drug to patient.

              • tucatinib

                tucatinib will increase the level or effect of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid concomitant use of tucatinib with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. If unavoidable, reduce CYP3A substrate dose according to product labeling.

              • voxelotor

                voxelotor will increase the level or effect of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Voxelotor increases systemic exposure of sensitive CYP3A4 substrates. Avoid coadministration with sensitive CYP3A4 substrates with a narrow therapeutic index. Consider dose reduction of the sensitive CYP3A4 substrate(s) if unable to avoid.

              Monitor Closely (58)

              • alpelisib

                alpelisib will decrease the level or effect of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely.

              • apalutamide

                apalutamide will decrease the level or effect of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Coadministration of apalutamide, a weak CYP2C9 inducer, with drugs that are CYP2C9 substrates can result in lower exposure to these medications. Evaluate for loss of therapeutic effect if medication must be coadministered.

              • atazanavir

                atazanavir increases effects of lacosamide by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of PR prolongation and cardiac arrhythmias.

                atazanavir increases levels of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP3A4 inhibitors.

              • cannabidiol

                cannabidiol will increase the level or effect of lacosamide by decreasing metabolism. Modify Therapy/Monitor Closely. Cannabidiol may potentially inhibit CYP2C9 activity. Consider reducing the dose when concomitantly using CYP2C9 substrates.

              • capecitabine

                capecitabine increases levels of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP2C9 inhibitors.

              • carbamazepine

                carbamazepine will decrease the level or effect of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • cenobamate

                cenobamate will decrease the level or effect of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increase dose of CYP3A4 substrate, as needed, when coadministered with cenobamate.

              • clarithromycin

                clarithromycin increases levels of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP3A4 inhibitors.

              • conivaptan

                conivaptan increases levels of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP3A4 inhibitors.

              • daridorexant

                lacosamide and daridorexant both increase sedation. Modify Therapy/Monitor Closely. Coadministration increases risk of CNS depression, which can lead to additive impairment of psychomotor performance and cause daytime impairment.

              • darunavir

                darunavir increases levels of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP3A4 inhibitors.

              • deutetrabenazine

                lacosamide and deutetrabenazine both increase sedation. Use Caution/Monitor.

              • difelikefalin

                difelikefalin and lacosamide both increase sedation. Use Caution/Monitor.

              • elagolix

                elagolix decreases levels of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Elagolix is a weak-to-moderate CYP3A4 inducer. Monitor CYP3A substrates if coadministered. Consider increasing CYP3A substrate dose if needed.

              • elvitegravir/cobicistat/emtricitabine/tenofovir DF

                elvitegravir/cobicistat/emtricitabine/tenofovir DF increases levels of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP3A4 inhibitors.

              • eslicarbazepine acetate

                eslicarbazepine acetate will increase the level or effect of lacosamide by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.

              • fedratinib

                fedratinib will increase the level or effect of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.

              • fluconazole

                fluconazole increases levels of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP2C9 inhibitors.

              • fluorouracil

                fluorouracil increases levels of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP2C9 inhibitors.

              • flurbiprofen

                flurbiprofen increases levels of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP2C9 inhibitors.

              • fosamprenavir

                fosamprenavir increases levels of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP3A4 inhibitors.

              • fosphenytoin

                fosphenytoin will decrease the level or effect of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • gemfibrozil

                gemfibrozil increases levels of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP2C9 inhibitors.

              • ibuprofen

                ibuprofen increases levels of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP2C9 inhibitors.

              • ibuprofen IV

                ibuprofen IV increases levels of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP2C9 inhibitors.

              • imatinib

                imatinib increases levels of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP3A4 inhibitors.

              • indinavir

                indinavir increases levels of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP3A4 inhibitors.

              • indomethacin

                indomethacin increases levels of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP2C9 inhibitors.

              • isoniazid

                isoniazid increases levels of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP3A4 inhibitors.

              • istradefylline

                istradefylline will increase the level or effect of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. This effect was not observed with istradefylline 20 mg/day. Consider dose reduction of sensitive CYP3A4 substrates.

              • itraconazole

                itraconazole increases levels of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP3A4 inhibitors.

              • ketoconazole

                ketoconazole increases levels of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. 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 in these patients.

                ketoconazole increases levels of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely. 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 in these patients.

              • levoketoconazole

                levoketoconazole increases levels of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely. 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 in these patients.

                levoketoconazole increases levels of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. 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 in these patients.

              • lopinavir

                lopinavir increases levels of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP3A4 inhibitors.

              • lumacaftor/ivacaftor

                lumacaftor/ivacaftor, lacosamide. affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. In vitro studies suggest that lumacaftor may induce and ivacaftor may inhibit CYP2C9 substrates. .

              • mefenamic acid

                mefenamic acid increases levels of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP2C9 inhibitors.

              • midazolam intranasal

                midazolam intranasal, lacosamide. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Concomitant use of barbiturates, alcohol, or other CNS depressants may increase the risk of hypoventilation, airway obstruction, desaturation, or apnea and may contribute to profound and/or prolonged drug effect.

              • mifepristone

                mifepristone will increase the level or effect of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • mitotane

                mitotane decreases levels of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Mitotane is a strong inducer of cytochrome P-4503A4; monitor when coadministered with CYP3A4 substrates for possible dosage adjustments.

              • nefazodone

                nefazodone increases levels of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP3A4 inhibitors.

              • nelfinavir

                nelfinavir, lacosamide. Either increases levels of the other by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP3A4 inhibitors.

              • nicardipine

                nicardipine, lacosamide. Either increases levels of the other by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP3A4 inhibitors.

                nicardipine increases levels of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP2C9 inhibitors.

              • nitisinone

                nitisinone will increase the level or effect of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Nitisinone inhibits CYP2C9. Caution if CYP2C9 substrate coadministered, particularly those with a narrow therapeutic index.

              • orlistat

                orlistat decreases levels of lacosamide by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Risk of convulsions.

              • piroxicam

                piroxicam increases levels of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP2C9 inhibitors.

              • posaconazole

                posaconazole, lacosamide. Either increases levels of the other by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP3A4 inhibitors.

              • quinidine

                quinidine, lacosamide. Either increases levels of the other by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP3A4 inhibitors.

              • ritonavir

                ritonavir increases levels of lacosamide by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Potential for increased toxicity. Use alternatives if available. Increased risk of PR prolongation and cardiac arrhythmias.

                ritonavir, lacosamide. Either increases levels of the other by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP3A4 inhibitors.

              • saquinavir

                saquinavir increases levels of lacosamide by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Potential for increased toxicity. Use alternatives if available. Increased risk of PR prolongation and cardiac arrhythmias.

                saquinavir increases levels of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP3A4 inhibitors.

              • sevelamer

                sevelamer decreases levels of lacosamide by increasing elimination. Use Caution/Monitor.

              • stiripentol

                stiripentol, lacosamide. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Stiripentol is a CYP3A4 inhibitor and inducer. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. CYP3A4 substrates may require dosage adjustment.

              • sulfadiazine

                sulfadiazine increases levels of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP2C9 inhibitors.

              • sulfamethoxazole

                sulfamethoxazole increases levels of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP2C9 inhibitors.

              • tazemetostat

                tazemetostat will decrease the level or effect of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • tecovirimat

                tecovirimat will decrease the level or effect of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Tecovirimat is a weak CYP3A4 inducer. Monitor sensitive CYP3A4 substrates for effectiveness if coadministered.

              • tipranavir

                tipranavir increases levels of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP3A4 inhibitors.

              • tolbutamide

                tolbutamide increases levels of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP2C9 inhibitors.

              • voriconazole

                voriconazole increases levels of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP3A4 inhibitors.

                voriconazole increases levels of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP2C9 inhibitors.

              Minor (18)

              • acetaminophen

                lacosamide decreases levels of acetaminophen by increasing metabolism. Minor/Significance Unknown. Enhanced metabolism incr levels of hepatotoxic metabolites.

              • acetaminophen IV

                lacosamide decreases levels of acetaminophen IV by increasing metabolism. Minor/Significance Unknown. Enhanced metabolism incr levels of hepatotoxic metabolites.

              • acetaminophen rectal

                lacosamide decreases levels of acetaminophen rectal by increasing metabolism. Minor/Significance Unknown. Enhanced metabolism incr levels of hepatotoxic metabolites.

              • atracurium

                lacosamide decreases effects of atracurium by pharmacodynamic antagonism. Minor/Significance Unknown.

              • biotin

                lacosamide decreases levels of biotin by unspecified interaction mechanism. Minor/Significance Unknown. Biotin supplementation may be necessary.

              • cisatracurium

                lacosamide decreases effects of cisatracurium by pharmacodynamic antagonism. Minor/Significance Unknown.

              • cyanocobalamin

                lacosamide decreases levels of cyanocobalamin by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.

              • dexmethylphenidate

                dexmethylphenidate increases effects of lacosamide by decreasing metabolism. Minor/Significance Unknown.

              • levocarnitine

                lacosamide decreases levels of levocarnitine by unspecified interaction mechanism. Minor/Significance Unknown.

              • onabotulinumtoxinA

                lacosamide decreases effects of onabotulinumtoxinA by pharmacodynamic antagonism. Minor/Significance Unknown.

              • pancuronium

                lacosamide decreases effects of pancuronium by pharmacodynamic antagonism. Minor/Significance Unknown.

              • rapacuronium

                lacosamide decreases effects of rapacuronium by pharmacodynamic antagonism. Minor/Significance Unknown.

              • ribociclib

                ribociclib will increase the level or effect of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • rocuronium

                lacosamide decreases effects of rocuronium by pharmacodynamic antagonism. Minor/Significance Unknown.

              • sage

                sage decreases effects of lacosamide by pharmacodynamic antagonism. Minor/Significance Unknown. Theoretical interaction; some species of sage may cause convulsions.

              • serdexmethylphenidate/dexmethylphenidate

                serdexmethylphenidate/dexmethylphenidate increases effects of lacosamide by decreasing metabolism. Minor/Significance Unknown.

              • succinylcholine

                lacosamide decreases effects of succinylcholine by pharmacodynamic antagonism. Minor/Significance Unknown.

              • vecuronium

                lacosamide decreases effects of vecuronium by pharmacodynamic antagonism. Minor/Significance Unknown.

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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

              Neurologic disorders: New or worsening seizures, dyskinesia

              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

              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

              Cardiac rhythm and conduction

              • Both atrial fibrillation and atrial flutter reported in open label partial-onset seizure trials and in postmarketing experience; therapy may predispose to atrial arrhythmias (atrial fibrillation or flutter), especially in patients with diabetic neuropathy and/or cardiovascular diseaseCardiac arrhythmias reported, including bradycardia, AV block, and ventricular tachyarrhythmia, which have rarely resulted in asystole, cardiac arrest, and death
              • Most, although not all, cases occurred in patients with underlying proarrhythmic conditions, or in those taking concomitant medications that affect cardiac conduction or prolong the PR interval
              • Events occurred with both PO or IV administration and at prescribed doses, as well as in the setting of overdose
              • Caution with underlying proarrhythmic conditions (eg, marked first-degree AV block, second-degree or higher AV block and sick sinus syndrome without pacemaker), severe cardiac disease, including myocardial ischemia or heart failure, or structural heart disease, and cardiac sodium disorders (eg, Brugada Syndrome)

              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
                • Use with caution when administered concomitantly with medications that affect cardiac conduction, including sodium channel blockers, beta-blockers, calcium channel blockers, potassium channel blockers, and medications that prolong the PR interval; obtain an ECG before beginning therapy, and after titrating to steady-state maintenance dose, in such patients; closely monitor if intravenous route used to administer medication
                • 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

              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)

              Adults

              • Administer by IV infusion over 30-60 minutes
              • May administer as rapidly as 15 minutes if needed

              Children

              • Administer by IV infusion over 30-60 minutes
              • Infusion duration <30 minutes not recommended

              Oral Administration

              Tablets or oral solution: Take with or without food

              Swallow tablets whole with liquid; do not divide tablets

              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 6 months 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 6 months 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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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              Vimpat oral
              -
              50 mg tablet
              Vimpat oral
              -
              150 mg tablet
              Vimpat oral
              -
              10 mg/mL solution
              Vimpat oral
              -
              10 mg/mL solution
              Vimpat oral
              -
              200 mg tablet
              Vimpat oral
              -
              100 mg tablet
              lacosamide oral
              -
              50 mg tablet
              lacosamide oral
              -
              200 mg tablet
              lacosamide oral
              -
              150 mg tablet
              lacosamide oral
              -
              100 mg tablet
              Vimpat intravenous
              -
              200 mg/20 mL vial

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Select a drug:
              Patient Education
              lacosamide intravenous

              NO MONOGRAPH AVAILABLE AT THIS TIME

              USES: Consult your pharmacist.

              HOW TO USE: Consult your pharmacist.

              SIDE EFFECTS: Consult your pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

              PRECAUTIONS: Consult your pharmacist.

              DRUG INTERACTIONS: Consult your pharmacist.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

              OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

              NOTES: No monograph available at this time.

              MISSED DOSE: Consult your pharmacist.

              STORAGE: Consult your pharmacist.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

              Information last revised July 2016. Copyright(c) 2022 First Databank, Inc.

              IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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              Formulary

              FormularyPatient Discounts

              Adding plans allows you to compare formulary status to other drugs in the same class.

              To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

              Adding plans allows you to:

              • View the formulary and any restrictions for each plan.
              • Manage and view all your plans together – even plans in different states.
              • Compare formulary status to other drugs in the same class.
              • Access your plan list on any device – mobile or desktop.

              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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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.