Motpoly Xr

— THERAPEUTIC CATEGORIES —
  • Seizure disorders

Motpoly Xr Generic Name & Formulations

General Description

Lacosamide 100mg, 150mg, 200mg; ext-rel caps.

Pharmacological Class

Sodium channel inactivator.

How Supplied

XR caps—60

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).

Generic Availability

NO

Mechanism of Action

The precise mechanism by which Motpoly XR exerts its antiepileptic effects in humans remains to be fully elucidated. In vitro electrophysiological studies have shown that lacosamide selectively enhances slow inactivation of voltage-gated sodium channels, resulting in stabilization of hyperexcitable neuronal membranes and inhibition of repetitive neuronal firing.

Motpoly Xr Indications

Indications

Treatment of partial-onset seizures in adult and pediatric patients weighing ≥50kg.

Motpoly Xr Dosage and Administration

Adult

Swallow whole. ≥17yrs (monotherapy): initially 200mg once daily; (adjunctive therapy): initially 100mg once daily; may increase at weekly intervals by 100mg/day. Maintenance dose: (monotherapy): 300–400mg once daily; (adjunctive): 200–400mg once daily. Dosages >400g/day were not more effective. Conversion from a single antiepileptic to Motpoly XR monotherapy: wait until the therapeutic dose is achieved and given for at least 4 days before withdrawing concomitant antiepileptic; should withdraw gradually over at least 6 weeks. Severe renal impairment (CrCl <30mL/min), ESRD, mild to moderate hepatic impairment: max 300mg; if concomitant strong CYP3A4/CYP2C9 inhibitors: may need dose reduction. Consider supplemental dose (up to 50%) after hemodialysis. Avoid abrupt cessation (withdraw over ≥1 week).

Children

<50kg: not established. Swallow whole. ≥50kg: initially 100mg once daily; may increase at weekly intervals by 100mg/day. Maintenance dose: (monotherapy): 300–400mg once daily; (adjunctive): 200–400mg once daily. Conversion from a single antiepileptic to Motpoly XR monotherapy: wait until the therapeutic dose is achieved and given for at least 4 days before withdrawing concomitant antiepileptic; should withdraw gradually over at least 6 weeks. Severe renal impairment (CrCl <30mL/min), ESRD, mild to moderate hepatic impairment: max 300mg; if concomitant strong CYP3A4/CYP2C9 inhibitors: may need dose reduction. Consider supplemental dose (up to 50%) after hemodialysis. Avoid abrupt cessation (withdraw over ≥1 week).

Motpoly Xr Contraindications

Not Applicable

Motpoly Xr Boxed Warnings

Not Applicable

Motpoly Xr Warnings/Precautions

Warnings/Precautions

Severe hepatic impairment: not recommended. Increased risk of suicidal thinking and behavior; monitor for clinical worsening or unusual changes. Cardiac conduction disturbances (eg, marked 1st-, 2nd-degree or higher AV block, sick sinus syndrome unless paced), sodium channelopathies (eg, Brugada Syndrome), or severe cardiac disease (eg, myocardial ischemia, HF, structural heart disease); obtain ECG before therapy and after titration. Risk for atrial arrhythmias esp. in those with diabetic neuropathy and/or cardiovascular disease. Elderly. Pregnancy. Nursing mothers: monitor infants.

Pregnancy Considerations

Pregnancy Exposure Registry

Encourage women who are taking Motpoly XR during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry by calling (888) 233-2334 or visiting http://www.aedpregnancyregistry.org/.

Risk Summary

Available data for lacosamide use in pregnant women are insufficient to identify a drug associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. 

Nursing Mother Considerations

Risk Summary

Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Motpoly XR and any potential adverse effects on the breastfed infant from Motpoly XR or from the underlying maternal condition.

Clinical Considerations

Monitor infants exposed to lacosamide through breastmilk for excess sedation.

Pediatric Considerations

Safety and effectiveness in pediatric patients weighing <50kg have not been established. 

Geriatric Considerations

In elderly patients, dose titration should be performed with caution, usually starting at the lower end of the dosing range, reflecting the greater frequency of decreased hepatic function, decreased renal function, increased cardiac conduction abnormalities, and polypharmacy.

Renal Impairment Considerations

No dose adjustment is necessary in patients with mild to moderate renal impairment (CrCl ≥30mL/min). 

In patients with severe renal impairment (CrCl <30mL/min as estimated by the Cockcroft-Gault equation for adults; CrCl <30mL/min/1.73m2 as estimated by the Schwartz equation for pediatric patients) and in those with end-stage renal disease, the maximum recommended dosage is 300mg once daily.

In all patients with renal impairment, dose initiation and titration should be based on clinical response and tolerability.

Dosage supplementation of up to 50% following hemodialysis should be considered. 

Hepatic Impairment Considerations

For mild to moderate hepatic impairment, the maximum recommended dosage is 300mg once daily.

Motpoly XR is not recommended in patients with severe hepatic impairment.

Motpoly Xr Pharmacokinetics

Absorption

Absolute bioavailability: ~100%. Peak plasma concentrations: reached in 7 hours (after oral admin). Steady state plasma concentrations: achieved after 4 days.

Distribution

Volume of distribution: ~0.67 L/kg. Plasma protein bound: <15%.

Metabolism

CYP3A4, CYP2C9, CYP2C19.

Elimination

Renal (~95%), fecal (<0.5%). Half-life: ~13 hours.

Motpoly Xr Interactions

Interactions

Caution with concomitant drugs that affect cardiac conduction (eg, sodium or potassium channel blockers, β-blockers, CCBs) or prolong PR interval. May be potentiated by strong CYP3A4/2C9 inhibitors in patients with renal or hepatic impairment. May cause CNS depression if concomitant with alcohol and other CNS depressants. 

Motpoly Xr Adverse Reactions

Adverse Reactions

Diplopia, dizziness, headache, nausea, blurred vision, diarrhea, fatigue, ataxia, somnolence, tremor; PR interval prolongation, AV block, syncope, DRESS/multi-organ hypersensitivity (discontinue if occurs). 

Motpoly Xr Clinical Trials

See Literature

Motpoly Xr Note

Not Applicable

Motpoly Xr Patient Counseling

Cost Savings Program