Lacosamide extended-release
Other products: Lacosamide, Lacosamide intravenous
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
Dosage Information for Patients with Renal Impairment For patients with mild to moderate renal impairment, no dosage adjustment is necessary. For patients with severe renal impairment [creatinine clearance (CL CR ) less than 30 mL/min as estimated by the Cockcroft-Gault equation for adults; CL CR less than 30 mL/min/1.73m 2 as estimated by the Schwartz equation for pediatric patients] or end-stage renal disease, the maximum recommended dosage is 300 mg.
In all patients with renal impairment, dose initiation and titration should be based on clinical response and tolerability. Hemodialysis MOTPOLY XR is effectively removed from plasma by hemodialysis. Following a 4-hour hemodialysis treatment, dosage supplementation of up to 50% should be considered. Concomitant Strong CYP3A4 or CYP2C9 Inhibitors Dose reduction may be necessary in patients with renal impairment who are taking strong inhibitors of CYP3A4 and CYP2C9 [see Drug Interactions , Use in Specific Populations , and Clinical Pharmacology ] .
Dosing in liver impairment
Dosage Information for Patients with Hepatic Impairment For patients with mild or moderate hepatic impairment, the maximum recommended dosage is 300 mg. The dose initiation and titration should be based on clinical response and tolerability in patients with hepatic impairment. MOTPOLY XR use is not recommended in patients with severe hepatic impairment.
Concomitant Strong CYP3A4 and CYP2C9 Inhibitors Dose reduction may be necessary in patients with hepatic impairment who are taking strong inhibitors of CYP3A4 and CYP2C9 [see Drug Interactions , Use in Specific Populations , and Clinical Pharmacology ] .
Preparation and administration
Administration Instructions for MOTPOLY XR Capsules MOTPOLY XR may be taken with or without food. MOTPOLY XR capsules should be swallowed whole with liquid. Do not open, chew, or crush the capsules.
Drug interactions
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- Lacosamide extended-release
Label text (4 paragraphs)
7 DRUG INTERACTIONS
7.1 Strong CYP3A4 or CYP2C9 Inhibitors Patients with renal or hepatic impairment who are taking strong inhibitors of CYP3A4 and CYP2C9 may have a significant increase in exposure to MOTPOLY XR. Dose reduction may be necessary in these patients.
7.2 Concomitant Medications that Affect Cardiac Conduction MOTPOLY XR should be used with caution in patients on concomitant medications that affect cardiac conduction (sodium channel blockers, beta-blockers, calcium channel blockers, potassium channel blockers) including those that prolong PR interval (including sodium channel blocking AEDs), because of a risk of AV block, bradycardia, or ventricular tachyarrhythmia. In such patients, obtaining an ECG before beginning MOTPOLY XR, and after MOTPOLY XR is titrated to steady-state, is recommended.
7.3 CNS Depressants Concomitant administration of lacosamide and alcohol or other CNS depressant drugs has not been evaluated in clinical studies. Because of the potential of MOTPOLY XR to cause CNS depression, as well as other cognitive and/or neuropsychiatric adverse reactions, MOTPOLY XR should be used with extreme caution if used in combination with alcohol and other CNS depressants.
Contraindications
None . None ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
DLikelihood score D: Possible rare cause of clinically apparent liver injury.
Lacosamide is an amino acid derivative with a unique anticonvulsant activity that is used in combination with other agents as therapy of partial onset seizures. Lacosamide therapy is associated with a low rate of transient serum enzyme elevations and has been linked to rare instances of clinically apparent liver injury.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as lacosamide, during pregnancy. Encourage women who are taking MOTPOLY XR during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/.
Risk Summary Available data from the North American Antiepileptic Drug (NAAED) pregnancy registry, a prospective cohort study, case reports, and a case series with 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. There are no adequate data on the developmental risks associated with the use of MOTPOLY XR 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. These effects were observed at doses associated with clinically relevant plasma exposures ( see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Data Animal Data Oral administration of lacosamide to pregnant rats (20, 75, or 200 mg/kg/day) and rabbits (6.25, 12.5, or 25 mg/kg/day) during the period of organogenesis did not produce any effects on the incidences of fetal structural abnormalities. However, the maximum doses evaluated were limited by maternal toxicity in both species and embryofetal death in rats. These doses were associated with maternal plasma lacosamide exposures (AUC) approximately 2 and 1 times (rat and rabbit, respectively) that in humans at the maximum recommended human dose (MRHD) of 400 mg/day.
In two studies in which lacosamide (25, 70, or 200 mg/kg/day and 50, 100, or 200 mg/kg/day) was orally administered to rats throughout pregnancy and lactation, increased perinatal mortality and decreased body weights in the offspring were observed at the highest dose tested. The no-effect dose for pre- and postnatal developmental toxicity in rats (70 mg/kg/day) was…
Breastfeeding (LactMed)
Limited information indicates that a maternal dose of 200 mg daily produce low levels in milk. Although one infant who was exposed during pregnancy and breastfeeding was seepy and fed poorly, several others have been breastfed with no adverse effects. Development of exposed infants has been normal. Until more data are available lacosamide should only be used with careful monitoring for drowsiness and adequate weight gain during breastfeeding, especially while nursing a newborn or preterm infant.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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