MOTPOLY XR lacosamide 150 mg Capsule, Extended Release, 60-count
Other active recalls for Lacosamide (different manufacturers) — 5 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Other antiepileptics class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- Lacosamide is used to treat seizures — specifically partial-onset seizures, which start in one part of the brain, in adults and children. It's also approved as an add-on treatment...
- Yes — dizziness is the most commonly reported side effect of lacosamide, and it's most likely to happen during the early weeks when your dose is being increased. It usually gets be...
- Is it normal to feel dizzy when I start this medication?
- Please don't stop suddenly. Stopping lacosamide abruptly can cause a sudden increase in seizures, which can be dangerous. If you're having side effects or want to stop, talk to you...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Lacosamide — tap one for details:
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII H3UP11403C
Ethylcellulose is a plant-derived polymer that thickens and forms protective coatings on tablets and capsules. It slows medicine release into the body and protects the contents from moisture and air.
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UNII 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
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UNII EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
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UNII R75537T0T4
Hypromellose 2910 is a plant-derived thickening agent made from cellulose. It serves as a binder that holds tablet ingredients together, a film-coating for pills, and a viscosity controller in liquids.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
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UNII XHX3C3X673
Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.
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UNII 8Z96QXD6UM
Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.
9 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $21.502 | $1,290.11 / 60 capsules |
| Medicaid paysCMS SDUD · 12 mo | $21.29 | $1,277.18 / 60 capsules |
| Medicare drug plans payPart D · Q2 2026 | $21.57 | $1,294.09 / 60 capsules |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Motpoly Xr 150 mgthis 73289-0064-02 | Aucta | 60 capsules | $21.502 | — | Availability likely | — |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 11337943 ↗ | Method of use | U-3660 | Jun 5, 2040 |
| US 11337943 ↗ | Method of use | U-3660 | Jun 5, 2040 |
| US 11337943 ↗ | Method of use | U-3660 | Jun 5, 2040 |
| US 12042474 ↗ | Method of use | U-3660 | Jun 5, 2040 |
| US 12042474 ↗ | Method of use | U-3954 | Jun 5, 2040 |
| US 12042474 ↗ | Method of use | U-3954 | Jun 5, 2040 |
| US 12042474 ↗ | Method of use | U-3954 | Jun 5, 2040 |
| US 12042474 ↗ | Method of use | U-3660 | Jun 5, 2040 |
| US 12042474 ↗ | Method of use | U-3660 | Jun 5, 2040 |
| US 11883374 ↗ | Method of use | U-3660 | Jun 5, 2040 |
| US 11883374 ↗ | Method of use | U-3954 | Jun 5, 2040 |
| US 11883374 ↗ | Method of use | U-3954 | Jun 5, 2040 |
| US 11883374 ↗ | Method of use | U-3954 | Jun 5, 2040 |
| US 11883374 ↗ | Method of use | U-3660 | Jun 5, 2040 |
| US 11883374 ↗ | Method of use | U-3660 | Jun 5, 2040 |
| US 11337943 ↗ | Method of use | U-3954 | Jun 5, 2040 |
| US 11337943 ↗ | Method of use | U-3954 | Jun 5, 2040 |
| US 11337943 ↗ | Method of use | U-3954 | Jun 5, 2040 |
Is there a generic version of MOTPOLY XR 150 MG CAPSULE?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
What is the difference between patents and exclusivity?
Why are there multiple patent dates?
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 73289-0064-02 You're viewing this | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (73289-0064-2) | 2023-05-05 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE MOTPOLY XR is indicated for: Treatment of partial-onset seizures in adults and in pediatric patients weighing at least 50 kg ( 1.1 ) Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and in pediatric patients weighing at least 50 kg (1.2)
1.1Partial-Onset Seizures MOTPOLY XR is indicated for the treatment of partial-onset seizures in adults and in pediatric patients weighing at least 50 kg.
1.2Primary Generalized Tonic-Clonic Seizures MOTPOLY XR is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and in pediatric patients weighing at least 50 kg. Additional pediatric use information is approved for UCB Inc.'s Vimpat (lacosamide) tablets, oral solution, and intravenous solution. However, due to UCB Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Adults (17 years and older): Initial dosage for monotherapy for the treatment of partial-onset seizures is 200 mg once daily (2.1) Initial dosage for adjunctive therapy for the treatment of partial-onset seizures or primary generalized tonic-clonic seizures is 100 mg once daily (2.1) Maximum recommended dosage for monotherapy and adjunctive therapy is 400 mg once daily (2.1) Pediatric patients weighing at least 50 kg: Initial dosage for treatment of partial-onset seizures or adjunctive therapy for primary generalized tonic-clonic seizures is 100 mg once daily (2.1) Increase dosage based on clinical response and tolerability, no more frequently than once per week (2.1) Dose adjustment is recommended for severe renal impairment(2.1, 12.3) Dose adjustment is recommended for mild or moderate hepatic impairment; use in patients with severe hepatic impairment is not recommended(2.4,12.3) MOTPOLY XR capsules should be swallowed whole with liquid.
Do not open, chew, or crush the capsules(2.5)
2.1Dosage Information The recommended dosage for monotherapy and adjunctive therapy for partial-onset seizures and for adjunctive therapy for primary generalized tonic-clonic seizuresin in adults and in pediatric patients weighing at least 50 kg is included in Table 1. Dosage should be increased based on clinical response and tolerability, no more frequently than once per week. Titration increments should not exceed those shown in Table 1.
Table 1: Recommended Dosages for Partial-Onset Seizures (Monotherapy or Adjunctive Therapy) and Primary Generalized Tonic-Clonic Seizures (Adjunctive Therapy) in Adults and in Pediatric Patients Weighing At Least 50 kg* Age and Body Weight Initial Dosage Titration Regimen Maintenance Dosage Adults (17 years and older) Monotherapy* *: 200 mg once daily Adjunctive Therapy : 100 mg once daily Increase by 100 mg once daily every week Monotherapy**: 300 mg to 400 mg once daily Adjunctive Therapy: 200 mg to 400 mg once daily Pediatric patients weighing at least 50 kg 100 mg once daily Increase by 100 mg once daily every week Monotherapy**: 300 mg to 400 mg once daily Adjunctive Therapy: 200 mg to 400 mg once daily *when not specified, the dosage is the same for monotherapy for partial-onset seizures and adjunctive therapy for partial-onset seizures or primary generalized tonic-clonic seizures . **Monotherapy for partial-onset seizures only In adjunctive clinical trials in adult patients with partial-onset seizures, a dosage higher than 400 mg per day was not more effective and was associated with a substantially higher rate of adverse reactions [see Adverse Reactions (6.1) and Clinical Studies (14.2) ] .
Additional pediatric use information is approved for UCB Inc.'s Vimpat (lacosamide) tablets, oral solution, and intravenous solution. However, due to UCB Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
2.2Converting From a Single Antiepileptic (AED) to MOTPOLY XR Monotherapy for the Treatment of Partial-Onset Seizures For patients who are already on a single AED and will convert to MOTPOLY XR monotherapy, withdrawal of the concomitant AED should not occur until the therapeutic dosage of MOTPOLY XR is achieved and has been administered for at least 4 days. A gradual withdrawal of the concomitant AED over at least 6 weeks is recommended.
2.3Dosage 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…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 100 mg, 150 mg, 200 mg extended-release capsules ( 3 ) MOTPOLY XR extended-release capsules contain white or off-white beads and are available in the following strengths: 100 mg: Yellow opaque cap with “A” printed in black ink and a white opaque body with “100” printed in black ink 150 mg: Brown opaque cap with “A” printed in black ink and a white opaque body with “150” printed in black ink 200 mg: Blue opaque cap with “A” printed in black ink and a white opaque body with “200” printed in black ink
⛔ Contraindications ▾
4 CONTRAINDICATIONS None . None ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Monitor patients for suicidal behavior and ideation ( 5.1 ) MOTPOLY XR may cause dizziness and ataxia ( 5.2 ) Cardiac Rhythm and Conduction Abnormalities: Obtaining ECG before beginning and after titration to steady-state maintenance is recommended in patients with underlying proarrhythmic conditions or on concomitant medications that affect cardiac conduction; closely monitor these patients ( 5.3 , 7.2 ) MOTPOLY XR may cause syncope ( 5.4 ) MOTPOLY XR should be gradually withdrawn to minimize the potential of increased seizure frequency ( 5.5 ) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/ Multi-Organ Hypersensitivity: Discontinue if no alternate etiology ( 5.6 )
5.1Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including MOTPOLY XR, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo.
In these trials, which had a median treatment duration of 12 weeks, the estimated incidence of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number of events is too small to allow any conclusion about drug effect on suicide.
The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed. The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed.
The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5-100 years) in the clinical trials analyzed. Table 2 shows absolute and relative risk by indication for all evaluated AEDs.
Table 2: Risk by Indication for Antiepileptic Drugs in the Pooled Analysis Indication Placebo Patients with Events Per 1000 Patients Drug Patients with Events Per 1000 Patients Relative Risk: Incidence of Events in Drug Patients/Incidence in Placebo Patients Risk Difference: Additional Drug Patients with Events Per 1000 Patients Epilepsy 1.0 3.4 3.5
2.4Psychiatric 5.7 8.5 1.5
2.9Other 1.0 1.8 1.9
0.9Total 2.4 4.3 1.8
1.9The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar. Anyone considering prescribing MOTPOLY XR or any other AED must balance this risk with the risk of untreated illness. Epilepsy and many other illnesses for which antiepileptics are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior.
Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.
5.2Dizziness and Ataxia MOTPOLY XR may cause dizziness and ataxia in adult and pediatric patients. In adult patients with…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: Suicidal Behavior and Ideation [ see Warnings and Precautions (5.1) ] Dizziness and Ataxia [ see Warnings and Precautions (5.2) ] Cardiac Rhythm and Conduction Abnormalities [ see Warnings and Precautions (5.3) ] Syncope [ see Warnings and Precautions (5.4) ] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Reactions [ see Warnings and Precautions (5.6) ] Adjunctive therapy: Most common adverse reactions in adults (≥10% and greater than placebo) are diplopia, headache, dizziness, nausea, and somnolence ( 6.1 ) Monotherapy: Most common adverse reactions are similar to those seen in adjunctive therapy studies ( 6.1 ) Pediatric patients: Adverse reactions are similar to those seen in adult patients ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aucta Pharmaceuticals, Inc. at 1-800-655-9902 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The studies described below were conducted with immediate-release lacosamide tablets; adverse reactions with MOTPOLY XR are expected to be similar to adverse reactions with immediate-release lacosamide. Lacosamide in Adults In the premarketing development of adjunctive therapy for partial-onset seizures, 1327 adult patients received lacosamide in controlled and uncontrolled trials, of whom 1000 were treated for longer than 6 months, and 852 for longer than 12 months.
The monotherapy development program for partial-onset seizures included 425 adult patients, 310 of whom were treated for longer than 6 months, and 254 for longer than 12 months. Partial-Onset Seizures Monotherapy Historical-Control Trial (Study 1) In the monotherapy trial for partial-onset seizures, 16% of patients randomized to receive lacosamide at the recommended doses of 300 and 400 mg/day discontinued from the trial as a result of an adverse reaction. The adverse reaction most commonly (≥1% on lacosamide) leading to discontinuation was dizziness.
Adverse reactions that occurred in this study were generally similar to those that occurred in adjunctive placebo-controlled studies. One adverse reaction, insomnia, occurred at a rate of ≥2% and was not reported at a similar rate in previous studies. This adverse reaction has also been observed in postmarketing experience [ see Adverse Reactions (6.2) ] .
Because this study did not include a placebo control group, causality could not be established. Dizziness, headache, nausea, somnolence, and fatigue all occurred at lower incidences during the AED Withdrawal Phase and Monotherapy Phase, compared with the Titration Phase [ see Clinical Studies (14.1) ] . Adjunctive Therapy Controlled Trials (Studies 2, 3, and 4) In adjunctive therapy controlled clinical trials for partial-onset seizures, the rate of discontinuation as a result of an adverse reaction was 8% and 17% in patients randomized to receive lacosamide at the recommended doses of 200 and 400 mg/day, respectively, 29% at 600 mg/day (1.5 times greater than the maximum recommended dose), and 5% in patients randomized to receive placebo.
The adverse reactions most commonly (>1% on lacosamide and greater than placebo) leading to discontinuation were dizziness, ataxia, vomiting, diplopia, nausea, vertigo, and blurred vision. Table 3 gives the incidence of adverse reactions that occurred in ≥2% of adult patients with partial-onset seizures in the lacosamide total group and for which the incidence was greater than placebo. Table 3: Adverse Reactions Incidence in Adjunctive Therapy Pooled, Placebo-Controlled Trials in Adult Patients with Partial-Onset Seizures (Studies 2, 3, and 4) Adverse Re…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS
7.1Strong 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.
7.2Concomitant 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.
7.3CNS 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.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm ( 8.1 ) Additional pediatric use information is approved for UCB Inc.'s Vimpat (lacosamide) tablets, oral solution, and intravenous solution. However, due to UCB Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
8.1Pregnancy 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 associated with a maternal plasma lacosamide AUC similar to that in humans at the MRHD.
Oral administration of lacosamide (30, 90, or 180 mg/kg/day) to rats during the neonatal and juvenile periods of development resulted in decreased brain weights and long-term neurobehavioral changes (altered open field performance, deficits in learning and memory). The early postnatal period in rats is generally thought to correspond to late pregnancy in humans in terms of brain development. The no-effect dose for developmental neurotoxicity in rats was associated with a plasma lacosamide AUC less than that in humans at the MRHD.
In Vitro Data Lacosamide has been shown in vitro to interfere with the activity of collapsin response mediator protein-2 (CRMP-2), a protein involved in neuronal differentiation and control of axonal outgrowth. Potential adverse effects on CNS development related to this activity cannot be ruled out.
8.2Lactation Risk Summary Data from published literature indicate that lacosamide is present in human milk. There are reports o…
🤰 Pregnancy ▾
8.1Pregnancy 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 associated with a maternal plasma lacosamide AUC similar to that in humans at the MRHD.
Oral administration of lacosamide (30, 90, or 180 mg/kg/day) to rats during the neonatal and juvenile periods of development resulted in decreased brain weights and long-term neurobehavioral changes (altered open field performance, deficits in learning and memory). The early postnatal period in rats is generally thought to correspond to late pregnancy in humans in terms of brain development. The no-effect dose for developmental neurotoxicity in rats was associated with a plasma lacosamide AUC less than that in humans at the MRHD.
In Vitro Data Lacosamide has been shown in vitro to interfere with the activity of collapsin response mediator protein-2 (CRMP-2), a protein involved in neuronal differentiation and control of axonal outgrowth. Potential adverse effects on CNS development related to this activity cannot be ruled out.
🧒 Pediatric Use ▾
8.4Pediatric Use Partial-Onset Seizures The safety and effectiveness of MOTPOLY XR for the treatment of partial-onset seizures have been established in pediatric patients weighing at least 50 kg. Use of MOTPOLY XR in this pediatric group is supported by evidence from adequate and well-controlled studies of lacosamide in adults with partial-onset seizures, pharmacokinetic data from adult and pediatric patients, and safety data in 328 pediatric patients [ see Adverse Reactions (6.1 ) and Clinical Pharmacology (12.3 )and Clinical Studies (14.1 , 14.2 ) ].
Safety and effectiveness of MOTPOLY XR in pediatric patients weighing less than 50 kg have not been established. Primary Generalized Tonic-Clonic Seizures Safety and effectiveness of MOTPOLY XR as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in pediatric patients with idiopathic generalized epilepsy weighing at least 50 kg was established in a 24-week double-blind, randomized, placebo-controlled, parallel-group, multi-center study (Study 5), which included pediatric patients [see Adverse Reactions (6.1), Clinical Pharmacology (12.3) and Clinical Studies (14.1, 14.3)] .
Safety and effectiveness in pediatric patients weighing less than 50 kg have not been established. Additional pediatric use information is approved for UCB Inc.'s Vimpat (lacosamide) tablets, oral solution, and intravenous solution. However, due to UCB Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Animal Data Lacosamide has been shown in vitro to interfere with the activity of collapsin response mediator protein-2 (CRMP-2), a protein involved in neuronal differentiation and control of axonal outgrowth. Potential related adverse effects on CNS development cannot be ruled out. Administration of lacosamide to rats during the neonatal and juvenile periods of postnatal development (approximately equivalent to neonatal through adolescent development in humans) resulted in decreased brain weights and long-term neurobehavioral changes (altered open field performance, deficits in learning and memory).
The no-effect dose for developmental neurotoxicity in rats was associated with a plasma lacosamide exposure (AUC) less than that in humans at the maximum recommended human dose of 400 mg/day.
🧓 Geriatric Use ▾
8.5Geriatric Use There were insufficient numbers of elderly patients enrolled in partial-onset seizure trials (n=18) to adequately determine whether they respond differently from younger patients. No MOTPOLY XR dose adjustment based on age is necessary. 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 [see Dosage and Administration (2.1 , 2.3 , 2.4 ) and Clinical Pharmacology (12.3) ] .
🆘 Overdosage ▾
10 OVERDOSAGE Events reported after an intake of more than 800 mg (twice the maximum recommended daily dosage) of lacosamide include dizziness, nausea, and seizures (generalized tonic-clonic seizures, status epilepticus). Cardiac conduction disorders, confusion, decreased level of consciousness, cardiogenic shock, cardiac arrest, and coma have also been observed. Fatalities have occurred following lacosamide overdoses of several grams.
There is no specific antidote for overdose with lacosamide. Standard decontamination procedures should be followed. General supportive care of the patient is indicated including monitoring of vital signs and observation of the clinical status of patient.
A Certified Poison Control Center should be contacted for up to date information on the management of overdose with lacosamide. Standard hemodialysis procedures result in significant clearance of lacosamide (reduction of systemic exposure by 50% in 4 hours). Hemodialysis may be indicated based on the patient's clinical state or in patients with significant renal impairment.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism 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.
12.2Pharmacodynamics A pharmacokinetic-pharmacodynamic (efficacy) analysis was performed based on the pooled data from the 3 efficacy trials for partial-onset seizures. Lacosamide exposure is correlated with the reduction in seizure frequency. However, doses above 400 mg/day do not appear to confer additional benefit in group analyses.
Cardiac Electrophysiology Electrocardiographic effects of lacosamide were determined in a double-blind, randomized clinical pharmacology trial of 247 healthy subjects. Chronic oral doses of 400 and 800 mg/day(equal to and two times the maximum recommended dose, respectively) were compared with placebo and a positive control (400 mg moxifloxacin). Lacosamide did not prolong QTc interval and did not have a dose-related or clinically important effect on QRS duration.
Lacosamide produced a small, dose-related increase in mean PR interval. At steady-state, the time of the maximum observed mean PR interval corresponded with t max . The placebo-subtracted maximum increase in PR interval (at t max ) was 7.3 ms for the 400 mg/day group and 11.9 ms for the 800 mg/day group.
For patients who participated in the controlled trials, the placebo-subtracted mean maximum increase in PR interval for a 400 mg/day lacosamide dose was 3.1 ms in patients with partial-onset seizures and 9.4 ms for patients with diabetic neuropathy.
12.3Pharmacokinetics Absorption Pharmacokinetic information for MOTPOLY XR following oral administration was obtained from studies conducted in healthy adult subjects. Lacosamide is completely absorbed after oral administration with negligible first-pass effect with a high absolute bioavailability of approximately 100%. In a multiple-dose pharmacokinetic study in healthy adult subjects, at steady-state, the peak plasma lacosamide concentrations (T max ) after oral administration of MOTPOLY XR was reached in 7 hours.
Steady state plasma concentrations are achieved after 4 days of once daily repeated administration. Pharmacokinetics of lacosamide are dose proportional (100-800 mg). Effect of Food Compared to the fasted state, high-fat meal has no effect on the C max , T max and AUC of MOTPOLY XR. [see Dosage and Administration (2.5)] .
Distribution The volume of distribution is approximately
0.67L/kg, which is close to the volume of total body water. Lacosamide is less than 15% bound to plasma proteins. Metabolism and Elimination Lacosamide is primarily eliminated from the systemic circulation by renal excretion and biotransformation.
After oral and intravenous administration of 100 mg [14C]-lacosamide approximately 95% of radioactivity administered was recovered in the urine and less than 0.5% in the feces. The major compounds excreted were unchanged lacosamide (approximately 40% of the dose), its O-desmethyl metabolite (approximately 30%), and a structurally unknown polar fraction (~20%). The plasma exposure of the major human metabolite, O-desmethyl-lacosamide, is approximately 10% of that of lacosamide.
This metabolite has no known pharmacological activity. The CYP isoforms mainly responsible for the formation of the major metabolite (O-desmethyl) are CYP3A4, CYP2C9, and CYP2C19. The elimination half-life of the unchanged drug is approximately 13 hours and is not altered by different doses, multiple dosing or intravenous administration.
There is no enantiomeric interconversion of lacosamide. Specific Populations Renal Impairment Lacosamide and its major metabolite are eliminated from the systemic circulation primarily by renal excretion. The AUC of lacosamide was increased appro…
🧬 Mechanism of Action ▾
12.1Mechanism 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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied MOTPOLY XR extended-release capsules contain white or off-white beads and are available in the following strengths: 100 mg are yellow opaque cap with “A” printed in black ink and a white opaque body with “100” printed in black ink. They are supplied as follows: Bottles of 60 NDC 73289-0063-2 150 mg are brown opaque cap with “A” printed in black ink and a white opaque body with “150” printed in black ink. They are supplied as follows: Bottles of 60 NDC 73289-0064-2 200 mg are blue opaque cap with “A” printed in black ink and a white opaque body with “200” printed in black ink.
They are supplied as follows: Bottles of 60 NDC 73289-0065-2
16.2Storage and Handling 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). [See USP Controlled Room Temperature]
📦 Storage and Handling ▾
16.2Storage and Handling 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). [See USP Controlled Room Temperature]
📋 Description ▾
11 DESCRIPTION The chemical name of lacosamide, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C 13 H 18 N 2 O 3 and its molecular weight is 250.30.
The chemical structure is: Lacosamide is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol. chemical-structure MOTPOLY XR extended-release capsules for oral administration contain lacosamide and the following inactive ingredients: ethylcellulose, hypromellose, microcrystalline cellulose, povidone, titanium dioxide, triacetin, triethyl citrate and dye pigments as specified below: The capsule shells contain the following coloring agents: 100 mg capsules: red iron oxide 150 mg capsules: red iron oxide, yellow iron oxide 200 mg capsules: black iron oxide, FD&C Blue #1, red iron oxide
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient or caregiver to read the FDA-approved patient labeling (Medication Guide). Administration Inform patients that MOTPOLY XR should be swallowed whole with liquid. Instruct patients to not open, chew, or crush the capsules [ see Dosage and Administration (2.5) ] .
Suicidal Thinking and Behavior Patients, their caregivers, and families should be counseled that AEDs, including MOTPOLY XR, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers [ see Warnings and Precautions (5.1) ] . Dizziness and Ataxia Patients should be counseled that MOTPOLY XR use may cause dizziness, double vision, abnormal coordination and balance, and somnolence.
Patients taking MOTPOLY XR should be advised not to drive, operate complex machinery, or engage in other hazardous activities until they have become accustomed to any such effects associated with MOTPOLY XR [ see Warnings and Precautions (5.2) ] . Cardiac Rhythm and Conduction Abnormalities Patients should be counseled that MOTPOLY XR is associated with electrocardiographic changes that may predispose to irregular heart beat and syncope. Cardiac arrest has been reported.
This risk is increased in patients with underlying cardiovascular disease, with heart conduction problems, or who are taking other medications that affect the heart. Patients should be made aware of and report cardiac signs or symptoms to their healthcare provider right away. Patients who develop syncope should lay down with raised legs and contact their health care provider [ see Warnings and Precautions (5.3) ] .
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multi-Organ Hypersensitivity Patients should be aware that MOTPOLY XR may cause serious hypersensitivity reactions affecting multiple organs such as the liver and kidney. MOTPOLY XR should be discontinued if a serious hypersensitivity reaction is suspected. Patients should also be instructed to report promptly to their physicians any symptoms of liver toxicity (e.g., fatigue, jaundice, dark urine) [ see Warnings and Precautions (5.6) ] .
Pregnancy Registry Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during MOTPOLY XR therapy. Encourage patients to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry if they become pregnant. This registry is collecting information about the safety of AEDs during pregnancy [ see Use in Specific Populations (8.1) ].
Lactation Advise breastfeeding women using MOTPOLY XR to monitor infants for excess sleepiness and to seek medical care if they notice this sign [ see Use in Specific Populations (8.2) ].
💬 Medication Guide ▾
This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 6/2024 MEDICATION GUIDE MOTPOLY XR (mot paa'lee) lacosamide extended release capsules, for oral use, CV Read this Medication Guide before you start taking MOTPOLY XR and each time you get a refill. There may be new information.
This Medication Guide describes important safety information about MOTPOLY XR. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. What is the most important information I should know about MOTPOLY XR?
Do not stop taking MOTPOLY XR without first talking to your healthcare provider. Stopping MOTPOLY XR suddenly can cause serious problems. Stopping seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).
MOTPOLY XR can cause serious side effects, including: 1. Like other antiepileptic drugs, MOTPOLY XR may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you : thoughts about suicide or dying attempt to commit suicide new or worse depression new or worse anxiety feeling agitated or restless panic attacks trouble sleeping (insomnia) new or worse irritability acting aggressive, being angry, or violent acting on dangerous impulses an extreme increase in activity and talking (mania) other unusual changes in behavior or mood How can I watch for early symptoms of suicidal thoughts and actions?
Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes. 2.MOTPOLY XR may cause you to feel dizzy, have double vision, feel sleepy, or have problems with coordination and walking.
Do not drive, operate heavy machinery, or do other dangerous activities until you know how MOTPOLY XR affects you. 3.MOTPOLY XR may cause you to have an irregular heartbeat or may cause you to faint. In rare cases, cardiac arrest has been reported.
Call your healthcare provider right away if you: have a fast, slow, or pounding heartbeat or feel your heart skip a beat have shortness of breath have chest pain feel lightheaded fainted or if you feel like you are going to faint If you have fainted or feel like you are going to faint you should lay down with your legs raised. 4.MOTPOLY XR is a federally controlled substance (CV) because it can be abused or lead to drug dependence. Keep your MOTPOLY XR in a safe place, to protect it from theft.
Never give your MOTPOLY XR to anyone else, because it may harm them. Selling or giving away this medicine is against the law. What is MOTPOLY XR?
MOTPOLY XR is a prescription medicine used: to treat partial-onset seizures in adults and in children weighing at least 110 pounds (50 kg). with other medicines to treat primary generalized tonic-clonic seizures in adults and children weighing at least 110 pounds (50 kg). It is not known if MOTPOLY XR is safe and effective for partial-onset seizures and primary generalized tonic-clonic seizuresin children weighing less than 50 kg. What should I tell my healthcare provider before taking MOTPOLY XR?
Before you take MOTPOLY XR, tell your healthcare provider about all of your medical conditions, including if you : have or have had depression, mood problems or suicidal thoughts or behavior. have heart problems. have kidney problems. have liver problems. have abused prescription medicines, street drugs or alcohol in the past. are pregnant or plan to become pregnant. It is not known if MOTPOLY XR can harm your unborn baby. Tell your…