Data from FDA (Food and Drug Administration, USA) - Curated by Marshall Pearce - Last updated 05 December 2017

Indication(s)

1 INDICATIONS AND USAGE VIMPAT is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. As the safety of VIMPAT injection in pediatric patients has not been established, VIMPAT injection is indicated for the treatment of partial-onset seizures only in adult patients (17 years of age and older). VIMPAT is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. As the safety of VIMPAT injection has not been established in pediatric patients, VIMPAT injection is indicated for the treatment of partial-onset seizures only in adult patients (17 years of age and older) ( 1)

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Advisory information

contraindications
4 CONTRAINDICATIONS None . None
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 ( 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 UCB, Inc. at 1-844-599-2273 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical 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. VIMPAT Tablet and Oral Solution In the premarketing development of adjunctive therapy for partial-onset seizures, 1327 adult patients received VIMPAT tablets 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 included 425 adult patients, 310 of whom were treated for longer than 6 months, and 254 for longer than 12 months. Monotherapy Historical-Control Trial (Study 1) In the monotherapy trial, 16% of patients randomized to receive VIMPAT 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 VIMPAT) 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, the rate of discontinuation as a result of an adverse reaction was 8% and 17% in patients randomized to receive VIMPAT 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 VIMPAT 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 VIMPAT 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 Reaction Placebo N=364 % VIMPAT 200 mg/day N=270 % VIMPAT 400 mg/day N=471 % VIMPAT 600 mg/day 600 mg dose is 1.5 times greater than the maximum recommended dose. N=203 % VIMPAT Total N=944 % Ear and labyrinth disorder Vertigo 1 5 3 4 4 Eye disorders Diplopia 2 6 10 16 11 Blurred Vision 3 2 9 16 8 Gastrointestinal disorders Nausea 4 7 11 17 11 Vomiting 3 6 9 16 9 Diarrhea 3 3 5 4 4 General disorders and administration site conditions Fatigue 6 7 7 15 9 Gait disturbance <1 <1 2 4 2 Asthenia 1 2 2 4 2 Injury, poisoning and procedural complications Contusion 3 3 4 2 3 Skin laceration 2 2 3 3 3 Nervous system disorders Dizziness 8 16 30 53 31 Headache 9 11 14 12 13 Ataxia 2 4 7 15 8 Somnolence 5 5 8 8 7 Tremor 4 4 6 12 7 Nystagmus 4 2 5 10 5 Balance disorder 0 1 5 6 4 Memory impairment 2 1 2 6 2 Psychiatric disorders Depression 1 2 2 2 2 Skin and subcutaneous disorders Pruritus 1 3 2 3 2 The overall adverse reaction rate was similar in male and female patients. Although there were few non-Caucasian patients, no differences in the incidences of adverse reactions compared to Caucasian patients were observed. Pediatric Patients (4 to less than 17 Years of Age) Safety of VIMPAT was evaluated in clinical studies of pediatric patients 4 to less than 17 years of age for the treatment of partial-onset seizures. Across studies in pediatric patients with partial-onset seizures, 328 patients 4 to less than 17 years of age received VIMPAT oral solution or tablet, of whom 148 received VIMPAT for at least 1 year. Adverse reactions reported in clinical studies of pediatric patients 4 to less than 17 years of age were similar to those seen in adult patients. Laboratory Abnormalities Abnormalities in liver function tests have occurred in controlled trials with VIMPAT in adult patients with partial-onset seizures who were taking 1 to 3 concomitant anti-epileptic drugs. Elevations of ALT to ≥3× ULN occurred in 0.7% (7/935) of VIMPAT patients and 0% (0/356) of placebo patients . One case of hepatitis with transaminases >20× ULN occurred in one healthy subject 10 days after VIMPAT treatment completion, along with nephritis (proteinuria and urine casts). Serologic studies were negative for viral hepatitis. Transaminases returned to normal within one month without specific treatment. At the time of this event, bilirubin was normal. The hepatitis/nephritis was interpreted as a delayed hypersensitivity reaction to VIMPAT. Other Adverse Reactions The following is a list of adverse reactions reported by patients treated with VIMPAT in all clinical trials in adult patients with partial-onset seizures, including controlled trials and long-term open-label extension trials. Adverse reactions addressed in other tables or sections are not listed here. 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, hypoaesthesia, dysarthria, disturbance in attention, cerebellar syndrome Psychiatric disorders: confusional state, mood altered, depressed mood VIMPAT Injection Adverse reactions with intravenous administration to adult patients generally were similar to those that occurred with the oral formulation, although intravenous administration was associated with local adverse reactions such as injection site pain or discomfort (2.5%), irritation (1%), and erythema (0.5%). One case of profound bradycardia (26 bpm: BP 100/60 mmHg) occurred in a patient during a 15-minute infusion of 150 mg VIMPAT. This patient was on a beta-blocker. Infusion was discontinued and the patient experienced a rapid recovery. The safety of a 15-minute loading dose administration of VIMPAT Injection 200 mg to 400 mg followed by oral administration of VIMPAT given twice daily at the same total daily dose as the initial intravenous infusion was assessed in an open-label study in adult patients with partial-onset seizures. Patients had to have been maintained on a stable dose regimen of 1 to 2 marketed antiepileptics for at least 28 days prior to treatment assignment. Treatment groups were as follows: Single dose of intravenous VIMPAT Injection 200 mg followed by oral VIMPAT 200 mg/day (100 mg every 12 hours) Single dose of intravenous VIMPAT Injection 300 mg followed by oral VIMPAT 300 mg/day (150 mg every 12 hours) Single dose of intravenous VIMPAT Injection 400 mg followed by oral VIMPAT 400 mg/day (200 mg every 12 hours). Table 4 gives the incidence of adverse reactions that occurred in ≥5% of adult patients in any VIMPAT dosing group. Table 4: Adverse Reactions in a 15-minute Infusion Study in Adult Patients with Partial-Onset Seizures Adverse Reaction VIMPAT 200 mg N=25 % VIMPAT 300 mg N=50 % VIMPAT 400 mg N=25 % VIMPAT Total N=100 % Eye disorders Diplopia 4 6 20 9 Blurred Vision 0 4 12 5 Gastrointestinal disorders Nausea 0 16 24 14 Dry mouth 0 6 12 6 Vomiting 0 4 12 5 Oral Paresthesia 4 4 8 5 Oral Hypoesthesia 0 6 8 5 Diarrhea 0 8 0 4 General disorders/administration site conditions Fatigue 0 18 12 12 Gait disturbance 8 2 0 3 Chest pain 0 0 12 3 Nervous system disorders Dizziness 20 46 60 43 Somnolence 0 34 36 26 Headache 8 4 16 8 Paresthesia 8 6 4 6 Tremor 0 6 4 4 Abnormal Coordination 0 6 0 3 Skin & subcutaneous tissue disorders Pruritus 0 6 4 4 Hyperhidrosis 0 0 8 2 Adverse reactions that occurred with infusion of VIMPAT 200 mg over 15-minutes followed by VIMPAT 100 mg administered orally twice per day were similar in frequency to those that occurred in 3-month adjunctive therapy controlled trials. Considering the difference in period of observations (1 week vs. 3 months), the incidence of CNS adverse reactions, such as dizziness, somnolence, and paresthesia may be higher with 15-minute administration of VIMPAT Injection than with administration over a 30-to 60-minute period. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of VIMPAT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Blood and lymphatic system disorders: Agranulocytosis Psychiatric disorders: Aggression, agitation, hallucination, insomnia, psychotic disorder Skin and subcutaneous tissue disorders: Angioedema, rash, urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION Adults (17 years and older):Initial dosage for monotherapy is 100 mg twice daily; initial dosage for adjunctive therapy is 50 mg twice daily; maximum recommended dosage for monotherapy and adjunctive therapy is 200 mg twice daily ( 2.1) Pediatric Patients 4 Years to less than 17 years: The recommended dosage is based on body weight and is administered orally twice daily ( 2.1) Increase dosage based on clinical response and tolerability, no more frequently than once per week ( 2.1) Injection: for intravenous and adult use only when oral administration is temporarily not feasible; dosing regimen is the same as oral regimen; administer over 15 to 60 minutes; obtaining ECG before initiation is recommended in certain patients ( 2.6, 5.3) Dose adjustment is recommended for severe renal impairment ( 2.3, 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) 2.1 Dosage Information Monotherapy and Adjunctive Therapy The recommended dosage for adults and pediatric patients 4 years to less than 17 years of age is included in Table 1. In pediatric patients 4 years to less than 17 years of age, the recommended dosing regimen is dependent upon body weight and is only recommended to be administered orally. 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 Dosage for Adults and Pediatric Patients 4 Years and Older when not specified, the dosage is the same for monotherapy and adjunctive therapy Age and Body Weight Initial Dosage Titration Regimen Maintenance Dosage Adults (17 years and older) Monotherapy: 100 mg twice daily (200 mg per day) Adjunctive Therapy: 50 mg twice daily (100 mg per day) Increase by 50 mg twice daily (100 mg per day) every week Monotherapy: 150 mg to 200 mg twice daily (300 mg to 400 mg per day) Adjunctive Therapy: 100 mg to 200 mg twice daily (200 mg to 400 mg per day) Alternate Initial Dosage: 200 mg single loading dose, followed 12 hours later by 100 mg twice daily Pediatric patients weighing 50 kg or more 50 mg twice daily (100 mg per day) Increase by 50 mg twice daily (100 mg per day) every week Monotherapy: 150 mg to 200 mg twice daily (300 mg to 400 mg per day) Adjunctive Therapy: 100 mg to 200 mg twice daily (200 mg to 400 mg per day) Pediatric patients weighing 30 kg to less than 50 kg 1 mg/kg twice daily (2 mg/kg/day) Increase by 1 mg/kg twice daily (2 mg/kg/day) every week 2 mg/kg to 4 mg/kg twice daily (4 mg/kg/day to 8 mg/kg/day) Pediatric patients weighing 11 kg to less than 30 kg 1 mg/kg twice daily (2 mg/kg/day) Increase by 1 mg/kg twice daily (2 mg/kg/day) every week 3 mg/kg to 6 mg/kg twice daily (6 mg/kg/day to 12 mg/kg/day) In adjunctive clinical trials in adult patients, a dosage higher than 200 mg twice daily (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) ]. VIMPAT Injection Dosage in Adult Patients (17 years and older) VIMPAT injection may be used for adult patients when oral administration is temporarily not feasible [ see Dosage and Administration (2.6) and Warnings and Precautions (5.3) ] . VIMPAT injection can be administered intravenously to adult patients with the same dosing regimens described for oral dosing, including the loading dose. The use of VIMPAT injection in pediatric patients has not been studied. The clinical study experience of intravenous VIMPAT is limited to 5 days of consecutive treatment. Loading Dose in Adult Patients (17 Years and Older) VIMPAT and VIMPAT injection may be initiated in adult patients with a single loading dose of 200 mg, followed approximately 12 hours later by 100 mg twice daily (200 mg per day). This maintenance dose regimen should be continued for one week. VIMPAT can then be titrated as recommended in Table 1. The adult loading dose should be administered with medical supervision because of the increased incidence of CNS adverse reactions [ see Adverse Reactions (6.1), Clinical Pharmacology (12.3) ]. The use of a loading dose in pediatric patients has not been studied. 2.2 Converting From a Single Antiepileptic (AED) to VIMPAT Monotherapy For patients who are already on a single AED and will convert to VIMPAT monotherapy, withdrawal of the concomitant AED should not occur until the therapeutic dosage of VIMPAT is achieved and has been administered for at least 3 days. A gradual withdrawal of the concomitant AED over at least 6 weeks is recommended. 2.3 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, a reduction of 25% of the maximum dosage is recommended. In all patients with renal impairment, the dose titration should be performed with caution. Hemodialysis VIMPAT 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 (7.1), Use in Specific Populations (8.6), Clinical Pharmacology (12.3) ]. 2.4 Dosage Information for Patients with Hepatic Impairment For patients with mild or moderate hepatic impairment, a reduction of 25% of the maximum dosage is recommended. The dose titration should be performed with caution in patients with hepatic impairment. VIMPAT 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 (7.1), Use in Specific Populations (8.7), Clinical Pharmacology (12.3) ]. 2.5 Administration Instructions for VIMPAT Tablets and Oral Solution VIMPAT may be taken with or without food. VIMPAT Oral Solution A calibrated measuring device is recommended to measure and deliver the prescribed dose accurately. A household teaspoon or tablespoon is not an adequate measuring device. VIMPAT oral solution may also be administered using a nasogastric tube or gastrostomy tube. Discard any unused VIMPAT oral solution remaining after 7 weeks of first opening the bottle. 2.6 Preparation and Administration Information for VIMPAT Injection for Adult Patients Preparation VIMPAT injection can be administered intravenously without further dilution or may be mixed with diluents listed below. The diluted solution should not be stored for more than 4 hours at room temperature. Diluents: Sodium Chloride Injection 0.9% (w/v) Dextrose Injection 5% (w/v) Lactated Ringer's Injection Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Product with particulate matter or discoloration should not be used. VIMPAT injection is for single-dose only. Any unused portion of VIMPAT injection should be discarded. Administration The recommended infusion rate is 30 to 60 minutes; however, infusions as rapid as 15 minutes can be administered if required [ see Adverse Reactions (6.1), Clinical Pharmacology (12.3) ] . Intravenous infusion of VIMPAT may cause bradycardia or AV blocks [ see Warnings and Precautions (5.3) ]. Obtaining an ECG before beginning VIMPAT and after VIMPAT is titrated to steady-state maintenance dose is recommended in patients with known cardiac conduction problems, on concomitant medications that prolong PR interval, or with severe cardiac disease. Storage and Stability The diluted solution should not be stored for more than 4 hours at room temperature. Any unused portion of VIMPAT injection should be discarded. 2.7 Discontinuation of VIMPAT When discontinuing VIMPAT, a gradual withdrawal over at least 1 week is recommended [ see Warnings and Precautions (5.5) ].
Use in special populations
8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm ( 8.1) 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 VIMPAT, during pregnancy. Encourage women who are taking VIMPAT 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 There are no adequate data on the developmental risks associated with the use of VIMPAT 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) . 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. The background risk of major birth defects and miscarriage for the indicated population is unknown. 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. 8.2 Lactation Risk Summary 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. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for VIMPAT and any potential adverse effects on the breastfed infant from VIMPAT or from the underlying maternal condition. 8.4 Pediatric Use Safety and effectiveness of VIMPAT tablets and oral solution have been established in pediatric patients 4 to less than 17 years of age. Use of VIMPAT in this age group is supported by evidence from adequate and well-controlled studies of VIMPAT in adults with partial-onset seizures, pharmacokinetic data from adult and pediatric patients, and safety data in 328 pediatric patients 4 to less than 17 years of age [ see Adverse Reactions (6.1) and Clinical Pharmacology (12.3) ]. Safety of VIMPAT injection in pediatric patients has not been established. Safety and effectiveness in pediatric patients below the age of 4 years have not been established. 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. 8.5 Geriatric 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 VIMPAT 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 or polypharmacy [ see Dosage and Administration (2.1, 2.3, 2.4), Clinical Pharmacology (12.3) ]. 8.6 Renal Impairment Based on data in adults, no dose adjustment is necessary in adult and pediatric patients with mild to moderate renal impairment (CL CR ≥30 mL/min). In adult and pediatric patients with severe renal impairment (CL CR <30 mL/min) and in those with end-stage renal disease, a reduction of 25% of the maximum dosage is recommended [ see Dosage and Administration (2.3), Clinical Pharmacology (12.3) ]. In all patients with renal impairment, dose titration should be performed with caution. VIMPAT is effectively removed from plasma by hemodialysis. Dosage supplementation of up to 50% following hemodialysis should be considered. 8.7 Hepatic Impairment Based on data in adults, for adult and pediatric patients with mild to moderate hepatic impairment, a reduction of 25% of the maximum dosage is recommended. Patients with mild to moderate hepatic impairment should be observed closely during dose titration [ see Dosage and Administration (2.4), Clinical Pharmacology (12.3) ]. The pharmacokinetics of lacosamide has not been evaluated in severe hepatic impairment. VIMPAT use is not recommended in patients with severe hepatic impairment.

Interactions

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 VIMPAT. Dose reduction may be necessary in these patients. 7.2 Concomitant Medications that Prolong PR Interval VIMPAT should be used with caution in patients on concomitant medications that prolong PR interval, because of a risk of AV block or bradycardia, e.g., beta-blockers and calcium channel blockers. In such patients, obtaining an ECG before beginning VIMPAT, and after VIMPAT is titrated to steady-state, is recommended. In addition, these patients should be closely monitored if they are administered VIMPAT through the intravenous route [ see Warnings and Precautions (5.3) ].

More information

Category Value
Authorisation number NDA022254
Agency product number 563KS2PQY5
Orphan designation No
Product NDC 0131-1810,0131-5410,0131-2470,0131-2477,0131-2478,0131-2479,0131-2480
Date Last Revised 17-11-2017
Type HUMAN PRESCRIPTION DRUG
RXCUI 809984
Storage and handling 16.2 Storage 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] Do not freeze VIMPAT injection or oral solution. Discard any unused VIMPAT oral solution remaining after seven (7) weeks of first opening the bottle.
Marketing authorisation holder UCB, Inc.