Vimpat Information
Vimpat (Lacosamide) Dosage And Administration
Vimpat (Lacosamide) may be taken with or without food.
When using Vimpat (Lacosamide) oral solution, it is recommended that a calibrated measuring device be obtained and used. A household teaspoon or tablespoon is not an adequate measuring device. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.
Vimpat (Lacosamide) Dosage Forms And Strengths
50 mg (pink), 100 mg (dark yellow), 150 mg (salmon), and 200 mg (blue) film-coated tablets
200 mg/20mL injection
10 mg/mL oral solution
Vimpat (Lacosamide) Contraindications
Vimpat (Lacosamide) Warnings And Precautions
Antiepileptic drugs (AEDs), including Vimpat (Lacosamide) , 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 1 shows absolute and relative risk by indication for all evaluated AEDs.
The 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 Vimpat (Lacosamide) 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.
Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and 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.
Patients should be advised that Vimpat (Lacosamide) may cause dizziness and ataxia. Accordingly, they should be advised not to drive a car or to operate other complex machinery until they are familiar with the effects of Vimpat (Lacosamide) on their ability to perform such activities.
In patients with partial-onset seizures taking 1 to 3 concomitant AEDs, dizziness was experienced by 25% of patients randomized to the recommended doses (200 to 400 mg/day) of Vimpat (Lacosamide) (compared with 8% of placebo patients) and was the adverse event most frequently leading to discontinuation (3%). Ataxia was experienced by 6% of patients randomized to the recommended doses (200 to 400 mg/day) of Vimpat (Lacosamide) (compared to 2% of placebo patients). The onset of dizziness and ataxia was most commonly observed during titration. There was a substantial increase in these adverse events at doses higher than 400 mg/day. [see ]
One case of symptomatic hepatitis and nephritis was observed among 4011 subjects exposed to Vimpat (Lacosamide) during clinical development. The event occurred in a healthy volunteer, 10 days after stopping Vimpat (Lacosamide) treatment. The subject was not taking any concomitant medication and potential known viral etiologies for hepatitis were ruled out. The subject fully recovered within a month, without specific treatment. The case is consistent with a delayed multiorgan hypersensitivity reaction. Additional potential cases included 2 with rash and elevated liver enzymes and 1 with myocarditis and hepatitis of uncertain etiology.
Multiorgan hypersensitivity reactions (also known as rug eaction with osinophilia and ystemic ymptoms, or DRESS) have been reported with other anticonvulsants and typically, although not exclusively, present with fever and rash associated with other organ system involvement, that may or may not include eosinophilia, hepatitis, nephritis, lymphadenopathy, and/or myocarditis. Because this disorder is variable in its expression, other organ system signs and symptoms not noted here may occur. If this reaction is suspected, Vimpat (Lacosamide) should be discontinued and alternative treatment started.
Vimpat (Lacosamide) Adverse Reactions
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.
In all controlled and uncontrolled trials in patients with partial-onset seizures, 1327 patients have received Vimpat (Lacosamide) of whom 1000 have been treated for longer than 6 months and 852 for longer than 12 months.
Vimpat (Lacosamide) Drug Interactions
Drug-drug interaction studies in healthy subjects showed no pharmacokinetic interactions between Vimpat (Lacosamide) and carbamazepine, valproate, digoxin, metformin, omeprazole, or an oral contraceptive containing ethinylestradiol and levonorgestrel. There was no evidence for any relevant drug-drug interaction of Vimpat (Lacosamide) with common AEDs in the placebo-controlled clinical trials in patients with partial-onset seizures [see ].
The lack of pharmacokinetic interaction does not rule out the possibility of pharmacodynamic interactions, particularly among drugs that affect the heart conduction system.
Vimpat (Lacosamide) Use In Specific Populations
The safety and effectiveness of Vimpat (Lacosamide) in pediatric patients
Lacosamide has been shown in vitro to interfere with the activity of CRMP-2, a protein involved in neuronal differentiation and control of axonal outgrowth. Potential adverse effects on CNS development can not be ruled out. Administration of lacosamide to rats during the neonatal and juvenile periods of postnatal development 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) approximately 0.5 times the human plasma AUC at the maximum recommended human dose of 400 mg/day.
There were insufficient numbers of elderly patients enrolled in partial-onset seizure trials (n=18) to adequately assess the effectiveness of Vimpat (Lacosamide) in this population.
In healthy subjects, the dose and body weight normalized pharmacokinetic parameters AUC and C were approximately 20% higher in elderly subjects compared to young subjects. The slightly higher lacosamide plasma concentrations in elderly subjects are possibly caused by differences in total body water (lean body weight) and age-associated decreased renal clearance. No Vimpat (Lacosamide) dose adjustment based on age is considered necessary. Caution should be exercised for dose titration in elderly patients.
Vimpat (Lacosamide) Overdosage
There is limited clinical experience with Vimpat (Lacosamide) overdose in humans. The highest reported accidental overdose of Vimpat (Lacosamide) during clinical development was 1200 mg/day which was non-fatal. The types of adverse events experienced by patients exposed to supratherapeutic doses during the trials were not clinically different from those of patients administered recommended doses of Vimpat (Lacosamide) .
There has been a single case of intentional overdose by a patient who self-administered 12 grams Vimpat (Lacosamide) along with large doses of zonisamide, topiramate, and gabapentin. The patient presented in a coma and was hospitalized. An EEG revealed epileptic waveforms. The patient recovered 2 days later.
There is no specific antidote for overdose with Vimpat (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 Vimpat (Lacosamide) .
Standard hemodialysis procedures result in significant clearance of Vimpat (Lacosamide) (reduction of systemic exposure by 50% in 4 hours). Hemodialysis has not been performed in the few known cases of overdose, but may be indicated based on the patient's clinical state or in patients with significant renal impairment.
Vimpat (Lacosamide) 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 CHNO 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.
Vimpat (Lacosamide) Clinical Pharmacology
The precise mechanism by which Vimpat (Lacosamide) exerts its antiepileptic effects in humans remains to be fully elucidated. 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.
Lacosamide binds to collapsin response mediator protein-2 (CRMP-2), a phosphoprotein which is mainly expressed in the nervous system and is involved in neuronal differentiation and control of axonal outgrowth. The role of CRMP-2 binding in seizure control is unknown.
The pharmacokinetics of Vimpat (Lacosamide) have been studied in healthy adult subjects (age range 18 to 87), adults with partial-onset seizures, adults with diabetic neuropathy, and subjects with renal and hepatic impairment.
Vimpat (Lacosamide) is completely absorbed after oral administration with negligible first-pass effect with a high absolute bioavailability of approximately 100%. The maximum lacosamide plasma concentrations occur approximately 1 to 4 hour post-dose after oral dosing, and elimination half-life is approximately 13 hours. Steady state plasma concentrations are achieved after 3 days of twice daily repeated administration. Pharmacokinetics of Vimpat (Lacosamide) are dose proportional (100-800 mg) and time invariant, with low inter- and intra-subject variability. Compared to lacosamide the major metabolite, O-desmethyl metabolite, has a longer T (0.5 to 12 hours) and elimination half-life (15-23 hours).
Vimpat (Lacosamide) Clinical Studies
Vimpat (Lacosamide) How Supplied/storage And Handling
Vimpat (Lacosamide) Tablets 50 mg are pink, oval, film-coated tablets debossed with "SP" on one side and "50" on the other. They are supplied as follows:
Vimpat (Lacosamide) Tablets 100 mg are dark yellow, oval, film-coated tablets debossed with "SP" on one side and "100" on the other. They are supplied as follows:
Vimpat (Lacosamide) Tablets 150 mg are salmon, oval, film-coated tablets debossed with "SP" on one side and "150" on the other. They are supplied as follows:
Vimpat (Lacosamide) Tablets 200 mg are blue, oval, film-coated tablets debossed with "SP" on one side and "200" on the other. They are supplied as follows:
Vimpat (Lacosamide) injection 200 mg/20 mL is a clear, colorless sterile solution supplied in 20 mL colorless single-use glass vials.
Vimpat (Lacosamide) oral solution 10 mg/mL is a clear, colorless to yellow or yellow-brown, strawberry-flavored liquid. It is supplied in PET bottles.
Vimpat (Lacosamide) Patient Counseling Information
Patients should be informed of the availability of a Medication Guide, and they should be instructed to read the Medication Guide prior to taking Vimpat (Lacosamide) . Patients should be instructed to take Vimpat (Lacosamide) only as prescribed.
Vimpat (Lacosamide) Medication Guide
Read this Medication Guide before you start taking Vimpat (Lacosamide) and each time you get a refill. There may be new information. This Medication Guide describes important safety information about Vimpat (Lacosamide) . This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
Stopping Vimpat (Lacosamide) suddenly can cause serious problems.
Vimpat (Lacosamide) is a prescription medicine used with other medicines to treat partial-onset seizures in people 17 years of age and older.
Taking Vimpat (Lacosamide) with certain other medicines may cause side effects or affect how they work. Do not start or stop other medicines without talking to your healthcare provider. Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist each time you get a new medicine.
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Vimpat (Lacosamide) may cause a serious allergic reaction that may affect your skin or other parts of your body such as your liver or blood cells. Call your healthcare provider right away if you have:
These are not all of the possible side effects of Vimpat (Lacosamide) . For more information ask your healthcare provider or pharmacist. Tell your healthcare provider about any side effect that bothers you or that does not go away. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Vimpat (Lacosamide) for a condition for which it was not prescribed. Do not give Vimpat (Lacosamide) to other people, even if they have the same symptoms you have. It may harm them.
This Medication Guide summarizes the most important information about Vimpat (Lacosamide) . If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Vimpat (Lacosamide) that is written for health professionals.
For more information, go to www.Vimpat (Lacosamide) .com or call 1-800-477-7877.
Manufactured forUCB, Inc. Smyrna, GA 30080
Issued 04/2011
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Vimpat (Lacosamide) is a registered trademark under license from Harris FRC Corporation and covered by one or more claims of U.S. Patent 38,551.
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Vimpat (Lacosamide) Principal Display Panel - Kit Carton
ATTENTION PHYSICIAN: Each patient is required to receive the accompanying Medication Guide.
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