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PHARMA-LACOSAMIDE is a brand name for Lacosamide, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
). Patients should be informed that if visual disturbances occur, they should notify their physician promptly. If visual disturbance persists, further assessment, including dose reduction and possible discontinuation of lacosamide, should be considered.
More frequent assessments should be considered for patients with known vision-related issues or those who are already routinely monitored for ocular conditions. Psychiatric Suicidal Ideation and Behaviour Suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents in several indications.
All patients treated with antiepileptic drugs, irrespective of indication, should be monitored for signs of suicidal ideation and behaviour and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
An FDA meta-analysis of randomized placebo controlled trials, in which antiepileptic drugs were used for various indications, has shown a small increased risk of suicidal ideation and behaviour in patients treated with these drugs.
The mechanism of this risk is not known. There were 43892 patients treated in the placebo controlled clinical trials that were included in the meta-analysis. Approximately 75% of patients in these clinical trials were treated for indications other than epilepsy and, for the majority of non-epilepsy indications the treatment (antiepileptic drug or placebo) was administered as monotherapy.
, patients in both treatment arms were being treated with one or more antiepileptic drug). 24% for patients on placebo) is based largely on patients that received monotherapy treatment (antiepileptic drug or placebo) for non-epilepsy indications.
The study design does not allow an estimation of the risk of suicidal ideation and behaviour for patients with epilepsy that are taking antiepileptic drugs, due both to this ______________________________________________________________________________ pharma-LACOSAMIDE Product Monograph Page 13 of 44 population being the minority in the study, and the drug-placebo comparison in this population being confounded by the presence of adjunct antiepileptic drug treatment in both arms.
4 Drug-Drug Interactions, Oral Contraceptives). Fertility No adverse effects on male or female fertility or reproduction were observed in rats at doses producing plasma exposures (AUC) up to approximately 2 times the plasma AUC in humans at the maximum recommended human dose (MRHD) of 400 mg/day.
Syncope In the short-term controlled adjunctive therapy trials of lacosamide in epilepsy patients with no significant system illnesses, there was no increase in syncope compared to placebo. 0% of patients who were treated with lacosamide reported an adverse reaction of syncope or loss of consciousness, compared to 0% of placebo-treated patients with diabetic neuropathy.
, Neurologic). Hepatic/Biliary/Pancreatic Rare post-marketing reports of severe liver injury, including acute liver failure, have been reported in patients treated with lacosamide. Some of the cases were considered clinically significant and possibly or probably related to lacosamide therapy.
, pruritus, dark urine, jaundice, right upper quadrant tenderness, or unexplained "flu-like" symptoms). 5 Post- Market Adverse Drug Reactions, Hepatic/Biliary/Pancreatic). ______________________________________________________________________________ pharma-LACOSAMIDE Product Monograph Page 11 of 44 Immune Hypersensitivity Multiorgan hypersensitivity reactions (including Drug Reaction with Eosinophilia and Systemic Symptoms, or DRESS), Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) have been reported with anticonvulsants, including lacosamide.
Typically, although not exclusively, DRESS presents with fever and rash associated with other organ system involvement, that may or may not include eosinophilia, hepatitis, nephritis, lymphadenopathy, and/or myocarditis. Because these disorders are variable in their expression, other organ system signs and symptoms not noted here may also occur.
If any of these hypersensitivity reactions are suspected, pharma-LACOSAMIDE should be discontinued and alternative treatment started. One case of symptomatic hepatitis and nephritis was observed among 4011 subjects exposed to lacosamide during clinical development.
The event occurred in a healthy volunteer, 10 days after stopping 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. SJS has been reported very rarely in post-marketing experience during treatment with lacosamide in combination with other antiepileptic drugs.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Most of the cases of syncope were observed in patients receiving doses above 400 mg/day. The cause of syncope was not determined in most cases. However, several were associated with either changes in orthostatic blood pressure, atrial flutter/fibrillation (and associated tachycardia), or bradycardia.
2 Clinical Trial Adverse Reactions, Syncope). 1 Pregnant Women There are no clinical studies with lacosamide in pregnant women. Studies in pregnant rats revealed that lacosamide and/or its metabolites readily crossed the placental barrier.
Data in rats and rabbits did not indicate teratogenic effects but embryotoxicity was observed at maternal toxic doses (see 5 OVERDOSAGE, Non-acute Overdose in Humans; 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology).
There are postmarketing reports of lacosamide crossing the placental barrier in humans. Since the potential risk for humans is not established pharma-LACOSAMIDE should not be used during pregnancy unless the benefit to the mother clearly outweighs the potential risk to the foetus.
If women decide to become pregnant while taking pharma-LACOSAMIDE, the use of this product should be carefully reevaluated. ______________________________________________________________________________ pharma-LACOSAMIDE Product Monograph Page 14 of 44 Pregnancy Registry: Physicians are advised to recommend that pregnant patients taking pharma-LACOSAMIDE enroll in the North American Antiepileptic Drug Pregnancy Registry (NAAED).
This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. 2 Breast-feeding Lacosamide is excreted in human breast milk in significant quantities. 83 have been reported. A decision should be made whether to discontinue nursing or to discontinue pharma-LACOSAMIDE, taking into account the benefits of the drug to the mother and any potential adverse effects of lacosamide on the breastfed infant.
3 Pediatrics: […]
A causal relationship between SJS and lacosamide treatment cannot be excluded. SJS was not reported during clinical development. No cases of TEN were reported during clinical development. TEN has been reported very rarely in post-marketing experience during treatment with lacosamide in combination with other drugs including antiepileptic drugs.
A causal relationship between TEN and lacosamide treatment cannot be excluded. Monitoring and Laboratory Tests See 7 WARNINGS AND PRECAUTIONS, Cardiovascular. Neurologic Dizziness and Ataxia Treatment with lacosamide has been associated with dizziness and ataxia which could increase the occurrence of accidental injury or falls (see 7 WARNINGS AND PRECAUTIONS, Driving and Operating Machinery).
In controlled adjunctive therapy clinical trials, dizziness was experienced by 25% of patients with partial-onset seizures taking 1 to 3 concomitant AEDs randomized to the recommended doses (200 to 400 mg/day) of lacosamide (compared with 8% of placebo patients) and was the adverse event most frequently leading to discontinuation (3%).
2 Clinical Trial Adverse Drug Reactions). There was a substantial increase in the frequency of occurrence of these events when patients received lacosamide doses greater than 400 mg/day. Ophthalmologic In controlled adjunctive therapy trials in patients with partial-onset seizures, lacosamide treatment was associated with vision-related adverse events such as blurred vision (lacosamide, 8%; placebo, 3%) and diplopia (lacosamide, 11%; placebo, 2%).
Three percent of patients randomized to lacosamide discontinued treatment due to vision-related adverse events (primarily diplopia) (see