Drugs List

Therapeutic Indications

Uses

Epilepsy - primary generalised tonic-clonic seizures - adjunctive
Epilepsy-partial seizures with/without secondary generalisation-adjunctive
Epilepsy-partial seizures with/without secondary generalisation-monotherapy

Intravenous lacosamide is intended as an alternative option when oral administration is temporarily unavailable.

Administration

For intravenous infusion only.

Contraindications

Children under 4 years
Second degree atrioventricular block
Severe hepatic impairment
Third degree atrioventricular block

Precautions and Warnings

Patients over 65 years
Restricted sodium intake
Breastfeeding
Cardiac conduction defects
Cardiac failure
Hepatic impairment
History of myocardial infarction
Pregnancy
Renal impairment - creatinine clearance below 30 ml/minute
Severe cardiac disorder

Sodium content of formulation may be significant
Advise patient dizziness may affect ability to drive or operate machinery
Folic acid 5mg daily required pre-conception to end of 1st trimester
Refer women considering pregnancy for specialist advice and monitoring
Advise patient to report any signs of cardiac arrhythmias
Advise patients/carers to seek medical advice if suicidal intent develops
Advise pt to seek medical advice if AV block or atrial fibrillation occur
Counsel patients on symptoms of AV block or arrhythmias
May exacerbate myoclonic seizures
Consider discontinuing therapy if serious cardiac arrhythmias occur
Advise patient not to take St John's wort concurrently
Advise patient to avoid alcohol during treatment
Female: Ensure adequate contraception during treatment

Antiepileptic drug hypersensitivity syndrome is a rare but potentially fatal syndrome associated with some antiepileptic drugs. Patients usually present with fever, rash, lymphadenopathy and other organ system involvement. Other possible symptoms include liver dysfunction, haematological, renal and pulmonary abnormalities, vasculitis and multi-organ failure. If signs or symptoms of hypersensitivity syndrome occur, the drug should be withdrawn immediately and expert advice sought.

Antiepileptic treatment is associated with a small increased risk of suicidal thoughts and behaviour; available data suggest that the increased risk applies to all antiepileptics and is seen as early as one week after starting treatment.

Patients should be alert to any mood changes, distressing thoughts, or feelings about suicide or harming themselves at any point during treatment. They should be advised to seek medical advice if they develop such thoughts or behaviour, and should be referred for appropriate treatment if necessary.

The available evidence does not define whether the risk of suicidal thoughts and behaviour differs between antiepileptics. Patients should not stop or switch treatment on the basis of this information and without speaking to a healthcare professional.

Use caution in children experiencing partial-onset seizures with secondary generalisation as the safety and efficacy in this group is currently unknown.

Pregnancy and Lactation

Pregnancy

Use lacosamide with caution in pregnancy.

At the time of writing, there are no adequate data on the use of lacosamide in pregnant women. Animal studies have not indicated any teratogenic effects in rats or rabbits, but embryotoxicity was observed in rats and rabbits at maternal toxic doses. The potential risk for humans is not known.

Due to the lack of data and experience, use of lacosamide during pregnancy is not recommended unless absolutely necessary. However, adjusting or stopping any anti-epileptic medication during pregnancy should not be done without specialist advice, and the relative benefits and risks should be discussed carefully first. The risk of harm to the mother and unborn child from seizures outweighs any teratogenic risk. Pregnancy in epileptic women is associated with a higher risk of congenital abnormalities, which are mainly associated with the use of anti-epileptic drugs rather than the disease itself. This risk is increased when multiple drugs are used. Routine monitoring of antiepileptic drugs is not recommended, but may be useful in cases where seizures have increased or are likely to, in order to plan the extent of dose adjustment needed. It is recommend that folic acid 5 mg daily should be prescribed to all women with epilepsy who are taking antiepileptic drugs, prior to conception and continued until the 12th week of pregnancy.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use lacosamide with caution in breastfeeding.

It is not known whether lacosamide is excreted in human breast milk, but animal studies have shown excretion. The manufacturer does not recommend breastfeeding during treatment with lacosamide. Mothers on anti-epileptic drugs are encouraged to breastfeed, except in rare circumstances, as it is generally considered safe. The risk of injury to the infant caused by a maternal seizure is low.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abnormal liver function tests
Aggression
Agitation
Agranulocytosis
Angioedema
Asthenia
Ataxia
Atrial fibrillation
Atrial flutter
Atrioventricular block
Attention disturbances
Blurred vision
Bradycardia
Cardiac arrhythmias
Cognitive impairment
Confusion
Constipation
Contusion
Depression
Diplopia
Dizziness
Drowsiness
Drug rash with eosinophilia and systemic symptoms (DRESS)
Dry mouth
Dysarthria
Dyspepsia
Erythema
Euphoria
Falls
Fatigue
Flatulence
Gait abnormality
Hallucinations
Headache
Hypersensitivity reactions
Hypoaesthesia
Impaired co-ordination
Impaired memory
Increases in hepatic enzymes
Insomnia
Irritability
Irritation (injection site)
Local pain (injection site)
Loss of balance
Muscle spasm
Nausea
Nystagmus
Prolongation of PR interval
Pruritus
Psychotic disorder
Rash
Seizures
Somnolence
Stevens-Johnson syndrome
Suicidal tendencies
Syncope
Tinnitus
Toxic epidermal necrolysis
Tremor
Urticaria
Vertigo
Vomiting

Presentation

Infusions of lacosamide.

Drugs List

Therapeutic Indications

Uses

Epilepsy - primary generalised tonic-clonic seizures - adjunctive
Epilepsy-partial seizures with/without secondary generalisation-adjunctive
Epilepsy-partial seizures with/without secondary generalisation-monotherapy

Intravenous lacosamide is intended as an alternative option when oral administration is temporarily unavailable.

Dosage

When converting patients from oral to intravenous lacosamide no dosage adjustments are required. The overall duration of intravenous treatment is at the prescriber's discretion, there is no set maximum.

Adults

Children

Patients with Renal Impairment

Patients with Hepatic Impairment

Additional Dosage Information

Administration

For intravenous infusion only.

Contraindications

Children under 4 years
Second degree atrioventricular block
Severe hepatic impairment
Third degree atrioventricular block

Precautions and Warnings

Patients over 65 years
Restricted sodium intake
Breastfeeding
Cardiac conduction defects
Cardiac failure
Hepatic impairment
History of myocardial infarction
Pregnancy
Renal impairment - creatinine clearance below 30 ml/minute
Severe cardiac disorder

Sodium content of formulation may be significant
Advise patient dizziness may affect ability to drive or operate machinery
Folic acid 5mg daily required pre-conception to end of 1st trimester
Refer women considering pregnancy for specialist advice and monitoring
Advise patient to report any signs of cardiac arrhythmias
Advise patients/carers to seek medical advice if suicidal intent develops
Advise pt to seek medical advice if AV block or atrial fibrillation occur
Counsel patients on symptoms of AV block or arrhythmias
May exacerbate myoclonic seizures
Consider discontinuing therapy if serious cardiac arrhythmias occur
Advise patient not to take St John's wort concurrently
Advise patient to avoid alcohol during treatment
Female: Ensure adequate contraception during treatment

Antiepileptic drug hypersensitivity syndrome is a rare but potentially fatal syndrome associated with some antiepileptic drugs. Patients usually present with fever, rash, lymphadenopathy and other organ system involvement. Other possible symptoms include liver dysfunction, haematological, renal and pulmonary abnormalities, vasculitis and multi-organ failure. If signs or symptoms of hypersensitivity syndrome occur, the drug should be withdrawn immediately and expert advice sought.

Antiepileptic treatment is associated with a small increased risk of suicidal thoughts and behaviour; available data suggest that the increased risk applies to all antiepileptics and is seen as early as one week after starting treatment.

Patients should be alert to any mood changes, distressing thoughts, or feelings about suicide or harming themselves at any point during treatment. They should be advised to seek medical advice if they develop such thoughts or behaviour, and should be referred for appropriate treatment if necessary.

The available evidence does not define whether the risk of suicidal thoughts and behaviour differs between antiepileptics. Patients should not stop or switch treatment on the basis of this information and without speaking to a healthcare professional.

Use caution in children experiencing partial-onset seizures with secondary generalisation as the safety and efficacy in this group is currently unknown.

Pregnancy and Lactation

Pregnancy

Use lacosamide with caution in pregnancy.

At the time of writing, there are no adequate data on the use of lacosamide in pregnant women. Animal studies have not indicated any teratogenic effects in rats or rabbits, but embryotoxicity was observed in rats and rabbits at maternal toxic doses. The potential risk for humans is not known.

Due to the lack of data and experience, use of lacosamide during pregnancy is not recommended unless absolutely necessary. However, adjusting or stopping any anti-epileptic medication during pregnancy should not be done without specialist advice, and the relative benefits and risks should be discussed carefully first. The risk of harm to the mother and unborn child from seizures outweighs any teratogenic risk. Pregnancy in epileptic women is associated with a higher risk of congenital abnormalities, which are mainly associated with the use of anti-epileptic drugs rather than the disease itself. This risk is increased when multiple drugs are used. Routine monitoring of antiepileptic drugs is not recommended, but may be useful in cases where seizures have increased or are likely to, in order to plan the extent of dose adjustment needed. It is recommend that folic acid 5 mg daily should be prescribed to all women with epilepsy who are taking antiepileptic drugs, prior to conception and continued until the 12th week of pregnancy.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use lacosamide with caution in breastfeeding.

It is not known whether lacosamide is excreted in human breast milk, but animal studies have shown excretion. The manufacturer does not recommend breastfeeding during treatment with lacosamide. Mothers on anti-epileptic drugs are encouraged to breastfeed, except in rare circumstances, as it is generally considered safe. The risk of injury to the infant caused by a maternal seizure is low.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abnormal liver function tests
Aggression
Agitation
Agranulocytosis
Angioedema
Asthenia
Ataxia
Atrial fibrillation
Atrial flutter
Atrioventricular block
Attention disturbances
Blurred vision
Bradycardia
Cardiac arrhythmias
Cognitive impairment
Confusion
Constipation
Contusion
Depression
Diplopia
Dizziness
Drowsiness
Drug rash with eosinophilia and systemic symptoms (DRESS)
Dry mouth
Dysarthria
Dyspepsia
Erythema
Euphoria
Falls
Fatigue
Flatulence
Gait abnormality
Hallucinations
Headache
Hypersensitivity reactions
Hypoaesthesia
Impaired co-ordination
Impaired memory
Increases in hepatic enzymes
Insomnia
Irritability
Irritation (injection site)
Local pain (injection site)
Loss of balance
Muscle spasm
Nausea
Nystagmus
Prolongation of PR interval
Pruritus
Psychotic disorder
Rash
Seizures
Somnolence
Stevens-Johnson syndrome
Suicidal tendencies
Syncope
Tinnitus
Toxic epidermal necrolysis
Tremor
Urticaria
Vertigo
Vomiting

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: September 2014

Reference Sources

Summary of Product Characteristics: Vimpat 10mg/ml solution for infusion. UCB Pharma Ltd. Revised December 2020.

MHRA Drug Safety Update Vol 2, Issue 1, August 2008
Antiepileptics: risk of suicidal thoughts and behaviour
Available at: www.mhra.gov.uk/Publications/Safetyguidance/DrugSafetyUpdate/CON023078
Last accessed: 3 September 2008