Levetiracetam subcutaneous injection: Amber Drug Guidance for Seizure Control in Palliative Care Patients

Amber Drug Level 2

• Prescribing Information
• Communication
• Declarations of Interest
• Responsibilities of Specialist
• Responsibilities of GP
• Responsibilities of Patient/Carer

Amber Level 2: Medicines initiated by a specialist where there is not a need for ongoing monitoring other than for general adverse effects/side effects (as listed in the BNF and SPC). These medicines are considered suitable for GP prescribing (which may include titration of dose) following specialist initiation and assessment of efficacy. All patients on Amber Level 2 drugs should still be regularly reviewed in primary care regarding their Amber Drug treatment. A brief prescribing guidance document will be available for these medicines, but there is no requirement for full Amber Drug Guidance.

The Palliative Care team consultant has started your patient on levetiracetam subcutaneous injections for seizure control. Your local specialist palliative care team will continue to see the patient and prescribe levetiracetam subcutaneous injections until the dose is stable and their seizures are controlled. After this period, the GP will be asked to take over prescribing and disease monitoring. No additional monitoring specific to the medicine to be undertaken by the GP.

Back to top

Prescribing Information

Drug: Levetiracetam 500mg/5ml concentrate for solution

Indication: Unlicensed continuous subcutaneous administration for the management of seizures in palliative care patients who are not in the last days/hours of life and oral administration is not feasible or GI absorption is impaired. Of note in palliative care, midazolam remains the drug of choice for acute management of seizures including those that are imminently dying.

Classification: Amber Level 2

Monitoring: Routine disease monitoring should continue. No additional monitoring specific to the medicine to be undertaken by the GP.

Follow up: Patients should be regularly monitored by the GP and the specialist palliative care team. Levetiracetam is only initiated after discussion with a palliative care consultant.

The following is a summary of prescribing information only. Consult the BNF and SPC for full and current prescribing information. Link to Leeds formulary.

Dose for Adults:

PO:SC of 1:1
The dose is administered over 24 hours by continuous subcutaneous infusion via a syringe pump.

Initial subcutaneous dose is usually equivalent to previous oral dose of levetiracetam. If the patient has not previously been taking levetiracetam then usual starting dose is 500 to 1000mg. Usual maximum dose - 3g over 24 hours (may need 2 syringe pumps for doses above 2g/day or with the appearance of a skin reaction).

Maximum dilution with water for injection or sodium chloride 0.9% to preserve infusion site.

Dose adjustments required in renal impairment and severe hepatic impairment.

Since there is limited compatibility data please contact your local specialist palliative care team for advice regarding combinations of drugs in a syringe pump.

Formulation: 500mg/5ml ampoules containing solution for injection

Adverse drug reactions: See SPC

Any adverse drug reactions should be highlighted to the prescriber immediately, documented on patient notes and via the Yellow Card Scheme

Cautions/Contra-indications:

Hepatic and renal impairment, uncontrolled seizures

Interactions:

Levetiracetam interacts with a wide range of other medicines, especially psychoactive medicines (including opioids). Levetiracetam can have CNS depressant effects and combination with other drugs with CNS depressant effects might affect the ability of the patient to perform skilled tasks. Any concerns can be discussed with your local Specialist Palliative Care Team.

A full list of interactions can be found in the BNF or following this link.

Pregnancy/breast-feeding:

The dose should be monitored carefully during pregnancy and after birth, and adjustments made on a clinical basis. Present in breast milk – manufacturers advise avoid.

Links to additional sources:

The Scottish Palliative Care guidelines has information on use of levetiracetam in palliative care.

Back to top

Communication

Contact Names and Details

Leeds Teaching Hospitals NHS Trust

Medicines Information phone number and e-mail: 0113 2064344
medicines.information@nhs.net

Medicines Information Patient Helpline phone number: 0113 2064376

Back to top

Declarations of interest

Declarations of Interest by authors

All (or any) declarations of interest were declared and considered, through the appropriate process.

Contributors are to declare any changes to their declaration of interest submission within 28 days.

Back to top

Responsibilities of Specialist

Specialist clinician responsibilities:

• Ensure current diagnosis of condition and the treatment options have been discussed and understood by the patient and their carers where appropriate.
• Ensure that the ongoing treatment has been agreed with and by the patient and carer where appropriate.
• To assess the suitability of the patient for this treatment.
• To discuss the benefits and side effects of treatment with the patient/carer and where applicable the need for long term monitoring.
• Checking for allergies, interactions and contra-indications.
• To initiate treatment in agreement with the patient.
• To assess and monitor the patient’s response to treatment until stable before prescribing transferred to General Practitioner (GP).
• Liaise with the patient’s General Practitioner (GP) whether they are willing to take over the prescribing and monitoring responsibilities under this amber drug guidance using a written request.
• To advise the GP on dose to be prescribed
• To forward results of monitoring to GP.
• Advise the GP when therapy may be reduced and stopped assuming no relapse in patient’s condition. Review periods to be agreed.
• Ensure this is also known, understood and agreed with the patient (and where appropriate their carers).
• Responding to issues raised by GP and informing the patient (and carers) of any changes to advice shared or agreements made.
• To monitor the patient for adverse events/side effects and report to the GP and where appropriate Commission on Human Medicines/MHRA (Yellow card scheme).
• Discuss with the patient their responsibilities outlined below, confirm understanding and confirm that the patient is happy to adhere to them.

Back to top

Responsibilities of GP

GP responsibilities:

• Checking for allergies, interactions and contra-indications when taking over prescribing and when changing treatment or initiating new treatments.
• To prescribe levetiracetam and adjust the dose as recommended by the specialist following initiation and stabilisation by the specialist.
• Monitoring the patient’s overall health and wellbeing, observing patient for evidence of ADRs and liaising with specialist clinician if necessary and where appropriate report to Commission on Human Medicines/MHRA (Yellow card scheme).
• Routine disease monitoring should continue.
• When patient attends for review of treatment confirm, in line with the information already provided, by the specialist (or other specialist acting on their behalf) the circumstances under which the medicines should be immediately stopped and what actions the patient is to take.
• To ensure that there is an agreed process in place for accessing the ongoing supply of the medicines that is not placing any unnecessary burden or workload on the patient or their carers.
• Ensure advice is sought from the responsible specialist clinician if there is any significant change in the patient’s physical health status that may affect prescribing or appropriateness of the amber medicine, or any information relevant to their care that becomes available that was not made available at the time of the specialist diagnosis and treatment option agreement.
• Take reasonable steps to ensure that the patient is using their medicines as prescribed and intended, i.e. include amber medication as part of medication review.
• Reducing/stopping treatment in line with specialist clinician’s original request
• Encourage the patient at medication review appointments to ask questions and raise any concerns they have about their treatment, particularly anything that may be affecting their adherence to treatment. Use the Me & My Medicines Charter - https://meandmymedicines.org.uk/the-charter/.

Back to top

Responsibilities of Patient/Carer

Patient/carer responsibilities:

• To agree and accept responsibility for taking this medication as prescribed.
• To understand how to take this medicine safely.
• To understand the most common adverse events/side effects and inform the Specialist/GP as soon as reasonably possible should they occur and significantly affect the use of the medicines.
• To understand the circumstances under which the medicines should be immediately stopped and what action to take.
• The duration of treatment prescribed initially by the hospital specialist should be understood.
• To attend for blood tests/disease monitoring on time (if appropriate).
• To check with the community pharmacist that there are no interactions with this medication, and other medications taken including other prescribed medications, medicines bought over the counter and herbal/homoeopathic products.
• To check with dentists or other specialists who may prescribe medicines that there are no interactions with this drug.
• To understand contents of written information provided by the Specialist and in the patient information leaflet supplied with the medicines and to seek clarification if required.
• To contact the GP, Specialist or Medicines Information patient helpline if further information or advice is needed about this medication or if there is anything they do not understand. More information on asking about medication can be found in the Me & My Medicines Charter https://meandmymedicines.org.uk/the-charter/.