Abstract
We developed this levetiracetam guideline using drug prescribing information and reviewing the available literature on relevant neuropsychiatric disorders in populations without intellectual disabilities because of the dearth of available literature on the population with intellectual disabilities. This guideline includes indications, contraindications, assessments prior to and during treatment, dosing with particular focus on dosing modifications required by drug–drug interactions or personal characteristics, and adverse drug reactions. The procedures contained in this guideline may not fully account for all of the possible risks of treatment in this population because of the limited studies available; thus, there will be a need to periodically update this guideline as new information becomes available. Nevertheless, we believe that this guideline provides a useful resource for clinicians who treat epilepsy in adult individuals with intellectual disabilities. A levetiracetam drug utilization review that summarizes this guideline is described.
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Appendix Drug Utilization Review: Levetiracetam
Appendix Drug Utilization Review: Levetiracetam
DRUG UTILIZATION REVIEW CRITERIA | CRITERIA MET | |||||
|---|---|---|---|---|---|---|
LEVETIRACETAM FOR ADULTS WITH IDs | YES | NO | NA | |||
1) Indication: Check one of the following indications for use | ||||||
| Adjunctive therapy for partial-onset seizures. | |||||
| Adjunctive therapy for myoclonic seizures. | |||||
| Adjunctive therapy for primary, generalized, tonic–clonic seizures. | |||||
| Off-label use, including other types of epilepsy and several types of myoclonus. Specify_______________________ When levetiracetam is used for off-label indications, the chart specifically includes an explanatory note (Y___ N___). | |||||
To meet indication criteria, at least one indication is present and documented. | | | ||||
2) Dose:__________ mg/day. Formulation: Not ER___ ER___. | ||||||
Levetiracetam solution or immediate-release tablets are given two times/day (Y__ N__) or XR tablets are given once a day (Y__ N__) unless otherwise recommended by a consultant with expertise in the area (Y__). | | | | |||
The first anticonvulsive daily dose was ≤ 1,000 mg/day: 500 mg/day twice a day for immediate release (Y__ N__) or 1,000 mg/day once for ER tablets (Y__ N__) unless otherwise recommended by consultant with expertise in the area (Y__). | | | | |||
Antiepileptic dosages were increased ≤ 500 mg/day every 2 weeks for immediate release (Y__ N__) or ≤ 1,000 mg/day every 2 weeks for ER tablets (Y__ N__) unless otherwise recommended by consultant with expertise in the area (Y__). | | | | |||
The maximum antiepileptic dose was ≤ 3,000 mg/day (Y__ N__) unless otherwise recommended by a consultant with expertise in the area (Y__). | | | | |||
Dosage for monotherapy for refractory partial epilepsy and other off-label indications was recommended by a consultant with expertise in the area and documented in the chart (Y__ N__). | | | | |||
Taking carbamazepine____ or topiramate______. Levetiracetam may increase their toxicity. The chart documents the interaction (Y__ N__). | | | | |||
Renal impairment requires lower doses. When creatinine clearance is >80 ml/min___, the dose should be 500–1,500 mg every 12 hours for non-ER tablets or 1,000–3,000 mg/day every 24 hours for ER tablets (Y__ N__); 50–80 ml/min___, the dose should be 500–1,000 mg every 12 hours for non-ER tablets or 1,000–2,000 mg/day every 24 hours for ER tablets (Y__ N__); 30–50 ml/min___, the dose should be 250–750 mg every 12 hours for non-ER tablets or 500–1,500 mg/day every 24 hours for ER tablets (Y__ N__); <30 ml/min___, the dose should be 250–500 mg every 12 hours for non-ER tablets (Y__ N__) or 500–1,000 mg/day every 24 hours for ER tablets (Y__ N__); End stage and dialysis___, the dose should be 500–1,000 mg every 24 hours for non-ER tablets (Y__ N__) and a supplement of 250–500 mg following dialysis (Y__ N__). | | | | |||
To meet dose criteria, all are Yes or NA. | | | ||||
3) Relative contraindications: Check any present. | ||||||
| Pregnancy (Category C) or breast feeding. | |||||
If any of the above are checked, rationale is documented in chart to meet relative contraindication criteria. If none are present, check NA. | | | | |||
4) Monitoring studies (only in patients with kidney disturbances or a high creatinine level): | ||||||
| Initial workup included creatinine clearance. | |||||
| Annual monitoring included creatinine clearance. | |||||
Answer Yes or No. If information is not applicable, check NA. | | | | |||
5) Discontinuation: | ||||||
Levetiracetam is or was withdrawn slowly to minimize the potential of increased seizure frequency (Y__ N__). Abrupt withdrawal was justified by a major medical reason (Y__ N__). | | | | |||
6) Adverse drug reactions (ADRs) due to levetiracetam: Check left boxes to indicate which ADRs are present. | ||||||
6.1) Common ADRs: | ||||||
| Somnolence, coordination difficulties, dizziness, asthenia, or headaches. | |||||
| Psychotic symptoms or behavioral symptoms (aggression, anger, anxiety, depersonalization, and depression). | | Gastrointestinal: Vomiting or anorexia. | |||
| Neuromuscular: Weakness. | | Respiratory: Rhinitis or cough. | |||
6.2) Relatively uncommon ADRs: | ||||||
| Paradoxical increase of seizures. | | Other_____________. | |||
6.3) Potentially lethal ADRs: | ||||||
| Suicidal ideation or behavior. | |||||
Answer Yes (intervention or benefit/risk discussion after ADRs developed) or No (neither intervention nor benefit/risk discussion after ADRs developed) or NA (no abnormality developed). | | | | |||
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de Leon, J. (2012). A Practitioner’s Guide to Prescribing Levetiracetam for Adults with Intellectual Disabilities. In: de Leon, J. (eds) A Practitioner's Guide to Prescribing Antiepileptics and Mood Stabilizers for Adults with Intellectual Disabilities. Springer, Boston, MA. https://doi.org/10.1007/978-1-4614-2012-5_10
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