A Practitioner’s Guide to Prescribing Rufinamide for Adults with Intellectual Disabilities

Abstract

We developed this rufinamide 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, 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 rufinamide drug utilization review that summarizes this guideline is described.

Appendix Drug Utilization Review: Rufinamide

DRUG UTILIZATION REVIEW CRITERIA				CRITERIA MET
RUFINAMIDE FOR ADULTS WITH IDs				YES	NO	NA
1) Indication: Check one of the following indications for use.
	For adjunctive treatment of seizures associated with Lennox–Gastaut syndrome.
	Off-label uses: adjunctive treatment of refractory partial seizures. Specify_________________________. When rufinamide is used for off-label indications, the chart will specifically include an explanatory note (Y___ N___).
To meet indication criteria this indication is present and documented.					
2) Dose: Specify current formulation and dosages______________________.
	Rufinamide is administered with food.					
	Rufinamide is given two times/day (Y__ N__) unless otherwise recommended by a consultant with expertise in the area (Y__).					
	The first anticonvulsive daily dose was ≤ 400–800 mg/day (Y__ N__) unless otherwise recommended by a consultant with expertise in the area (Y__).					
	Dosages were increased ≤ 400–800 mg/day every 2 days (Y__ N__) unless otherwise recommended by a consultant with expertise in the area (Y__).					
	The maximum antiepileptic dose was ≤ 3,200 mg/day (Y__ N__) unless otherwise recommended by a consultant with expertise in the area (Y__).					
	Taking phenytoin__, carbamazepine__, phenobarbital__, primidone__. The chart documents the interaction (Y___ N___). The dosage of rufinamide may need to be increased when any of these antiepileptic drugs are added and the discontinuation of any of these inducers may need to be followed by a decrease in rufinamide dosage.					
	Taking valproate__. The chart documents the interaction (Y___ N___). The dosage of rufinamide may need to be decreased when valproate is added and the discontinuation of valproate may need to be followed by a decrease in rufinamide dosage.					
	Taking oral contraceptives___. The chart documents that the oral contraceptive may not be effective (Y___ N___).					
	Hemodialysis____. The chart documents that rufinamide doses are adjusted (Y___ N___).					
To meet dose criteria all are Yes or NA.					
3) Relative contraindications: Check left boxes of any present.
	Pregnancy (Category C) or breastfeeding.
	Severe liver impairment.
Answer Yes if none is checked, or if any of the above are checked and rationale is documented in the chart to meet relative ­contraindication criteria. Answer No if rationale is NOT ­documented in the chart.					
4) Baseline monitoring studies:
	EKG.
	Liver function tests.
	Serum concentrations of the concomitantly administered antiepileptics that are usually followed by therapeutic drug monitoring.
Answer Yes (all completed) or No. If information is not available check NA.						
5) Discontinuation:
	Rufinamide 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 rufinamide: Check left boxes to indicate which ADRs are present.
6.1) Common ADRs:
	Somnolence or fatigue.		Coordination abnormalities, dizziness, gait disturbances or ataxia.
	Headaches.		Nausea.
	Convulsions.
6.2) Relatively uncommon ADRs:
	QT shortening.		Elevation in liver enzymes.
	Other_____________		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).