Generic Name: Rufinamide
Class: Anticonvulsants, Miscellaneous
ATC Class: N03AF03
Chemical Name: 1-[(2,6-difluorophenyl)methyl]-1H-1,2,3-triazole-4 carboxamide
Molecular Formula: C10H8F2N4O
CAS Number: 106308-44-5

Warning(s)

REMS:

FDA approved a REMS for rufinamide to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page () or the ASHP REMS Resource Center ().

Introduction

Anticonvulsant; a triazole derivative.1 6 7 9 10 11 12 13 14 15 17 18

Uses for Banzel

Seizure Disorders

Management (in combination with other anticonvulsants) of seizures associated with Lennox-Gastaut syndrome in adults and children ≥4 years of age.1 5 6 8 9 10 11 28 Designated an orphan drug by FDA for use in this condition.5 8 10

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Has been studied with some success in the adjunctive management of refractory or inadequately controlled partial seizures in adolescents and adults;6 7 10 11 12 13 16 17 18 19 21 22 24 25 29 30 further study needed to establish role in therapy.11 19

Banzel Dosage and Administration

General

  • Withdraw rufinamide gradually to minimize the potential for increased seizure frequency or status epilepticus in patients with seizure disorders.1 (See Dosage under Dosage and Administration.) If abrupt discontinuance is necessary, closely supervise transition to another anticonvulsant.1

  • Closely monitor for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.1 2 3 4 20 (See Suicidality Risk under Cautions.)

Administration

Oral Administration

Administer orally as tablets or oral suspension twice daily in equally divided doses with food.1

Tablets

Administer scored tablets whole, as half tablets, or crushed.1 21

Scored tablets may not provide the exact mg/kg dosage that has been calculated for use in children; manufacturer's recommended dosages in children are therefore designated as approximate.1 21

Oral Suspension

Shake well prior to administration of each dose.1

Administer using bottle adapter and calibrated oral dosing syringe supplied by manufacturer.1

Firmly insert bottle adapter into neck of bottle before use; allow adapter to remain in place as long as bottle is in use (up to 90 days).1

To dispense dose, insert oral dosing syringe into adapter in upright bottle, then invert bottle and withdraw appropriate dose into oral dosing syringe.1 Replace cap over bottle adapter after each use.1 Consult manufacturer's patient information (medication guide) for detailed information on administration of oral suspension.1

Dosage

Pediatric Patients

Seizure Disorders
Adjunctive Therapy in Lennox-Gastaut Syndrome
Oral

Children ≥4 years of age: Initially, approximately 10 mg/kg daily administered in 2 equally divided doses.1 Increase daily dosage in increments of approximately 10 mg/kg every other day up to a target dosage of 45 mg/kg or 3.2 g daily, whichever is lower.1 Efficacy of dosages lower than the target dosage has not been established.1

Initiate therapy at a dosage lower than 10 mg/kg daily in children receiving valproic acid.1 11 (See Specific Drugs under Interactions.)

Reduce dosage gradually if discontinuing therapy.1 In clinical trials, rufinamide dosage was tapered by approximately 25% every other day.1

Adults

Seizure Disorders
Adjunctive Therapy in Lennox-Gastaut Syndrome
Oral

Initially, 400–800 mg daily administered in 2 equally divided doses.1 Increase dosage in increments of 400–800 mg daily every other day until a maximum dosage of 3.2 g daily is reached.1 Efficacy of dosages lower than 3.2 g daily has not been established.1

Initiate therapy at a dosage lower than 400 mg daily in adults receiving valproic acid.1 11 (See Specific Drugs under Interactions.)

Reduce dosage gradually if discontinuing therapy.1 In clinical trials, rufinamide dosage was tapered by approximately 25% every other day.1

Prescribing Limits

Pediatric Patients

Seizure Disorders
Adjunctive Therapy in Lennox-Gastaut Syndrome
Oral

Children ≥4 years of age: Maximum 45 mg/kg or 3.2 g daily, whichever is less.1

Adults

Seizure Disorders
Adjunctive Therapy in Lennox-Gastaut Syndrome
Oral

Maximum 3.2 g daily.1

Special Populations

Hepatic Impairment

Not studied in patients with hepatic impairment.1 21 Do not use in patients with severe hepatic impairment.1 21 (See Hepatic Impairment under Cautions.)

Renal Impairment

No dosage adjustment necessary in patients with renal impairment (Clcr <30 mL/minute).1 11 21

Consider dosage adjustment in hemodialysis patients; hemodialysis within 3 hours after a dose may reduce drug exposure to a limited extent (by about 30%).1 11 21

Geriatric Patients

Select dosage carefully, usually initiating therapy at lower end of usual dosage range, because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.1 10

Cautions for Banzel

Contraindications

  • Familial short QT syndrome.1 21 (See Shortening of QT Interval under Cautions and see Drugs that Shorten QT Interval under Interactions.)

Warnings/Precautions

Warnings

Suicidality Risk

Increased risk of suicidality (suicidal behavior or ideation) observed in an analysis of studies using various anticonvulsants in patients with epilepsy, psychiatric disorders (e.g., bipolar disorder, depression, anxiety), and other conditions (e.g., migraine, neuropathic pain); risk in patients receiving anticonvulsants (0.43%) was approximately twice that in patients receiving placebo (0.24%).1 2 3 4 20 Increased suicidality risk was observed ≥1 week after initiation of anticonvulsant therapy and continued through 24 weeks.1 2 3 4 Risk was higher for patients with epilepsy compared with those receiving anticonvulsants for other conditions.1 2 4

Closely monitor all patients currently receiving or beginning anticonvulsant therapy for changes in behavior that may indicate emergence or worsening of suicidal thoughts or behavior or depression.1 2 3 4 20 Anxiety, agitation, hostility, hypomania, and mania may be precursors to emerging suicidality.2

Balance risk of suicidality with risk of untreated illness.1 2 Epilepsy and other illnesses treated with anticonvulsants are themselves associated with morbidity and mortality and an increased risk of suicidality.1 20 If suicidal thoughts or behavior emerges during anticonvulsant therapy, consider whether these symptoms may be related to the illness itself.1 20 (See Advice to Patients.)

Nervous System Effects

Two general categories of adverse CNS effects reported: 1) somnolence or fatigue, and 2) coordination abnormalities, dizziness, gait disturbances, and ataxia.1 (See Suicidality Risk under Cautions.)

Sensitivity Reactions

Multiorgan Hypersensitivity Reactions

Multiorgan hypersensitivity syndrome reported with rufinamide and other anticonvulsants; presentation is variable but typically includes fever and rash associated with other organ system involvement.1 32

One case with rash, urticaria, facial edema, fever, elevated eosinophils, stuporous state, and severe hepatitis began on day 29 of rufinamide therapy;1 other possible cases (with rash accompanied by fever, elevated liver function test results, hematuria, and/or lymphadenopathy) reported in children <12 years of age within 4 weeks of treatment initiation.1 Cases resolved or improved following drug discontinuance.1

If multiorgan hypersensitivity reaction is suspected, discontinue rufinamide and initiate alternative treatment.1 21 Closely monitor patients who develop a rash.1 21

General Precautions

Shortening of QT Interval

Shortening of QT interval reported;1 reported degree of shortening (mean of 20 msec at dosages ≥2.4 mg twice daily) is without known clinical risk.1 11

Familial short QT syndrome is associated with increased risk of sudden death and ventricular arrhythmias, particularly ventricular fibrillation, primarily when the corrected QT (QTc) interval is <300 msec.1 Nonclinical data indicate QT-interval shortening is associated with ventricular fibrillation.1

Manufacturer and some clinicians state that patients with familial short QT syndrome should not receive rufinamide; caution advised when administering rufinamide with other drugs that shorten the QT interval.1 11 21 28 Some clinicians recommend using rufinamide with caution in patients with a history of an abnormal ECG demonstrating QT-interval shortening or a family history of unexplained cardiac arrhythmia or sudden death.28 (See Contraindications under Cautions and also see Drugs that Shorten QT Interval under Interactions.)

Discontinuance of Anticonvulsants

Abrupt withdrawal of anticonvulsants may result in increased seizure frequency or status epilepticus in patients with seizure disorders.1 If discontinuing therapy, withdraw rufinamide gradually (see Dosage under Dosage and Administration).1 If abrupt discontinuance is necessary, closely supervise transition to another anticonvulsant.1

Status Epilepticus

Incidence of treatment-emergent status epilepticus in rufinamide-treated patients is difficult to estimate because standard definitions were not employed in studies.1 9 Incidence of possible status epilepticus with rufinamide treatment was 4.1% in one study of Lennox-Gastaut syndrome and 0.9% across all controlled clinical trials of the drug.1

Specific Populations

Pregnancy

Category C.1

UCB AED Pregnancy Registry at 888-537-7734 (for clinicians and patients) and North American Antiepileptic Drug (NAAED) Pregnancy Registry at 888-233-2334 (for patients); NAAED registry information also available on the website .1

Effect on labor and delivery is unknown.1

Lactation

Likely to be distributed into milk.1 21 Discontinue nursing or the drug.1 21

Pediatric Use

Safety and efficacy not established in children <4 years of age.1 21

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger patients.1 No clinically important differences in pharmacokinetics between healthy geriatric individuals and younger healthy adults.1

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.1

Hepatic Impairment

Not studied in hepatic impairment.1 Use with caution in patients with mild to moderate hepatic impairment.1 Use in severe hepatic impairment not recommended.1

Renal Impairment

Renal impairment (Clcr <30 mL/minute) does not substantially alter pharmacokinetics; hemodialysis may reduce exposure.1 (See Renal Impairment under Dosage and Administration and also see Absorption: Special Populations and Elimination: Special Populations, under Pharmacokinetics.)

Common Adverse Effects

As adjunctive therapy in pediatric patients: Somnolence, headache, fatigue, dizziness, influenza, nasopharyngitis, nausea, vomiting, decreased appetite.1 6 9 10 11 13 14 15 21

As adjunctive therapy in adults: Headache, dizziness, fatigue, somnolence, diplopia, tremor, nystagmus, blurred vision, nausea, vomiting.1 6 9 10 11 13 14 15 21

Interactions for Banzel

Metabolized by carboxylesterases.1

Demonstrates little or no inhibition of most CYP isoenzymes.1 8 Weak inhibitor of CYP2E1;1 21 weak inducer of CYP3A4.1 11 14 21

Unlikely to be involved in clinically important pharmacokinetic interactions.1

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

Substrates of CYP2E1: Potential pharmacokinetic interaction (increased plasma substrate concentrations).1 21 (See Specific Drugs under Interactions.)

Substrates of CYP3A4: Potential pharmacokinetic interaction (decreased exposure of substrates).1 11 14 21 (See Specific Drugs under Interactions.)

Inducers of carboxylesterases: Potential pharmacokinetic interaction (increased rufinamide clearance); broad-spectrum inducers may have minor effects on rufinamide metabolism via this mechanism.1 (See Specific Drugs under Interactions.)

Inhibitors of carboxylesterases: Potential pharmacokinetic interaction (decreased rufinamide metabolism).1 8

Anticonvulsants

Typical average steady-state plasma rufinamide concentrations generally have little effect on the pharmacokinetics of other anticonvulsants.1 Effects, when present, are more marked in pediatric patients.1 (See Specific Drugs under Interactions.)

Clinical importance of drug interactions between rufinamide and potentially interacting anticonvulsants is unknown; some clinicians recommend monitoring plasma concentrations of other anticonvulsants and rufinamide following initiation or withdrawal of anticonvulsant therapy if clinically warranted.28

Drugs that Shorten QT Interval

Potential pharmacologic interaction; use concomitantly with caution.1 21 23 (See Specific Drugs under Interactions and see Shortening of QT Interval under Cautions.)

Protein-bound Drugs

Pharmacokinetic interaction unlikely; not highly bound to plasma proteins.1

Specific Drugs

Drug

Interaction

Comments

Benzodiazepines

Clinically important pharmacokinetic interactions with benzodiazepines unlikely; possible additive CNS effects1 13 21 24

Clonazepam: Pharmacokinetic interaction unlikely6 13 24

Triazolam: Decreased triazolam AUC (by 37%) and peak plasma concentrations (by 23%)1 11 12

Carbamazepine

Decreased plasma carbamazepine concentrations (by 7–13%)1

Decreased plasma rufinamide concentrations (by 19–26% depending on carbamazepine dosage)1

Chlorzoxazone

Possible increased plasma chlorzoxazone concentrations1 21

CNS agents (e.g., alcohol, benzodiazepines)

Possible additive CNS effects (e.g., sedation)1 21

Contraceptives, oral

Decreased AUC and peak plasma concentrations of ethinyl estradiol (by 22 and 31%, respectively) and norethindrone (by 14 and 18%, respectively)1 8 10 11 12 14 15 18 23

Additional nonhormonal contraceptive methods recommended1 10 21

Digoxin

Possible additive effect on shortening of QT-interval1 21 23

Use concomitantly with caution1 21 23

Lamotrigine

Decreased plasma lamotrigine concentrations (by 7–13%)1

Possible additive effect on shortening of QT-interval1 21 23

Use concomitantly with caution1 21 23

Magnesium

Possible additive effect on shortening of QT-interval1 21 23

Use concomitantly with caution1 21 23

Mexiletine

Possible additive effect on shortening of QT-interval1 21 23

Use concomitantly with caution1 21 23

Olanzapine

Pharmacokinetic interaction unlikely1 8 12 14 18

Oxcarbazepine

Pharmacokinetic interaction unlikely6 13 24

Phenobarbital

Increased plasma phenobarbital concentrations (by 8–13%)1

Decreased plasma rufinamide concentrations (by 25–46% independent of phenobarbital dosage or concentration)1

Phenytoin

Increased plasma phenytoin concentrations (by 7–21%)1

Decreased plasma rufinamide concentrations (by 25–46% independent of phenytoin dosage or concentration)1

US manufacturer states routine dosage adjustment not recommended;1 others state reduction in phenytoin dosage may be considered33

Primidone

Decreased plasma rufinamide concentrations (by 25–46% independent of primidone dosage or concentration)1

Ranolazine

Possible additive effect on shortening of QT-interval1 21 23

Use concomitantly with caution1 21 23

Topiramate

Pharmacokinetic interaction unlikely1

Valproate

Increased plasma rufinamide concentrations (by <16 to 70% depending on valproate concentration); may be more pronounced in pediatric patients1 10 11 12 13 14 16 18 21 23 24 26 27

In patients stabilized on rufinamide, initiate valproic acid at low dosage and titrate to clinically effective dosage1

In patients receiving valproic acid, initiate rufinamide at dosage <400 mg daily in adults and <10 mg/kg daily in children1 11

Banzel Pharmacokinetics

Absorption

Bioavailability

Well absorbed following oral administration; peak plasma concentrations occur 4–6 hours after a dose.1 Extent of absorption decreases with increasing doses.1

Food

Food increased the extent of absorption and peak exposure of a single 400-mg dose by 34 and 56%, respectively.1

Under fed conditions, ≥85% of a single 600-mg dose was absorbed.1

Special Populations

Peak plasma concentrations and AUC are decreased by 16 and 29%, respectively, at 3 hours after a hemodialysis session.1

Distribution

Plasma Protein Binding

34% (mainly albumin).1 6

Elimination

Metabolism

Extensively metabolized, primarily via carboxylesterase-mediated hydrolysis of the carboxylamide group to an inactive acid derivative (GCP 47292).1 6 8 10 11 12 13 14 15 16 17 18 21 Metabolic pathways do not involve CYP isoenzymes and glutathione.1 6 8 10 12 16 18

Elimination Route

Eliminated principally in urine (85%), mostly as metabolites (≥66% as CGP 47292); only 2% of dose is excreted as unchanged drug.1 6 8 10 11 12 13 15 16 17 18 21

Half-life

Approximately 6–10 hours.1 6

Special Populations

Effect of hepatic impairment on pharmacokinetics not evaluated.1

Renal impairment (Clcr <30 mL/minute) does not substantially alter pharmacokinetics; hemodialysis may reduce exposure (see Absorption: Special Populations under Pharmacokinetics).1

Pharmacokinetics in pediatric patients 4–17 years of age similar to pharmacokinetics in adults.1

No clinically important pharmacokinetic differences between healthy geriatric individuals and younger healthy adults.1

Stability

Storage

Oral

Suspension

25°C (may be exposed to 15–30°C).1

Tablets

25°C (may be exposed to 15–30°).1 Protect from moisture.1

Actions

  • Triazole-derivative anticonvulsant; structurally unrelated to other currently available anticonvulsants.1 6 7 9 10 11 12 13 14 15 16 17 18 21 28

  • Exact mechanism(s) of anticonvulsant action is unknown, but may involve modulation of sodium channel activity and, in particular, prolongation of the inactive state of the channel.1 6 7 9 10 11 12 13 14 15 16 17 18 21

  • Does not appear to substantially interact with monoaminergic, cholinergic, histaminergic, glycine, GABA, or glutamate receptors or systems.6 7 10 13 14 17 18

Advice to Patients

  • Importance of providing copy of written patient information (medication guide) each time rufinamide is dispensed.1 20 31 Importance of patients reading this information prior to taking the drug.1 31

  • Risk of suicidality (anticonvulsants, including rufinamide, may increase risk of suicidal thoughts or actions in about 1 in 500 people).1 2 20 34 Importance of patients, family members, and caregivers being alert to day-to-day changes in mood, behavior, and actions and immediately informing clinician of any new or worrisome behaviors (e.g., talking or thinking about wanting to hurt oneself or end one's life, withdrawing from friends and family, becoming depressed or experiencing worsening of existing depression, becoming preoccupied with death and dying, giving away prized possessions).1 2 34

  • Risk of multiorgan hypersensitivity reactions.1 34 Importance of notifying clinician if rash (with or without fever) occurs.1 34

  • Importance of taking rufinamide only as prescribed.1 34

  • Importance of taking rufinamide with food.1 31 Importance of informing patients that rufinamide scored tablets may be swallowed whole, broken in half, or crushed.1 31 Importance of instructing patients in proper techniques for administration of the oral suspension, including use of the bottle adapter and oral dosing syringe.1

  • When applicable, advise patients that rufinamide oral suspension does not contain lactose, gluten, or carbohydrates and is dye-free.1

  • Risk of sleepiness, difficulty with coordination, and dizziness; importance of advising patients to avoid driving or operating machinery until they gain experience with the drug's effects.1 21 Risk of additive CNS effects (e.g., sedation) if used with alcohol or other drugs that affect the CNS.1 21 34

  • Importance of informing patients not to stop taking rufinamide without first talking to their clinician since stopping the drug suddenly can cause serious problems, including seizures.1 31 34

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 Importance of clinicians informing women about the existence of and encouraging enrollment in pregnancy registries (see Pregnancy under Cautions).1 Potential increased risk of pregnancy in women taking hormonal contraceptives; importance of discussing use of additional contraceptive methods.1 10 21

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses (e.g., hepatic disease, depression, bipolar disorder), family history of suicidality or bipolar disorder, or current diagnosis or history of familial short QT syndrome.1 31 34

  • Importance of advising patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Rufinamide

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Suspension

40 mg/mL

Banzel

Eisai

Tablets, film-coated

200 mg

Banzel (scored)

Eisai

400 mg

Banzel (scored)

Eisai

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Eisai Co., Ltd. Banzel (rufinamide) tablets prescribing information. Woodcliff Lake, NJ; 2011 Mar.

2. Food and Drug Administration. FDA Alert: Information for healthcare professionals: suicidality and antiepileptic drugs. Rockville, MD; 2008 Jan 31. From the FDA website.

3. Food and Drug Administration. FDA News: FDA alerts health care providers to risk of suicidal thoughts and behavior with antiepileptic medications. Rockville, MD; 2008 Jan 31. From the FDA website.

4. Food and Drug Administration. FDA Alert: Suicidality and antiepileptic drugs. Rockville, MD; 2008 Jan 31. From the FDA website.

5. Food and Drug Administration. Orphan designations pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97 414). Rockville, MD. From FDA website. Accessed 2009 Apr 22.

6. Heaney D, Walker MC. Rufinamide. Drugs Today (Barc). 2007; 43:455-60. [PubMed 17728846]

7. Rogawski MA. Diverse mechanisms of antiepileptic drugs in the development pipeline. Epilepsy Res. 2006; 69:273-94. [PubMed 16621450]

8. Perucca E, Cloyd J, Critchley D et al. Rufinamide: clinical pharmacokinetics and concentration-response relationships in patients with epilepsy. Epilepsia. 2008; 49:1123-41. [PubMed 18503564]

9. Glauser T, Kluger G, Sachdeo R et al. Rufinamide for generalized seizures associated with Lennox-Gastaut syndrome. Neurology. 2008; 70:1950-8. [PubMed 18401024]

10. Cheng-Hakimian A, Anderson GD, Miller JW. Rufinamide: pharmacology, clinical trials, and role in clinical practice. Int J Clin Pract. 2006; 60:1497-501. [PubMed 17073844]

11. . Rufinamide (Banzel) for epilepsy. Med Lett Drugs Ther. 2009; 51:18-20. [PubMed 19265777]

12. Deeks ED, Scott LJ. Rufinamide. CNS Drugs. 2006; 20:751-60; discussion 761. [PubMed 16953653]

13. Hakimian S, Cheng-Hakimian A, Anderson GD et al. Rufinamide: a new anti-epileptic medication. Expert Opin Pharmacother. 2007; 8:1931-40. [PubMed 17696794]

14. Johannessen Landmark C, Johannessen SI. Pharmacological management of epilepsy: recent advances and future prospects. Drugs. 2008; 68:1925-39. [PubMed 18778117]

15. Chung AM, Eiland LS. Use of second-generation antiepileptic drugs in the pediatric population. Paediatr Drugs. 2008; 10:217-54. [PubMed 18590343]

16. Bialer M, Johannessen SI, Kupferberg HJ et al. Progress report on new antiepileptic drugs: a summary of the Eighth Eilat Conference (EILAT VIII). Epilepsy Res. 2007; 73:1-52. [PubMed 17158031]

17. Bialer M, Johannessen SI, Kupferberg HJ et al. Progress report on new antiepileptic drugs: a summary of the Fifth Eilat Conference (EILAT V). Epilepsy Res. 2001; 43:11-58. [PubMed 11137386]

18. Arroyo S. Rufinamide. Neurotherapeutics. 2007; 4:155-62. [PubMed 17199032]

19. Pålhagen S, Canger R, Henriksen O et al. Rufinamide: a double-blind, placebo-controlled proof of principle trial in patients with epilepsy. Epilepsy Res. 2001; 43:115-24. [PubMed 11164700]

20. Food and Drug Administration. Suicidal behavior and ideation and antiepileptic drugs: update 5/5/2009. Rockville, MD; 2009 May 5. From the FDA website.

21. Hussar DA, Bilbow C. New drugs: Febuxostat, lacosamide, and rufinamide. J Am Pharm Assoc. 2009; 49:460-3.

22. Glauser T, Kluger G, Sachdeo R et al. Open-label study of the efficacy and safety of rufinamide adjunctive therapy in patients with Lennox-Gastaut syndrome. Epilepsia. 2005; 46 (Suppl. 6):408. Abstr. p1356.

23. Eisai Inc., Woodcliff Lake, NJ: Personal communication.

24. Luszczki JJ. Third-generation antiepileptic drugs: mechanisms of action, pharmacokinetics and interactions. Pharmacol Rep. 2009 Mar-Apr; 61:197-216.

25. Herman ST. Adopting an orphan drug: rufinamide for lennox-gastaut syndrome. Epilepsy Curr. 2009 May-Jun; 9:72-4.

26. Kluger G, Bauer B. Role of rufinamide in the management of Lennox-Gastaut syndrome (childhood epileptic encephalopathy). Neuropsychiatr Dis Treat. 2007; 3:3-11. [PubMed 19300535]

27. Ferrie CD, Patel A. Treatment of Lennox-Gastaut Syndrome (LGS). Eur J Paediatr Neurol. 2009; : [epub ahead of print].. [PubMed 19211283]

28. Saneto RP, Anderson GD. Onset of action and seizure control in Lennox-Gastaut syndrome. Ther Clin Risk Manag. 2009; 5:271-80. [PubMed 19536315]

29. Brodie MJ, Rosenfeld WE, Vazquez B et al. Rufinamide for the adjunctive treatment of partial seizures in adults and adolescents: a randomized placebo-controlled trial. Epilepsia. 2009; Jun 1: 1-11.

30. Kluger G, Kurlemann G, Haberlandt E et al. Effectiveness and tolerability of rufinamide in children and adults with refractory epilepsy: first European experience. Epilepsy Behav. 2009; 14:491-5. [PubMed 19162229]

31. American Society of Health-System Pharmacists. AHFS Consumer Medication Information. Rufinamide. 2009 Jan 1.

32. Krivoy N, Taer M, Neuman MG. Antiepileptic drug-induced hypersensitivity syndrome reactions. Curr Drug Safety. 2006; 1:288-99.

33. Eisai Ltd. Inovelon (rufinamide) film-coated tablets summary of product characteristics. 2007.

34. Eisai Inc. About Banzel (rufinamide). 2009. From the Banzel web site. Accessed 2009 Jul 10.

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