Home About

RUFINAMIDE

RUFINAMIDE

Manufacturer: Aurobindo Pharma Limited

Score: 142.0

Quick Summary

Rufinamide is an antiepileptic medication used for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults. The precise mechanism of action is unknown, but it is believed to modulate the activity of sodium channels. Rufinamide is available in film-coated tablets and should be given with food. The recommended starting daily dose is 10 mg/kg per day in pediatric patients and 400 mg to 800 mg per day in adults, with gradual increases until a maximum dose of 45 mg/kg per day or 3200 mg per day is reached. Important safety information includes the risk of suicidal behavior and ideation, central nervous system reactions, QT shortening, and multi-organ hypersensitivity. Contraindications include Familial Short QT syndrome. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

  • Adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults
  • Modulation of sodium channel activity
  • Available in film-coated tablets

Important Safety Information

Warning

Risk of suicidal behavior and ideation, central nervous system reactions, QT shortening, and multi-organ hypersensitivity

Contraindications

  • Familial Short QT syndrome

Adverse Reactions

  • Headache
  • Dizziness
  • Fatigue
  • Somnolence
  • Nausea

Dosing Recommendations

General Guidance

Increase by 10 mg/kg increments every other day to maximum dose of 45 mg/kg per day, not to exceed 3200 mg per day, in two divided doses

Lennox-Gastaut Syndrome

Adult Dose

400 mg to 800 mg per day in two equally divided doses

Pediatric Dose

10 mg/kg per day in two equally divided doses

Special Population Considerations

Pregnancy

  • There are no adequate data on the developmental risks associated with use of rufinamide in pregnant women
  • Use in patients with severe hepatic impairment is not recommended

Nursing Mothers

  • Use of rufinamide may reduce the effectiveness of hormonal contraceptives containing ethinyl estradiol or norethindrone
  • Advise women of reproductive potential taking rufinamide who are using a contraceptive containing ethinyl estradiol and norethindrone to use an additional non-hormonal form of contraception

Pediatric Use

  • Safety and effectiveness have been established in pediatric patients 1 to 17 years of age
  • The effectiveness of rufinamide in pediatric patients 4 years of age and older was based upon an adequate and well-controlled trial of rufinamide

Geriatric Use

  • Clinical studies of rufinamide did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects
  • In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range