Rufinamide
Generic Name: rufinamide
Brand Names:
Rufinamide
11 DESCRIPTION Rufinamide, USP is a triazole derivative structurally unrelated to currently marketed antiepileptic drugs (AEDs). Rufinamide, USP has the chemical name 1-[(2,6-difluorophenyl)methyl]-1 H- 1,2,3-triazole-4 carboxamide. It has an empirical formula of C 10 H 8 F 2 N 4 O and a molecular weight of 238.2 g/mol. The drug substance is a white to off-white crystalline powder.
Overview
11 DESCRIPTION Rufinamide, USP is a triazole derivative structurally unrelated to currently marketed antiepileptic drugs (AEDs). Rufinamide, USP has the chemical name 1-[(2,6-difluorophenyl)methyl]-1 H- 1,2,3-triazole-4 carboxamide. It has an empirical formula of C 10 H 8 F 2 N 4 O and a molecular weight of 238.2 g/mol. The drug substance is a white to off-white crystalline powder.
Uses
1 INDICATIONS AND USAGE Rufinamide tablets are indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults. Rufinamide tablets are indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients 1 year of age and older, and in adults ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION Rufinamide tablets should be given with food. Tablets can be administered whole, as half tablets, or crushed ( 2.2 ) Pediatric patients 1 year and older: • Starting daily dose: 10 mg/kg per day in two equally divided doses ( 2.1 ) • Increase by 10 mg/kg increments every other day to maximum dose of 45 mg/kg per day, not to exceed 3,200 mg per day, in two divided doses ( 2.1 ) Adults: • Starting daily dose: 400 mg per day to 800 mg per day in two equally divided doses ( 2.1 ) • Increase by 400 mg to 800 mg every other day until a maximum dose of 3,200 mg per day, in two divided doses, is reached ( 2.1 ) 2.1 Dosage Information Pediatric patients (1 year to less than 17 years) The recommended starting daily dose of rufinamide in pediatric patients with Lennox-Gasta...
Side Effects
6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: • Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.1 )] • Central Nervous System Reactions [see Warnings and Precautions ( 5.2 )] • QT Shortening [see Warnings and Precautions ( 5.3 )] • Multi-organ Hypersensitivity/Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see Warnings and Precautions ( 5.4 )] • Leukopenia [see Warnings and Precautions ( 5.7 )] Most common adverse reactions (≥ 10% and greater than placebo) were headache, dizziness, fatigue, somnolence, and nausea ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Interactions
7 DRUG INTERACTIONS • Patients on valproate should begin at a rufinamide dose lower than 10 mg/kg per day (pediatric patients) or 400 mg per day (adults) ( 7.2 ) • Hormonal contraceptives may be less effective with rufinamide; use additional non-hormonal forms of contraception ( 7.3 ) 7.1 Effects of Rufinamide on other AEDs Population pharmacokinetic analysis of average concentration at steady state of carbamazepine, lamotrigine, phenobarbital, phenytoin, topiramate, and valproate showed that typical rufinamide C avss levels had little effect on the pharmacokinetics of other AEDs. Any effects, when they occur, have been more marked in the pediatric population. Table 6 summarizes the drug-drug interactions of rufinamide with other AEDs.
Warnings
5 WARNINGS AND PRECAUTIONS • Monitor patients for new or worsening depression, suicidal thoughts/behavior, and unusual changes in mood or behavior ( 5.1 ) • Central nervous system reactions can occur ( 5.2 ) • Use caution when administering rufinamide with other drugs that shorten the QT interval ( 5.3 ) • Discontinue rufinamide if multi-organ hypersensitivity reaction occurs ( 5.4 ) • Withdraw rufinamide gradually to minimize the risk of precipitating seizures, seizure exacerbation, or status epilepticus ( 5.5 ) 5.1 Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including rufinamide, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. 4 CONTRAINDICATIONS Rufinamide is contraindicated in patients with Familial Short QT syndrome [ see Warnings and Precautions ( 5.3 ) ]. • Rufinamide is contraindicated in patients with Familial Short QT syndrome ( 4 )
Pregnancy
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, such as rufinamide, during pregnancy. Encourage women who are taking Rufinamide during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org. Risk Summary There are no adequate data on the developmental risks associated with use of rufinamide in pregnant women.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Rufinamide Tablets, USP 200 mg (containing 200 mg rufinamide, USP) are pink, film-coated, oblong-shaped tablets with functional scoring, embossed with ‘713’ and a ‘G’ on either side of a break line on one side and plain with a break line on the other side.
Frequently Asked Questions
What is Rufinamide used for?▼
1 INDICATIONS AND USAGE Rufinamide tablets are indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults. Rufinamide tablets are indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients 1 year of age and older, and in adults ( 1 )
What are the side effects of Rufinamide?▼
6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: • Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.1 )] • Central Nervous System Reactions [see Warnings and Precautions ( 5.2 )] • QT Shortening [see Warnings and Precautions ( 5.3 )] • Multi-organ Hypersensitivity/Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see Warnings and Precautions ( 5.4 )] • Leukopenia [see Warnings and Precautions ( 5.7 )] Most common adverse reactions (≥ 10% and greater than placebo) were headache, dizziness, fatigue, somnolence, and nausea ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Can I take Rufinamide during pregnancy?▼
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, such as rufinamide, during pregnancy. Encourage women who are taking Rufinamide during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org. Risk Summary There are no adequate data on the developmental risks associated with use of rufinamide in pregnant women.
What are the important warnings for Rufinamide?▼
5 WARNINGS AND PRECAUTIONS • Monitor patients for new or worsening depression, suicidal thoughts/behavior, and unusual changes in mood or behavior ( 5.1 ) • Central nervous system reactions can occur ( 5.2 ) • Use caution when administering rufinamide with other drugs that shorten the QT interval ( 5.3 ) • Discontinue rufinamide if multi-organ hypersensitivity reaction occurs ( 5.4 ) • Withdraw rufinamide gradually to minimize the risk of precipitating seizures, seizure exacerbation, or status epilepticus ( 5.5 ) 5.1 Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including rufinamide, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. 4 CONTRAINDICATIONS Rufinamide is contraindicated in patients with Familial Short QT syndrome [ see Warnings and Precautions ( 5.3 ) ]. • Rufinamide is contraindicated in patients with Familial Short QT syndrome ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.