SAFETY PROFILE (ADVERSE REACTIONS) IN CLINICAL TRIALS OF BANZEL® (rufinamide)

SAFETY PROFILE (ADVERSE REACTIONS) IN CLINICAL TRIALS OF BANZEL®

The safety of BANZEL® has been evaluated in children and adults

 

Safety evaluated in children

In pediatric patients with epilepsy treated in all double-blind, adjunctive clinical trials (at recommended dose of 45 mg/kg/day)1

Most common treatment-emergent adverse reactions (≥10%) with a higher frequency than placebo


BANZEL safety was evaluated in children. The most common treatment-emergent adverse reactions (≥10%) with a higher frequency than placebo were as follows: in 187 of BANZEL patients 17% experienced somnolence, 17% vomiting and 16% headaches. In comparison, in 182 of placebo patients 9% experienced somnolence, 7% vomiting, and 8% headaches. BANZEL safety was evaluated in children. The most common treatment-emergent adverse reactions (≥10%) with a higher frequency than placebo were as follows: in 187 of BANZEL patients 17% experienced somnolence, 17% vomiting and 16% headaches. In comparison, in 182 of placebo patients 9% experienced somnolence, 7% vomiting, and 8% headaches.

Most common treatment-emergent adverse reactions (>1%) leading to discontinuation


The most common treatment emergent adverse reactions (>1%) leading to discontinuation for BANZEL in children were as follows:  convulsion (2%); rash (2%); fatigue (2%); and vomiting (1%); for placebo: convulsion (1%); rash (1%); fatigue (0%); and vomiting (0%). The most common treatment emergent adverse reactions (>1%) leading to discontinuation for BANZEL in children were as follows:  convulsion (2%); rash (2%); fatigue (2%); and vomiting (1%); for placebo: convulsion (1%); rash (1%); fatigue (0%); and vomiting (0%).

Pediatric (age 1 to less than 4 years)

  • In pediatric patients (1 year to less than 4 years of age) with Lennox-Gastaut syndrome, the most commonly observed (≥10%) adverse reactions and with a higher frequency with BANZEL vs any other AED, respectively, were vomiting (24% vs 9%), somnolence (16% vs 0%), constipation (12% vs 9%), cough (12% vs 9%), bronchitis (12% vs 0%), rash (12% vs 9%), and decreased appetite (12% vs 9%)2

Safety evaluated in adults

In adult patients with epilepsy treated in all double-blind, adjunctive clinical trials (at doses up to maximum dose of 3200 mg/day)1

Most common treatment-emergent adverse reactions (10%) with a higher frequency than placebo



BANZEL safety was evaluated in adults. The most common treatment-emergent adverse reactions (≥10%) with a higher frequency than placebo in BANZEL patients (n=823) in adults were as follows: headache (27%); dizziness (19%); fatigue (16%); nausea (12%); and somnolence (11%). The comparisons for placebo patients (n=376) were: headache (26%); dizziness (12%); fatigue (10%); nausea (9%); and somnolence (9%). BANZEL safety was evaluated in adults. The most common treatment-emergent adverse reactions (≥10%) with a higher frequency than placebo in BANZEL patients (n=823) in adults were as follows: headache (27%); dizziness (19%); fatigue (16%); nausea (12%); and somnolence (11%). The comparisons for placebo patients (n=376) were: headache (26%); dizziness (12%); fatigue (10%); nausea (9%); and somnolence (9%).

Most common treatment-emergent adverse reactions (>1%) leading to discontinuation


The most common treatment emergent adverse reactions (>1%) leading to discontinuation in BANZEL (n=823) vs placebo (n=376) patients were as follows: dizziness (3% vs 1%); fatigue (2% vs 1%); headache (2% vs 1%); nausea (1% vs 0%), and ataxia (1% vs 0%). The most common treatment emergent adverse reactions (>1%) leading to discontinuation in BANZEL (n=823) vs placebo (n=376) patients were as follows: dizziness (3% vs 1%); fatigue (2% vs 1%); headache (2% vs 1%); nausea (1% vs 0%), and ataxia (1% vs 0%).
 
  • References: 1. BANZEL® (rufinamide) prescribing information, Eisai Inc. 2. Data on file, Eisai Inc.