Safety and side effects in clinical trials

The safety of SEGLENTIS was studied in 550 patients across 7 clinical trials, including both single and multiple administrations.1

In a placebo-controlled post-bunionectomy with osteotomy acute pain trial, 637 patients received either 200 mg of SEGLENTIS every 12 hours, 50 mg of tramadol hydrochloride every 6 hours, 100 mg of celecoxib every 12 hours, or placebo orally for 48 hours (blinded period) and were followed up to 7 days postdose:

Reported adverse reactions in >5% of patients in any
treatment group and greater in SEGLENTIS than placebo1

Reported adverse reactions chart
Reported adverse reactions chart Reported adverse reactions chart

Total daily dose: 400 mg of SEGLENTIS (200 mg twice a day), 200 mg of tramadol hydrochloride (50 mg 4 times a day), 200 mg of celecoxib (100 mg twice a day), or placebo.

Note: Acetaminophen 1 g intravenous and oxycodone hydrochloride 5 mg immediate-release (IR) tablets were permitted as rescue medication.

SEGLENTIS has convenient
12-hour dosing1

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  1. SEGLENTIS [prescribing information]. Montgomery, AL: Kowa Pharmaceuticals America, Inc.; October 2021.