Nustendi Special Precautions

Hyperuricemia: Bempedoic acid, a component of Nustendi, inhibits renal tubular OAT2 and may increase blood uric acid levels [see Pharmacology: Pharmacokinetics under Actions]. In clinical trials, 26% of bempedoic acid-treated patients with normal baseline uric acid values (versus 9.5% placebo) experienced hyperuricemia one or more times, and 3.5% of patients experienced clinically significant hyperuricemia reported as an adverse reaction (versus 1.1% placebo). Increases in uric acid levels usually occurred within the first 4 weeks of treatment initiation and persisted throughout treatment. After 12 weeks of treatment, the mean placebo-adjusted increase in uric acid compared to baseline was 0.8 mg/dL for patients treated with bempedoic acid.
Elevated blood uric acid may lead to the development of gout. In clinical trials, gout was reported in 1.5% of patients treated with bempedoic acid versus 0.4% of patients treated with placebo. The risk for gout events was higher in patients with a prior history of gout (11.2% bempedoic acid versus 1.7% placebo), although gout also occurred more frequently than placebo in patients treated with bempedoic acid who had no prior gout history (1.0% bempedoic acid versus 0.3% placebo).
Advise patients to contact their healthcare provider if symptoms of hyperuricemia occur. Assess serum uric acid when clinically indicated. Monitor patients for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate.
Tendon Rupture: Bempedoic acid, a component of Nustendi, is associated with an increased risk of tendon rupture or injury. In clinical trials, tendon rupture occurred in 0.5% of patients treated with bempedoic acid versus 0% of placebo-treated patients and involved the rotator cuff (the shoulder), biceps tendon, or Achilles tendon. Tendon rupture occurred within weeks to months of starting bempedoic acid. Tendon rupture may occur more frequently in patients over 60 years of age, in those taking corticosteroid or fluoroquinolone drugs, in patients with renal failure, and in patients with previous tendon disorders.
Discontinue Nustendi immediately if the patient experiences rupture of a tendon. Consider discontinuing Nustendi if the patient experiences joint pain, swelling, or inflammation.
Advise patients to rest at the first sign of tendinitis or tendon rupture and to contact their healthcare provider if tendinitis or tendon rupture symptoms occur. Consider alternative therapy in patients with a history of tendon disorders or tendon rupture.
Renal Impairment: No dosage adjustment is necessary in patients with mild or moderate renal impairment. There is limited experience with bempedoic acid in patients with severe renal impairment (eGFR <30 mL/min/1.73 m²), and bempedoic acid has not been studied in patients with end-stage renal disease (ESRD) receiving dialysis [see Pharmacology: Pharmacokinetics under Actions].
Hepatic Impairment: No dosage adjustment is necessary in patients with mild hepatic impairment (Child-Pugh A) [see Pharmacology: Pharmacokinetics under Actions]. Nustendi is not recommended in patients with moderate or severe hepatic impairment (Child-Pugh B or C) due to the unknown effects of the increased exposure to ezetimibe [see Pharmacology: Pharmacokinetics under Actions].
Use in Children: The safety and effectiveness of Nustendi have not been established in pediatric patients.
Use in the Elderly: Of the 301 patients in the clinical trial of Nustendi, 149 (50%) were 65 and over, while 49 (16%) were 75 and over. No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out.