hours of stopper puncture [see Dosage and Administration (2.3)].
5.2 Hypotension and Reflex Tachycardia
Cleviprex may produce systemic hypotension and reflex tachycardia. If either occurs, decrease the dose of Cleviprex. There is limited experience with short-duration therapy with beta-blockers as a treatment for Cleviprexinduced tachycardia. Beta-blocker use for this purpose is not recommended.
5.3 Lipid Intake
Cleviprex contains approximately 0.2 g of lipid per mL (2.0 kcal). Lipid intake restrictions may be necessary for patients with significant disorders of lipid metabolism. For these patients, a reduction in the quantity of concurrently administered lipids may be necessary to compensate for the amount of lipid infused as part of the Cleviprex formulation.
5.4 Negative Inotropy
Dihydropyridine calcium channel blockers can produce negative inotropic effects and exacerbate heart failure. Monitor heart failure patients carefully.
5.5 Beta-Blocker Withdrawal
Cleviprex is not a beta-blocker, does not reduce heart rate, and gives no protection against the effects of abrupt beta-blocker withdrawal. Betablockers should be withdrawn only after a gradual reduction in dose.
5.6 Rebound Hypertension
Patients who receive prolonged Cleviprex infusions and are not transitioned to other antihypertensive therapies should be monitored for the possibility of rebound hypertension for at least 8 hours after the infusion is stopped.
5.7 Pheochromocytoma
There is no information to guide use of Cleviprex in treating hypertension associated with pheochromocytoma.
6 ADVERSE REACTIONS
The following risk is discussed elsewhere in the labeling:
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Hypotension and Reflex Tachycardia [see Warnings and Precautions (5.2)]
6.1 Clinical Trials Experience
Cleviprex clinical development included 19 studies, with 99 healthy subjects and 1307 hypertensive patients who received at least one dose of clevidipine butyrate (1406 total exposures). Clevidipine butyrate was eva luated in 15 studies in hypertensive patients: 1099 patients with perioperative hypertension, 126 with severe hypertension and 82 patients with essential hypertension.
The desired therapeutic response was achieved at doses of 4-6 mg/hour. Cleviprex was infused for <24-hours in the majority of patients (n=1199); it was infused as a continuous infusion in an additional 93 patients for durations between 24 and 72 hours.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Perioperative Hypertension
The placebo-controlled experience with Cleviprex in the perioperative setting was both small and brief (about 30 minutes). Table 2 shows treatmentemergent adverse reactions and the category of 揳ny common adverse event� in ESCAPE-1 and ESCAPE-2 where the rate on Cleviprex exceeded the rate on placebo by at least 5% (common adverse reactions).
Table 2. Common adverse reactions in placebo-controlled perioperative studies.
Three randomized, parallel, open-label studies called ECLIPSE, with longer exposure in cardiac surgery patients define the adverse reactions for patients with perioperative hypertension. Each ECLIPSE study compared Cleviprex (n=752) to |
