In clinical trials, a similar increase in heart rate was observed in both Cleviprex and comparator arms. Dihydropyridine calcium channel blockers can produce negative inotropic effects and exacerbate heart failure. Heart failure patients should be monitored carefully. Cleviprex gives no protection against the effects of abrupt beta-blocker withdrawal. Most common adverse reactions (>2%) are headache, nausea, and vomiting. Cleviprex should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Maintain aseptic technique while handling Cleviprex. Cleviprex contains phospholipids and can support microbial growth. Do not use if contamination is suspected. Once the stopper is punctured, use or discard within 12 hours. Drug interactions
No clinical drug interaction studies were conducted. Cleviprex does not have the potential for blocking or inducing any CYP enzymes. Storage
Cleviprex is available in ready-to-use 50- and 100-mL glass vials at a concentration of 0.5 mg/mL of clevidipine butyrate. Vials should be refrigerated at 2-8oC (36-46 °F). Cleviprex can be stored to controlled room temperature for up to 2 months. Cleviprex is photosensitive and storage in cartons protects against photodegradation. Protection from light during administration is not required. Phase III clinical trial results
Cleviprex has been evaluated in 6 Phase III clinical studies including the perioperative and emergency department/intensive care settings. These include ESCAPE-1, ESCAPE-2, ECLIPSE, and VELOCITY trials. ESCAPE-1 was a double-blind, randomized, placebo-controlled efficacy trial of 105 cardiac surgery patients.
The maximum infusion rate for Cleviprex is 32 mg/hour. Most patients in clinical trials were treated with doses of 16 mg/hour or less. Because of lipid load restrictions, no more than 1000 mL (or an average of 21 mg/hour) of Cleviprex infusion is recommended per 24 hours. In clinical studies, no significant changes occurred in serum triglyceride levels in the Cleviprex treated patients. There is little experience with infusion durations beyond 72 hours at any dose. The infusion can be reduced or discontinued to achieve desired blood pressure while appropriate oral therapy is established. Safety information
Cleviprex is intended for intravenous use. Titrate drug depending on the response of the individual patient to achieve the desired blood pressure reduction. Monitor blood pressure and heart rate continually during infusion, and then until vital signs are stable. 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. In clinical trials, the safety profile of clevidipine was generally similar to sodium nitroprusside, nitroglycerin, or nicardipine in patients undergoing cardiac surgery.Cleviprex is contraindicated in patients with allergies to soybeans, soy products, eggs, or egg products; defective lipid metabolism such as pathologic hyperlipemia (rare genetic disorders characterized by abnormal triglyceride metabolism), lipoid nephrosis, or acute pancreatitis if it is accompanied by hyperlipidemia; and in patients with severe aortic stenosis. Hypotension and reflex tachycardia are potential consequences of rapid upward titration of Cleviprex.