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Cleviprex (clevidipine butyrate) injectable emulsion is the latest-generation IV dihydropyridine calcium channel blocker.1 It has a rapid onset and offset of effect and is metabolized in the blood and extravascular tissues, independent of the liver and kidney.1 Cleviprex does not require adjustment of the initial dose in patients with renal or hepatic dysfunction, and its potential to interact with other drugs is low.1

In clinical trials of 215 patients with preoperative or postoperative hypertension (ESCAPE trials) and 126 patients presenting to the ED or intensive care unit with severe hypertension (VELOCITY trial), Cleviprex decreased SBP to study-specific goal within 30 minutes in more than 90% of patients.2-4 Cleviprex has also demonstrated comparable safety and efficacy to established IV antihypertensive treatments in clinical trials comprising 1,512 cardiac surgery patients who required perioperative or postoperative BP reduction (ECLIPSE trials).5

IMPORTANT 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.

Cleviprex is contraindicated in patients with allergies to soybeans, soy products, eggs, or egg products; defective lipid metabolism such as pathologic hyperlipemia, 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. Dihydropyridine calcium channel blockers can produce negative inotropic effects and exacerbate heart failure. Monitor heart failure patients 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 and discard within 4 hours.

Please see full Prescribing Information.

References

  1. CLEVIPREX™ (clevidipine butyrate) injectable emulsion [prescribing information]. Parsippany, NJ: The Medicines Company; August 1, 2008.
  2. Levy JH, Mancao MY, Gitter R, et al. Clevidipine effectively and rapidly controls blood pressure preoperatively in cardiac surgery patients: the results of the randomized, placebo-controlled efficacy study of clevidipine assessing its preoperative antihypertensive effect in cardiac surgery-1. Anesth Analg. 2007;105:918-925.
  3. Singla N, Warltier DC, Gandhi SD, et al, for the ESCAPE-2 Study Group. Treatment of acute postoperative hypertension in cardiac surgery patients: an efficacy study of clevidipine assessing its postoperative antihypertensive effect in cardiac surgery-2 (ESCAPE-2), a randomized, double-blind, placebo-controlled trial. Anesth Analg. 2008;107:59-67.
  4. Pollack CV, Varon J, Garrison NA, Ebrahimi R, Dunbar L, Peacock WF IV. Clevidipine, an intravenous dihydropyridine calcium channel blocker, is safe and effective for the treatment of patients with acute severe hypertension. Ann Emerg Med. 2008; Jun 6. [Epub ahead of print].
  5. Aronson S, Dyke CM, Stierer KA, et al. The ECLIPSE trials: comparative studies of clevidipine to nitroglycerin, sodium nitroprusside, and nicardipine for acute hypertension treatment in cardiac surgery patients. Anesth Analg. 2008; 107:1110-1121.
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