CLEVIPREX^® (clevidipine) Frequently asked questions

Cleviprex vials

CLEVIPREX Efficacy & Pharmacology

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What were the results of clinical trials of CLEVIPREX?

CLEVIPREX efficacy was evaluated in 4 clinical trials:

CLEVIPREX was also studied against active comparators in 3 parallel, prospective, open-label studies (ECLIPSE). The ECLIPSE safety studies included patients undergoing cardiac surgery (N=1506) who were randomized to receive either CLEVIPREX or nicardipine, nitroglycerin, or sodium nitroprusside.¹ Learn more about the results of the ECLIPSE trials..

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Is CLEVIPREX an alternative to other calcium channel blockers?

Yes, CLEVIPREX is an intravenously administered dihydropyridine calcium channel blocker indicated for the reduction of BP when oral therapy is not feasible or not desirable.²

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What is the onset and offset of CLEVIPREX?

CLEVIPREX begins to reduce SBP within 2 minutes of initiation dose. In most patients, full recovery of BP is achieved 5-15 minutes after the infusion is stopped.²

CLEVIPREX Safety Profile

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What are the most common side eﬀects of CLEVIPREX?

In clinical trials, the most adverse reactions (>2%) with CLEVIPREX were headache, nausea, and vomiting.²

CLEVIPREX Dosing

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How do you dose CLEVIPREX?

CLEVIPREX provides low-volume, non–weight-based, titratable dosing (dose may be doubled every 90 seconds initially). It is metabolized by esterases in the blood and extravascular tissues, so elimination is unlikely to be affected by hepatic or renal dysfunction.² Learn more about how to dose and administer CLEVIPREX.

CLEVIPREX Guidelines

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Is CLEVIPREX recommended by AIS guidelines?

Since 2018, the Guidelines for the Early Management of Patients With Acute Ischemic Stroke (AIS) have recommended CLEVIPREX as an option for lowering arterial hypertension before, during, and after acute reperfusion therapy.^4*

CLEVIPREX is not indicated for the prevention or treatment of stroke.

Important Safety Information

CLEVIPREX^® (clevidipine) Injectable Emulsion is contraindicated in patients with:

Allergies to soybeans, soy products, eggs, or egg products;
Defective lipid metabolism seen in conditions such as pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis if it is accompanied by hyperlipidemia; and
Severe aortic stenosis.

CLEVIPREX^® is intended for intravenous use. Use aseptic technique and discard any unused product within 12 hours of stopper puncture.

Hypotension and reflex tachycardia are potential consequences of rapid upward titration of CLEVIPREX^®. If either occurs, decrease the dose of CLEVIPREX^®. There is limited experience with short-duration therapy with beta-blockers as a treatment for CLEVIPREX^®-induced tachycardia. Beta-blocker use for this purpose is not recommended.

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.

Dihydropyridine calcium channel blockers can produce negative inotropic effects and exacerbate heart failure. Monitor heart failure patients carefully.

CLEVIPREX^® is not a beta-blocker, does not reduce heart rate, and gives no protection against the effects of abrupt beta-blocker withdrawal. Beta-blockers should be withdrawn only after a gradual reduction in dose.

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.

There is no information to guide use of CLEVIPREX^® in treating hypertension associated with pheochromocytoma.

Most common adverse reactions for CLEVIPREX^® (>2%) are headache, nausea, and vomiting.

Indication

CLEVIPREX^® (clevidipine) is a dihydropyridine calcium channel blocker indicated for the reduction of blood pressure (BP) when oral therapy is not feasible or not desirable.

Please see Full Prescribing Information.

References: 1. 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(4):1110-1121. 2. CLEVIPREX® (clevidipine) Prescribing Information. 2021. 3. Pollack CV, Varon J, Garrison NA, Ebrahimi R, Dunbar L, Peacock WF. Clevidipine, an intravenous dihydropyridine calcium channel blocker, is safe and effective for the treatment of patients with acute severe hypertension. Ann Emerg Med. 2009;53(3):329-338. 4. Powers WJ, Rabinstein AA, Ackerson T, et al; American Heart Association Stroke Council. 2018 Guidelines for the Early Management of Patients with Acute Ischemic Stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2018;49(3):e46-e110. 5. Greenberg SM, Ziai WC, Cordonnier C, et al; American Heart Association/American Stroke Association. 2022 guideline for the management of patients with spontaneous intracerebral hemorrhage: a guideline from the American Heart Association/American Stroke Association. Stroke. 2022;53(7):e282-e361.