CLEVIPREX^® (clevidipine) pharmacology and mechanism of action

Cleviprex vials

CLEVIPREX rapidly lowers arterial blood pressure¹

Titratable, fast onset of action¹

CLEVIPREX begins to reduce SBP within 2 minutes of initiation dose. An approximately 1 to 2 mg/h increase will generally produce an additional 2 to 4 mm Hg decrease in SBP.

~1-minute half-life¹

CLEVIPREX has a half-life of ~1 minute. In most patients, full recovery of BP is achieved 5 to 15 minutes after the infusion is stopped.

Metabolism¹

Dosing of CLEVIPREX is independent of hepatic and renal function due to metabolism by plasma and tissue esterases.

The pharmacology of CLEVIPREX¹

CLEVIPREX is titrated to the desired reduction in BP. The effect of CLEVIPREX appears to plateau at approximately 25% of baseline SBP. The infusion rate for which half the maximal effect is observed is approximately 10 mg/h.

(7:13)

Mechanism of action¹

CLEVIPREX works by selectively dilating arterial smooth muscle via calcium channel blockade, reducing systemic vascular resistance without affecting preload.

(7:52)

Stroke Guidelines

CLEVIPREX has been recommended in the AHA/ASA Acute Ischemic Stroke Guidelines since 2018.³

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Proven efficacy in clinical studies^1,2,4-6

CLEVIPREX provided BP reduction in a range of patients and in various clinical settings.

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Individualized, titratable administration¹

CLEVIPREX offers low-volume, non–weight-based dosing that is independent of renal or hepatic function.

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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. CLEVIPREX® (clevidipine) Prescribing Information. 2021. 2. 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. 3. 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. 4. 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(4):918-925. 5. Singla N, Warltier DC, Gandhi SD, et al; 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(1):59-67. 6. Graffagnino C, Bergese S, Love J, et al. Clevidipine rapidly and safely reduces blood pressure in acute intracerebral hemorrhage: the ACCELERATE trial. Cerebrovasc Dis. 2013;36(3):173-180.