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CLEVIPREX® (CLEVIDIPINE) PHARMACOLOGY AND MECHANISM OF ACTION

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CLEVIPREX RAPIDLY LOWERS ARTERIAL BLOOD PRESSURE


TITRATABLE, FAST ONSET OF ACTION1

CLEVIPREX begins to reduce SBP within 2 minutes of initiation dose. An
approximately 1–2 mg/hr increase will generally produce an additional 2–4 mmHg
decrease in systolic pressure.

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~1-MINUTE HALF-LIFE1

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

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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 systolic pressure. The
infusion rate for which half the maximal effect is observed is approximately
10 mg/hr.

(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)

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DR. HOROWITZ SPEAKS ABOUT CLEVIPREX

Renowned anesthesiologist Dr. Todd Horowitz discusses CLEVIPREX clinical trial
results and dosing in a series of informative videos for healthcare
professionals.

Watch videos‍

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INDIVIDUALIZED, TITRATABLE ADMINISTRATION1

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

Review dosing and administration

--------------------------------------------------------------------------------


STROKE GUIDELINES

CLEVIPREX has been recommended in the AHA/ASA Acute Ischemic Stroke Guidelines
since 20182

View the recommendations


PROVEN EFFICACY IN CLINICAL STUDIES1,3-6

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


Explore the
clinical studies

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. 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. 3. 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. 4. 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.
5. 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. 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.

 * Chiesi USA, Inc.
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 * Request Information

CLEVIPREX® is a registered trademark of Chiesi Farmaceutici S.p.A.
©2022 Chiesi USA, Inc. All rights reserved. 02/2022 PP‑CP‑0021 V7.0

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IMPORTANT SAFETY INFORMATION

INDICATION

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.

FOR US HEALTHCARE PROFESSIONALS

The information provided in this website is intended for US healthcare
professionals only.

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