Accelerate Study Design | CLEVIPREX® (clevidipine)

SBP changes over time with CLEVIPREX⁵

Median time to achieve target SBP range was
5.5 minutes⁵

All patients achieved target SBP within 30 minutes⁵
96.9% achieved target SBP with CLEVIPREX monotherapy⁵
Mild/moderate hypotension was reported in 3 patients and resolved with dose reduction or drug discontinuation⁵

Mean (+/-SE) change in SBP with clevidipine (mITT population, n=33).
Mean baseline SBP=186 mmHg.

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 Beta-blockers should be withdrawn only after a gradual reduction in dose.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.

SBP changes over time with CLEVIPREX5

Median time to achieve target SBP range was 5.5 minutes5

SBP changes over time with CLEVIPREX⁵

Median time to achieve target SBP range was
5.5 minutes⁵