CLEVIPREX

What it is

Cleviprex contains clevidipine. Cleviprex is a milky white opaque injectable emulsion with non-reflective surface and free of visible particulate matter. Cleviprex is available as 25 mg in 50 mL injectable emulsion and 50 mg in 100 mL injectable emulsion. Clevidipine is a dihydropyridine L-type calcium channel blocker.

Approved indications

— Short-term treatment of hypertension when oral therapy is not feasible or desirable.

Dosing overview

Initial dose is 1–2 mg/h; the dose may be doubled every 90 seconds initially. As the blood pressure approaches goal, the increase in doses should be less than doubling and the time between dose adjustments should be lengthened to every 5–10 minutes. Continue titration until desired target range is achieved. The desired therapeutic response for most patients occurs at doses of 4–6 mg/h. The maximum recommended dose is 32 mg/h although most patients were treated with maximum doses of 16 mg/h or less. Because of lipid load restrictions, no more than 1000 mL or an average of 21 mg/hour of Cleviprex infusion is recommended per 24-hour period. There is little experience with infusion durations beyond 72 hours at any dose.

Key safety warnings

Rapid pharmacologic reductions in blood pressure may produce systemic hypotension and reflex tachycardia that may be associated with a worsening of clinical outcome. If either occurs with Cleviprex, decrease the dose. Dihydropyridine calcium channel blockers can produce negative inotropic effects and exacerbate heart failure. Monitor heart failure patients carefully. Cleviprex does not reduce heart rate and offers no protection against the effects of abrupt beta-blocker withdrawal. Beta-blockers should be withdrawn only after gradual reduction in dose.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.

Contraindications

Cleviprex is contraindicated in patients with known allergies to clevidipine, soybeans, soy products, eggs or egg products or to any of the excipients. Cleviprex should not be used in patients with defective lipid metabolism such as pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis if it is accompanied by hyperlipidemia. Cleviprex should not be used in patients with severe aortic stenosis because excessive afterload reduction can reduce myocardial oxygen delivery in these patients.

Regulatory history

Cleviprex was first approved on 9 April 2010. Two strengths were listed on the ARTG on 27 June 2013: Cleviprex 25 mg in 50 mL (ARTG 203313) and Cleviprex 50 mg in 100 mL (ARTG 203314), both as single-use vials under licence category RE.