© 2009 The Medicines Company
Acute Care Hospital Products
NASDAQ: MDCO
Acute Care Hospital Products
NASDAQ: MDCO
Excursions Over and Under Target Range Define BP Control
BP control was assessed as a prespecified secondary end point by measuring the magnitude and duration of excursions outside the predefined SBP target ranges of 75-145 mmHg for pre- and postoperative control and
65-135 mmHg for intraoperative control. The following example illustrates a single patient’s excursions used to assess BP control.
AUC=area under the curve; SBP=systolic blood pressure.
Minimal Excursions Outside of SBP Target Range With Cleviprex
AUC=area under the curve; NIC=nicardipine; NTG=nitroglycerin; SBP=systolic blood pressure;
SNP=sodium nitroprusside.
- In general, the incidence of adverse events (AEs) and serious AEs, including the most commonly occurring AEs of atrial fibrillation and acute renal failure, were similar between Cleviprex and the comparator agents
- No clinically significant differences in clinical laboratory data were seen between Cleviprex and the comparators, including no change in triglyceride levels from baseline
IMPORTANT SAFETY INFORMATION
Cleviprex is intended for intravenous use. Titrate drug depending on the response of the individual patient to achieve the desired blood pressure reduction. Monitor blood pressure and heart rate continually during infusion, and then until vital signs are stable. 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.
Cleviprex is contraindicated in patients with allergies to soybeans, soy products, eggs, or egg products; defective lipid metabolism such as pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis if it is accompanied by hyperlipidemia; and in patients with severe aortic stenosis.
Hypotension and reflex tachycardia are potential consequences of rapid upward titration of Cleviprex. Dihydropyridine calcium channel blockers can produce negative inotropic effects and exacerbate heart failure. Monitor heart failure patients carefully. Cleviprex gives no protection against the effects of abrupt beta-blocker withdrawal.
Most common adverse reactions (> 2%) are headache, nausea, and vomiting.
Cleviprex should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Maintain aseptic technique while handling Cleviprex. Cleviprex contains phospholipids and can support microbial growth. Do not use if contamination is suspected. Once the stopper is punctured, use and discard within 4 hours.
Please see full Prescribing Information.