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Titratable Control Maintains Performance

  • Patients achieving target BP within 30 minutes continued infusion up to 32 mg/h for a protocol-specified duration of at least 18 hours and up to 96 hours, with dosing adjustments as needed to maintain desired blood pressure
     

  • More than 90% of patients maintained BP control on Cleviprex monotherapy, eliminating the need for additional intravenous antihypertensive therapy
  • Headache (6.3%; 8 of 126), nausea (4.8%; 6 of 126), chest discomfort (3.2%; 4 of 126), and vomiting (3.2%; 4 of 126) were the most common AEs
  • Cleviprex did not raise serum triglyceride levels
    • Median percentage change in concentration of serum triglyceride levels was zero at 6 hours after cessation of therapy
    • No relationship between change in triglyceride levels and total dose of Cleviprex received (Pearson’s correlation coefficient = -0.0269)
       

Cleviprex Provides a Reliable Transition to Oral Antihypertensive Therapy

  • 98% (115 of 118) of eligible patients successfully transitioned to oral therapy to a predefined target BP within 6 hours of discontinuing Cleviprex
  • Patients were maintained on a steady infusion of Cleviprex without evidence of tachyphylaxis, drug accumulation, or rebound hypertension on discontinuation

 

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.

Reference

  1. Pollack CV, Varon J, Garrison NA, Ebrahimi R, Dunbar L, Peacock WF IV. Clevidipine, an intravenous dihydropyridine calcium channel blocker, is safe and effective for the treatment of patients with acute severe hypertension. Ann Emerg Med. 2008; Jun 6. [Epub ahead of print].