IV Calcium Channel Blocker Wins FDA Okay
by Peggy Peck Peggy Peck, Executive Editor, MedPage Today August 05, 2008
PARSIPPANY, N.J., Aug. 5 -- The FDA has approved the IV calcium channel blocker clevidipine butyrate (Cleviprex) for treatment of hypertension in patients in whom oral therapy is not feasible or is ineffective, the Medicines Company announced.
The injectable emulsion has a rapid onset and offset of action, which the drug maker said improves titration for precise blood pressure control.
And because the drug is metabolized in the blood, rather than the kidneys or the liver, it can be used in patients with late-stage disease in those organs.
The manufacturer said the FDA approval was based on results from six phase III trials that enrolled 1,406 medical and surgical patients treated with the IV dihydropyridine calcium channel blocker. All trials met their primary endpoints.
Patients treated with clevidipine should have continuous monitoring of heart rate and blood pressure during infusion, continuing until vital signs are stable, the company said. The drug should be discontinued or titrated downward when oral therapy can be established.
Patients who receive prolonged infusions and are not transitioned to other antihypertensive therapies should be monitored for the possibility of rebound hypertension for at least eight hours after the infusion is stopped.
The drug is contraindicated in patients with allergies to soybeans, soy products, eggs, or egg products; defective lipid metabolism such as pathologic hyperlipidemia, lipoid nephrosis, or acute pancreatitis if it is accompanied by hyperlipidemia. It is also contraindicated in patients with severe aortic stenosis.
Hypotension and reflex tachycardia are potential consequences of rapid upward titration.
Dihydropyridine calcium channel blockers produce negative inotropic effects and can exacerbate heart failure. Heart failure patients should be monitored carefully. The drug gives no protection against the effects of abrupt beta-blocker withdrawal.
In clinical trials the most common adverse reactions (>2%) were headache, nausea, and vomiting.
The drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
The drug contains phospholipids and can support microbial growth, so it is important to maintain aseptic technique when handling.
Reviewed by Zalman S. Agus, MD Emeritus Professor
University of Pennsylvania School of Medicine