Pharmacy & Therapeutics - September 2008 - (Page 550)

Pharmaceutical Approval Update Mar vin M. Goldenberg, PhD, RPh, MS Clevidipine Butyrate (Cleviprex) Manufacturer: The Medicines Company, Parsippany, N.J. Indication: Clevidipine butyrate injectable emulsion is used to reduce blood pressure when oral therapy is not feasible or desirable. Drug Class: Clevidipine butyrate is the latestgeneration intravenous (IV) dihydropyridine calciumchannel blocker. Uniqueness of Drug: Clevidipine butyrate has a rapid onset and offset of action. It is metabolized in the blood and tissues and doesn’t accumulate in the body, whereas current IV antihypertensive drugs are metabolized in the kidney, the liver, or both. Clevidipine butyrate is available as a ready-to-use formulation that does not need to be reconstituted in the hospital. Warnings and Precautions: Need for aseptic technique. Aseptic technique is required, and any unused product should be discarded, including the product being infused, within four hours of puncture of the stopper. Hypotension and reflex tachycardia. Clevidipine butyrate may produce systemic hypotension and reflex tachycardia. If either occurs, the dose should be reduced. There is limited experience with short-duration treatment with beta blockers as a therapy for clevidipine butyrate–induced tachycardia. The use of beta blockers for this purpose is not recommended. Lipid intake. Clevidipine butyrate contains approximately 0.2 mg of lipids per mL (2.0 kcal). Lipid restrictions may be necessary for patients with significant disorders of lipid metabolism. For these patients, a reduced quantity of concurrently administered lipids may be necessary to compensate for the amount of lipid infused as part of the clevidipine butyrate formulation. Negative inotropy. Dihydropyridine calcium-channel blockers can produce negative inotropic effects and may exacerbate heart failure. Patients with heart failure should be carefully monitored. Beta-blocker withdrawal. Clevidipine butyrate is not a beta blocker, does not reduce the heart rate, and does not protect against the effects of abrupt beta-blocker withdrawal. Beta blockers should be withdrawn after a gradual reduction in dose. Rebound hypertension. Patients who receive prolonged clevidipine butyrate infusions and who 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. Pheochromocytoma. No information is available about The author is President of Pharmaceutical and Scientific Services at Marvin M. Goldenberg, LLC, in Westfield, N.J. His e-mail address is marvinmgoldenberg@verizon.net. the use of this drug for treating hypertension associated with pheochromocytoma. Dosage and Administration: Clevidipine butyrate is intended for IV use. The dose should be titrated to achieve the desired reduction in blood pressure, and the dosage should be tailored for patients according to their blood pressure response and blood pressure goal. Monitoring. Blood pressure and heart rate should be monitored during the infusion until vital signs stabilize. Initial dose and titration. The initial dose is infused at a rate of 1 to 2 mg/hour. The dose is doubled at short (90second) inter vals initially. As blood pressure goals are achieved, the dose should be increased by less than doubling, and the time between dose adjustments should be lengthened to every 5 to 10 minutes. An increase of 1 to 2 mg/hour generally produces an additional decrease of 2 to 4 mm Hg in systolic pressure. Maintenance dose. Most patients achieve the desired therapeutic response at approximately 4 to 6 mg/hour. Patients with severe hypertension are likely to require higher doses. Maximum dose. Most patients have received maximum doses of clevidipine butyrate at 16 mg/hour or less. Experience is limited with short-term dosing as high as 32 mg/hour. Because of lipid load restrictions, no more than 1,000 mL, or an average of 21 mg/hour, of the infusion is recommended for each 24-hour period. Experience beyond 72 hours at any dose is limited. Commentar y: Injectable clevidipine butyrate is approved for patients with difficult-to-treat high blood pressure and for those who cannot take oral medications. An acute elevation of blood pressure, acute hypertension, or poorly controlled blood pressure is a life-threatening condition that can cause permanent damage to the brain, heart, kidneys, and blood vessels. Uncontrolled blood pressure occurs in nearly 50% of patients arriving at hospitals with acute heart failure and is common in patients with renal dysfunction. Occurring in a broad range of patients, it frequently affects those undergoing surgery and those presenting in emergency departments. Clevidipine butyrate is the first non-tablet medication in 10 years to receive approval for acute hypertension. The IV formulation can be titrated for predictable blood pressure control. Unlike antihypertensive treatments that are metabolized by the kidney or liver, clevidipine butyrate is metabolized in the tissue and blood and does not accumulate in the body. This makes it suitable for patients with end-organ damage, and it may represent an advance over other therapies. Supported by comprehensive data in the emergency department, operating room, and intensive-care unit, the product offers physicians an important therapeutic option. Common adverse reactions can include headache, nausea, and vomiting at an incidence of less than 2%. Source: www.themedicinescompany.com 550 P&T® • September 2008 • Vol. 33 No. 9 http://www.themedicinescompany.com

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Pharmacy & Therapeutics - September 2008 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/New Medical Devices Drug Forecast Effect of Prescription Copays on Adherence and Treatment Failure with Oral Antidiabetic Medications Vaccine Declinations Present New Challenges for Public Health Universal Health Care in America Digestive Disease Week and American Diabetes Association Pharmaceutical Approval Update

Pharmacy & Therapeutics - September 2008

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