HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Cleviprex safely and effectively. See full prescribing information for Cleviprex. Cleviprex (clevidipine) injectable ...
These highlights do not include all the information needed to use Cleviprex safely and effectively. See full prescribing information for Cleviprex.
Cleviprex (clevidipine) injectable emulsion, for intravenous use
Initial U.S. Approval: 2008
INDICATIONS AND USAGE
Cleviprex is a dihydropyridine calcium channel blocker indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable. (1)
DOSAGE AND ADMINISTRATION
For intravenous use: Cleviprex is intended for intravenous use. Titrate Cleviprex to achieve the desired blood pressure reduction. Individualize dosage depending on the blood pressure response of the patient and the goal blood pressure. (2.2)
Monitoring: Monitor blood pressure and heart rate during infusion, and until vital signs stabilize. (2.1)
Initial dose: Initiate intravenous infusion of Cleviprex at 1- 2 mg/hour. (2.2)
Dose titration: Double the dose at short (90 second) intervals initially. As the blood pressure approaches goal, increase the dose by less than doubling and lengthen the time between dose adjustments to every 5-10 minutes. An approximately 1-2 mg/hour increase will generally produce an additional 2-4 mmHg decrease in systolic pressure. (2.2)
Maintenance dose: Most patients will achieve the desired therapeutic response at approximately 4-6 mg/hour. Severe hypertension is likely to require higher doses. (2.2)
Maximum dose: Most patients have received maximum doses of 16 mg/hour or less. There is limited experience with short-term dosing as high as 32 mg/hour. 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 beyond 72 hours at any dose. (2.2
DOSAGE FORMS AND STRENGTHS
Injectible Emulsion. Single-use vials. 50 mL, or 100 mL, or 250 mL. Concentration is 0.5 mg/mL. (3)
CONTRAINDICATIONS
Cleviprex is contraindicated in patients with:
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Allergy to soy or eggs (4.1)
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Defective lipid metabolism (4.2)
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Severe aortic stenosis (4.3)
WARNINGS AND PRECAUTIONS
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Maintain aseptic technique. Discard unused portion 12 hours after stopper puncture. (5.1)
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Hypotension and reflex tachycardia are potential consequences of rapid upward titration of Cleviprex. (5.2)
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Dihydropyridine calcium channel blockers can produce negative inotropic effects and exacerbate heart failure. Monitor heart failure patients carefully. (5.4)
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Cleviprex gives no protection against the effects of abrupt beta-blocker withdrawal. (5.5)
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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. (5.6)
ADVERSE REACTIONS
Most common adverse reactions (>2%) are headache, nausea, and vomiting. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact The Medicines Company at 1-888-977-MDCO (6326) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
At clinically relevant concentrations, clevidipine and its metabolites do not inhibit or induce any CYP450 enzymes. The potential of clevidipine to interact with other drugs is low. (7)
USE IN SPECIFIC POPULATIONS
Pediatric use: Safety and effectiveness of Cleviprex in children under 18 years of age have not been established. (8.4)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 11/2013
FULL PRESCRIBING INFORMATION: CONTENTS*
Table of Contents
1 INDICATIONS AND USAGE
Cleviprex is indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable.
Cleviprex is indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable.
2 DOSAGE AND ADMINISTRATION
2.1 Monitoring - Monitor blood pressure and heart rate continually during infusion, and then until vital signs are stable. Patients who receive prolonged Cleviprex ...
2.1 Monitoring
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. These patients may need follow-up adjustments in blood pressure control.
2.2 Recommended Dosing
Cleviprex is intended for intravenous use. Titrate drug to achieve the desired blood pressure reduction. Individualize dosage depending on the blood pressure to be obtained and the response of the patient.
Initial dose: Initiate the intravenous infusion of Cleviprex at 1-2 mg/hour.
Dose titration: The dose may be doubled at short (90 second) intervals 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. An approximately 1-2 mg/hour increase will generally produce an additional 2-4 mmHg decrease in systolic pressure.
Maintenance dose: The desired therapeutic response for most patients occurs at doses of 4-6 mg/hour. Patients with severe hypertension may require doses up to 32 mg/hour, but there is limited experience at this dose rate.
Maximum dose: Most patients were treated with maximum doses of 16 mg/hour or less.There is limited short-term experience with doses up to 32 mg/hour. 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. In clinical trials, 55 hypertensive patients were treated with >500mL of Cleviprex infusion per 24 hour period. There is little experience with infusion durations beyond 72 hours at
