"The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing of selexipag (Uptravi, Actelion Registration Ltd) for the treatment of adults with pulmonary arterial hypertension (PAH)./"...
Cleviprex is indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable.
DOSAGE AND ADMINISTRATION
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.
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.
Initiate the intravenous infusion of Cleviprex at 1-2 mg/hour.
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.
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.
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 any dose.
Transition To An Oral Antihypertensive Agent
Discontinue Cleviprex or titrate downward while appropriate oral therapy is established. When an oral antihypertensive agent is being instituted, consider the lag time of onset of the oral agent's effect. Continue blood pressure monitoring until desired effect is achieved.
Special populations were not specifically studied. In clinical trials, 78 patients with abnormal hepatic function (one or more of the following: elevated serum bilirubin, AST/SGOT, ALT/SGPT) and 121 patients with moderate to severe renal impairment were treated with Cleviprex. An initial Cleviprex infusion rate of 1-2 mg/hour is appropriate in these patients.
Table 1 is a guideline for dosing conversion from mg/hour to mL/hour.
Table 1: Dose conversion
|Dose (mg/hour)||Dose (mL/hour)|
Instructions For Administration
Maintain Aseptic Technique While Handling Cleviprex
Cleviprex is a single-use parenteral product. Do not use if contamination is suspected. Once the stopper is punctured, use within 12 hours and discard any unused portion.
Cleviprex is supplied in sterile, pre-mixed, ready-to-use 50 mL, or 100 mL, or 250 mL vials. Invert vial gently several times before use to ensure uniformity of the emulsion prior to administration. Inspect parenteral drug products for particulate matter and discoloration prior to administration whenever solution and container permit. Administer Cleviprex using an infusion device allowing calibrated infusion rates. Commercially available standard plastic cannulae may be used to administer the infusion. Administer Cleviprex by a central line or a peripheral line.
Cleviprex should not be administered in the same line as other medications.
Cleviprex should not be diluted, but it can be administered with the following:
Dosage Forms And Strengths
Cleviprex is a sterile, milky white injectable emulsion for intravenous use, available in the following configurations:
- 50 mL single use vial with 0.5 mg/mL clevidipine
- 100 mL single use vial with 0.5 mg/mL clevidipine
- 250 mL single use vial with 0.5 mg/mL clevidipine
Storage And Handling
Cleviprex (clevidipine) injectable emulsion is supplied as a sterile, milky white liquid emulsion product in single-use glass vials at a concentration of 0.5 mg/mL of clevidipine.
NDC 65293-005-50: 50 mL vial
NDC 65293-005-00: 100 mL vial
NDC 65293-005-25: 250 mL vial
Leave vials in cartons until use. Clevidipine is photosensitive and storage in cartons protects against photodegradation. Protection from light during administration is not required.
Store vials refrigerated at 2-8°C (36-46°F). Do not freeze. Vials in cartons may be transferred to 25°C (77°F, USP controlled room temperature) for a period not to exceed 2 months. Upon transfer to room temperature, mark vials in cartons “This product was removed from the refrigerator on _/_/_ date. It must be used or discarded 2 months after this date or the labeled expiration date (whichever date comes first).” Do not return to refrigerated storage after beginning room temperature storage.
Maintain aseptic technique while handling Cleviprex. Cleviprex is a single-use parenteral product that contains 0.005% disodium edetate to inhibit the rate of growth of microorganisms, for up to 12 hours, in the event of accidental contamination. However, Cleviprex can still support the growth of microorganisms, as it is not an antimicrobially preserved product under USP standards. Do not use if contamination is suspected. Once the stopper is punctured, use within 12 hours and discard any unused portion.
Cleviprex inhibits microbial growth for up to 12 hours, as demonstrated by test data for representative USP microorganisms, staphylococcus epidermidis and serratiamarcescens.
Manufactured by: Fresenius Kabi Austria GmbH, Graz, Austria. Marketed by:The Medicines Company, Parsippany, New Jersey 07054. Revised: Nov 2013This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/31/2016
Additional Cleviprex Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Get tips on handling your hypertension.