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Dosing and Administration for CLEVIPREX® (clevidipine)

Module 1: Appropriate dosing and administration

CLEVIPREX®
injectable emulsion

Materials needed:

The following items are needed to administer CLEVIPREX®:

CLEVIPREX vial
Vial of CLEVIPREX®
50 mL or 100 mL vial of CLEVIPREX®
Standard vented IV tubing
Standard vented IV tubing
Infusion pump
Infusion pump
Either a volumetric infusion pump or syringe pump may be used; the infusion device should allow for calibrated infusion rates.
BP cuff or arterial line
BP cuff or arterial line
to monitor BP continually during CLEVIPREX® infusion

Before administration

The following steps should be performed before CLEVIPREX® is administered1:

  • CLEVIPREX® can be administered intravenously by a dedicated peripheral line or a dedicated central catheter. CLEVIPREX® is a low-volume infusion
  • Consider priming intravenous line with CLEVIPREX® according to your hospital policy
  • Maintain strict aseptic technique while handling CLEVIPREX®
  • Once the stopper is punctured, use within 12 hours and discard any unused portion
  • Invert vial gently several times before use to ensure uniformity of the emulsion prior to administration
  • Inspect for particulate matter and discoloration before administration (do not use if contamination is suspected)
  • Administer CLEVIPREX® using an infusion device allowing calibrated infusion rates

IV compatibility1

CLEVIPREX® should not be administered in the same line as other medications.

CLEVIPREX® has Y-site compatibility with Water for Injection, USP; Sodium Chloride (0.9%) Injection, USP; Dextrose (5%) Injection, USP; Dextrose (5%) in Sodium Chloride (0.9%) Injection, USP; Dextrose (5%) in Ringer’s Lactate Injection, USP; Lactated Ringer’s Injection, USP; 10% Amino Acid.

During administration

Monitor BP & heart rate1

BP and heart rate should be monitored continually during CLEVIPREX® infusion, and then until vital signs are stable (via BP cuff or arterial line).

Initial dose1

1-2 mg/h (convert to mL/h by multiplying by 2).

Dose conversion1

mg/h
mL/h
1
2
2
4
4
8
6
12
-
-
32
64

Titration1

  • Titrate dose to desired BP reduction
  • Initially, dose may be doubled at 90-second intervals
  • As BP approaches goal, dose increases should be less than doubling and the time between dose adjustments should be every 5–10 minutes
  • An approximately 1–2 mg/h increase will generally produce an additional 2–4 mmHg decrease in systolic blood pressure

Maintenance dose1

The desired therapeutic response for most patients occurs at doses of 4-6 mg/h. Patients with severe hypertension may require doses up to 32 mg/h, but there is limited experience at this dose rate.

Maximum dose1

  • Most patients were treated with maximum doses of 16 mg/h or less
  • There is limited short-term experience with doses up to 32 mg/h
  • Because of lipid load restrictions no more than 1000 mL, or an average of 21 mg/h, is recommended per 24-hour period (other lipid-containing fluids should be considered when calculating lipid load for individual patients)
  • There is little experience with infusions beyond 72 hours at any dose

Discarding the vial1

  • Discard any unused product within 12 hours of stopper puncture
  • Change tubing per existing hospital policy

Discontinuation of CLEVIPREX®

Factors to consider1

  • The initial phase half-life is approximately 1 minute and accounts for 85%-90% of clevidipine elimination
  • Offset of effect: In most patients, full recovery of BP is achieved in 5-15 minutes after the infusion is stopped
  • Titrate downward or discontinue to achieve desired BP while appropriate oral therapy is established
  • Consider the lag time of onset of the oral agent’s effect
  • Continue BP monitoring until desired effect is achieved
  • If CLEVIPREX® is discontinued without transition to another agent, monitor for the possibility of rebound hypertension for at least 8 hours after infusion is stopped

Product overview

How supplied1

CLEVIPREX® is supplied as a sterile, milky-white lipid emulsion in single-use 50 mL and 100 mL glass vials at a concentration of 0.5 mg/mL of clevidipine for intravenous administration.

Metabolism1

CLEVIPREX® is rapidly metabolized by blood and tissue esterases; initial phase half life of approximately 1 minute.

Mechanism of action1

CLEVIPREX® blocks the entry of calcium through L-type calcium channels which mediate the influx of calcium during depolarization in arterial smooth muscle, decreasing systemic vascular resistance and resulting in a reduction of mean arterial pressure.

Storage1

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°C–8°C (36°F–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.

Reference: 1. CLEVIPREX® (clevidipine) Prescribing Information. 2013.

Important Safety Information

CLEVIPREX® (clevidipine) Injectable Emulsion is contraindicated in patients with:

  • Allergies to soybeans, soy products, eggs, or egg products;
  • Defective lipid metabolism seen in conditions such as pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis if it is accompanied by hyperlipidemia; and
  • Severe aortic stenosis.

CLEVIPREX® is intended for intravenous use. Use aseptic technique and discard any unused product within 12 hours of stopper puncture.

Hypotension and reflex tachycardia are potential consequences of rapid upward titration of CLEVIPREX®. If either occurs, decrease the dose of CLEVIPREX®. There is limited experience with short-duration therapy with beta-blockers as a treatment for CLEVIPREX®-induced tachycardia. Beta-blocker use for this purpose is not recommended.

CLEVIPREX® contains approximately 0.2 g of lipid per mL (2.0 kcal). Lipid intake restrictions may be necessary for patients with significant disorders of lipid metabolism.

Dihydropyridine calcium channel blockers can produce negative inotropic effects and exacerbate heart failure. Monitor heart failure patients carefully.

CLEVIPREX® is not a beta-blocker, does not reduce heart rate, and gives no protection against the effects of abrupt beta-blocker withdrawal. Beta-blockers should be withdrawn only after a gradual reduction in dose.

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.

There is no information to guide use of CLEVIPREX® in treating hypertension associated with pheochromocytoma.

Most common adverse reactions for CLEVIPREX® (>2%) are headache, nausea, and vomiting.

See Full Prescribing Information

www.cleviprex.com

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