Cleviprex™ (clevidipine butyrate): Pharmacy

Pharmacy

Indication:	Cleviprex™ (clevidipine butyrate) injectable emulsion is a dihydropyridine calcium channel blocker (CCB) indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable.

Product Description:	Cleviprex injectable emulsion is a rapid-acting, vascular and arterial selective dihydropyridine CCB with an ultrashort half-life.

NDC Numbers:	Cleviprex 50 mL:	Single vial box	NDC 65293-002-50
		Outer box of 10 vials	NDC 65293-002-55

	Cleviprex 100 mL:	Single vial box	NDC 65293-002-00
		Outer box of 10 vials	NDC 65293-002-11

How Supplied:	Cleviprex is supplied as a sterile, milky-white lipid emulsion in single-use 50-mL or 100-mL glass vials at a concentration of 0.5 mg/mL of clevidipine butyrate for intravenous administration.

Minimum Order:	Cleviprex 50 mL:	1 box of 10 vials
	Cleviprex 100 mL:	1 box of 10 vials

Weight:	Cleviprex 50 mL:	2.5 lb
	Cleviprex 100 mL:	5 lb

Dimensions:	Cleviprex 50 mL:	Single vial carton 1.75 x 1.875 x 3.75 (inches)
	Cleviprex 100 mL:	Single vial carton 2.12 x 2.25 x 4.6 (inches)

Storage:	Leave vials in cartons until use. Cleviprex 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.

Indication:

Cleviprex™ (clevidipine butyrate) injectable emulsion is a dihydropyridine calcium channel blocker (CCB) indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable.

Product Description:

Cleviprex injectable emulsion is a rapid-acting, vascular and arterial selective dihydropyridine CCB with an ultrashort half-life.

NDC Numbers:

Cleviprex 50 mL:

Single vial box

NDC 65293-002-50

Outer box of 10 vials

NDC 65293-002-55

Cleviprex 100 mL:

Single vial box

NDC 65293-002-00

Outer box of 10 vials

NDC 65293-002-11

How Supplied:

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

Minimum Order:

Cleviprex 50 mL:

1 box of 10 vials

Cleviprex 100 mL:

1 box of 10 vials

Weight:

Cleviprex 50 mL:

2.5 lb

Cleviprex 100 mL:

5 lb

Dimensions:

Cleviprex 50 mL:

Single vial carton 1.75 x 1.875 x 3.75 (inches)

Cleviprex 100 mL:

Single vial carton 2.12 x 2.25 x 4.6 (inches)

Storage:

Leave vials in cartons until use. Cleviprex 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.

IMPORTANT SAFETY INFORMATION

Cleviprex is intended for intravenous use. Titrate drug depending on the response of the individual patient to achieve the desired blood pressure reduction. 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.

Cleviprex is contraindicated in patients with allergies to soybeans, soy products, eggs, or egg products; defective lipid metabolism such as pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis if it is accompanied by hyperlipidemia; and in patients with severe aortic stenosis.

Hypotension and reflex tachycardia are potential consequences of rapid upward titration of Cleviprex. Dihydropyridine calcium channel blockers can produce negative inotropic effects and exacerbate heart failure. Monitor heart failure patients carefully. Cleviprex gives no protection against the effects of abrupt beta-blocker withdrawal.

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

Cleviprex should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Maintain aseptic technique while handling Cleviprex. Cleviprex contains phospholipids and can support microbial growth. Do not use if contamination is suspected. Once the stopper is punctured, use and discard within 4 hours.