Clevidipine

Clevidipine is a dihydropyridine L-type calcium channel blocker. L-type calcium channels mediate the influx of calcium during depolarization in arterial smooth muscle.

• Cleviprex is indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable. Cleviprex is a dihydropyridine calcium channel blocker indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable.

• Cleviprex is contraindicated in patients with: Allergy to soy or eggs (4.1) Defective lipid metabolism (4.2) Severe aortic stenosis (4.3) 4.1 Known Allergy Cleviprex is contraindicated in patients with allergies to soybeans, soy products, eggs, or egg products. 4.2 Defective Lipid Metabolism Cleviprex is contraindicated in patients with defective lipid metabolism such as pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis if it is accompanied by hyperlipidemia.contraindicated

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) 2.1 Monitoring Monitor blood pressure and heart rate continually during infusion, and then until vital signs are stable.

Maintain aseptic technique. Discard unused portion 12 hours after stopper puncture. (5.1) Hypotension and reflex tachycardia are potential consequences of rapid upward titration of Cleviprex. (5.2) Dihydropyridine calcium channel blockers can produce negative inotropic effects and exacerbate heart failure. Monitor heart failure patients carefully. (5.4) Cleviprex gives no protection against the effects of abrupt beta-blocker withdrawal. (5.5) 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) 5.1 Need for Aseptic Technique Use aseptic technique and discard any unused product within 12 hours of stopper puncture [see Dosage and Administration (2.3)] . 5.2 Hypotension and Reflex Tachycardia Cleviprex may produce systemic hypotension and reflex tachycardia. 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. 5.3 Lipid Intake 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. For these patients, a reduction in the quantity of concurrently administered lipids may be necessary to compensate for the amount of lipid infused as part of the Cleviprex formulation.

The following risk is discussed elsewhere in the labeling: Hypotension and Reflex Tachycardia [see Warnings and Precautions (5.2)] 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. 6.1 Clinical Trials Experience Cleviprex clinical development included 19 studies, with 99 healthy subjects and 1307 hypertensive patients who received at least one dose of clevidipine (1406 total exposures). Clevidipine was evaluated in 15 studies in hypertensive patients: 1099 patients with perioperative hypertension, 126 with severe hypertension and 82 patients with essential hypertension. The desired therapeutic response was achieved at doses of 4-6 mg/hour. Cleviprex was infused for <24 hours in the majority of patients (n=1199); it was infused as a continuous infusion in an additional 93 patients for durations between 24 and 72 hours. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Perioperative Hypertension The placebo-controlled experience with Cleviprex in the perioperative setting was both small and brief (about 30 minutes).

Pediatric use : Safety and effectiveness of Cleviprex in children under 18 years of age have not been established. (8.4 ) 8.1 Pregnancy Pregnancy Category C There are no adequate and well-controlled studies of Cleviprex use in pregnant women. In animal studies, clevidipine caused increases in maternal and fetal mortality and length of gestation. Cleviprex should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There was decreased fetal survival when pregnant rats and rabbits were treated with clevidipine during organogenesis at doses 0.7 times (on a body surface area basis) the maximum recommended human dose (MRHD) in rats and 2 times the MRHD in rabbits. In pregnant rats dosed with clevidipine during late gestation and lactation, there were dose-related increases in maternal mortality, length of gestation and prolonged parturition at doses greater than or equal to 1/6 of the MRHD based on body surface area. When offspring of these dams were mated, they had a conception rate lower than that of controls. Clevidipine has been shown to cross the placenta in rats [see Nonclinical Toxicology (13.3)] . 8.2 Labor and Delivery Cleviprex in the labor and delivery setting has not been established as safe and effective. Other calcium channel blockers suppress uterine contractions in humans.

Metabolism

Clevidipine is rapidly distributed and metabolized resulting in a very short half life. The arterial blood concentration of clevidipine declines in a multi-phasic pattern following termination of the infusion.

There has been no experience of overdosage in human clinical trials. In clinical trials, doses of Cleviprex up to 106 mg/hour or 1153 mg maximum total dose were administered. The expected major effects of overdose would be hypotension and reflex tachycardia. Discontinuation of Cleviprex leads to a reduction in antihypertensive effects within 5 to 15 minutes [see Clinical Pharmacology (12.2)] . In case of suspected overdosage, Cleviprex should be discontinued immediately and the patient’s blood pressure should be supported.

• Aug 1, 2008NDANDA022156Chiesi

1. 1Drug Ineffective359.7%
2. 2Hypotension298.1%
3. 3Hypoxia257.0%
4. 4Ventilation Perfusion Mismatch257.0%
5. 5Oxygen Saturation Decreased185.0%
6. 6Tachycardia174.7%
7. 7Atrial Fibrillation154.2%
8. 8Bradycardia133.6%
9. 9Extravasation133.6%
10. 10Blood Pressure Inadequately Controlled113.1%
11. 11Off Label Use113.1%
12. 12Infusion Site Extravasation102.8%
13. 13Blood Triglycerides Increased92.5%
14. 14Drug Administration Error92.5%
15. 15No Adverse Event82.2%

The 10 most recently updated of 34 ClinicalTrials.gov registrations naming Clevidipine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
  Recruiting · Observational · 1,000 enrolled · Zeenat Qureshi Stroke Institute
  NCT06402968updated 2026-06-12
• Association of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers With Post-Stroke Pneumonia: A Real-World Retrospective Cohort Study
  Not yet recruiting · Observational · 13,656 enrolled · First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
  NCT07262710updated 2025-12-04
• Assessment of Efficacy, Safety and Dosing of Clevidipine in Pediatric Participants Undergoing Surgery (PIONEER)
  Terminated · Phase 4 · Interventional · 22 enrolled · Chiesi Farmaceutici S.p.A.
  NCT01938547updated 2025-04-17
• Clevidipine Infusion for Blood Pressure Management After Successful Revascularization in Acute Ischemic Stroke
  Completed · Phase 3 · Interventional · 80 enrolled · ProMedica Health System
  NCT05175547updated 2025-01-07
• Effect of Treatment of Pre-induction Hypertension on Hemodynamic Stability During Induction of General Anesthesia
  Not yet recruiting · Phase 4 · Interventional · 64 enrolled · University of California, San Diego
  NCT06063772updated 2024-11-08
• a Study Evaluating the Safety and Efficacy of Clevidipine for Patients Who With Hypertensive Emergency and Sub-emergency
  Unknown · Phase 3 · Interventional · 378 enrolled · Qilu Pharmaceutical (Hainan) Co., Ltd.
  NCT05922436updated 2023-06-28
• A Study of Clevidipine Butyrate Injectable Emulsion in the Treatment of Hypertensive Emergency and Sub-emergency
  Unknown · Phase 3 · Interventional · 398 enrolled · CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
  NCT05783557updated 2023-03-24
• Safety and Efficacy Study of Clevidipine to Control Hypertension in Patients Admitted With Aneurysmal Subarachnoid Hemorrhage
  Terminated · Phase 2 · Interventional · 5 enrolled · Henry Ford Health System
  NCT00978822updated 2023-03-02
• Clevidipine for Vasospasm After Subarachnoid Hemorrhage (SAH)
  Withdrawn · Phase 2 · Interventional · 0 enrolled · Henry Ford Health System
  NCT02011321updated 2023-02-01
• Effect of Changing Physiological Conditions on Myogenic Oscillations: Pilot Study
  Completed · Early phase 1 · Interventional · 40 enrolled · University of California, San Francisco
  NCT03719001updated 2022-06-30

Frequently asked questions

How does Clevidipine work?

Clevidipine is a dihydropyridine L-type calcium channel blocker. L-type calcium channels mediate the influx of calcium during depolarization in arterial smooth muscle.

What is Clevidipine used for?

According to FDA labeling, Clevidipine carries indications including: Cleviprex is indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable. Cleviprex is a dihydropyridine calcium channel blocker indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Clevidipine?

Clevidipine is classified as Dihydropyridine derivatives, Dihydropyridine Calcium Channel Blocker, Calcium Channel Antagonists, L-Calcium Channel Receptor Antagonists, Arterial Vasodilation, Decreased Blood Pressure, Lipid Metabolism Alteration.

What are the brand names for Clevidipine?

Clevidipine is marketed under brand names including Cleviprex.

What are the contraindications for Clevidipine?

Clevidipine labeling lists contraindications including: Cleviprex is contraindicated in patients with: Allergy to soy or eggs (4.1) Defective lipid metabolism (4.2) Severe aortic stenosis (4.3) 4.1 Known Allergy Cleviprex is contraindicated in patients with allergies to soybeans, soy products, eggs, or egg products. 4.2 Defective Lipid Metabolism Cleviprex is contraindicated in patients with defective lipid metabolism such as pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis if it is accompanied by hyperlipidemia.. Always consult the full prescribing information and a clinician.