Cleviprex Side Effects
Please note - some side effects for Cleviprex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects of Cleviprex - for the Consumer
Cleviprex
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Cleviprex:
Seek medical attention right away if any of these SEVERE side effects occur when using Cleviprex:Dizziness; drowsiness; headache; nausea; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fainting; fast or irregular heartbeat; pounding in the chest; shortness of breath; sudden severe dizziness; swelling of feet or legs; vision changes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopCleviprex Side Effects - for the Professional
Cleviprex
The following risk is discussed elsewhere in the labeling:
- Hypotension and Reflex Tachycardia [see Warnings and Precautions (5.2)]
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). Table 2 shows treatment-emergent adverse reactions and the category of “any common adverse event” in ESCAPE-1 and ESCAPE-2 where the rate on Cleviprex exceeded the rate on placebo by at least 5% (common adverse reactions).
| ESCAPE-1 | ESCAPE-2 | |||
| CLV N=53(%) |
PBO N=51(%) |
CLV N=61(%) |
PBO N=49(%) |
|
| Any common adverse event | 27 (51%) | 21 (41%) | 32 (53%) | 24 (49%) |
| Acute renal failure | 5 (9%) | 1 (2%) | -- | -- |
| Atrial fibrillation | -- | -- | 13 (21%) | 6 (12%) |
| Nausea | -- | -- | 13 (21%) | 6 (12%) |
Three randomized, parallel, open-label studies called ECLIPSE, with longer exposure in cardiac surgery patients define the adverse reactions for patients with perioperative hypertension. Each ECLIPSE study compared Cleviprex (n=752) to an active comparator: nitroglycerin (NTG, n=278), sodium nitroprusside (SNP, n=283), or nicardipine (NIC, n=193). The pooled mean maximum dose in these studies was 10 mg/hour and the mean duration of treatment was 8 hours.
There were many adverse events associated with the operative procedure in the clinical studies of Cleviprex and relatively few plausibly related to the drugs used to lower blood pressure. Thus, the ability to differentiate the adverse event profile between treatments is limited. The adverse events observed within one hour of the end of the infusion were similar in patients who received Cleviprex and in those who received comparator agents. There was no adverse reaction that was more than 2% more common on Cleviprex than on the average of all comparators.
Serious Adverse Events and Discontinuation – Perioperative Hypertension Studies
The incidence of adverse events leading to study drug discontinuation in patients with perioperative hypertension receiving Cleviprex was 5.9% versus 3.2% for all active comparators. For patients receiving Cleviprex and all active comparators the incidence of serious adverse events within one hour of drug infusion discontinuation was similar.
Severe Hypertension
The adverse events for patients with severe hypertension are based on an uncontrolled study in patients with severe hypertension (VELOCITY, n=126).
The common adverse reactions for Cleviprex in severe hypertension included headache (6.3%), nausea (4.8%), and vomiting (3.2%). The incidence of adverse events leading to study drug discontinuation for Cleviprex in severe hypertension was 4.8%.
Less Common Adverse Reactions in Patients with Severe or Essential Hypertension
Adverse reactions that were reported in <1% of patients with severe or essential hypertension included:
Cardiac: myocardial infarction, cardiac arrest
Nervous system: syncope
Respiratory: dyspnea
Side Effects by Body System - for Healthcare Professionals
Cardiovascular
Cardiovascular side effects have included hypotension, reflex tachycardia, atrial fibrillation, myocardial infarction, and cardiac arrest.
Renal
Renal side effects have included acute renal failure.
Gastrointestinal
Gastrointestinal side effects have included nausea and vomiting.
Nervous system
Nervous system side effects have included headache and syncope.
Respiratory
Respiratory side effects have included dyspnea.
TopMore Cleviprex resources
- Cleviprex Prescribing Information (FDA)
- Cleviprex Advanced Consumer (Micromedex) - Includes Dosage Information
- Cleviprex MedFacts Consumer Leaflet (Wolters Kluwer)
- Cleviprex Consumer Overview
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