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Cleviprex

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Cleviprex

Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Need for Aseptic Technique

Use aseptic technique and discard any unused productwithin 12 hours of stopper puncture [see DOSAGE AND ADMINISTRATION].

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.

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.

Negative Inotropy

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

Beta-Blocker Withdrawal

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 bewithdrawn only aftera gradual reduction indose.

Rebound Hypertension

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.

Pheochromocytoma

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

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Clevidipine displayed positive genotoxic potentials in vitro in the Ames test, mouse lymphoma thymidine kinase locus assay, and chromosomal aberration assay but not in vivo in the mouse micronucleus test. Formaldehyde, a metabolite of clevidipine, a known genotoxicant in vitro and a probable human carcinogen, appears to be at least partially responsible for the positives in vitro results. Long-term studies for evaluation of carcinogenic potential have not been performed with clevidipine due to the intended short-term duration of human use. There were no adverse effects on fertility or mating behavior of male rats at clevidipine doses of up to 55 mg/kg/day, approximately equivalent to the maximum recommended human dose (MRHD) of 504 mg/day (21 mg/hour x 24 hours) on a body surface area basis. Female rats demonstrated pseudopregnancy and changes in estrus cycle at doses as low as 13 mg/kg/day (about 1/4th the MRHD); however, doses of up to 55 mg/kg/day did not affect mating performance or fertility.

Use In Specific Populations

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].

Labor and Delivery

Cleviprex in the labor and delivery setting has not been establishedassafe and effective.Other calcium channel blockers suppress uterine contractions in humans.Pregnant rats treated with clevidipine during late gestation had an increased rate of prolonged parturition.

Nursing Mothers

It is not known whether clevidipine is excreted in human milk. Because many drugs are excreted in human milk, consider possible infant exposure when Cleviprex is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of Cleviprex in children under 18 years of age have not been established.

Geriatric Use

Of the 1406 subjects (1307with hypertension) treated with Cleviprex in clinical studies, 620 were ≥ 65 years of age and 232 were ≥ 75 years of age. No overall differences in safety or effectiveness were observed between these and younger patients.Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, for an elderly patient doses should betitrated cautiously, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Last reviewed on RxList: 1/4/2012
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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