Prialt (ziconotide acetate)

Ziconotide therapy should be initiated using a slow dosage titration schedule in order to minimize the risk of adverse effects that are serious or require drug discontinuance. A faster titration schedule should be used only if an urgent need for analgesia outweighs the risk to patient safety.

The recommended initial dosage of ziconotide for management of severe chronic pain in adults is 2.4 mcg per 24 hours (0.1 mcg/hour) or less. Dosage is then titrated based on patient response. Dosage can be increased 2 or 3 times per week in increments of up to 2.4 mcg per 24 hours (0.1 mcg/hour), up to a maximum recommended dosage of 19.2 mcg per 24 hours (0.8 mcg/hour) by day 21. In a study that evaluated efficacy of ziconotide using the slow dosage titration schedule, the average dosage at day 21 was 6.9 mcg per 24 hours (0.29 mcg/hour); the maximum dosage was 19.2 mcg per 24 hours.

Ziconotide therapy can be interrupted or discontinued abruptly without withdrawal effects.

Ziconotide is administered intrathecally using a programmable implanted variable-rate microinfusion device (i.e., Medtronic SynchroMed(R) EL or SynchroMed(R) II) or an external microinfusion device and catheter (i.e., CADD-Micro(R) ambulatory infusion pump) by or under the supervision of a qualified clinician familiar with the drug, the techniques of intrathecal administration, and the device being used. The device manufacturer's manual should be consulted for specific instructions and precautions for performing a reservoir rinse, initial filling, refilling the reservoir or replacing the drug cartridge, and programming.

An appropriate vial strength and final concentration of the drug should be selected in accordance with the manufacturer's instructions. The commercially available preparation containing ziconotide 25 mcg/mL may be used undiluted; the preparation containing ziconotide 100 mcg/mL may be used undiluted or may be diluted with 0.9% sodium chloride injection prior to placement in the pump. Sodium chloride solutions containing preservatives are not appropriate for intrathecal administration and should not be used to dilute ziconotide. Diluted ziconotide solutions should be refrigerated; freezing should be avoided. Infusion of diluted ziconotide solutions should be initiated within 24 hours of preparation.

Ziconotide is not for IV administration.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

Concomitant treatments or medical conditions (e.g., presence of infection at the microinfusion injection site, uncontrolled bleeding diathesis, spinal canal obstruction that impairs CSF circulation) that make intrathecal therapy hazardous.

History of psychosis.

Known hypersensitivity to ziconotide or any ingredient in the formulation.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Adverse effects reported in 25% or more of patients receiving ziconotide include dizziness, nausea, confusion, headache, somnolence, nystagmus, asthenia, and pain.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

Safety and efficacy not established in patients younger than 18 years of age.

Category C. (See Users Guide.)

Not known whether ziconotide is distributed into milk. Discontinue nursing or the drug, taking into account the importance of the drug to the mother.

In clinical studies, 22% of patients were 65 years of age or older and 7% were 75 years of age or older. In all studies, the incidence of confusion was higher in individuals 65 years of age or older than in younger adults. No substantial difference in efficacy in geriatric patients relative to younger adults.

Select dosage with caution, starting at the low end of the dosage range, because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.