PRIALT (ziconotide) solution, intrathecal infusion is indicated for the management of severe chronic pain in adult patients for whom intrathecal therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or intrathecal morphine.

General Information

PRIALT is intended for administration by or under the direction of a physician experienced in the technique of intrathecal administration and who is familiar with the drug and device labeling.

PRIALT is not intended for intravenous administration.

PRIALT is intended for intrathecal delivery using the Medtronic SynchroMed® II Infusion System and CADD-Micro Ambulatory Infusion Pump [see WARNINGS AND PRECAUTIONS]. Refer to the manufacturer's manual for specific instructions and precautions for programming the microinfusion device and/or refilling the reservoir.

PRIALT may be used for therapy undiluted (25 mcg/mL in 20 mL vial) or diluted (100 mcg/mL in 1 or 5 mL vials). The 100 mcg/mL formulation may be administered undiluted once an appropriate dose has been established.

Dilute PRIALT with 0.9% Sodium Chloride Injection, USP (preservative free) using aseptic procedures to the desired concentration prior to placement in the microinfusion pump.

• Saline solutions containing preservatives are not appropriate for intrathecal drug administration and should not be used due to risk of neurotoxicity.
• Refrigerate but do not freeze all PRIALT solutions after preparation and begin infusion within 24 hours.

Inspect vials of PRIALT visually for particulate matter and discoloration prior to administration whenever solution and container permit. Discard any PRIALT solution with observed particulate matter or discoloration and any unused portion left in the vial.

Dosing

Dose Initiation

Initiate dosing with PRIALT via intrathecal device at no more than 2.4 mcg/day (0.1 mcg/hr).

Dose Titration

Titrate doses by up to 2.4 mcg/day (0.1 mcg/hr) at intervals of no more than 2 to 3 times per week based on analgesic response and adverse events. Dose increases in increments of less than 2.4 mcg/day (0.1 mcg/hr) and less frequently than 2 to 3 times per week may be used. For each dose titration, assess the dosing requirements and adjust the pump infusion flow rate as required to achieve the new dosing.

The maximum recommended dose is 19.2 mcg/day (0.8 mcg/hr).

Adjust the dose of intrathecal PRIALT according to the severity of pain, the patient's response to therapy, and the occurrence of adverse reactions.

Instructions for Use with the Medtronic SynchroMed II Infusion System

Refer to the manufacturer's manuals for specific instructions and precautions for performing a reservoir rinse, initial filling, refilling the reservoir, and programming. [see WARNINGS AND PRECAUTIONS]

Naïve Pump Priming (i.e., first time use with PRIALT)

Use only the undiluted 25 mcg/mL formulation for naïve pump priming. Rinse the internal surfaces of the pump with 2 mL of PRIALT at 25 mcg/mL. Repeat twice for a total of three rinses.

Initial Pump Fill

Use only the undiluted 25 mcg/mL formulation for the initial pump fill. Fill the naïve pump after priming with the appropriate volume of PRIALT 25 mcg/mL. Begin dosing at a delivery rate no higher than 2.4 mcg/day (0.1 mcg/hr). In a naïve pump, PRIALT is lost due to two factors that do not occur upon subsequent refills: adsorption on internal device surfaces, such as titanium, and by dilution in the residual space of the device. Consequently, the pump reservoir should be refilled with PRIALT within 14 days of the initial fill to ensure appropriate dose administration.

Pump Refills

For subsequent pump refills, fill the pump at least every 40 days if PRIALT is used diluted. For undiluted PRIALT, fill the pump at least every 84 days. To ensure aseptic transfer of PRIALT into the device, use the Medtronic refill kit. Empty the pump contents prior to refill with PRIALT.

If the internal infusion system must be surgically replaced while the person is receiving PRIALT, rinse the replacement pump with PRIALT according to Naïve Pump Priming, and replace the initial fill solution within 14 days according to Initial Pump Fill.

Instructions for Use in the CADD-Micro Ambulatory Infusion Pump

Refer to the manufacturer's manuals for specific instructions and precautions for performing the initial filling, refilling of the reservoir or replacement of the drug cartridge, and operation. The CADD-Micro Ambulatory Infusion Pump is filled for the first time with PRIALT solution at a concentration of 5 mcg/mL. This solution is prepared by diluting PRIALT with 0.9% Sodium Chloride, USP (preservative free).

The recommended initial flow rate for the external microinfusion is 0.02 mL/hr to deliver the initial dose rate of 2.4 mcg/day (0.1 mcg/hr) of PRIALT. Changes in dose rate are made by adjusting the flow rate of the infusion system and/or the concentration of PRIALT solution. [see WARNINGS AND PRECAUTIONS]

Dosage Forms And Strengths

PRIALT (ziconotide) solution, intrathecal infusion is supplied as a 25 mcg/mL concentration in single-use 20 mL glass vials and as a 100 mcg/mL concentration in single-use glass vials containing 1 mL or 5 mL of solution.

Storage And Handling

PRIALT is supplied as a 25 mcg/mL solution in a single-use 20 mL glass vial and as a 100 mcg/mL solution in single-use glass vials containing 1 mL or 5 mL of solution. One vial is packaged per carton.

Presentation (NDC)

25 mcg/mL: 20 mL vial (18860-723-10). Only the undiluted 25 mcg/mL formulation should be used for PRIALT naïve pump priming.

100 mcg/mL: 1 mL vial (18860-720-10)
                    5 mL vial (18860-722-10)

Storage

Refrigerate PRIALT during transit.

• Store PRIALT at 2°C to 8°C (36°F to 46°F).
• PRIALT, once diluted aseptically with saline, may be stored at 2°C to 8°C for 24 hours.
• Do NOT freeze PRIALT.
• Protect from light.

Distributed by: Azur Pharma, Inc. 1818 Market Street, Suite 2350 Philadelphia, PA 19103. Revised: 09/2011

Last reviewed on RxList: 9/12/2011
This monograph has been modified to include the generic and brand name in many instances.