PRIALT is a prescription medicine used to treat severe chronic pain in adults who cannot take other treatments or when other treatments do not work, stop working or cause bothersome side effects. PRIALT can only be delivered by or under the direction of a doctor who injects the medicine into your spinal fluid through a special device (a procedure called intrathecal infusion) and should only be used in patients who are appropriate for this procedure.
IMPORTANT SAFETY INFORMATION
PRIALT may cause serious side effects including psychiatric (mental) symptoms and problems thinking (confusion, memory problems, speech difficulties).
Your doctor should be called immediately if, while taking PRIALT, you are confused or disoriented, are less alert, see or hear things that are not real (hallucinations), have changes in mood or consciousness.
Your doctor may stop your treatment with PRIALT, give you other medicines, or require you to be hospitalized if you experience any of these symptoms.
FULL PRESCRIBING INFORMATION
WARNING: NEUROPSYCHIATRIC ADVERSE REACTIONS
PRIALT is contraindicated in patients with a preexisting history of psychosis. Severe psychiatric symptoms and neurological
impairment may occur during treatment with PRIALT. Monitor all patients frequently for evidence of cognitive impairment,
hallucinations, or changes in mood or consciousness. Discontinue PRIALT therapy in the event of serious neurological or
psychiatric signs or symptoms.
1 INDICATIONS AND USAGE
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.
2 DOSAGE AND ADMINISTRATION
2.1 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 (5.2)]. 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.
2.2 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.
2.3 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 (5.2)]
Na�ve Pump Priming (i.e., first time use with PRIALT)
Use only the undiluted 25 mcg/mL formulation for na�ve 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 na�ve 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 na�ve 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
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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 Na�ve Pump Priming [see Dosage and Administration (2.4)], and replace the initial fill solution within 14 days
according to Initial Pump Fill [see Dosage and Administration (2.4)].
PRIALT
(ziconotide) solution, intrathecal infusion
Initial Fill
Expiry
Refill
Expiry
25 mcg/mL, undiluted 14 Days 84 Days
100 mcg/mL, undiluted N/A 84 Days
100 mcg/mL, diluted N/A 40 Days
2.4 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 (5.2)]
3 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.
