PRIALT

PRIALT- ziconotide acetate injection, solution
TerSera Therapeutics LLC

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) ]

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 [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.

4 CONTRAINDICATIONS

  • PRIALT is contraindicated in patients with a known hypersensitivity to ziconotide or any of its formulation components.
  • PRIALT is contraindicated in patients with any other concomitant treatment or medical condition that would render intrathecal administration hazardous. Contraindications to the use of intrathecal analgesia include the presence of infection at the microinfusion injection site, uncontrolled bleeding diathesis, and spinal canal obstruction that impairs circulation of CSF.
  • PRIALT is contraindicated in patients with a pre-existing history of psychosis.

5 WARNINGS AND PRECAUTIONS

5.1 Cognitive and Neuropsychiatric Adverse Reactions

Severe psychiatric symptoms and neurological impairment may occur during treatment with PRIALT. PRIALT is contraindicated in patients with a pre-existing history of psychosis. Monitor all patients frequently for evidence of cognitive impairment, hallucinations, or changes in mood or consciousness. PRIALT therapy can be interrupted or discontinued abruptly without evidence of withdrawal effects in the event of serious neurological or psychiatric signs or symptoms.

Events of acute psychiatric disturbances such as hallucinations (12%), paranoid reactions (3%), hostility (2%), delirium (2%), psychosis (1%), and manic reactions (0.4%) have been reported in patients treated with PRIALT. Patients with pretreatment psychiatric disorders may be at an increased risk. PRIALT may cause or worsen depression with the risk of suicide in susceptible patients. In placebo-controlled trials, there was a higher incidence of suicide, suicide attempts, and suicide ideations in PRIALT-treated patients than in the placebo group (0.27/patient year for PRIALT patients and 0.10/patient year for placebo patients).

Management of psychiatric complications may need to include discontinuation of PRIALT, treatment with psychotherapeutic agents and/or short-term hospitalization. Before drug is reinitiated, careful evaluation must be performed on an individual basis.

Use of PRIALT has been associated with cognitive impairment and decreased alertness/unresponsiveness. The following cognitive adverse reaction rates were reported: confusion (33%), memory impairment (22%), speech disorder (14%), aphasia (12%), thinking abnormal (8%), and amnesia (1%). Cognitive impairment may appear gradually after several weeks of treatment. Reduce the dose of PRIALT or discontinue the use of PRIALT if signs or symptoms of cognitive impairment develop, but other contributing causes must also be considered. The cognitive effects of PRIALT are generally reversible within 2 weeks after drug discontinuation. The median time to reversal of the individual cognitive effects ranged from 3 to 15 days. The elderly (≥ 65 years of age) are at higher risk for confusion. [see Use in Specific Populations (8.5) ]

There may be additive effects on cognitive impairment and decreased alertness when PRIALT is used in conjunction with other CNS-depressant drugs that may necessitate dosage adjustments.

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