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PRIALT is indicated for the management of severe chronic pain in patients for whom
intrathecal (IT) therapy is warranted, and who are intolerant of or refractory to
other treatment, such as systemic analgesics, adjunctive therapies or IT morphine.
PRIALT is for use only in the Medtronic SynchroMed® EL, Synchromed® II Infusion
System and the CADD-Micro ambulatory infusion pump.
Important Safety Information
Contraindications:
PRIALT is contraindicated in patients with a known hypersensitivity to ziconotide
or any of its formulation components and in patients with any other concomitant
treatment or medical condition that would render IT administration hazardous.
Patients with a pre-existing history of psychosis should not be treated with ziconotide.
Contraindications to the use of IT analgesia include conditions such as the presence
of infection at the microinfusion injection site, uncontrolled bleeding diathesis,
and spinal canal obstruction that impairs circulation of CSF.
WARNINGS: Severe psychiatric symptoms and neurological impairment may occur
during treatment with PRIALT. Patients with a pre-existing history of psychosis
should not be treated with PRIALT. All patients should be monitored 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.
Precautions:
Meningitis and Other Infections: Meningitis can occur due
to inadvertent contamination of the microinfusion device and other means. Patients,
caregivers, and healthcare providers must be particularly vigilant for the signs
and symptoms of meningitis.
Cognitive and Neuropsychiatric Adverse Events: Use of PRIALT has
been associated with CNS-related adverse events, including psychiatric symptoms,
cognitive impairment, and decreased alertness/unresponsiveness. The PRIALT dose
should be reduced or discontinued if signs or symptoms of cognitive impairment develop,
but other contributing causes should also be considered.
Reduced Level of Consciousness: Patients have become unresponsive
or stuporous while receiving PRIALT. PRIALT should be discontinued until the event
resolves, and other etiologies should be considered.
Elevation of Serum Creatine Kinase (CK-MM): In clinical studies
(mostly open label), 40% of patients had serum creatine kinase (CK) levels above
the upper limit of normal (ULN), and 11% had CK levels that were > 3 times the
ULN. Most patients who experienced elevations in CK, even for prolonged periods
of time, did not have limiting side effects. It is recommended that physicians monitor
serum CK in patients undergoing treatment with PRIALT periodically.
Adverse Reactions:
The most frequently reported adverse events (> 25%) in the 1,254 patients (662
patient years) in clinical trials were dizziness, nausea, confusional state,
and nystagmus. Serious adverse events and discontinuation of PRIALT for adverse
events are less frequent when the drug is slowly titrated over 21 days than with
a faster titration schedule.
Please see accompanying
full prescribing information including boxed WARNING and important safety information.
References: 1. PRIALT® (ziconotide intrathecal
infusion) Prescribing Information. --company details--2.
Rauck RL, Wallace MS, Leong MS, et al. A randomized, double-blind, placebo-controlled
study of intrathecal ziconotide in adults with severe chronic pain. J Pain Sym Man.
2006;31(5):393-406. 3. Staats PS, Yearwood T, Charapata SG, et
al. Intrathecal ziconotide in the treatment of refractory pain in patients with
cancer or AIDS. JAMA. 2004;291(1):63-70. 4. Wallace MS,
Charapata SG, Fisher R, et al. Intrathecal ziconotide in the treatment of chronic
nonmalignant pain: a randomized, double-blind, placebo-controlled clinical trial.
Neuromodulation. 2006;9(2):75-86.
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