PRIALT experience
Types of severe chronic pain in clinical trials*1-5
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.
WARNING: 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.
Please see accompanying full
prescribing information including boxed WARNING and important safety information.
References:
- 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.
- 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.
- Wallace MS, Charapata SG, Fisher R, et al. Intrathecal ziconotide in the treatment
of chronic nonmalignant pain: a randomized, doubleblind, placebo-controlled clinical
trial. Neuromodulation. 2006;9(2):75-86.
- PRIALT® (ziconotide intrathecal infusion) Prescribing Information.--company details--
- Data on file.--company details--
|
|
