Starting on PRIALT
Defining the Therapeutic Window: Start Low and Go Slow6
Results from the studies showed that tolerability improved when the PRIALT dose was started low and slowly titrated upward. The fast titration schedule resulted in less tolerability and substantially more frequent adverse events. Slower titration may result in fewer serious adverse events and discontinuations for adverse reactions.6
Dosing with PRIALT was started at 2.4 mcg/day (0.1 mcg/hr) and the dose was increased by 2.4 mcg/day (0.1 mcg/hr) 2 to 3 times/week (minimum titration interval 24 hours) to a maximum dose of 19.2 mcg/day (0.8 mcg/hr) as needed for management of pain. The final mean dose at the end of the trial at 21 days was 6.9 mcg/day (0.29 mcg/hr). The primary efficacy measure was mean percent reduction in VASPI score from baseline to day 21.6
Important Safety Information
- Advise patients that psychiatric symptoms (paranoia, hostility, mania, depressive, suicidal) and cognitive symptoms (confusion, memory problems, speech disorder) may occur during treatment with PRIALT.
- Caution patients against engaging in hazardous activity requiring complete mental alertness or motor coordination such as operating machinery or driving a motor vehicle during treatment with PRIALT.
- Caution patients about possible combined effects with other CNS-depressant drugs. Dosage adjustments may be necessary when PRIALT is administered with such agents because of the potentially additive effects.
- Advise patients to contact a physician if the patient experiences new or worsening muscle pain, soreness, weakness with or without darkened urine.