How do I establish tolerability before starting a long-acting injectable antipsychotic medication (LAI), and how do I ensure the patient will not have side effects?

Information on this topic is found in the FDA medication label. Medication labels can be found by searching Drugs@FDA at the FDA website. Labels are also available using the Drugs@FDA app for Apple or Android devices. Labels change over time, and the current label should always be consulted. The labels for long acting injectable (LAI) paliperidone and aripiprazole indicate that when patients have never taken the medication, one should establish tolerability to the oral medication before initiating treatment with the LAI. This indicates that tolerability to a medication can be established once for each patient. Currently, both LAI aripiprazole formulation (Aristada and Abilify Maintena) labels additionally states that, “due to the half-life of oral aripiprazole, it may take up to 2 weeks to fully assess tolerability.” The paliperidone label does not specify a duration. The decision regarding the length of oral medication needed to establish tolerability is a clinical decision, based on the label, medication half-life, and potential risks and benefits in a particular patient. In practice, this length of time has varied. Clinicians consider the likelihood of serious side effects and how long side effects take to develop. The half-life of paliperidone has been reported to be about 23 hours. The half-life of aripiprazole and dehydroaripiprazole have been reported to be about 75 and 94 hours, with steady state concentrations reached within 14 days.

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