Physicians are advised to discuss the following issues with patients for whom they prescribe INVEGA®.

Orthostatic Hypotension

Patients should be advised that there is risk of orthostatic hypotension, particularly at the time of initiating treatment, re-initiating treatment, or increasing the dose [see WARNINGS and PRECAUTIONS].

Interference with Cognitive and Motor Performance

As INVEGA® has the potential to impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that INVEGA® therapy does not affect them adversely [see WARNINGS and PRECAUTIONS].

Pregnancy

Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with INVEGA® [see Use in Specific Populations].

Nursing

Caution should be exercised when INVEGA® is administered to a nursing woman. The known benefits of breastfeeding should be weighed against the unknown risks of infant exposure to paliperidone. [See Use in Specific Populations] .

Concomitant Medication

Patients should be advised to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs, as there is a potential for interactions [see DRUG INTERACTIONS].

Alcohol

Patients should be advised to avoid alcohol while taking INVEGA® [see DRUG INTERACTIONS].

Heat Exposure and Dehydration

Patients should be advised regarding appropriate care in avoiding overheating and dehydration [see WARNINGS and PRECAUTIONS].

Administration

Patients should be informed that INVEGA® should be swallowed whole with the aid of liquids. Tablets should not be chewed, divided, or crushed. The medication is contained within a nonabsorbable shell designed to release the drug at a controlled rate. The tablet shell, along with insoluble core components, is eliminated from the body; patients should not be concerned if they occasionally notice something that looks like a tablet in their stool [see DOSAGE AND ADMINISTRATION].

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