Invega- Antipsychotic in extended-release form

Product:

Invega

Company:

Janssen

Pharmacologic class:

Antipsychotic (benzisoxazole)

Active ingredient:

Paliperidone 3 mg, 6 mg, 9 mg; extended-release tabs.

Indication:

Schizophrenia.

Pharmacology:

Paliperidone is the major active metabolite of risperidone. Although the mechanism of action of this atypical antipsychotic is unknown, the therapeutic effect may be due to a combination of central dopamine type 2 (D2) and serotonin type 2 (5HT2a) receptor antagonism. Paliperidone also antagonizes at a1 and a2 adrenergic receptors and H1 histaminergic receptors.

Invega tablets use osmotic pressure to deliver paliperidone at a controlled rate. Peak plasma concentrations occur approximately 24 hours after dosing; steady state concentrations are attained within four to five days.

Since paliperidone is the major active metabolite of risperidone, consideration should be given to the additive paliperidone exposure if risperidone is coadministered with paliperidone.

Clinical trials:

The short-term efficacy of paliperidone was determined in three placebo-controlled and active-controlled (olanzapine), six-week, fixed-dose trials involving 1,665 patients who met DSM-IV criteria for schizophrenia. The doses studied among these three trials included 3, 6, 9, 12, and 15 mg/day. Efficacy was evaluated using the Positive and Negative Syndrome scale (PANSS) and the Personal and Social Performance scale (PSP). In all three studies, paliperidone was superior to placebo on the PANSS at all doses.

Paliperidone was also superior to placebo on the PSP in these trials.

The efficacy of paliperidone has not been evaluated in placebo-controlled trials for longer than six weeks. Therefore, patients who are taking paliperidone for extended periods should be reevaluated periodically.

Adults:

Swallow whole. ≥18 yrs: 6 mg once daily in am; may increase in increments of 3 mg/day at intervals of greater than five days if needed. Max 12 mg/day.

Renal impairment: CrCl ≥50-80 mL/min: max 6 mg/day; CrCl 10-<50 mL/min: max 3 mg/day.

Children:

<18 yrs: not recommended.

Precautions:

Avoid in congenital long QT syndrome, cardiac arrhythmias. Diabetes risk factors (obtain baseline fasting blood sugar). Monitor for hyperglycemia. Pre- existing severe GI narrowing: not recommended. Cardiovascular or cerebrovascular disease. Orthostatic hypotension. History of seizures. Patients at risk for aspiration pneumonia. Renal insufficiency. Severe hepatic impairment.

Exposure to extreme temperatures. May have antiemetic effect. Suicidal patients. Re-evaluate periodically. Elderly (not for dementia-related psychosis); consider monitoring renal function and for orthostatic effects. Pregnancy (Cat. C).

Nursing mothers: not recommended.

Interactions:

Avoid alcohol, drugs that prolong QT interval (e.g., Class IA and Class III antiarrhythmics). Caution with other central nervous system drugs. May antagonize levodopa, other dopamine agonists.

Adverse reactions:

Tachycardia, extrapyramidal effects, akathisia, dizziness, anxiety, somnolence, headache, GI upset; may cause neuroleptic malignant syndrome, tardive dyskinesia, QT prolongation, hyperglycemia, orthostatic hypotension, syncope, hyperprolactinemia, priapism.

How supplied:

Tabs—30, 350.

For more information, call 800.JANSSEN or visit www.Invega.com

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