"The US Food and Drug Administration (FDA) has approved a quarterly injection form of paliperidone (Invega Trinza, Janssen Pharmaceuticals) for schizophrenia, the company announced today.
Janssen Pharmaceuticals already markets a "...
No cases of overdose were reported in premarketing studies with INVEGA SUSTENNA® . Because INVEGA SUSTENNA® is to be administered by health care professionals, the potential for overdosage by patients is low.
While experience with paliperidone overdose is limited, among the few cases of overdose reported in premarketing trials with oral paliperidone, the highest estimated ingestion was 405 mg. Observed signs and symptoms included extrapyramidal symptoms and gait unsteadiness. Other potential signs and symptoms include those resulting from an exaggeration of paliperidone's known pharmacological effects, i.e., drowsiness and sedation, tachycardia and hypotension, and QT prolongation. Torsades de pointes and ventricular fibrillation have been reported in a patient in the setting of overdose with oral paliperidone.
Paliperidone is the major active metabolite of risperidone. Overdose experience reported with risperidone can be found in the OVERDOSAGE section of the risperidone package insert.
Management Of Overdosage
Contact a Certified Poison Control Center for the most up to date information on the management of INVEGA SUSTENNA® overdosage (1-800-222-1222 or www.poison.org). Provide supportive care, including close medical supervision and monitoring. Treatment should consist of general measures employed in the management of overdosage with any drug. Consider the possibility of multiple drug overdosage. Ensure an adequate airway, oxygenation, and ventilation. Monitor cardiac rhythm and vital signs. Use supportive and symptomatic measures. There is no specific antidote to paliperidone.
Consider the prolonged-release characteristics of INVEGA SUSTENNA® and the long apparent half-life of paliperidone when assessing treatment needs and recovery.
INVEGA SUSTENNA® is contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the INVEGA SUSTENNA® formulation. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with paliperidone. Paliperidone palmitate is converted to paliperidone, which is a metabolite of risperidone.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/13/2016
Additional Invega Sustenna Information
- Invega Sustenna Drug Interactions Center: paliperidone palmitate im
- Invega Sustenna Side Effects Center
- Invega Sustenna Overview including Precautions
- Invega Sustenna FDA Approved Prescribing Information including Dosage
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