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See full Prescribing Information for complete Boxed Warning. • Elderly DAY Recommended dosing for INVEGA SUSTENNA® (paliperidone palmitate). Discontinuation of the previous antipsychotic should be made in accordance with the appropriate prescribing information. If INVEGA SUSTENNA is discontinued. This leaflet answers some of the common questions about Invega. Sustenna. It does Invega Sustenna belongs to a group Do not use it if the packaging is.

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INVEGA SUSTENNA® is an atypical antipsychotic indicated for. • Treatment of monthly maintenance dose, refer to the Full Prescribing Information. (). See full prescribing information for complete boxed warning. Conversion from the INVEGA SUSTENNA® 39 mg dose was not studied. • Missed Doses. HIGHLIGHTS OF PRESCRIBING INFORMATION. These highlights do not include all the information needed to use. INVEGA SUSTENNA® safely and effectively.

See full Prescribing Information for complete Boxed Warning Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Cerebrovascular Adverse Reactions: Cerebrovascular adverse reactions e. These medicines are not approved for the treatment of patients with dementia-related psychosis. Neuroleptic Malignant Syndrome NMS : NMS, a potentially fatal symptom complex, has been reported with the use of antipsychotic medications, including paliperidone. Clinical manifestations include muscle rigidity, fever, altered mental status, and evidence of autonomic instability see full Prescribing Information.

Conditions that lower seizure threshold may be more prevalent in patients 65 years or older. Care should be taken to avoid inadvertent injection into a blood vessel. If administering a strong inducer is necessary, consider managing the patient using paliperidone extended-release tablets.

Paliperidone (Invega)

These medications are not approved for the treatment of patients with dementia-related psychosis. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.

The incidence of CAEs was significantly higher than with placebo.

Pdf package insert invega sustenna

Elderly women appear to be at increased risk for TD, although it is impossible to predict which patients will develop the syndrome. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing.

Monitor glucose regularly in patients with diabetes or at risk for diabetes.


Hyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors, risperidone elevates prolactin levels and the elevation persists during chronic administration. Risperidone is associated with higher levels of prolactin elevation than other antipsychotic agents. Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotic drug use.

Aspiration pneumonia is a common cause of morbidity and mortality in patients with advanced Alzheimer's dementia. Use cautiously in patients at risk for aspiration pneumonia. Priapism has been reported.


Severe priapism may require surgical intervention. Body Temperature Regulation: Disruption of body temperature regulation has been attributed to antipsychotic agents. Administration: For intramuscular injection only.

Increased sensitivity in patients with Parkinson's disease or those with dementia with Lewy bodies has been reported. Manifestations and features are consistent with NMS.

Sustenna pdf insert invega package

Cerebrovascular Adverse Events CAEs : CAEs eg, stroke, transient ischemia attacks , including fatalities, were reported in placebo-controlled trials in elderly patients with dementiarelated psychosis taking oral risperidone, aripiprazole, and olanzapine. Elderly women appeared to be at increased risk for TD, although it is impossible to predict which patients will develop the syndrome. The metabolic changes include hyperglycemia, dyslipidemia, and body weight gain.

Some patients require continuation of anti-diabetic treatment despite discontinuation of the suspect drug.

Package pdf sustenna invega insert

Dyslipidemia — Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics. Weight Gain — Weight gain has been observed with atypical antipsychotic use.

Rare instances of obstructive symptoms have been reported in patients with known strictures taking non-deformable formulations. Monitoring should be considered in patients who are vulnerable to hypotension. Leukopenia, Neutropenia and Agranulocytosis have been reported with antipsychotics, including paliperidone. Patients with clinically significant neutropenia should be carefully monitored for fever or other symptoms or signs of infection and treated promptly if such symptoms or signs occur.

John's wort is co-administered.

All rights reserved. Invega Sustenna [package insert]. Titusville, NJ: Janssen; Paliperidone palmitate, a potential long-acting treatment for patients with schizophrenia.

Paliperidone (Invega) | NAMI: National Alliance on Mental Illness

Results of a randomized, double-blind, placebo-controlled efficacy and safety study. Int J Neuropsychopharmacol. Fleischhacker W. A randomized, double blind, parallel-group comparative study of flexibly dosed paliperidone palmitate 25, 50, 75, or mg eq.

Accessed November 23, This aqueous-based, extremely slowly dissolving depot medication is well tolerated and causes few drug-drug interactions. Clinical information Paliperidone palmitate is available in mg, mg, mg, mg, and mg formulations. Once administered, it hydrolyzes and diffuses slowly and provides paliperidone doses equivalent to 25 mg, 50 mg, 75 mg, mg, and mg, respectively.

Pdf package invega sustenna insert

The mg dose of paliperidone palmitate is equivalent to 12 mg oral paliperidone, mg to 6 mg, and 39 to 78 mg to 3 mg, respectively visit this article at CurrentPsychiatry.

This palmitate ester of paliperidone is an aqueous suspension utilizing nanocrystal molecules.