Renal Dose Adjustment (Based on CrCl)
- 50-79 mL/min: Initially 234 mg IM x1, then 156 mg IM x1 in 1wk ; continue with monthly maintenance dose of 78 mg
- <50 mL/min: Contraindicated
Hepatic Dose Adjustment
- Mild-Moderate impairment (Child-Pugh Class A and B): No dose adjustments
- Severe impairment (Child-Pugh Class C): Dose adjustments not defined, caution advised
- Use not recommended for dementia-related psychosis [US Black Box Warning]
- Mortality risk is increased in elderly dementia patients on conventional or atypical antipsychotics; most deaths have been occurred due to cardiovascular or infectious events [US Black Box Warning]
- The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristics of the patients is not clear [US Black Box Warning]
- Therapy may cause an increased incidence of cerebrovascular adverse reactions including stroke, transient ischemic attack, including fatalities in elderly patients with dementia- related psychoses treated with atypical antipsychotics
- A potentially fatal symptom complex called Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs
- As therapy is associated with prolonged QT interval, avoid use with drugs that also increase QT interval and in patients with risk factors for prolonged QT interval. Hyperkalemia or hypermagnesemia increase risk of torsade de pointes and sudden death
- Irreversible, involuntary, dyskinetic movements (Tardive Dyskinesia) may occur with the therapy. Discontinue therapy if such condition occurs
- Therapy is associated with metabolic changes that may increase cardiovascular/ cerebrovascular risk including hyperglycemia, dyslipidemia, and weight gain. Monitor for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, weakness and increased glucose in patients with diabetes or at risk for diabetes
- Undesirable alterations in lipids may occur in patients treated with paliperidone
- Clinical monitoring of weight is recommended as weight gain has been observed with the use of therapy
- Prolactin elevations occur and persist during prolonged use of therapy
- Do not administer therapy in patients with preexisting severe gastrointestinal narrowing as obstructive symptoms have been reported in such patients with the use of therapy
- Because of alpha-blocking activity paliperidone can induce orthostatic hypotension and syncope. Use cautiously in patients with known cardiovascular or cerebrovascular disease and patients predisposed to hypotension
- Frequently perform CBC counts in patients with a history of a clinically significant low WBC count or a drug-induced leukopenia/neutropenia during the first few months of therapy as leukopenia, neutropenia, and agranulocytosis have been reported with the use of therapy
- Suspend therapy at the first sign of a clinically significant decline in WBC in the absence of other causative factors
- As therapy has potential for cognitive and motor impairment, caution advised while operating machinery
- Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold
- Closely supervise high-risk patients for suicidal tendencies
- Disruption of body temperature regulation has been reported
Cautions: Use cautiously in:
- Renal impairment
- Hepatic impairment
- Dementia
- Dementia with Lewy bodies
- Parkinson disease
- Cerebrovascular disease
- History of neuroleptic malignant syndrome
- History of MI or IHD
- Orthostatic hypotension
- History of seizure disorder
- Diabetes mellitus
- Presence of risk factors for diabetes mellitus
- Geriatric Patients
Pregnancy Category:C
Breastfeeding: According to manufacturer data women receiving therapy should not breast feed infants.
Pricing data from www.DrugStore.com in U.S.A.
- Invega Sustenna 78 MG/0.5ML SUSP [Syringe] (JANSSEN)
0.5 0.5ml = $617.02
1.5 0.5ml = $1781.04
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
