Invega Sustenna Special Precautions

Neuroleptic Malignant Syndrome: Neuroleptic Malignant Syndrome (NMS), characterized by hyperthermia, muscle rigidity, autonomic instability, altered consciousness, and elevated serum creatine phosphokinase levels has been reported to occur with antipsychotic drugs, including paliperidone. Additional clinical signs may include myoglobinuria (rhabdomyolysis) and acute renal failure. If a patient develops signs or symptoms indicative of NMS, all antipsychotic drugs, including Paliperidone palmitate (Invega Sustenna), should be discontinued.
Tardive dyskinesia/extrapyramidal symptoms: Drugs with dopamine receptor antagonistic properties have been associated with the induction of tardive dyskinesia characterized by rhythmical, involuntary movements, predominantly of the tongue and/or face. If signs and symptoms of tardive dyskinesia appear, the discontinuation of all antipsychotic drugs, including Paliperidone palmitate (Invega Sustenna), should be considered.
Extrapyramidal symptoms and psychostimulants: Caution is warranted in patients receiving both psychostimulants (e.g. methylphenidate) and paliperidone concomitantly, as extrapyramidal symptoms could emerge when adjusting one or both medications. Gradual withdrawal of one or both treatments should be considered (see Interactions).
QT interval: As with other antipsychotics, caution should be exercised when Paliperidone palmitate (Invega Sustenna) is prescribed in patients with a history of cardiac arrhythmias, in patients with congenital long QT syndrome, and in concomitant use with drugs known to prolong the QT interval (see Pharmacology: Pharmacodynamics: Effect on QT/QTc interval and cardiac electrophysiology under Actions).
Hypersensitivity reactions: Although tolerability with oral paliperidone or risperidone should be established prior to initiating treatment with Paliperidone palmitate (Invega Sustenna), very rare cases of anaphylactic reactions have been reported during postmarketing experience in patients who have previously tolerated oral risperidone or oral paliperidone (see Dosage & Administration and Adverse Reactions).
If hypersensitivity reactions occur, discontinue use of Paliperidone palmitate (Invega Sustenna); initiate general supportive measures as clinically appropriate and monitor the patient until signs and symptoms resolve. (See Contraindications and Adverse Reactions.)
Hyperglycemia and diabetes mellitus: Hyperglycemia, diabetes mellitus, and exacerbation of pre-existing diabetes have been reported during treatment with Paliperidone palmitate (Invega Sustenna). Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia or schizoaffective disorder and the increasing incidence of diabetes mellitus in the general population. Given these confounders, the relationship between atypical antipsychotic use and hyperglycemia-related adverse events is not completely understood. Any patient treated with atypical antipsychotics, including Paliperidone palmitate (Invega Sustenna) should be monitored for symptoms of hyperglycemia and diabetes mellitus. (See Adverse Reactions).
Weight gain: Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended.
Orthostatic hypotension: Paliperidone may induce orthostatic hypotension in some patients based on its alpha-blocking activity. Paliperidone palmitate (Invega Sustenna) should be used with caution in patients with known cardiovascular disease (e.g., heart failure, myocardial infarction or ischemia, conduction abnormalities), cerebrovascular disease, or conditions that predispose the patient to hypotension (e.g., dehydration, hypovolemia, and treatment with antihypertensive medications).
Seizures: As with other antipsychotic drugs, Paliperidone palmitate (Invega Sustenna) should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.
Leukopenia, neutropenia, and agranulocytosis: Events of leukopenia, neutropenia, and agranulocytosis have been reported with antipsychotic agents, including Paliperidone palmitate (Invega Sustenna). Agranulocytosis has been reported very rarely (<1/10000 patients) during postmarketing surveillance.
Patients with a history of a clinically significant low white blood cell count (WBC) or a drug-induced leukopenia/neutropenia should be monitored during the first few months of therapy and discontinuation of Paliperidone palmitate (Invega Sustenna) should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors.
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. Patients with severe neutropenia (absolute neutrophil count <1 X 10⁹/L) should discontinue Paliperidone palmitate (Invega Sustenna) and have their WBC followed until recovery.
Venous thromboembolism: Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with Paliperidone palmitate (Invega Sustenna) and preventive measures undertaken.
Parkinson's disease and dementia with Lewy bodies: Physicians should weigh the risks versus the benefits when prescribing antipsychotic drugs, including Paliperidone palmitate (Invega Sustenna), to patients with Parkinson's Disease or Dementia with Lewy Bodies (DLB) since both groups may be at increased risk of Neuroleptic Malignant Syndrome as well as having an increased sensitivity to antipsychotic medications. Manifestation of this increased sensitivity can include confusion, obtundation, postural instability with frequent falls, in addition to extrapyramidal symptoms.
Priapism: Drugs with alpha-adrenergic blocking effects have been reported to induce priapism. Priapism has been reported with paliperidone during postmarketing surveillance (see Adverse Reactions).
Body temperature regulation: Disruption of the body's ability to reduce core body temperature has been attributed to antipsychotic agents. Appropriate care is advised when prescribing Paliperidone palmitate (Invega Sustenna) to patients who will be experiencing conditions which may contribute to an elevation in core body temperature, e.g., exercising strenuously, exposure to extreme heat, receiving concomitant medication with anticholinergic activity, or being subject to dehydration.
Antiemetic effect: An antiemetic effect was observed in preclinical studies with paliperidone. This effect, if it occurs in humans, may mask the signs and symptoms of overdosage with certain drugs or of conditions such as intestinal obstruction, Reye's syndrome, and brain tumor.
Administration: Care must be taken to avoid inadvertent injection of Paliperidone palmitate (Invega Sustenna) into a blood vessel.
Intraoperative floppy iris syndrome: Intraoperative floppy iris syndrome (IFIS) has been observed during cataract surgery in patients treated with medicines with alpha1a-adrenergic antagonist effect, such as Paliperidone palmitate (Invega Sustenna) (see Adverse Reactions).
IFIS may increase the risk of eye complications during and after the operation. Current or past use of medicines with alpha1aadrenergic antagonist effect should be made known to the ophthalmic surgeon in advance of surgery. The potential benefit of stopping alpha1 blocking therapy prior to cataract surgery has not been established and must be weighed against the risk of stopping the antipsychotic therapy.
Effects on Ability to Drive and use Machines: Paliperidone palmitate (Invega Sustenna) may interfere with activities requiring mental alertness and may have visual effects (see Adverse Reactions). Therefore, patients should be advised not to drive or operate machinery until their individual susceptibility is known.
Use in the Elderly: Elderly patients with dementia: Paliperidone palmitate (Invega Sustenna) has not been studied in elderly patients with dementia.
Overall mortality: In a meta-analysis of 17 controlled clinical trials, elderly patients with dementia treated with other atypical antipsychotic drugs, including risperidone, aripiprazole, olanzapine, and quetiapine, had an increased risk of mortality compared to placebo. Among those treated with risperidone, the mortality was 4% compared with 3.1% for placebo.
Cerebrovascular adverse events: In placebo-controlled trials in elderly patients with dementia treated with some atypical antipsychotic drugs, including risperidone, aripiprazole, and olanzapine, there was a higher incidence of cerebrovascular adverse events (cerebrovascular accidents and transient ischemic attacks) including fatalities, compared to placebo.