Indicated for:

Schizophrenia in Adults:

Bipolar I Disorder:

• Acute monotherapy treatment of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age.

• Adjunctive treatment to lithium or valproate in adults.

• Maintenance monotherapy treatment in adults.

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

SAPHRIS should also be avoided in patients with a history of cardiac arrhythmias and in other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death in association with the use of drugs that prolong the QTc interval, including bradycardia; hypokalemia or hypomagnesemia; and presence of congenital prolongation of the QT interval.

In placebo-controlled trials in elderly subjects with dementia, patients randomized to risperidone, aripiprazole, and olanzapine had a higher incidence of stroke and transient ischemic attack, including fatal stroke.

SAPHRIS is contraindicated in patients with severe hepatic impairment (Child Pugh C).

A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with administration of antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, delirium, and autonomic instability.

SAPHRIS may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries. For patients with diseases, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy.

Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may develop in patients treated with antipsychotic drugs, including SAPHRIS. The risk appears to be highest among the elderly, especially elderly women, but it is not possible to predict which patients are likely to develop the syndrome. Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown. The risk of tardive dyskinesia and the likelihood that it will become irreversible increase with the duration of treatment and the cumulative dose. The syndrome can develop after a relatively brief treatment period, even at low doses. It may also occur after discontinuation of treatment. 

Atypical antipsychotic drugs, including SAPHRIS, have caused metabolic changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and body weight gain. 

Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics.

In clinical trial and postmarketing experience, leukopenia and neutropenia have been reported temporally related to antipsychotic agents, including SAPHRIS.

The use of SAPHRIS should be avoided in combination with other drugs known to prolong QTc including Class 1A antiarrhythmics (e.g., quinidine, procainamide) or Class 3 antiarrhythmics (e.g., amiodarone, sotalol), antipsychotic medications (e.g., ziprasidone, chlorpromazine, thioridazine), and antibiotics (e.g., gatifloxacin, moxifloxacin). 

As with other antipsychotic drugs, SAPHRIS should be used with caution in patients with a history of seizures or with conditions that potentially lower the seizure threshold.

Atypical antipsychotics may disrupt the body’s ability to reduce core body temperature.

Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients
receiving prolactin-elevating compounds. Long-standing hyperprolactinemia when associated with hypogonadism may lead to decreased bone density in both female and male subjects.

Dysphagia has been reported with SAPHRIS. SAPHRIS and other antipsychotic drugs should be used cautiously in patients at risk for aspiration.

SAPHRIS should be used cautiously when treating patients who receive treatment with other drugs that can induce hypotension, bradycardia, respiratory or central nervous system depression.

Reduce paroxetine by half when used in combination with SAPHRIS.

Full therapeutic dose of fluvoxamine is expected to cause a greater increase in asenapine exposure.

Studies have not been conducted with SAPHRIS in pregnant women. Animal studies: post-implantation loss, decreased weight gain and decreased survival.

Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms.

Lactation studies have not been conducted to assess the presence of asenapine in human milk, the effects of asenapine on the breastfed infant, or the effects of asenapine on milk production. Asenapine is excreted in rat milk.

GoToSource

• Use in patients under the age of 10 for treatment of acute monotherapy bipolar I disorder. GoToSource

• Use in patients under the age of 18 for treatment of schizophrenia. GoToSource

• Dosage greater than 20 mg per day. GoToSource

• Stuttering. GoToSource

• Obsessive-compulsive disorder, post-traumatic stress disorder, personality disorders, tourette syndrome and autism. GoToSource

• Attention-deficit hyperactivity disorder, anxiety, behavioral disturbances of dementia, eating disorders, insomnia and substance use and dependence disorders. GoToSource

Weight gain. GoToSource

Sedation, akathisia (movement disorder) and prolactin elevation. GoToSource

Neuroleptic malignant syndrome (life-threatening neurological disorder). GoToSource

Tardive dyskinesia (involuntary movements), electrocardiogram QT prolongation, syncope and orthostatic hypotension. GoToSource

Pityriasis rosea (rash that usually begins as a large circular or oval spot on chest, abdomen or back). GoToSource

Increased risk of death in elderly patients with dementia-related psychosis. GoToSource

Anaphylaxis (life-threatening allergic reaction), angioedema (swelling), tachycardia (rapid heart rate) and respiratory distress. GoToSource  

Hyperglycemia (high blood sugar) and dyslipidemia (elevated total or LDL cholesterol levels). GoToSource

Leukopenia, neutropenia, agranulocytosis (decreased white blood cells), dysphagia (difficulty swallowing) and seizures. GoToSource

Lawsuits filed for severe allergic reactions.