constantly [1%),:<1% (Limited to important or life-threatening): Accommodation disturbance, anaphylaxis, anemia, angioedema, application site reaction (including blisters, inflammation, peeling, oral ulcers, sloughing), blurred vision, bundle branch block (temporary), choking sensation, diabetes mellitus, diplopia, dysarthria, dyslipidemia, dysphagia, falling, gastroesophageal reflux disease, hyperglycemia, hypersensitivity reaction, hyponatremia, hypotension, leukopenia, neuroleptic malignant syndrome, neutropenia, seizure, skin photosensitivity, tardive dyskinesia, thrombocytopenia, tongue edema, urinary incontinence, wheezing ALERT: U.S. Boxed Warning Increased mortality in elderly patients with dementia-related psychosis: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Asenapine is not approved for the treatment of patients with dementia-related psychosis. Warnings/Precautions Concerns related to adverse reactions: Blood dyscrasias: Leukopenia, neutropenia, and agranulocytosis (sometimes fatal) have been reported with antipsychotic use; presence of risk factors (eg, preexisting low WBC or history of drug-induced leuko/neutropenia) should have a complete blood count performed frequently during the first few months of therapy. Discontinue therapy at first signs of blood dyscrasias or if absolute neutrophil count> <1,000/mm 3 . CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery or driving). Dyslipidemia: Has been reported with atypical antipsychotics; risk profile may differ between agents. In clinical trials, the incidence of hypertriglyceridemia observed with asenapine was greater than that observed with placebo, while total cholesterol elevations were similar. Esophageal dysmotility/aspiration: Antipsychotic use has been associated with esophageal dysmotility, dysphagia, and aspiration; use with caution in patients at risk of aspiration pneumonia (eg, Alzheimer disease) (Maddalena 2004). Extrapyramidal symptoms: May cause extrapyramidal symptoms (EPS), including pseudoparkinsonism, acute dystonic reactions, akathisia, and tardive dyskinesia (risk of these reactions is generally much lower relative to typical/conventional antipsychotics; frequencies reported are similar to placebo). Risk of dystonia (and probably other EPS) may be greater with increased doses, use of conventional antipsychotics, males, and younger patients. Factors associated with greater vulnerability to tardive dyskinesia include older in age, female gender combined with postmenopausal status, Parkinson disease, pseudoparkinsonism symptoms, affective disorders (particularly major depressive disorder), concurrent medical diseases such as diabetes, previous brain damage, alcoholism, poor treatment response, and use of high doses of antipsychotics (APA [Lehman 2004]; Soares-Weiser 2007). Consider therapy discontinuation with signs/symptoms of tardive dyskinesia. Falls: May increase the risk for falls due to somnolence, orthostatic hypotension and motor or sensory instability. Complete fall risk assessments at baseline and periodically during treatment in patients with diseases, conditions, or on medications that may increase fall risk. Hyperglycemia: Atypical antipsychotics have been associated with development of hyperglycemia; in some cases, may be extreme and associated with ketoacidosis, hyperosmolar coma, or death. All patients should be monitored for symptoms of hyperglycemia (eg, polydipsia, polyuria, polyphagia, weakness). Use with caution in patients with diabetes or other disorders of glucose regulation; monitor for worsening of glucose control. Patients with risk factors for diabetes (eg, obesity or family history) should have a baseline fasting blood sugar (FBS) and periodic assessment of glucose regulation. Hypersensitivity: Anaphylaxis and hypersensitivity reactions (eg, angioedema, hypotension, tachycardia, swollen tongue, dyspnea, wheezing, and rash) have been reported; some cases have occurred after a single dose. Hyperprolactinemia: May increase prolactin levels; clinical significance of hyperprolactinemia in patients with breast cancer or other prolactin-dependent tumors is unknown. Neuroleptic malignant syndrome (NMS): Use may be associated with NMS; monitor for mental status changes, fever, muscle rigidity, and/or autonomic instability. NMS can recur. Following recovery from NMS, reintroduction of drug therapy should be carefully considered; if an antipsychotic agent is resumed, monitor closely for NMS. Orthostatic hypotension: May cause orthostatic hypotension and syncope; use with caution in patients at risk of this effect (eg, concurrent medication use which may predispose to hypotension/bradycardia or presence of dehydration or hypovolemia) or in those who would not tolerate transient hypotensive episodes. Use caution with history of cerebrovascular or cardiovascular disease (MI, heart failure, conduction abnormalities, or ischemic disease). QT prolongation: May result in QTc prolongation. Risk may be increased by conditions or concomitant medications which cause bradycardia, hypokalemia, and/or hypomagnesemia. Avoid use in combination with QTc-prolonging drugs and in patients with congenital long QT syndrome or patients with history of cardiac arrhythmia. Suicidal ideation: The possibility of a suicide attempt is inherent in psychotic illness or bipolar disorder; use with caution in high-risk patients during initiation of therapy. Prescriptions should be written for the smallest quantity consistent with good patient care. Temperature regulation: Antipsychotic use has been associated with impaired core body temperature regulation; caution with strenuous exercise, heat exposure, dehydration, and concomitant medication possessing anticholinergic effects (Kerwin 2004; Kowk 2005; Martinez 2002). Weight gain: Significant weight gain has been observed with antipsychotic therapy; incidence varies with product. Monitor waist circumference and BMI. Disease-related concerns: Cardiovascular disease: Use with caution in patients with cardiac disease, cerebrovascular disease, hemodynamic instability, prior myocardial infarction, or ischemic heart disease. Dementia: [US Boxed Warning]: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Most deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Use with caution in patients with Lewy body dementia or Parkinson disease dementia due to greater risk of adverse effects, increased sensitivity to extrapyramidal effects, and association with irreversible cognitive decompensation or death. (APA [Reus 2016]). Asenapine is not approved for the treatment of dementia-related psychosis. Hepatic impairment: Use is contraindicated in patients with severe hepatic impairment (Child-Pugh class C); increased drug concentrations may occur. Parkinson disease: Use with caution in patients with Parkinson disease; patients may have increased risk of extrapyramidal side effects, including tardive dyskinesia (APA [Lehman 2004]; APA [Reus 2016]; Soares-Weiser 2007). Seizures: Use with caution in patients at risk of seizures or conditions that potentially lower the seizure threshold (eg, Alzheimer dementia). Elderly patients may be at increased risk of seizures due to an increased prevalence of predisposing factors. Concurrent drug therapy issues: Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Special populations: Elderly: Pharmacokinetic studies showed a decrease in clearance in older adults (65 to 85 years of age) with psychosis compared to younger adults; increased risk of adverse effects and orthostasis may occur. Pediatric: Pediatric patients may be more sensitive to dystonia with initial dosing and when the recommended dosing escalation schedule is not followed. Other warnings/precautions: Discontinuation of therapy: When discontinuing antipsychotic therapy, the American Psychiatric Association (APA), Canadian Psychiatric Association (CPA), and World Federation of Societies of Biological Psychiatry (WFSBP) guidelines recommend gradually tapering antipsychotics to avoid physical withdrawal symptoms, including anorexia, anxiety, diaphoresis, diarrhea, dizziness, dyskinesia, headache, myalgia, nausea, paresthesia, restlessness, tremulousness, and vomiting (APA [Lehman 2004]; CPA [Addington 2005]; Lambert 2007; WFSBP [Hasan 2012]). The risk of withdrawal symptoms is highest following abrupt discontinuation of highly anti-cholinergic or dopaminergic antipsychotics (Cerovecki 2013). Additional factors such as duration of antipsychotic exposure, the indication for use, medication half-life, and risk for relapse should be considered. In schizophrenia, there is no reliable indicator to differentiate the minority who will not from the majority who will relapse with drug discontinuation. However, studies in which the medication of well-stabilized patients were discontinued indicate that 75% of patients relapse within 6 to 24 months. Indefinite maintenance antipsychotic medication is generally recommended, and especially for patients who have had multiple prior episodes or 2 episodes within 5 years (APA [Lehman 2004]). Monitoring Parameters Mental status; vital signs (as clinically indicated); blood pressure and pulse (baseline; repeat 3 months after antipsychotic initiation, then yearly); weight, height, BMI, waist circumference (baseline; repeat at 4, 8, and 12 weeks after initiating or changing therapy, then quarterly; consider switching to a different antipsychotic for a weight gain more than 5% of initial weight [ADA 2004]); CBC (as clinically indicated; monitor frequently during the first few months of therapy in patients with preexisting low WBC or history of drug-induced leukopenia/neutropenia); electrolytes and liver function (annually and as clinically indicated); personal and family history of obesity, diabetes, dyslipidemia, hypertension, or cardiovascular disease (baseline; repeat annually); fasting plasma glucose level/HbA 1c (baseline; repeat 3 months after starting antipsychotic, then yearly); fasting lipid panel (baseline; repeat 3 months after initiation of antipsychotic; if low-density lipoprotein level is normal, repeat at 2- to 5-year intervals or more frequently if clinical indicated [ADA 2004]); prolactin level (baseline [NICE 2014]); changes in menstruation, libido, development of galactorrhea, and erectile and ejaculatory function (yearly); abnormal involuntary movements or parkinsonian signs (baseline; repeat weekly until dose stabilized for at least 2 weeks after introduction and for 2 weeks after any significant dose increase); tardive dyskinesia (every 12 months; high-risk patients every 6 months); ocular examination (yearly in patients older than 40 years; every 2 years in younger patients) (ADA 2004; Lehman 2004; Marder 2004; NICE 2014). Pregnancy Considerations Antipsychotic use during the third trimester of pregnancy has a risk for abnormal muscle movements (extrapyramidal symptoms [EPS]) and/or withdrawal symptoms in newborns following delivery. Symptoms in the newborn may include agitation, feeding disorder, hypertonia, hypotonia, respiratory distress, somnolence, and tremor; these effects may be self-limiting or require hospitalization; monitoring of the neonate is recommended. Asenapine may cause hyperprolactinemia, which may decrease reproductive function in both males and females. The ACOG recommends that therapy during pregnancy be individualized; treatment with psychiatric medications during pregnancy should incorporate the clinical expertise of the mental health clinician, obstetrician, primary healthcare provider, and pediatrician. Safety data related to atypical antipsychotics during pregnancy is limited and routine use is not recommended. However, if a woman is inadvertently exposed to an atypical antipsychotic while pregnant, continuing therapy may be preferable to switching to a typical antipsychotic that the fetus has not yet been exposed to; consider risk:benefit (ACOG 2008). Healthcare providers are encouraged to enroll women 18-45 years of age exposed to asenapine during pregnancy in the Atypical Antipsychotics Pregnancy Registry (866-961-2388 or http://www.womensmentalhealth.org/pregnancyregistry). Patient Education Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?) Patient may experience fatigue, headache, agitation, vomiting, numbness or tingling of mouth, weight gain, insomnia, or constipation. Have patient report immediately to prescriber signs of infection, signs of high blood sugar (confusion, fatigue, increased thirst, increased hunger, polyuria, flushing, fast breathing, or breath that smells like fruit), signs of depression (suicidal ideation, anxiety, emotional instability, or confusion), abnormal heartbeat, bradycardia, tachycardia, shortness of breath, severe dizziness, passing out, abnormal movements, twitching, change in balance, difficulty swallowing, difficulty speaking, menstrual changes, enlarged breasts, nipple discharge, sexual dysfunction, mouth pain or sores, seizures, signs of neuroleptic malignant syndrome (fever, muscle cramps or stiffness, dizziness, severe headache, confusion, change in thinking, tachycardia, abnormal heartbeat, or sweating a lot), or signs of tardive dyskinesia (unable to control body movements; tongue, face, mouth, or jaw sticking out; mouth puckering; or puffing cheeks) (HCAHPS). Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions. Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients. Next Interactions Print this page Add to My Med List More about asenapine Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Support Group En Español 269 Reviews Add your own review/rating Drug class: atypical antipsychotics Consumer resources Asenapine Asenapine Sublingual (Advanced Reading) Professional resources Asenapine Maleate (AHFS Monograph) Other brands: Saphris Related treatment guides Bipolar Disorder Borderline Personality Disorder Post Traumatic Stress Disorder Schizoaffective Disorder Schizophrenia> ]} Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Asenapine Rating 269 User Reviews 7.4 /10 269 User Reviews 7.4 Rate it! 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