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In the fixed-dose, 3-week, pediatric bipolar mania monotherapy trial:
*All data are at 3 weeks in the short-term, pediatric bipolar mania trial (SAPHRIS 2.5, 5, or 10 mg BID). These patients had assessments at both baseline and endpoint.
Weight Gain: Increases in weight have been observed with SAPHRIS. Monitor weight regularly in patients on SAPHRIS.1
In the fixed-dose, 3-week, pediatric bipolar mania monotherapy trial:
*All data are at 3 weeks in the short-term, pediatric bipolar mania trial (SAPHRIS 2.5, 5, or 10 mg BID). These patients had assessments at both baseline and endpoint.
Hyperglycemia and Diabetes Mellitus: Hyperglycemia, in some cases associated with ketoacidosis, hyperosmolar coma, or death, has been reported in patients treated with atypical antipsychotics. Patients with risk factors for diabetes mellitus starting treatment with antipsychotics should undergo fasting blood glucose testing at the beginning of and during treatment. Monitor any patient treated with antipsychotics for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop these symptoms during treatment should undergo fasting blood glucose testing. In some cases, hyperglycemia resolved when the antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the antipsychotic drug.1
In the fixed-dose, 3-week, pediatric bipolar mania monotherapy trial:
*All data are at 3 weeks in the short-term, pediatric bipolar mania trial (SAPHRIS 2.5, 5, or 10 mg BID). These patients had assessments at both baseline and endpoint.
Hyperglycemia and Diabetes Mellitus: Hyperglycemia, in some cases associated with ketoacidosis, hyperosmolar coma, or death, has been reported in patients treated with atypical antipsychotics. Patients with risk factors for diabetes mellitus starting treatment with antipsychotics should undergo fasting blood glucose testing at the beginning of and during treatment. Monitor any patient treated with antipsychotics for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop these symptoms during treatment should undergo fasting blood glucose testing. In some cases, hyperglycemia resolved when the antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the antipsychotic drug.1
In the fixed-dose, 3-week, pediatric bipolar mania monotherapy trial:
Dyslipidemia: Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics.1
Percent of patients with LDL and*All data are at 3 weeks in the short-term, pediatric bipolar mania trial (SAPHRIS 2.5, 5, or 10 mg BID). These patients had assessments at both baseline and endpoint.
In the fixed-dose, 3-week, pediatric bipolar mania monotherapy trial:
*All data are at 3 weeks in the short-term, pediatric bipolar mania trial (SAPHRIS 2.5, 5, or 10 mg BID). These patients had assessments at both baseline and endpoint.
Dyslipidemia: Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics.1
SAPHRIS 2.5 mg BID (n=104) % |
SAPHRIS 5 mg BID (n=99) % |
SAPHRIS 10 mg BID (n=99) % |
Placebo (n=101) % |
|
---|---|---|---|---|
Somnolence† | 46 | 53 | 49 | 12 |
Dizziness | 6 | 10 | 5 | 3 |
Dysgeusia | 4 | 5 | 9 | 2 |
Oral paresthesia‡ | 25 | 25 | 30 | 4 |
Nausea | 6 | 6 | 6 | 3 |
Increased appetite | 10 | 9 | 6 | 2 |
Fatigue§ | 4 | 8 | 14 | 5 |
Increased weight | 6 | 2 | 2 | 0 |
SAPHRIS 2.5 mg BID (n=104) % |
SAPHRIS 5 mg BID (n=99) % |
SAPHRIS 10 mg BID (n=99) % |
Placebo (n=101) % |
|
---|---|---|---|---|
Somnolence† | 46 | 53 | 49 | 12 |
Dizziness | 6 | 10 | 5 | 3 |
Dysgeusia | 4 | 5 | 9 | 2 |
Oral paresthesia‡ | 25 | 25 | 30 | 4 |
Nausea | 6 | 6 | 6 | 3 |
Increased appetite | 10 | 9 | 6 | 2 |
Fatigue§ | 4 | 8 | 14 | 5 |
Increased weight | 6 | 2 | 2 | 0 |
*All data are based on the 3-week, short-term, pediatric bipolar mania trial (SAPHRIS 2.5, 5, or 10 mg BID).
†Includes the preferred terms somnolence, sedation, and hypersomnia.
‡Includes the preferred terms oral hypoesthesia, oral paresthesia, and oral dysesthesia.
§Includes the preferred terms fatigue and lethargy.
The only apparent dose-related adverse reaction was fatigue1
SAPHRIS 2.5 mg BID (n=104) % |
SAPHRIS 5 mg BID (n=99) % |
SAPHRIS 10 mg BID (n=99) % |
Placebo (n=101) % |
|
Incidence of somnolence | 46 | 53 | 49 | 12 |
Discontinuation rates due to somnolence | 3 | 1 | 2 | 0 |
SAPHRIS 2.5 mg BID (n=104) % |
SAPHRIS 5 mg BID (n=99) % |
SAPHRIS 10 mg BID (n=99) % |
Placebo (n=101) % |
|
Incidence of somnolence | 46 | 53 | 49 | 12 |
Discontinuation rates due to somnolence | 3 | 1 | 2 | 0 |
*Includes somnolence, sedation, and hypersomnia.
1%-3% of SAPHRIS patients
discontinued due to somnolence*1
SAPHRIS 2.5 mg BID (n=104) % |
SAPHRIS 5 mg BID (n=99) % |
SAPHRIS 10 mg BID (n=99) % |
Placebo (n=101) % |
|
EPS, excluding akathisia | 4 | 3 | 5 | 3 |
---|---|---|---|---|
Akathisia | 2 | 2 | 1 | 0 |
SAPHRIS 2.5 mg BID (n=104) % |
SAPHRIS 5 mg BID (n=99) % |
SAPHRIS 10 mg BID (n=99) % |
Placebo (n=101) % |
|
EPS, excluding akathisia | 4 | 3 | 5 | 3 |
---|---|---|---|---|
Akathisia | 2 | 2 | 1 | 0 |
*EPS-related events include: bradykinesia, dyskinesia, dystonia, oromandibular dystonia, muscle contractions involuntary, muscle twitching, musculoskeletal stiffness, parkinsonism, protrusion tongue, resting tremor, and tremor.
Tardive Dyskinesia (TD): Risk of developing TD (a syndrome of potentially irreversible, involuntary dyskinetic movements) and the likelihood it will become irreversible may increase as the duration of treatment and total cumulative dose of antipsychotic drugs given to the patient increase. The syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. Prescribe SAPHRIS in a manner most likely to minimize TD. If signs and symptoms of TD appear, drug discontinuation should be considered.1
Tardive Dyskinesia (TD): Risk of developing TD (a syndrome of potentially irreversible, involuntary dyskinetic movements) and the likelihood it will become irreversible may increase as the duration of treatment and total cumulative dose of antipsychotic drugs given to the patient increase. The syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. Prescribe SAPHRIS in a manner most likely to minimize TD. If signs and symptoms of TD appear, drug discontinuation should be considered.1
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. SAPHRIS is not approved for treatment of patients with dementia-related psychosis.
Contraindications: SAPHRIS is contraindicated in patients with severe hepatic impairment (Child-Pugh C) or known hypersensitivity to SAPHRIS or its formulation components. Reactions have included anaphylaxis, angioedema, hypotension, tachycardia, swollen tongue, dyspnea, wheezing and rash.
Cerebrovascular Adverse Events, Including Stroke: In clinical trials with antipsychotic drugs, elderly subjects with dementia had a higher incidence of stroke (including fatal stroke) and transient ischemic attack vs placebo. SAPHRIS is 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 antipsychotics. NMS may cause hyperpyrexia, muscle rigidity, delirium, and autonomic instability. If NMS is suspected, immediately discontinue SAPHRIS and provide intensive symptomatic treatment and monitoring.
Tardive Dyskinesia (TD): Risk of developing TD (a syndrome of potentially irreversible, involuntary dyskinetic movements) and the likelihood it will become irreversible increase as the duration of treatment and total cumulative dose of antipsychotic drugs, including SAPHRIS, given to the patient increase. The syndrome can develop, after relatively brief treatment periods, even at low doses, and may also occur after discontinuation of treatment. Prescribe SAPHRIS in a manner most likely to minimize TD. If signs and symptoms of TD appear, drug discontinuation should be considered.
Metabolic Changes: Atypical antipsychotics, including SAHPRIS, have caused metabolic changes, including the following:
Hypersensitivity Reactions: Hypersensitivity reactions, including anaphylaxis, angioedema, hypotension, tachycardia, swollen tongue, dyspnea, wheezing, and rash, have been observed in patients treated with SAPHRIS. In several cases, these reactions occurred after the first dose.
Orthostatic Hypotension, Syncope, and Other Hemodynamic Effects: SAPHRIS has caused orthostatic hypotension and syncope. Generally the risk is greatest during initial titration and when increasing the dose. Monitor orthostatic vital signs and monitor patients who are vulnerable to hypotension (elderly patients, patients with dehydration, hypovolemia, concomitant treatment with antihypertensive medications, patients with cardiovascular and/or cerebrovascular disease). Use SAPHRIS cautiously with other drugs that can cause hypotension, bradycardia, or respiratory or central nervous system depression. Monitor orthostatic vital signs, and consider a dose reduction if hypotension occurs.
Falls: 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 antipsychotics and recurrently for patients on long-term therapy.
Leukopenia, Neutropenia, and Agranulocytosis: : Leukopenia/neutropenia have been reported with antipsychotics, including SAPHRIS. Agranulocytosis (including fatal cases) has been reported with other antipsychotics. Monitor complete blood count in patients with pre-existing low white blood cell count (WBC) or absolute neutrophil count or history of drug-induced leukopenia or neutropenia. Discontinue SAPHRIS at the first sign of a clinically significant decline in WBC and in severely neutropenic patients.
QT Prolongation: In an adult QT study, SAPHRIS was associated with increases in the QTc interval from 2 to 5 msec vs placebo. No SAPHRIS patients had QTc increases of ≥60 msec or a QTc of ≥500 msec. Avoid SAPHRIS in combination with other drugs known to prolong QTc interval, in patients with congenital prolongation of QT interval or a history of cardiac arrhythmias, and in circumstances that may increase occurrence of torsades de pointes and/or sudden death in association with the use of drugs that prolong QTc interval.
Hyperprolactinemia: Like other drugs that antagonize dopamine D2 receptors, SAPHRIS can elevate prolactin levels and the elevation can persist during chronic administration. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin-elevating compounds.
Seizures: Use SAPHRIS with caution in patients with history of seizures or with conditions that lower the seizure threshold.
Potential for Cognitive and Motor Impairment: Somnolence was reported with SAPHRIS. Caution patients about performing activities requiring mental alertness (eg, operating hazardous machinery or a motor vehicle).
Body Temperature Regulation: Appropriate care is advised when using SAPHRIS in patients who will experience conditions that increase body temperature, eg, exercising strenuously, extreme heat, concomitant anticholinergics, or dehydration.
Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotics. Dysphagia has been reported with SAPHRIS. Use SAPHRIS cautiously in patients at risk for dysphagia.
Drug Interactions: Monitor blood pressure and adjust antihypertensive drugs when taken with SAPHRIS. Based on clinical response, SAPHRIS dose reduction may be necessary when used with strong CYP1A2 inhibitors (fluvoxamine). Reduce paroxetine (CYP2D6 substrate and inhibitor) dose by half when taken with SAPHRIS.
Pregnancy: Advise patients to notify their healthcare provider of a known or suspected pregnancy. SAPHRIS may cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. Based on animal data, SAPHRIS may cause fetal harm. The National Pregnancy Registry for Atypical Antipsychotics monitors pregnancy outcomes in women exposed to antipsychotics, including SAPHRIS, during pregnancy. For information, contact 1-866-961-2388 or http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.
Adverse Reactions: In clinical trials, the most commonly observed adverse reactions in adults treated with SAPHRIS (5 and 10 mg BID) or pediatric patients (ages 10-17) treated with SAPHRIS (2.5, 5, and 10 mg BID) vs placebo were:
Postmarketing Experience: Application site reactions, primarily sublingual, have been reported (eg, oral ulcers, blisters, peeling/sloughing, and inflammation). Choking has been reported, sometimes associated with oropharyngeal muscular dysfunction or hypoesthesia.
In bipolar I disorder: SAPHRIS (asenapine) is indicated for the acute treatment of manic or mixed episodes of bipolar I disorder as monotherapy in adults or pediatric patients (ages 10-17) or as adjunctive therapy with either lithium or valproate in adults.
In schizophrenia: SAPHRIS is indicated for the acute and maintenance treatment of schizophrenia in adults.
Please also see the full Prescribing Information, including Boxed Warning.
The product information provided in this site is intended for US healthcare professionals only. The products described on this site may have different product labeling in countries outside of the United States.
For additional information about SAPHRIS, call AbbVie Medical Information toll-free at 1.800.678.1605. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/Safety/MedWatch or call 1-800-FDA-1088.
The trademarks SAPHRIS, SAPHRIS & Star Design, and Star Design are used by AbbVie under license from Merck Sharp & Dohme B.V.
© 2022 Merck Sharp & Dohme B.V.; used by AbbVie under license.
All other trademarks are the property of their respective owners.
© 2022 AbbVie. All rights reserved.
SPH40445_v3 11/18
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. SAPHRIS is not approved for treatment of patients with dementia-related psychosis.
Contraindications: SAPHRIS is contraindicated in patients with severe hepatic impairment (Child-Pugh C) or known hypersensitivity to SAPHRIS or its formulation components. Reactions have included anaphylaxis, angioedema, hypotension, tachycardia, swollen tongue, dyspnea, wheezing and rash.
Cerebrovascular Adverse Events, Including Stroke: In clinical trials with antipsychotic drugs, elderly subjects with dementia had a higher incidence of stroke (including fatal stroke) and transient ischemic attack vs placebo. SAPHRIS is 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 antipsychotics. NMS may cause hyperpyrexia, muscle rigidity, delirium, and autonomic instability. If NMS is suspected, immediately discontinue SAPHRIS and provide intensive symptomatic treatment and monitoring.
Tardive Dyskinesia (TD): Risk of developing TD (a syndrome of potentially irreversible, involuntary dyskinetic movements) and the likelihood it will become irreversible increase as the duration of treatment and total cumulative dose of antipsychotic drugs, including SAPHRIS, given to the patient increase. The syndrome can develop, after relatively brief treatment periods, even at low doses, and may also occur after discontinuation of treatment. Prescribe SAPHRIS in a manner most likely to minimize TD. If signs and symptoms of TD appear, drug discontinuation should be considered.
Metabolic Changes: Atypical antipsychotics, including SAHPRIS, have caused metabolic changes, including the following:
Hypersensitivity Reactions: Hypersensitivity reactions, including anaphylaxis, angioedema, hypotension, tachycardia, swollen tongue, dyspnea, wheezing, and rash, have been observed in patients treated with SAPHRIS. In several cases, these reactions occurred after the first dose.
Orthostatic Hypotension, Syncope, and Other Hemodynamic Effects: SAPHRIS has caused orthostatic hypotension and syncope. Generally the risk is greatest during initial titration and when increasing the dose. Monitor orthostatic vital signs and monitor patients who are vulnerable to hypotension (elderly patients, patients with dehydration, hypovolemia, concomitant treatment with antihypertensive medications, patients with cardiovascular and/or cerebrovascular disease). Use SAPHRIS cautiously with other drugs that can cause hypotension, bradycardia, or respiratory or central nervous system depression. Monitor orthostatic vital signs, and consider a dose reduction if hypotension occurs.
Falls: 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 antipsychotics and recurrently for patients on long-term therapy.
Leukopenia, Neutropenia, and Agranulocytosis: : Leukopenia/neutropenia have been reported with antipsychotics, including SAPHRIS. Agranulocytosis (including fatal cases) has been reported with other antipsychotics. Monitor complete blood count in patients with pre-existing low white blood cell count (WBC) or absolute neutrophil count or history of drug-induced leukopenia or neutropenia. Discontinue SAPHRIS at the first sign of a clinically significant decline in WBC and in severely neutropenic patients.
QT Prolongation: In an adult QT study, SAPHRIS was associated with increases in the QTc interval from 2 to 5 msec vs placebo. No SAPHRIS patients had QTc increases of ≥60 msec or a QTc of ≥500 msec. Avoid SAPHRIS in combination with other drugs known to prolong QTc interval, in patients with congenital prolongation of QT interval or a history of cardiac arrhythmias, and in circumstances that may increase occurrence of torsades de pointes and/or sudden death in association with the use of drugs that prolong QTc interval.
Hyperprolactinemia: Like other drugs that antagonize dopamine D2 receptors, SAPHRIS can elevate prolactin levels and the elevation can persist during chronic administration. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin-elevating compounds.
Seizures: Use SAPHRIS with caution in patients with history of seizures or with conditions that lower the seizure threshold.
Potential for Cognitive and Motor Impairment: Somnolence was reported with SAPHRIS. Caution patients about performing activities requiring mental alertness (eg, operating hazardous machinery or a motor vehicle).
Body Temperature Regulation: Appropriate care is advised when using SAPHRIS in patients who will experience conditions that increase body temperature, eg, exercising strenuously, extreme heat, concomitant anticholinergics, or dehydration.
Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotics. Dysphagia has been reported with SAPHRIS. Use SAPHRIS cautiously in patients at risk for dysphagia.
Drug Interactions: Monitor blood pressure and adjust antihypertensive drugs when taken with SAPHRIS. Based on clinical response, SAPHRIS dose reduction may be necessary when used with strong CYP1A2 inhibitors (fluvoxamine). Reduce paroxetine (CYP2D6 substrate and inhibitor) dose by half when taken with SAPHRIS.
Pregnancy: Advise patients to notify their healthcare provider of a known or suspected pregnancy. SAPHRIS may cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. Based on animal data, SAPHRIS may cause fetal harm. The National Pregnancy Registry for Atypical Antipsychotics monitors pregnancy outcomes in women exposed to antipsychotics, including SAPHRIS, during pregnancy. For information, contact 1-866-961-2388 or http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.
Adverse Reactions: In clinical trials, the most commonly observed adverse reactions in adults treated with SAPHRIS (5 and 10 mg BID) or pediatric patients (ages 10-17) treated with SAPHRIS (2.5, 5, and 10 mg BID) vs placebo were:
Postmarketing Experience: Application site reactions, primarily sublingual, have been reported (eg, oral ulcers, blisters, peeling/sloughing, and inflammation). Choking has been reported, sometimes associated with oropharyngeal muscular dysfunction or hypoesthesia.
In bipolar I disorder: SAPHRIS (asenapine) is indicated for the acute treatment of manic or mixed episodes of bipolar I disorder as monotherapy in adults or pediatric patients (ages 10-17) or as adjunctive therapy with either lithium or valproate in adults.
In schizophrenia: SAPHRIS is indicated for the acute and maintenance treatment of schizophrenia in adults.
Please also see the full Prescribing Information, including Boxed Warning.
1. SAPHRIS (asenapine) Prescribing Information. Irvine, CA: Allergan USA, Inc. 2. Findling RL, Landbloom RL, Szegedi A, Koppenhaver J, Braat S, Zhu Q, et al. J Am Acad Child Adolesc Psychiatry. 2015;54:1032-1041 [reprint]. 3. Data on file. Allergan. 4. Young RC, Biggs JT, Ziegler VE, Meyer DA. A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry. 1978;133:429-435. 5. Spearing MK, Post RM, Leverich GS, Brandt D, Nolen W. Modification of the Clinical Global Impressions (CGI) scale for use in bipolar illness (BP): the CGI-BP. Psych Res. 1997;73:159-171. 6. American Psychiatric Association. Practice Guideline for the Treatment of Patients with Bipolar Disorder. Second Edition. Washington, DC: American Psychiatric Association; 2002.
*All data are at 3 weeks in the short-term, pediatric bipolar mania trial (SAPHRIS 2.5, 5, or 10 mg BID). These patients had assessments at both baseline and endpoint.
Weight Gain: Increases in weight have been observed with SAPHRIS. Monitor weight regularly in patients on SAPHRIS.1
*Shift from >45 and <100 to ≥126 mg/dL.
†All data are at 3 weeks in the short-term, pediatric bipolar mania trial (SAPHRIS 2.5, 5, or 10 mg BID).
These patients had assessments at both baseline and endpoint.
Hyperglycemia and Diabetes Mellitus: Hyperglycemia, in some cases associated with ketoacidosis, hyperosmolar coma, or death, has been reported in patients treated with atypical antipsychotics. Patients with risk factors for diabetes mellitus starting treatment with antipsychotics should undergo fasting blood glucose testing at the beginning of and during treatment. Monitor any patient treated with antipsychotics for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop these symptoms during treatment should undergo fasting blood glucose testing. In some cases, hyperglycemia resolved when the antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the antipsychotic drug.1
*Shift from normal (<110) to high (≥130 mg/dL).
†All data are at 3 weeks in the short-term, pediatric bipolar mania trial (SAPHRIS 2.5, 5, or 10 mg BID).
These patients had assessments at both baseline and endpoint.
*Shift from normal (≥40) to low (<40 mg/dL).
†All data are at 3 weeks in the short-term, pediatric bipolar mania trial (SAPHRIS 2.5, 5, or 10 mg BID).
These patients had assessments at both baseline and endpoint.
Dyslipidemia: Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics.1
*Shift from normal (<170) to high (≥200 mg/dL).
†All data are at 3 weeks in the short-term, pediatric bipolar mania trial (SAPHRIS 2.5, 5, or 10 mg BID).
These patients had assessments at both baseline and endpoint.
*Shift from normal (<150) to high (≥200 mg/dL).
†All data are at 3 weeks in the short-term, pediatric bipolar mania trial (SAPHRIS 2.5, 5, or 10 mg BID).
These patients had assessments at both baseline and endpoint.
Dyslipidemia: Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics1
Tachycardiaıı (3%, 0%, 1%, vs 0%) | Headache (8%, 11%, 9%, vs 6%) |
Vomiting (4%, 4%, 4%, vs 3%) | Akathisia (2%, 2%, 1%, vs 0%) |
Abdominal pain¶ (9%, 3%, 5%, vs 7%) | Parkinsonism (1%, 0%, 2%, vs 0%) |
Glossodynia (0%, 2%, 0%, vs 0%) | Insomnia (3%, 4%, 3%, vs 3%) |
Irritability (1%, 1%, 2%, vs 1%) | Suicidal ideation (4%, 1%, 3%, vs 1%) |
Muscle strain (0%, 0%, 2%, vs 0%) | Anger (0%, 0%, 2%, vs 0%) |
Increased weight (6%, 2%, 2%, vs 0%) | Dysmenorrhea (0%, 2%, 0%, vs 1%) |
Hyperinsulinemia# (1%, 3%, 1%, vs 0%) | Oropharyngeal pain (0%, 3%, 1%, vs 2%) |
ALT increased (0%, 0%, 2%, vs 0%) | Nasal congestion (0%, 2%, 0%, vs 1%) |
AST increased (0%, 0%, 2%, vs 0%) | Dyspnea (0%, 2%, 0%, vs 0%) |
Dehydration (0%, 2%, 0%, vs 1%) | Rash (0%, 1%, 2%, vs 1%) |
Myalgia (0%, 2%, 1%, vs 0%) |
ıı Includes the preferred terms tachycardia and heart rate increased.
¶ Includes the preferred terms abdominal pain, abdominal pain upper, abdominal pain lower, and abdominal discomfort.
# Includes the preferred terms hyperinsulinemia and blood insulin increased.
Tachycardiaıı (3%, 0%, 1%, vs 0%) | Headache (8%, 11%, 9%, vs 6%) |
Vomiting (4%, 4%, 4%, vs 3%) | Akathisia (2%, 2%, 1%, vs 0%) |
Abdominal pain¶ (9%, 3%, 5%, vs 7%) | Parkinsonism (1%, 0%, 2%, vs 0%) |
Glossodynia (0%, 2%, 0%, vs 0%) | Insomnia (3%, 4%, 3%, vs 3%) |
Irritability (1%, 1%, 2%, vs 1%) | Suicidal ideation (4%, 1%, 3%, vs 1%) |
Muscle strain (0%, 0%, 2%, vs 0%) | Anger (0%, 0%, 2%, vs 0%) |
Increased weight (6%, 2%, 2%, vs 0%) | Dysmenorrhea (0%, 2%, 0%, vs 1%) |
Hyperinsulinemia# (1%, 3%, 1%, vs 0%) | Oropharyngeal pain (0%, 3%, 1%, vs 2%) |
ALT increased (0%, 0%, 2%, vs 0%) | Nasal congestion (0%, 2%, 0%, vs 1%) |
AST increased (0%, 0%, 2%, vs 0%) | Dyspnea (0%, 2%, 0%, vs 0%) |
Dehydration (0%, 2%, 0%, vs 1%) | Rash (0%, 1%, 2%, vs 1%) |
Myalgia (0%, 2%, 1%, vs 0%) |
ıı Includes the preferred terms tachycardia and heart rate increased.
¶ Includes the preferred terms abdominal pain, abdominal pain upper,
abdominal pain lower, and abdominal discomfort.
# Includes the preferred terms hyperinsulinemia and blood insulin increased.
Hyperprolactinemia: Like other drugs that antagonize dopamine D2 receptors,
SAPHRIS can elevate prolactin levels and the elevation can persist
during chronic administration.
Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving
prolactin-elevating compounds.
Hyperprolactinemia: Like other drugs that antagonize dopamine D2 receptors, SAPHRIS can elevate prolactin levels and the elevation can persist during chronic administration. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin-elevating compounds.
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. SAPHRIS is not approved for treatment of patients with dementia-related psychosis.
Contraindications: SAPHRIS is contraindicated in patients with severe hepatic impairment (Child-Pugh C) or known hypersensitivity to SAPHRIS or its formulation components. Reactions have included anaphylaxis, angioedema, hypotension, tachycardia, swollen tongue, dyspnea, wheezing and rash.
Cerebrovascular Adverse Events, Including Stroke: In clinical trials with antipsychotic drugs, elderly subjects with dementia had a higher incidence of stroke (including fatal stroke) and transient ischemic attack vs placebo. SAPHRIS is 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 antipsychotics. NMS may cause hyperpyrexia, muscle rigidity, delirium, and autonomic instability. If NMS is suspected, immediately discontinue SAPHRIS and provide intensive symptomatic treatment and monitoring.
Tardive Dyskinesia (TD): Risk of developing TD (a syndrome of potentially irreversible, involuntary dyskinetic movements) and the likelihood it will become irreversible increase as the duration of treatment and total cumulative dose of antipsychotic drugs, including SAPHRIS, given to the patient increase. The syndrome can develop, after relatively brief treatment periods, even at low doses, and may also occur after discontinuation of treatment. Prescribe SAPHRIS in a manner most likely to minimize TD. If signs and symptoms of TD appear, drug discontinuation should be considered.
Metabolic Changes: Atypical antipsychotics, including SAHPRIS, have caused metabolic changes, including the following:
Hypersensitivity Reactions: Hypersensitivity reactions, including anaphylaxis, angioedema, hypotension, tachycardia, swollen tongue, dyspnea, wheezing, and rash, have been observed in patients treated with SAPHRIS. In several cases, these reactions occurred after the first dose.
Orthostatic Hypotension, Syncope, and Other Hemodynamic Effects: SAPHRIS has caused orthostatic hypotension and syncope. Generally the risk is greatest during initial titration and when increasing the dose. Monitor orthostatic vital signs and monitor patients who are vulnerable to hypotension (elderly patients, patients with dehydration, hypovolemia, concomitant treatment with antihypertensive medications, patients with cardiovascular and/or cerebrovascular disease). Use SAPHRIS cautiously with other drugs that can cause hypotension, bradycardia, or respiratory or central nervous system depression. Monitor orthostatic vital signs, and consider a dose reduction if hypotension occurs.
Falls: 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 antipsychotics and recurrently for patients on long-term therapy.
Leukopenia, Neutropenia, and Agranulocytosis: : Leukopenia/neutropenia have been reported with antipsychotics, including SAPHRIS. Agranulocytosis (including fatal cases) has been reported with other antipsychotics. Monitor complete blood count in patients with pre-existing low white blood cell count (WBC) or absolute neutrophil count or history of drug-induced leukopenia or neutropenia. Discontinue SAPHRIS at the first sign of a clinically significant decline in WBC and in severely neutropenic patients.
QT Prolongation: In an adult QT study, SAPHRIS was associated with increases in the QTc interval from 2 to 5 msec vs placebo. No SAPHRIS patients had QTc increases of ≥60 msec or a QTc of ≥500 msec. Avoid SAPHRIS in combination with other drugs known to prolong QTc interval, in patients with congenital prolongation of QT interval or a history of cardiac arrhythmias, and in circumstances that may increase occurrence of torsades de pointes and/or sudden death in association with the use of drugs that prolong QTc interval.
Hyperprolactinemia: Like other drugs that antagonize dopamine D2 receptors, SAPHRIS can elevate prolactin levels and the elevation can persist during chronic administration. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin-elevating compounds.
Seizures: Use SAPHRIS with caution in patients with history of seizures or with conditions that lower the seizure threshold.
Potential for Cognitive and Motor Impairment: Somnolence was reported with SAPHRIS. Caution patients about performing activities requiring mental alertness (eg, operating hazardous machinery or a motor vehicle).
Body Temperature Regulation: Appropriate care is advised when using SAPHRIS in patients who will experience conditions that increase body temperature, eg, exercising strenuously, extreme heat, concomitant anticholinergics, or dehydration.
Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotics. Dysphagia has been reported with SAPHRIS. Use SAPHRIS cautiously in patients at risk for dysphagia.
Drug Interactions: Monitor blood pressure and adjust antihypertensive drugs when taken with SAPHRIS. Based on clinical response, SAPHRIS dose reduction may be necessary when used with strong CYP1A2 inhibitors (fluvoxamine). Reduce paroxetine (CYP2D6 substrate and inhibitor) dose by half when taken with SAPHRIS.
Pregnancy: Advise patients to notify their healthcare provider of a known or suspected pregnancy. SAPHRIS may cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. Based on animal data, SAPHRIS may cause fetal harm. The National Pregnancy Registry for Atypical Antipsychotics monitors pregnancy outcomes in women exposed to antipsychotics, including SAPHRIS, during pregnancy. For information, contact 1-866-961-2388 or http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.
Adverse Reactions: In clinical trials, the most commonly observed adverse reactions in adults treated with SAPHRIS (5 and 10 mg BID) or pediatric patients (ages 10-17) treated with SAPHRIS (2.5, 5, and 10 mg BID) vs placebo were:
Postmarketing Experience: Application site reactions, primarily sublingual, have been reported (eg, oral ulcers, blisters, peeling/sloughing, and inflammation). Choking has been reported, sometimes associated with oropharyngeal muscular dysfunction or hypoesthesia.
In bipolar I disorder: SAPHRIS (asenapine) is indicated for the acute treatment of manic or mixed episodes of bipolar I disorder as monotherapy in adults or pediatric patients (ages 10-17) or as adjunctive therapy with either lithium or valproate in adults.
In schizophrenia: SAPHRIS is indicated for the acute and maintenance treatment of schizophrenia in adults.
Please also see the full Prescribing Information, including Boxed Warning.
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Scale ranges from 0 (no manic symptoms) to 60 (maximum score) and includes the following symptoms:
The efficacy of SAPHRIS was based on the YMRS total score, not on any individual component of the scale.
Total PANSS scores can range from 30 to 210.
The efficacy of SAPHRIS was based on the PANSS total score, not on any individual component of the scale.
7 positive symptoms | 7 negative symptoms | 16 cognitive or general psychopathology symptoms |
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The efficacy of SAPHRIS was based on the PANSS total score, not on any individual component of the scale. |