SAPHRIS (ASENAPINE MALEATE)
- Mania associated with bipolar disorder
- Mixed bipolar I disorder
- Schizophrenia
10 mg sublingual tablet
- Place 1 tablet (10 mg) under the tongue and allow to dissolve by sublingual route 2 times per day
2.5 mg sublingual tablet
- Place 2 tablets (5 mg) under the tongue and allow to dissolve by sublingual route 2 times per day
5 mg sublingual tablet
- Place 1 tablet (5 mg) under the tongue and allow to dissolve by sublingual route 2 times per day
10 mg sublingual tablet
- Place 1 tablet (10 mg) under the tongue and allow to dissolve by sublingual route 2 times per day
2.5 mg sublingual tablet
- Place 2 tablets (5 mg) under the tongue and allow to dissolve by sublingual route 2 times per day
5 mg sublingual tablet
- Place 1 tablet (5 mg) under the tongue and allow to dissolve by sublingual route 2 times per day
Mania associated with bipolar disorder
- Place 1 tablet (5 mg) under the tongue and allow to dissolve by sublingual route 2 times per day
- Place 2 tablets (5 mg) under the tongue and allow to dissolve by sublingual route 2 times per day
- Place 2 tablets (10 mg) under the tongue and allow to dissolve by sublingual route 2 times per day
- Place 1 tablet (10 mg) under the tongue and allow to dissolve by sublingual route 2 times per day
Mixed bipolar I disorder
- Place 1 tablet (5 mg) under the tongue and allow to dissolve by sublingual route 2 times per day
- Place 2 tablets (5 mg) under the tongue and allow to dissolve by sublingual route 2 times per day
- Place 2 tablets (10 mg) under the tongue and allow to dissolve by sublingual route 2 times per day
- Place 1 tablet (10 mg) under the tongue and allow to dissolve by sublingual route 2 times per day
Schizophrenia
- Place 1 tablet (5 mg) under the tongue and allow to dissolve by sublingual route 2 times per day
- Place 2 tablets (5 mg) under the tongue and allow to dissolve by sublingual route 2 times per day
- Place 2 tablets (10 mg) under the tongue and allow to dissolve by sublingual route 2 times per day
- Place 1 tablet (10 mg) under the tongue and allow to dissolve by sublingual route 2 times per day
- metoclopramide HCl
- Metozolv Odt
- Reglan
Contraindicated
- cabergoline
- sodium oxybate
- Xyrem
Severe
Moderate
- Aplenzin
- Apokyn
- apomorphine
- Buproban
- bupropion HBr
- bupropion HCl
- carbidopa-levodopa
- carbidopa-levodopa-entacapone
- Comtan
- entacapone
- Forfivo Xl
- Mirapex
- Mirapex Er
- pramipexole
- Requip
- Requip Xl
- ropinirole
- Sinemet
- Sinemet Cr
- Stalevo 100
- Stalevo 125
- Stalevo 150
- Stalevo 200
- Stalevo 50
- Stalevo 75
- Wellbutrin
- Wellbutrin Sr
- Wellbutrin Xl
- Zyban
- Neuroleptic malignant syndrome
Contraindicated
- Acute myocardial infarction
- Alzheimer's disease
- Bradycardia
- Cardiac arrhythmia
- Cerebrovascular accident
- Cerebrovascular disorder
- Chronic heart failure
- Congenital long QT syndrome
- Esophageal dysmotility
- Hypokalemia
- Hypomagnesemia
- Leukopenia
- Myocardial ischemia
- Neutropenic disorder
- Orthostatic hypotension
- Parkinsonism
- Pregnancy
- Prolonged QT interval
- Senile dementia
- Severe hepatic disease
- Tardive dyskinesia
- Transient cerebral ischemia
Severe
Moderate
- Acute confusion
- Diabetes mellitus
- Dysphagia
- Hyperlipidemia
- Hyperprolactinemia
- Lower seizure threshold
- Obesity
- Predisposition to aspiration
- Seizure disorder
- Suicidal ideation
- Weight gain
SAPHRIS (ASENAPINE MALEATE)
- Mania associated with bipolar disorder
- Mixed bipolar I disorder
- Schizophrenia
- Akathisia
- Extrapyramidal disease
- Dizziness
- Drowsy
- Insomnia
- Oral hypoesthesia
More Frequent
Severe
Less Severe
- Hypertension
- Acute abdominal pain
- Arthralgias
- Constipation
- Dysgeusia
- Dyspepsia
- Fatigue
- Headache disorder
- Hypercholesterolemia
- Hypertriglyceridemia
- Increased appetite
- Irritability
- Pain
- Sialorrhea
- Symptoms of anxiety
- Tremor
- Vomiting
- Weight gain
- Xerostomia
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Accidental fall
- Agranulocytosis
- Anaphylaxis
- Anemia
- Angioedema
- Bradycardia
- Bundle branch block
- Choking sensation
- Diabetes mellitus
- DRESS syndrome
- Dysphagia
- Dyspnea
- Esophageal dysmotility
- Heat stroke
- Hyperglycemia
- Hyponatremia
- Hypotension
- Leukopenia
- Neuroleptic malignant syndrome
- Neutropenic disorder
- Prolonged QT interval
- Seizure disorder
- Sleep apnea
- Suicidal ideation
- Tachycardia
- Tardive dyskinesia
- Thrombocytopenic disorder
- Tongue swelling
Less Severe
- Acquired dystonia
- Acute confusion
- Amenorrhea
- Blurred vision
- Diplopia
- Dysarthria
- Erectile dysfunction
- Fever
- Gait abnormality
- Galactorrhea not associated with childbirth
- Gastroesophageal reflux disease
- Gynecomastia
- Hyperprolactinemia
- Orthostatic hypotension
- Phototoxicity
- Sensation of warmth
- Skin rash
- Stomatitis
- Syncope
- Urinary incontinence
- Wheezing
Contraindicated
None
Severe Precaution
None
Management or Monitoring Precaution
Asenapine
Safety and efficacy not evaluated age < 10 years.
Monitor growth. Supervise behavior of high risk patients.
- 1 Day – 10 Years
- Safety and efficacy not evaluated age < 10 years.
- Monitor growth. Supervise behavior of high risk patients.
- 10 Years – 18 Years
- Safety and efficacy not evaluated age < 10 years.
- Monitor growth. Supervise behavior of high risk patients.
Asenapine
- Severity Level:
D
- Additional Notes: Non-teratogenic complications (resp, gi,cns) with exposure during 3rd trimester
Contraindicated
None
General | Excretion Potential | Effect on Infant | Notes |
None |
Precaution Exists
Asenapine
Insuff human data; manufacturer does not recommend
General | Excretion Potential | Effect on Infant | Notes |
Evaluate use carefully | Unknown | Not known; no or inclusive data | Insuff human data; manufacturer does not recommend |
No Known Risk
None
General | Excretion Potential | Effect on Infant | Notes |
None |
Contraindicated
None
Precaution Exists
Asenapine
Neuro/Psych-Boxed Warning-Increased mortality in elderly patients with dementia-related psychosis. Not approved for treatment of dementia-related psychosis. Cardiovascular-Orthostatic hypotension more likely in the elderly. QT prolongation risk. Metabolic changes from atypical antipsychotics may increase cardiovascular/cerebrovascular risk. Endocrine-May unmask or worsen diabetes. Hyperprolactinemia may occur due to dopamine D2 blockade.
Organ / System | HEP | REN | CARD | ENDO | NEURO / PSYCH | PULM |
Increased Risk / Adverse Effects | N | N | Y | Y | N | Y |
BEERS: Y HEDIS: Y STOPP: Y
No Known Risk
None
- There may be a slightly increased risk of serious, possibly fatal side effects (such as stroke, heart failure, fast/irregular heartbeat, pneumonia) when this medication is used by older adults with dementia. This medication is not approved for the treatment of dementia-related behavior problems. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for dementia-related behavior problems, with the doctor. If you are using asenapine in combination with other medication to treat depression, also carefully read the drug information for the other medication.
Mania associated with bipolar disorder | |
F31.1 | Bipolar disorder, current episode manic without psychotic features |
F31.10 | Bipolar disorder, current episode manic without psychotic features, unspecified |
F31.11 | Bipolar disorder, current episode manic without psychotic features, mild |
F31.12 | Bipolar disorder, current episode manic without psychotic features, moderate |
F31.13 | Bipolar disorder, current episode manic without psychotic features, severe |
F31.2 | Bipolar disorder, current episode manic severe with psychotic features |
F31.73 | Bipolar disorder, in partial remission, most recent episode manic |
Mixed bipolar I disorder | |
F31.6 | Bipolar disorder, current episode mixed |
F31.60 | Bipolar disorder, current episode mixed, unspecified |
F31.61 | Bipolar disorder, current episode mixed, mild |
F31.62 | Bipolar disorder, current episode mixed, moderate |
F31.63 | Bipolar disorder, current episode mixed, severe, without psychotic features |
F31.64 | Bipolar disorder, current episode mixed, severe, with psychotic features |
F31.77 | Bipolar disorder, in partial remission, most recent episode mixed |
F31.78 | Bipolar disorder, in full remission, most recent episode mixed |
Schizophrenia | |
F20 | Schizophrenia |
F20.0 | Paranoid schizophrenia |
F20.1 | Disorganized schizophrenia |
F20.2 | Catatonic schizophrenia |
F20.3 | Undifferentiated schizophrenia |
F20.5 | Residual schizophrenia |
F20.8 | Other schizophrenia |
F20.81 | Schizophreniform disorder |
F20.89 | Other schizophrenia |
F20.9 | Schizophrenia, unspecified |
0-9 | A-Z |
---|---|
F20 | Schizophrenia |
F20.0 | Paranoid schizophrenia |
F20.1 | Disorganized schizophrenia |
F20.2 | Catatonic schizophrenia |
F20.3 | Undifferentiated schizophrenia |
F20.5 | Residual schizophrenia |
F20.8 | Other schizophrenia |
F20.81 | Schizophreniform disorder |
F20.89 | Other schizophrenia |
F20.9 | Schizophrenia, unspecified |
F31.1 | Bipolar disorder, current episode manic without psychotic features |
F31.10 | Bipolar disorder, current episode manic without psychotic features, unspecified |
F31.11 | Bipolar disorder, current episode manic without psychotic features, mild |
F31.12 | Bipolar disorder, current episode manic without psychotic features, moderate |
F31.13 | Bipolar disorder, current episode manic without psychotic features, severe |
F31.2 | Bipolar disorder, current episode manic severe with psychotic features |
F31.6 | Bipolar disorder, current episode mixed |
F31.60 | Bipolar disorder, current episode mixed, unspecified |
F31.61 | Bipolar disorder, current episode mixed, mild |
F31.62 | Bipolar disorder, current episode mixed, moderate |
F31.63 | Bipolar disorder, current episode mixed, severe, without psychotic features |
F31.64 | Bipolar disorder, current episode mixed, severe, with psychotic features |
F31.73 | Bipolar disorder, in partial remission, most recent episode manic |
F31.77 | Bipolar disorder, in partial remission, most recent episode mixed |
F31.78 | Bipolar disorder, in full remission, most recent episode mixed |