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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 |
Formulary Reference Tool