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Saphris (asenapine) is an antipsychotic medication. It works by changing the actions of chemicals in the brain.
Saphris sublingual tablets are used to treat schizophrenia in adults, and bipolar I disorder in adults and children who are at least 10 years old.
Saphris may also be used for purposes not listed in this medication guide.
You should not use Saphris if you are allergic to asenapine, or if you have severe liver disease.
Saphris can cause serious neurologic problems. Stop taking this medicine and call your doctor at once if you have: very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, feeling light-headed, tremors, twitching, or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs.
Saphris is not FDA-approved for use in psychotic conditions related to dementia. Asenapine may increase the risk of death in older adults with dementia-related conditions.
You should not use Saphris if you are allergic to asenapine, or if you have:
severe liver disease; or
a history of severe allergic reaction to asenapine.
To make sure Saphris is safe for you, tell your doctor if you have:
liver disease;
heart disease, high blood pressure, heart rhythm problems;
a history of heart attack or stroke;
a history of breast cancer;
seizures or epilepsy;
diabetes (asenapine may raise your blood sugar);
trouble swallowing;
Parkinson's disease;
a history of low white blood cell (WBC) counts; or
a personal or family history of Long QT syndrome.
It is not known whether Saphris will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
Taking antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant while taking Saphris, do not stop taking it without your doctor's advice.
It is not known whether asenapine passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.
Saphris should not be given to a child younger than 10 years old. Saphris is not FDA-approved for schizophrenia in anyone younger than 18 years old.
Saphris is usually taken 2 times per day. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
To take Saphris sublingual (under the tongue) tablets:
Keep the tablet in its blister pack until you are ready to take the medicine. Open the package and peel back the colored tab from the tablet blister. Do not push a tablet through the blister or you may damage the tablet.
Using dry hands, gently remove the tablet and place it under your tongue. Do not crush or break the tablet. It will begin to dissolve right away.
Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.
Do not eat or drink anything for 10 minutes after the tablet has dissolved.
Saphris may cause you to have high blood sugar (hyperglycemia). Symptoms include increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, and blurred vision. If you are diabetic, check your blood sugar levels on a regular basis while you are taking Saphris.
Your doctor will need to check your progress while you are using Saphris.
Store at room temperature away from moisture and heat.
Usual Adult Dose of Saphris for Schizophrenia:
Acute treatment:
Starting dose: 5 mg sublingually twice a day
Recommended dose: 5 mg sublingually twice a day, if tolerated may increase to 10 mg sublingually twice a day after 1 week if necessary
Maximum dose: 10 mg sublingually twice a day
Comments: Controlled trials revealed no added benefit with the higher dose, but a clear increase in certain adverse reactions. The safety of doses above 10 mg twice daily has not been evaluated in clinical studies.
Maintenance Treatment:
Recommended dose: 5 to 10 mg sublingually twice a day
Maximum dose: 10 mg sublingually twice a day
Comments: There is no available evidence to answer the question of how long the schizophrenic patient should remain on therapy; it is generally recommended that responding patients be continued beyond the acute response.
Use: Treatment of schizophrenia.
Usual Adult Dose of Saphris for Bipolar Disorder:
Monotherapy:
Starting dose: 10 mg sublingually twice a day
Recommended dose: 5 to 10 mg sublingually twice a day
Maximum dose: 10 mg sublingually twice a day
Comment: In controlled trials, the starting dose was 10 mg twice daily. On the second and subsequent days, the dose could be lowered to 5 mg twice daily, however less than 10% of patients had their dose reduced.
Adjunctive Therapy:
Starting dose: 5 mg sublingually twice a day
Maintenance dose: 5 to 10 mg sublingually twice a day
Maximum dose: 10 mg sublingually twice a day
Comments:
-The dose should be titrated based on clinical response and tolerability.
-There is no available evidence to answer the question of how long the patient should remain on therapy; it is generally recommended that responding patients be continued beyond the acute response.
Uses: For the acute treatment of manic or mixed episodes associated with bipolar 1 disorder either as monotherapy or as adjunctive therapy with either lithium or valproate.
Usual Pediatric Dose for Bipolar Disorder:
Age: 10 years or older
Starting dose: 2.5 mg sublingually twice a day
Dose titration: After 3 days, may increase to 5 mg sublingually twice daily, and after an additional 3 days to 10 mg twice a day, as needed and as tolerated
Recommended dose: 2.5 to 10 mg sublingually twice a day
Maximum dose: 10 mg sublingually twice a day
Comment: Pediatric patients appear to be more sensitive to dystonia with initial dosing and therefore gradual dose escalation is recommended. The safety of doses above 10 mg twice a day has not been studied.
Use: As monotherapy for the acute treatment of manic or mixed episodes associated with bipolar 1 disorder.
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
While you are taking Saphris, you may be more sensitive to temperature extremes such as very hot or cold conditions. Avoid getting too cold, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking Saphris.
Saphris may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you.
Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or severe drowsiness can cause falls, fractures, or other injuries.
Avoid drinking alcohol. Dangerous side effects could occur.
Get emergency medical help if you have signs of an allergic reaction to Saphris: hives; fast heartbeats, feeling light-headed; wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.
Saphris can cause serious neurologic problems. Stop taking this medicine and call your doctor at once if you have: very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, feeling light-headed, tremors, twitching, or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs.
High doses or long-term use of Saphris can cause a serious movement disorder that may not be reversible. Symptoms of this disorder include uncontrollable muscle movements of your lips, tongue, eyes, face, arms, or legs. The longer you take Saphris, the more likely you are to develop a serious movement disorder. The risk of this side effect is higher in women and older adults.
Call your doctor at once if you have:
slow heartbeats, a light-headed feeling (like you might pass out);
uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
sudden weakness or ill feeling, fever, chills, sore throat, swollen gums, painful mouth sores, skin sores, cold or flu symptoms, cough;
breast pain or swelling, nipple discharge;
trouble swallowing; or
sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance.
Common Saphris side effects may include:
dizziness, drowsiness, feeling tired;
inability to sleep;
feeling restless or being unable to sit still;
numbness or tingling inside or around your mouth;
ulcers, blisters, swelling, or peeling of your gums;
nausea, altered sense of taste; or
increased appetite, weight gain.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Taking Saphris with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.
Tell your doctor about all your current medicines and any you start or stop using, especially:
an antibiotic;
an antidepressant;
anti-malaria medication;
cancer medicine;
heart or blood pressure medicine; or
other antipsychotic medications.
This list is not complete. Other drugs may interact with asenapine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Saphris only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Saphris (www.drugs.com/saphris.html).
Note: This document contains side effect information about asenapine. Some of the dosage forms listed on this page may not apply to the brand name Saphris.
Common side effects of Saphris include: akathisia, drowsiness, extrapyramidal reaction, headache, and dizziness. Other side effects include: gastric hypersecretory conditions, hypoesthesia, sialorrhea, and weight gain. See below for a comprehensive list of adverse effects.
Applies to asenapine: sublingual tablet
Sublingual route (Tablet)
Use of antipsychotic drugs increases the risk of death in elderly patients with dementia-related psychosis. Asenapine is not approved for treatment of patients with dementia-related psychosis.
Along with its needed effects, asenapine (the active ingredient contained in Saphris) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking asenapine:
More common
Less common
Rare
Some side effects of asenapine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Less common
Applies to asenapine: sublingual tablet
The most commonly reported adverse reactions in adults included akathisia, dizziness, extra pyramidal symptoms other than akathisia, oral hypoesthesia, somnolence, and increased weight. The most commonly reported adverse reactions in pediatric patients included somnolence, dizziness, dysgeusia, oral paresthesia, nausea, increased appetite, fatigue, and increased weight.
Somnolence occurred in up to 53% of patients aged 10 to 17 years given 5 mg orally 2 times a day.
Extrapyramidal symptoms occurred in 25% of patients given 10 mg, compared to 11% of patients given 5 mg.
Very common (10% or greater): Somnolence (up to 53%), extrapyramidal symptoms (up to 25%), sedation (up to 19.2%), akathisia (up to 15%), headache (up to 11%), dizziness (up to 10.1%)
Common (1% to 10%): Dysgeusia, dyskinesia, dystonia/acute dystonia, extrapyramidal disorder, parkinsonism, tremor
Uncommon (0.1% to 1%): Dysarthria, restless leg syndrome, seizure, syncope
Rare (less than 0.1%): Neuroleptic malignant syndrome
Frequency not reported: Bradykinesia, cerebrovascular events, hyperkinesia, hypersomnia, lethargy, motor impairment, myoclonus, resting tremor, tardive dyskinesia
Oral hypoesthesia occurred in up to 30% of pediatric patients and up to 24% of adults.
Application site reactions that include oral ulcers, blisters, peeling/sloughing, and inflammation primarily in the sublingual area have led to discontinuation of therapy in many cases. Oral hypoesthesia and/or oral paraesthesia may occur directly after administration and usually resolve in 1 hour.
Very common (10% or greater): Oral hypoesthesia (up to 30%), oral paresthesia (up to 11%)
Common (1% to 10%): Abdominal pain, constipation, dry mouth, dyspepsia, glossodynia, nausea, oropharyngeal pain, salivary hypersecretion, stomach discomfort, toothache, vomiting
Uncommon (0.1% to 1%): Dysphagia, gastroesophageal reflux disease (GERD/GORD), oromucosal lesions (ulcerations, blustering, inflammation), swollen tongue
Postmarketing reports: Abdominal discomfort, abdominal pain lower, abdominal pain upper, oral dysesthesia, oral peeling/sloughing, oromandibular dystonia, oropharyngeal muscular dysfunction, pharyngeal edema, swallowing difficulty, swollen throat, tongue disorder, tongue protrusion
Very common (10% or greater): Insomnia (up to 16%)
Common (1% to 10%): Agitation, anger, anxiety, bipolar disorder, bipolar I disorder, depression, depressive symptoms, irritability, mania, schizophrenia, suicidal ideation
Frequency not reported: Cognitive impairment
Very common (10% or greater): Fatigue (up to 14%)
Uncommon (0.1% to 1%): Fall
Rare (less than 0.1%): Idiosyncratic drug reaction
Frequency not reported: Body temperature dysregulation, neonatal drug withdrawal syndrome
While all atypical antipsychotics have been associated with metabolic changes including hyperglycemia, dyslipidemia, and weight gain, the degree of metabolic change differs for each agent.
In clinical trials with this drug, changes from baseline in fasting glucose ranged from -0.6 to 3.8 mg/dL in adults and -0.45 to 1.43 mg/dL in pediatric patients treated with this drug for 3 to 6 weeks compared with -0.2 and -2.24 mg/dL in adults and pediatric patients receiving placebo, respectively. In a 52-week double-blind, comparator-controlled trial in primarily schizophrenic patients, the mean increase in fasting glucose from baseline was 2.4 mg/dL.
An increase of 7% or more in body weight occurred in 8% to 12% of adults and 4.4% to 4.8% of pediatric patients treated with this drug for 3 weeks compared with 1.1% and 1.6%, respectively in adults and pediatric patients receiving placebo. In a 52-week double-blind, comparator-controlled trial in primarily schizophrenic patients, the mean increase in weight from baseline was 0.9 kg.
Very common (10% or greater): Weight gain of at least 7% (up to 13.1%)
Common (1% to 10%): Dehydration, hyperinsulinemia, increased appetite, new-onset metabolic syndrome, weight increased
Uncommon (0.1% to 1%): Hyperglycemia, hyponatremia
Frequency not reported: Blood insulin increased, diabetes mellitus, dyslipidemia, metabolic changes
Very common (10% or greater: Creatine kinase elevations (up to 11.1%)
Common (1% to 10%): Arthralgia, muscle rigidity, muscle strain, myalgia
Frequency not reported: Involuntary muscle contractions, muscle spasms, muscle twitching, musculoskeletal stiffness, neck muscle spasm
Common (1% to 10%): Edema, hypertension, orthostatic hypotension, peripheral edema, tachycardia
Uncommon (0.1% to 1%): Bundle branch block, hypotension, QT prolongation on ECG, sinus bradycardia, sinus tachycardia, temporary bundle branch block
Frequency not reported: Heart rate increased
In a dedicated QT study in patients with schizophrenia, doses of 5, 10, 15, and 20 mg twice a day were compared with placebo. QTc interval increases ranged from 2 to 5 msec. No patients had QTc increases of 60 msec or greater, nor did any patient experience a QTc of 500 msec or greater.
Orthostatic hypotension was reported in 4.1% of elderly subjects compared with 0.3% in the combined study populations.
Common (1% to 10%): ALT increased, AST increased, angioedema, transient asymptomatic elevations in hepatic transaminases
Transient elevations in serum transaminases (primarily ALT) in the short-term schizophrenia and bipolar mania trials were more common in treated patients but mean changes were not clinically relevant. In short-term, placebo-controlled schizophrenia trials, the mean increase in transaminase levels for treated patients was 1.6 units/L compared to a decrease of 0.4 units/L for placebo treated patients. The proportion of patients with transaminase elevations three or more times the ULN (at the endpoint) was 0.9% for treated patients versus 1.3% for placebo treated patients. In short-term, placebo-controlled bipolar mania trials, the mean increase in transaminase levels for treated patients was 8.9 units/L compared to a decrease of 4.9 units/L in placebo treated patients. The proportion of patients with transaminase elevations three or more times the ULN (at the endpoint) was 2.5% for treated patients versus 0.6% for placebo treated patients. No cases of more severe liver injury were seen. In a 52 week, double-blind, comparator controlled trial of patients with schizophrenia and schizoaffective disorder, the mean increase from baseline of ALT was 1.7 units/L.
Common (1% to 10%): Dyspnea, nasal congestion, nasopharyngitis
Rare (less than 0.1%): Pulmonary embolism
Frequency not reported: Difficulty breathing, throat tightness, upper respiratory tract infection
Postmarketing reports: Choking, wheezing
Common (1% to 10%): Dysmenorrhea
Uncommon (0.1% to 1%): Amenorrhea, enuresis, sexual dysfunction
Rare (less than 0.1%): Galactorrhea
Common (1% to 10%): Rash
Uncommon (0.1% to 1%): Photosensitivity reaction
Uncommon (0.1% to 1%): Accommodation disorder, blurred vision, diplopia
Frequency not reported: Blepharospasm, oculogyration
Uncommon (0.1% to 1%): Anemia
Rare (less than 0.1%): Neutropenia, thrombocytopenia
Frequency not reported: Agranulocytosis, leukopenia
Uncommon (0.1% to 1%): Decreased prolactin levels
Rare (less than 0.1%): Gynecomastia
Frequency not reported: Hyperprolactinemia
Uncommon (0.1% to 1%): Allergic reactions
Postmarketing reports: Anaphylactic/anaphylactoid reactions, serious hypersensitivity reactions
Postmarketing reports: Sublingual application site reactions
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Saphris (www.drugs.com/saphris.html).
March 28, 2020
March 28, 2020
March 28, 2020
March 28, 2020
March 28, 2020
March 28, 2020
