Asenapine (Sublingual route)

Pronunciation:

a-SEN-a-peen

Brand Names:

Saphris

Dosage Forms:

Tablet

Warnings:

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 .

Classifications:

Therapeutic—

Antipsychotic

Uses of This Medicine:

Asenapine is used to treat schizophrenia in adults. It is also used alone or together with lithium or valproate to treat symptoms of psychotic (mental) disorders, such as mania or bipolar disorder. This medicine should not be used to treat behavioral problems in older adult patients who have dementia.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of asenapine in the pediatric population. Safety and efficacy have not been established in children younger than 10 years of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of asenapine in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Bepridil
Bromopride
Cisapride
Dronedarone
Levoketoconazole
Mesoridazine
Metoclopramide
Pimozide
Piperaquine
Saquinavir
Sparfloxacin
Terfenadine
Thioridazine
Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acecainide
Adagrasib
Ajmaline
Alfentanil
Alfuzosin
Alprazolam
Amiodarone
Amisulpride
Amitriptyline
Amoxapine
Anagrelide
Apomorphine
Aripiprazole
Aripiprazole Lauroxil
Arsenic Trioxide
Artemether
Astemizole
Atazanavir
Azimilide
Azithromycin
Bedaquiline
Benzhydrocodone
Bretylium
Bromazepam
Bunazosin
Buprenorphine
Buserelin
Butorphanol
Calcium Oxybate
Cannabidiol
Cannabis
Ceritinib
Cetirizine
Chloroquine
Chlorpromazine
Ciprofloxacin
Citalopram
Clarithromycin
Clobazam
Clofazimine
Clomipramine
Clonazepam
Clothiapine
Clozapine
Codeine
Crizotinib
Cyclobenzaprine
Dabrafenib
Daridorexant
Dasatinib
Degarelix
Delamanid
Desipramine
Deslorelin
Deutetrabenazine
Dexmedetomidine
Dihydrocodeine
Disopyramide
Dofetilide
Dolasetron
Domperidone
Donepezil
Doxazosin
Doxylamine
Droperidol
Duloxetine
Efavirenz
Eliglustat
Encorafenib
Enoxacin
Entrectinib
Erythromycin
Escitalopram
Esketamine
Etrasimod
Fentanyl
Fexinidazole
Fingolimod
Flecainide
Flibanserin
Fluconazole
Fluoxetine
Fluvoxamine
Formoterol
Foscarnet
Fostemsavir
Gabapentin
Gabapentin Enacarbil
Gatifloxacin
Gemifloxacin
Gepirone
Glasdegib
Gonadorelin
Goserelin
Granisetron
Halofantrine
Haloperidol
Histrelin
Hydrocodone
Hydromorphone
Hydroquinidine
Hydroxychloroquine
Hydroxyzine
Ibutilide
Iloperidone
Imipramine
Inotuzumab Ozogamicin
Ivabradine
Ivosidenib
Ketamine
Ketoconazole
Lacosamide
Lapatinib
Lefamulin
Lemborexant
Lenvatinib
Leuprolide
Levocetirizine
Levofloxacin
Levorphanol
Lofexidine
Lopinavir
Loxapine
Lumefantrine
Macimorelin
Magnesium Oxybate
Mefloquine
Meperidine
Methadone
Metronidazole
Mifepristone
Mirtazapine
Mobocertinib
Morphine
Morphine Sulfate Liposome
Moxifloxacin
Moxisylyte
Nafarelin
Nalbuphine
Nilotinib
Norfloxacin
Nortriptyline
Octreotide
Ofloxacin
Olanzapine
Oliceridine
Ondansetron
Osilodrostat
Osimertinib
Oxaliplatin
Oxycodone
Oxymorphone
Ozanimod
Pacritinib
Paliperidone
Panobinostat
Paroxetine
Pasireotide
Pazopanib
Pentazocine
Periciazine
Phenobarbital
Phenoxybenzamine
Phentolamine
Pimavanserin
Pirmenol
Pitolisant
Ponesimod
Posaconazole
Potassium Oxybate
Prajmaline
Prazosin
Pregabalin
Primidone
Procainamide
Prochlorperazine
Promethazine
Propafenone
Protriptyline
Quetiapine
Quinidine
Quinine
Quizartinib
Ranolazine
Relugolix
Remifentanil
Remimazolam
Ribociclib
Risperidone
Ropeginterferon Alfa-2b-njft
Selpercatinib
Sematilide
Sertindole
Sertraline
Sevoflurane
Siponimod
Sodium Oxybate
Sodium Phosphate
Sodium Phosphate, Dibasic
Sodium Phosphate, Monobasic
Solifenacin
Sorafenib
Sotalol
Sufentanil
Sulpiride
Sultopride
Sunitinib
Tacrolimus
Tapentadol
Tedisamil
Telavancin
Telithromycin
Terazosin
Tetrabenazine
Topiramate
Toremifene
Tramadol
Trazodone
Triclabendazole
Trifluoperazine
Trimipramine
Triptorelin
Urapidil
Vandetanib
Vardenafil
Vemurafenib
Venlafaxine
Vilanterol
Vinflunine
Voclosporin
Voriconazole
Zolpidem
Zotepine
Zuclopenthixol
Zuranolone

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Blood vessel or circulation problems or
Dehydration or
Heart attack, history of or
Heart disease or
Heart failure or
Heart rhythm problems (eg, arrhythmia, QT prolongation) or
Hypotension (low blood pressure) or
Hypovolemia (low amount of blood) or
Stroke, history of—May cause side effects to become worse.

Bradycardia (slow heartbeat), history of or
Heart rhythm problem (eg, congenital long QT syndrome) or
Hypokalemia (low potassium in the blood) or
Hypomagnesemia (low magnesium in the blood)—May increase risk for more serious side effects.

Diabetes or
Hyperglycemia (high blood sugar)—This medicine may raise your blood sugar levels.

Hyperprolactinemia (high prolactin in the blood) or
Neuroleptic malignant syndrome (NMS), history of or
Seizures, history of or
Trouble with swallowing—Use with caution. May make these conditions worse.

Liver disease, severe—Should not be used in patients with this condition.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine comes with patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.

To use the sublingual tablet:

Make sure your hands are dry before you handle the tablet.
Do not open the blister pack that contains the tablet until you are ready to take it.
Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil.
Place the tablet under your tongue. It should melt quickly.
Do not split, crush, chew, or swallow the tablet.
Do not eat or drink anything for at least 10 minutes after using this medicine.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (sublingual tablets):
- For bipolar disorder:
  - For patients taking asenapine only:
    - Adults—At first, 5 to 10 milligrams (mg) two times a day. Your doctor may adjust your dose as needed.
    - Children 10 to 17 years of age—2.5 to 10 mg two times a day. Your doctor may adjust your dose as needed and tolerated.
    - Children younger than 10 years of age—Use and dose must be determined by your doctor.
  - For patients taking asenapine together with lithium or valproate:
    - Adults—At first, 5 milligrams (mg) two times a day. If needed, your doctor may adjust your dose to 10 mg two times a day.
    - Children—Use and dose must be determined by your doctor.
- For maintenance treatment of bipolar disorder:
  - Adults—5 to 10 milligrams (mg) two times a day. Your doctor may increase your dose as needed.
  - Children—Use and dose must be determined by your doctor.
- For schizophrenia:
  - Adults—At first, 5 milligrams (mg) two times a day. Your doctor may increase your dose as needed.
  - Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for any unwanted effects.

Tell your doctor right away if you have sores or blisters in the mouth, or numbness or tingling of the mouth or throat after using this medicine.

Check with your doctor right away if you have any of the following symptoms while using this medicine: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have any of the following symptoms while using this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

For diabetic patients: This medicine may affect your blood sugar levels. Check with your doctor right away if you have increased thirst or increased urination. If you notice a change in the results of your urine or blood sugar tests, or if you have any questions, check with your doctor.

This medicine may increase your weight. Your doctor may need to check your weight on a regular basis while you are using this medicine. Talk to your doctor about ways to prevent weight gain.

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, dizziness or lightheadedness, trouble breathing, trouble swallowing, or any swelling of your hands, face, tongue, or throat while you are using this medicine.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position suddenly. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

Asenapine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection, or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine can cause changes in the heart rhythm, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

This medicine may cause dizziness, drowsiness, trouble with thinking, or trouble with controlling body movements. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that requires you to be alert, well-coordinated, or able to think well.

This medicine might reduce how much you sweat. Your body could get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. You might vomit or have an upset stomach. Do not get too hot while you are exercising. Avoid places that are very hot. Call your doctor if you are too hot and cannot cool down.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicines including other narcotics, medicine for seizures (eg, barbiturates), muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine 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:

More common: Abnormal or decreased touch sensation; inability to move the eyes; inability to sit still; increase in body movements; increased blinking or spasms of the eyelid; lip smacking or puckering; need to keep moving; puffing of the cheeks; rapid or worm-like movements of the tongue; restlessness; shakiness in the legs, arms, hands, or feet; sticking out of tongue; trembling or shaking of the hands or feet; trouble with breathing, speaking, or swallowing; twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs; uncontrolled chewing movements; uncontrolled twisting movements of the neck, trunk, arms, or legs; unusual facial expressions; weakness of the arms and legs

Less common: Blurred vision; dizziness; headache; nervousness; pounding in the ears; slow or fast heartbeat

Rare: Black, tarry stools; bleeding gums; blood in the urine or stools; burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings; changes in patterns and rhythms of speech; coma; confusion; convulsions; decreased urine output; fast, pounding, or irregular heartbeat or pulse; increased thirst; muscle pain or cramps; nausea or vomiting; pale skin; pinpoint red spots on the skin; slurred speech; swelling of the face, ankles, or hands; troubled breathing with exertion; unusual bleeding or bruising; unusual tiredness or weakness

Some side effects 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: Constipation; sleepiness or unusual drowsiness; trouble sleeping; unusually deep sleep; unusually long duration of sleep

Less common: Acid or sour stomach; belching; depression; difficulty with moving; dry mouth; fear or nervousness; heartburn; increased appetite; increased watering of the mouth; increased weight; indigestion; irritability; muscle pain or stiffness; pain in the arms or legs; pain in the joints; stomach discomfort, upset, or pain; toothache

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Last Updated: 4/24/2024

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