Pronunciation:

a-SEN-a-peen

Brand Names:

• Secuado

Dosage Forms:

• Patch, Extended Release

Warnings:

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 skin patch is used to treat schizophrenia. 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 skin patch in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of asenapine skin patch 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
• 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
• 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
• 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 history of 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:

Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use 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 Secuado® skin patch:

• This medicine should only be used on skin that is not irritated or injured. Do not put the patch in your mouth, chew it, or swallow it.
• Asenapine skin patches are packaged in sealed pouches. Do not cut open the foil pouch and remove the patch from the sealed pouch until you are ready to apply it.
• Apply the patch to a dry, flat skin area on your upper arm, upper back, abdomen, or hips. Choose a place where the skin is not very oily and is free of scars, cuts, burns, or irritation.
• Apply 1 patch to 1 application site every 24 hours. Rotate your application site every time you change a patch. Do not wear the patch longer than 24 hours.
• If the patch lifts or falls off after applying it, throw it away and apply a new patch in the same area.
• Do not shave the skin where you will apply the patch. You may cut the hair with a pair of scissors.
• Avoid bathing or swimming while wearing the patch. You may take a shower while using it.

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 transdermal dosage form (skin patch):
  • For schizophrenia:
    • Adults—At first, 1 patch (containing 3.8 milligrams (mg) of asenapine) every 24 hours. After 1 week, your doctor may increase your dose as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.

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.

To dispose of the Secuado® patch, fold the patch in half with the sticky side inside. If the patch has not been used, take it out of the pouch and remove the liner that covers the sticky side of the patch before folding it in half. Ask your pharmacist about the best way to dispose of patches you do not use. Do not flush the pouch or the protective liner down the toilet. Put them in a trash can.

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.

This medicine may cause serious 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.

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.

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.

Heat can cause the asenapine in the patch to be absorbed into your body faster. This may increase the chance of serious side effects or an overdose. While you are using this medicine, do not use a heating pad, electric blanket, heat or tanning lamps, sauna, a sunlamp, or a heated water bed, and do not sunbathe, or take long baths or showers in hot water.

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:

Less common

Abdominal or stomach pain

blurred vision

dry mouth

flushed, dry skin

fruit-like breath odor

inability to move the eyes

increased blinking or spasms of the eyelid

increased hunger

increased thirst

increased urination

nausea

sticking out of the tongue

sweating

trouble breathing, speaking, or swallowing

uncontrolled twisting movements of the neck, trunk, arms, or legs

unexplained weight loss

unusual facial expressions

vomiting

Incidence not known

Black, tarry stools

chest pain

chills

cold sweats

confusion

convulsions

cough or hoarseness

difficulty in moving

dizziness, faintness, or lightheadedness when getting up from lying or sitting position

fainting

fast, pounding, or irregular heartbeat or pulse

fever with or without chills

high fever

high or low blood pressure

hives, itching, skin rash

joint pain

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

lip smacking or puckering

loss of bladder control

lower back or side pain

muscle aching or cramping

muscle pains or stiffness

painful or difficult urination

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

rapid or worm-like movements of the tongue

severe muscle stiffness

sore throat

sores, ulcers, or white spots on the lips or in the mouth

swollen glands

swollen joints

tightness in the chest

tiredness

uncontrolled chewing movements

uncontrolled movements of the arms and legs

unusual bleeding or bruising

unusual tiredness or weakness

unusually pale skin

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

Difficulty having a bowel movement (stool)

difficulty in speaking

drooling

loss of balance control

muscle trembling, jerking, or stiffness

redness, itching, or swelling of the skin where the patch is applied

restlessness

shuffling walk

stiffness of the limbs

Less common

Acid or sour stomach

belching

diarrhea

heartburn

increased appetite

indigestion

sleepiness or unusual drowsiness

stomach discomfort, upset, or pain

stuffy or runny nose

Incidence not known

Dry mouth

lack or loss of strength

swelling of breasts or unusual milk production

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.