Asenapine Transdermal Patch

What is Asenapine Transdermal Patch?

• Asenapine Transdermal Patch (Secuado) is an atypical antipsychotic used for the treatment of adults with schizophrenia.

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What are the uses of this medicine?

• Asenapine Transdermal Patch (Secuado) is used for the treatment of adults with schizophrenia.

How does this medicine work?

• Asenapine (a sen' a peen) is a second generation antipsychotic agent which appears to act as a dopamine type 2 (D2) and serotonin (5-HT)-2A receptor antagonist.
• Maximum asenapine concentrations are typically reached between 12 and 24 hours, with sustained concentrations during wear time (24 hours). Following Secuado removal, the apparent elimination half-life is approximately 30 hours.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Severe hepatic impairment
• A history of hypersensitivity reactions to asenapine or any components of the transdermal system.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• alpha blockers such as doxazosin (Cardura), prazosin (Minipress), and terazosin
• angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril, enalapril (Vasotec, in Vaseretic), fosinopril, lisinopril (Prinivil, in Zestoretic), moexipril, perindopril (Aceon, in Prestalia), quinapril (Accupril, in Quinaretic), ramipril (Altace), and trandolapril (Mavik, in Tarka)
• angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi, in Edarbyclor), candesartan (Atacand, in Atacand HCT), eprosartan (Teveten), irbesartan (Avapro, in Avalide), losartan (Cozaar, in Hyzaar), olmesartan (Benicar, in Azor, in Benicar HCT, in Tribenzor), telmisartan (Micardis, in Micardis HCT, in Twynsta), and valsartan (in Exforge HCT)
• beta blockers such as atenolol (Tenormin, in Tenoretic), labetalol (Trandate), metoprolol (Lopressor, Toprol XL, in Dutoprol), nadolol (Corgard, in Corzide), and propranolol (Inderal, InnoPran)
• certain antibiotics including ciprofloxacin (Cipro), enoxacin (not available in the U.S.), gatifloxacin (Tequin) (not available in the U.S.), and moxifloxacin (Avelox)
• antihistamines
• certain medications for irregular heartbeat such as amiodarone (Cordarone, Pacerone), procainamide, quinidine, and sotalol (Betapace, Sorine)
• diuretics ('water pills')
• fluvoxamine (Luvox)
• medications for glaucoma, inflammatory bowel disease, motion sickness, myasthenia gravis, Parkinson's disease, ulcers, or urinary problems medications for mental illness such as chlorpromazine (Thorazine), thioridazine, and ziprasidone (Geodon)
• paroxetine (Paxil, Pexeva)

Is this medicine FDA approved?

• A transdermal formulation of asenapine was approved in the United States in October 2019 under the brand name Secuado.

How should this medicine be used?

Recommended dosage:

• The recommended starting dose of Secuado is 3.8 mg/24 hours.
• May increase dosage to 5.7 mg/24 hours or 7.6 mg/24 hours after one week.

Administration:

• Transdermal asenapine comes as a patch to apply to the skin.
• For transdermal use only.
• Apply one Secuado transdermal system every 24 hours.
• Apply the asenapine patch at around the same time each day.
• Your doctor will probably start you on a low dose of asenapine and gradually increase your dose, not more often than once a week.
• Apply Secuado to one of the following sites: the hip, abdomen, upper arm, or upper back area.
• If your skin is irritated or burns after you apply an asenapine patch, remove the patch and apply a new patch to a different area.
• After you apply an asenapine patch, you should wear it all the time until you are ready to remove it and put on a new patch.
• If the patch loosens before it is time to replace it, try to press it back in place with your fingers.
• If the patch cannot be pressed back on or falls off, dispose of it and apply a new patch to a different area.
• However, you should remove the new patch at the time that you were scheduled to remove the original patch.
• While you are wearing an asenapine patch, protect the patch from direct heat such as heating pads, electric blankets, hair dryers, heat lamps, saunas, hot tubs, and heated water beds.
• You may shower while you are wearing an asenapine patch, but do not take a bath or go swimming.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Transdermal System: 3.8 mg/24 hours, 5.7 mg/24 hours and 7.6 mg/24 hours

This medicine is available in fallowing brand namesː

• Secuado

What side effects can this medication cause?

The most common side effects of this medicine include:

• Extrapyramidal disorder, application site reaction, and weight gain

Additional side effects may include:

• Constipation
• Dyspepsia
• Diarrhea
• Blood glucose increased
• Weight Increased
• Hepatic enzyme increased
• Infections and Infestations
• Nasopharyngitis
• Upper respiratory tract infection
• Metabolism and nutrition disorders
• Increased appetite
• Headache
• Extrapyramidal symptoms
• Akathisia
• Somnolence
• Dystonia
• Vascular Disorders
• Hypertension

What special precautions should I follow?

• Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Secuado is not approved for the treatment of patients with dementia-related psychosis.
• Secuado is not approved for the treatment of patients with dementia-related psychosis.
• A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with administration of antipsychotic drugs. If NMS is suspected, immediately discontinue Secuado and provide intensive symptomatic treatment and monitoring.
• Tardive dyskinesia, a syndrome of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs, including Secuado. If signs and symptoms of tardive dyskinesia appear in a patient on Secuado, drug discontinuation should be considered. However, some patients may require treatment with Secuado despite the presence of the syndrome.
• Atypical antipsychotic drugs, including Secuado, have caused metabolic changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and body weight gain.
• Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics. Assess fasting plasma glucose before or soon after initiation of antipsychotic medication, and monitor periodically during long-term treatment.
• Atypical antipsychotics cause adverse alterations in lipids. Before or soon after initiation of antipsychotic medication, obtain a fasting lipid profile at baseline and monitor periodically during treatment.
• Weight gain has been observed with atypical antipsychotic use, including Secuado. Monitor weight at baseline and frequently thereafter.
• Hypersensitivity reactions have been observed in patients treated with asenapine, including Secuado.
• Atypical antipsychotics cause orthostatic hypotension and syncope. Generally, the risk is greatest during initial dose titration and when increasing the dose. Monitoring of orthostatic vital signs should be considered in all such patients, and a dose reduction should be considered if hypotension occurs.
• Secuado may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries. Complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy.
• Events of leukopenia and neutropenia have been reported temporally related to antipsychotic agents, including asenapine. Monitor patients with clinically significant neutropenia for fever or other symptoms or signs of infection and treat promptly if such symptoms or signs occur. Discontinue Secuado in patients with severe neutropenia (absolute neutrophil count <1000/mm3) and follow their WBC until recovery.
• Increases in QT interval is observed. Avoid use with drugs that also increase the QT interval and in patients with risk factors for prolonged QT interval.
• Like other drugs that antagonize dopamine D2 receptors, Secuado can elevate prolactin levels, and the elevation can persist during chronic administration.
• As with other antipsychotic drugs, Secuado should be used with caution in patients with a history of seizures or with conditions that potentially lower the seizure threshold. Conditions that lower the seizure threshold may be more prevalent in patients 65 years or older.
• Secuado, like other antipsychotics, has the potential to impair judgment, thinking or motor skills. Patients should be cautioned about operating hazardous machinery, including motor vehicles, until they are reasonably certain that Secuado therapy does not affect them adversely.
• Atypical antipsychotics may disrupt the body’s ability to reduce core body temperature. Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use Secuado with caution in patients who may experience these conditions.
• Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Secuado and other antipsychotic drugs should be used cautiously in patients at risk for aspiration.
• When heat is applied to Secuado after application, both the rate and extent of absorption are increased. Advise patients to avoid exposing Secuado to direct external heat sources such as hair dryers, heating pads, electric blankets, heated water beds, etc., while wearing Secuado.
• Local skin reactions, such as irritation, were reported with Secuado. Instruct patients to select a different application site each day to minimize skin reactions.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• There were no reports of accidental or intentional acute overdosage of Secuado.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• There is no specific antidote to Secuado.
• The possibility of multiple drug involvement should be considered.
• An electrocardiogram should be obtained and management of overdose should concentrate on supportive therapy, maintaining an adequate airway, oxygenation and ventilation, and management of symptoms.
• Hypotension and circulatory collapse should be treated with appropriate measures, such as intravenous fluids and/or sympathomimetic agents (epinephrine and dopamine should not be used, since beta stimulation may worsen hypotension in the setting of Secuado-induced alpha blockade).
• In case of severe extrapyramidal symptoms, anticholinergic medication should be administered.
• Close medical supervision and monitoring should continue until the patient recovers.

Can this medicine be used in pregnancy?

• Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms.
• Studies have not been conducted with Secuado in pregnant women.
• There are no available human data informing the drug-associated risk.
• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including Secuado, during pregnancy. For more information contact the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388.

Can this medicine be used in children?

• Safety and effectiveness of Secuado in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active Ingredient:

• Asenapine

Inactive Ingredients:

• alicyclic saturated hydrocarbon resin, butylated hydroxytoluene, isopropyl palmitate, maleate salts (monosodium maleate and disodium maleate), mineral oil, polyester film backing, polyisobutylene, silicone-treated polyester release liner, sodium acetate anhydrous, and styrene-isoprene-styrene block copolymer.

Who manufactures and distributes this medicine?

Manufactured by:

• Hisamitsu Pharmaceutical Co., Inc., Tashirodaikan-machi, Tosu, Saga, Japan, Hisamitsu Pharmaceutical Co., Inc. All rights reserved.

Distributed by:

• Noven Therapeutics, LLC, Miami, Florida USA

• Secuado is a registered trademark of Hisamitsu Pharmaceutical Co., Inc.

What should I know about storage and disposal of this medication?

• Store Secuado patches at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Secuado patches and all medicines out of the reach of children.

Antipsychotic agents

First Generation

• Phenothiazines
  • Chlorpromazine, Fluphenazine, Perphenazine, Prochlorperazine, Thioridazine, Trifluoperazine

• Other
  • Haloperidol, Lithium, Loxapine, Molindone, Pimozide

Second Generation (Atypicals)

• Aripiprazole, Asenapine, Brexpiprazole, Cariprazine, Clozapine, Iloperidone, Lurasidone, Olanzapine, Paliperidone, Pimavanserin, Quetiapine, Risperidone, Ziprasidone

• Dailymed label info on Asenapine Transdermal Patch
• FDA Asenapine Transdermal Patch

Asenapine Transdermal Patch Resources
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