Secuado

• Generic Name: asenapine transdermal system
• Brand Name: Secuado

Secuado (Asenapine Transdermal System) side effects drug center

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PROFESSIONAL

CONSUMER

SIDE EFFECTS

• Overview
• Professional Information

 

Secuado Side Effects Center

What Is Secuado?

Secuado (asenapine) is a transdermal atypical antipsychotic formulation used to treat adults with schizophrenia. Asenapine, the drug contained in Secuado, is also available as a sublingual tablet formulation under the brand name Saphris.

What Are Side Effects of Secuado?

Common side effects of Secuado include:

• headache,
• extrapyramidal disorder (muscle spasms, restlessness, muscle rigidity, slowness of movement, tremors, and irregular, jerky movements),
• application site reactions (skin discoloration, discomfort, dryness, swelling, redness, peeling, hard lump, irritation, pain, bumps, or itching), and
• weight gain

Dosage for Secuado

The recommended starting dose of Secuado is 3.8 mg/24 hours. Apply one Secuado patch to the skin (hip, abdomen, upper arm, or upper back area) every 24 hours.

Secuado In Children

The safety and effectiveness of Secuado in pediatric patients has not been established.

What Drugs, Substances, or Supplements Interact with Secuado?

Secuado may interact with other medicines such as:

• diuretics,
• ACE inhibitors,
• angiotensin receptor blockers (ARBs),
• beta-blockers,
• alpha-blockers,
• fluvoxamine,
• ciprofloxacin,
• enoxacin, and
• paroxetine

Tell your doctor all medications and supplements you use.

Secuado During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Secuado. Secuado may cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure during pregnancy. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including Secuado, during pregnancy. It is unknown if Secuado passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Secuado (asenapine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

 

Secuado Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; fast heartbeats, feeling light-headed; wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

High doses or long-term use of asenapine can cause a serious movement disorder that may not be reversible. The longer you use asenapine, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

Call your doctor at once if you have:

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• a light-headed feeling, like you might pass out;
• breast pain or swelling, nipple discharge;
• low white blood cell counts--fever, chills, mouth sores, skin sores, sore throat, cough, trouble breathing; or
• severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Common side effects may include:

• muscle stiffness, jerky muscle movements;
• weight gain; or
• skin pain, redness, itching, swelling, or other irritation where the patch was worn.

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.

Read the entire detailed patient monograph for Secuado (Asenapine Transdermal System)

 

Secuado Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in more detail in other sections of the labeling:

• Use in Elderly Patients with Dementia-Related Psychosis [WARNINGS AND PRECAUTIONS]
• Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia- Related Psychosis [see WARNINGS AND PRECAUTIONS]
• Neuroleptic Malignant Syndrome [see WARNINGS AND PRECAUTIONS]
• Tardive Dyskinesia [see WARNINGS AND PRECAUTIONS]
• Metabolic Changes [see WARNINGS AND PRECAUTIONS]
• Hypersensitivity Reactions [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS and PATIENT INFORMATION]
• Orthostatic Hypotension, Syncope, and other Hemodynamic Effects [see WARNINGS AND PRECAUTIONS]
• Falls [see WARNINGS AND PRECAUTIONS]
• Leukopenia, Neutropenia, and Agranulocytosis [see WARNINGS AND PRECAUTIONS]
• QT Interval Prolongation [see WARNINGS AND PRECAUTIONS]
• Hyperprolactinemia [see WARNINGS AND PRECAUTIONS]
• Seizures [see WARNINGS AND PRECAUTIONS]
• Potential for Cognitive and Motor Impairment [see WARNINGS AND PRECAUTIONS]
• Body Temperature Regulation [see WARNINGS AND PRECAUTIONS]
• Dysphagia [see WARNINGS AND PRECAUTIONS]
• External Heat [see WARNINGS AND PRECAUTIONS]
• Application Site Reactions [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of SECUADO was evaluated in a total of 315 adult patients diagnosed with schizophrenia who were exposed to SECUADO for up to 6 weeks in a placebo-controlled trial.

Adverse Reactions Leading To Discontinuation Of Treatment

A total of 4.9% (10/204) patients treated with SECUADO 3.6 mg/24 hours, 7.8% (16/204) patients treated with SECUADO 7.8 mg/24 hours, and 6.8% (14/206) patients on placebo discontinued due to adverse reactions in the placebo-controlled trial. The adverse reaction that most commonly led to discontinuation among SECUADO-treated patients in this trial was akathisia, which was led to discontinuation in no (0/204) patients treated with SECUADO 3.6 mg/24 hours, 1.5% (3/204) patients treated with SECUADO 7.8 mg/24 hours, and 0.5% (1/206) patients on placebo.

Commonly Observed Adverse Reactions

The most common adverse reactions (≥5% and at least twice the rate of placebo) reported in adult patients with schizophrenia treated with SECUADO in the placebo-controlled trial were extrapyramidal disorder, application site reaction, and weight gain.

Adverse Reactions Occurring At An Incidence Of 2% Or More In SECUADO-Treated Patients.

Adverse reactions associated with the use of SECUADO (incidence of ≥2%, rounded to the nearest percent, and SECUADO incidence greater than placebo) that occurred during the placebo-controlled trial are shown in Table 5.

Table 5: Adverse Reactions in ≥ 2% of Patients in Any SECUADO Dose Group and Which Occurred at Greater Incidence Than in the Placebo Group in 6-Week Schizophrenia Trials

System Organ Class Preferred Term	Placebo	SECUADO
	N = 206 (%)	3.8 mg/24 hrs N = 204 (%)	7.6 mg/24 hrs N = 204 (%)
Gastrointestinal disorders
Constipation	4	5	4
Dyspepsia	1	1	3
Diarrhea	1	3	1
General Disorders
Application Site Reactions*	4	15	14
Investigations
Blood glucose increased*	1	3	1
Weight Increased	2	4	6
Hepatic enzyme increased*	0	2	2
Infections and Infestations
Nasopharyngitis	2	3	1
Upper respiratory tract infection	2	3	1
Metabolism and nutrition disorders
Increased appetite	0	3	1
Nervous System Disorders
Headache	6	9	9
Extrapyramidal symptoms*	2	8	13
Akathisia	2	4	4
Somnolence*	1	4	3
Dystonia	0	1	3
Vascular Disorders
Hypertension*	1	2	2
* The following terms were combined: Application site reactions includes application site dermatitis, discoloration, discomfort, dryness, edema, erythema, exfoliation, induration, irritation, pain, papules, pruritis, and reaction. Blood glucose increased includes blood glucose increased, blood insulin increased, glycosylated hemoglobin increased, hyperglycemia, Type 2 diabetes mellitus, diabetes mellitus, and hyperinsulinemia. Hepatic enzyme increased includes hepatic enzyme increased, alanine aminotransferase increased, aspartate aminotransferase increased, and gamma-glutamyltransferase increased. Extrapyramidal symptoms includes dyskinesia, dystonia, extrapyramidal disorder, parkinsonism. tardive dyskinesia, muscle spasm, and musculoskeletal stiffness. Somnolence includes somnolence, sedation, lethargy, and hypersomnia. Hypertension includes hypertension, blood pressure increased, diastolic hypertension, and hypertensive crisis.

Dose-Related Adverse Reactions

In the placebo-controlled schizophrenia trial, the incidence of an extrapyramidal disorder and weight increased appear to be dose-related (see Table 5).

Dystonia:

Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups [CLINICAL PHARMACOLOGY].

Extrapyramidal Symptoms:

In the short-term, placebo-controlled schizophrenia adult trial, data were objectively collected on the Simpson Angus Rating Scale for extrapyramidal symptoms (EPS), the Barnes Akathisia Scale (for akathisia) and the Assessments of Involuntary Movement Scales (for dyskinesias). The mean change from baseline for the SECUADO 3.8 mg/24 hours or 7.6 mg/24 hours treated group was similar to placebo in each of the rating scale scores.

In the short-term, placebo-controlled schizophrenia adult trial, the incidence of reported extrapyramidal disorder events, excluding events related to akathisia, was 7.8% for patients treated with SECUADO 3.6 mg/24 hours, 12.8% for patients treated with SECUADO 7.8 mg/24 hours SECUADO and 2.4% for placebo-treated patients; and the incidence of akathisia-related events was 3.9% for patients treated with SECUADO 3.6 mg/24 hours, 4.4% for patients treated with SECUADO 7.8 mg/24 hours and 2.4% for placebo-treated patients.

Laboratory Test Abnormalities

Transaminases

Transient elevations in serum transaminases (primarily ALT) were more common in SECUADO-treated patients. The mean increase in ALT levels for SECUADOtreated patients was 6.0 units/L and 3.8 units/L for the SECUADO 3.8 mg/24 hours and 7.6 mg/24 hours treated groups, respectively, compared to a decrease of 1.1 units/L for placebotreated patients. The proportion of patients with ALT elevations ≥3 times ULN (at any time) was 1.6% and 3.1% for patients treated with SECUADO 3.8 mg/24 hours and 7.6 mg/24 hours, respectively, and 0% for placebo-treated patients.

In a 52-week, double-blind, comparator-controlled trial that included primarily adult patients with schizophrenia, the mean increase from baseline of ALT was 1.7 units/L for sublingual asenapine.

Prolactin

The proportion of patients with prolactin elevations ≥4 times ULN (at Endpoint) were 0.0% and 1.3% for patients treated with SECUADO 3.8 mg/24 hours and 7.8 mg/24 hours, respectively, as compared to 2.4% for placebo-treated patients in the short-term placebocontrolled trial.

In a long-term (52-week), double-blind, comparator-controlled adult trial that included primarily patients with schizophrenia, the mean decrease in prolactin from baseline for sublingual asenapine-treated patients was 26.9 ng/mL.

Creatine Kinase (CK)

The proportion of adult patients with CK elevations ≥3 times ULN at any time were 1.6% and 2.1% for patients treated with SECUADO 3.8 mg/24 hours and 7.6 mg/24 hours, respectively, as compared to 1.5% for placebo-treated patients in the short-term, placebocontrolled trial. The clinical relevance of this finding is unknown.

Other Adverse Reactions Observed During The Premarketing Evaluation Of SECUADO

Other adverse reactions (<2% frequency) within the 6-week placebo-controlled trial in patients with schizophrenia are listed below. The reactions listed are those that could be of clinical importance, as well as reactions that are plausibly drug-related on pharmacologic or other grounds. Reactions that appear elsewhere in the SECUADO label are not included.

Gastrointestinal disorders: vomiting, dry mouth

General disorders and administration site conditions: asthenia

Musculoskeletal and connective tissue disorders: myalgia

Other Adverse Reactions Reported In Clinical Trials With Sublingual Asenapine

Following is a list of MedDRA terms that reflect adverse reactions reported by patients treated with sublingual asenapine at multiple doses of ≥5 mg twice daily during any phase of a trial within the database of adult patients. The reactions listed are those that could be of clinical importance, as well as reactions that are plausibly drug-related on pharmacologic or other grounds. Reactions already listed for adult patients in other parts of ADVERSE REACTIONS, or those considered in CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS or OVERDOSE are not included. Reactions are further categorized by MedDRA system organ class and listed in order of decreasing frequency according to the following definitions: those occurring in at least 1/100 patients (frequent) (only those not already listed in the tabulated results from placebocontrolled trials appear in this listing); those occurring in 1/100 to 1/1000 patients (infrequent); and those occurring in fewer than 1/1000 patients (rare).

Blood and lymphatic disorders: infrequent: anemia; rare: thrombocytopenia

Cardiac disorders: infrequent: temporary bundle branch block

Eye disorders: infrequent: accommodation disorder

Gastrointestinal disorders: infrequent: swollen tongue

General disorders: rare: idiosyncratic drug reaction

Investigations: infrequent: hyponatremia

Nervous system disorders: infrequent: dysarthria

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of sublingual asenapine and are possible with SECUADO treatment. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to establish a causal relationship to drug exposure.

• Choking has been reported by patients, some of whom may have also experienced oropharyngeal muscular dysfunction.

DRUG INTERACTIONS

Drugs Having Clinically Important Drug Interactions With SECUADO

Table 6: Clinically Important Drug Interactions with SECUADO

Antihypertensive Drugs
Clinical Implication	Because of its α1-adrenergic antagonism with potential for inducing hypotension, SECUADO may enhance the effects of certain antihypertensive agents [see WARNINGS AND PRECAUTIONS].
Prevention or Management:	Monitor blood pressure and adjust dosage of antihypertensive drug accordingly.
Examples:	Diuretics, ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers, Alpha-blockers
Strong CYP1A2 Inhibitors
Clinical Implication	Asenapine is metabolized by CYP1A2. Concomitant use of SECUADO with a CYP1A2 inhibitor increases AUC and Cmax of asenapine [see CLINICAL PHARMACOLOGY].
Prevention or Management:	Dosage reduction for SECUADO based on clinical response may be necessary.
Examples:	Fluvoxamine, ciprofloxacin, enoxacin
CYP2D6 substrates and inhibitors
Clinical Implication	Asenapine may enhance the inhibitory effects of paroxetine on its own metabolism by CYP2D6. Concomitant use of SECUADO with paroxetine increases paroxetine AUC and Cmax [see CLINICAL PHARMACOLOGY].
Prevention or Management:	Reduce paroxetine dose by half when paroxetine is used in combination with SECUADO.
Examples:	Paroxetine

Drug Abuse And Dependence

Controlled Substance

SECUADO is not a controlled substance.

Abuse

SECUADO has not been systematically studied in animals or humans for its abuse potential or its ability to induce tolerance or physical dependence. Thus, it is not possible to predict the extent to which a CNS-active drug will be misused, diverted and/or abused once it is marketed. Patients should be evaluated carefully for a history of drug abuse, and such patients should be observed carefully for signs that they are misusing or abusing SECUADO (e.g., drug-seeking behavior, increases in dose).

Read the entire FDA prescribing information for Secuado (Asenapine Transdermal System)

&Copy; Secuado Patient Information is supplied by Cerner Multum, Inc. and Secuado Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.