ASENAPINE

ASENAPINE- asenapine tablet
Sigmapharm Laboratories, LLC

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Asenapine is not approved for the treatment of patients with dementia –related psychosis. [see Warnings and Precautions ( 5.1, 5.2)] .

1 INDICATIONS AND USAGE

Asenapine sublingual tablet(s) is indicated for:

  • Bipolar I disorder [see Clinical Studies ( 14.2)]
    • Adjunctive treatment to lithium or valproate in adults

2 DOSAGE AND ADMINISTRATION

2.1 Administration Instructions

Asenapine sublingual tablet(s) is a sublingual tablet. To ensure optimal absorption, patients should be instructed to place the tablet under the tongue and allow it to dissolve completely. The tablet will dissolve in saliva within seconds. Asenapine sublingual tablet(s) should not be split, crushed, chewed, or swallowed [see Clinical Pharmacology ( 12.3)] . Patients should be instructed to not eat or drink for 10 minutes after administration [see Clinical Pharmacology ( 12.3)] .

2.3 Bipolar I Disorder

Acute Treatment of Manic or Mixed Episodes:

The recommended starting dose of Asenapine sublingual tablet(s) is 5 mg twice daily when administered as adjunctive therapy with either lithium or valproate. Depending on the clinical response and tolerability in the individual patient, the dose can be increased to 10 mg twice daily. The safety of doses above 10 mg twice daily as adjunctive therapy with lithium or valproate has not been evaluated in clinical trials. Adjunctive Therapy in Adults: The recommended starting dose of Asenapine sublingual tablet(s) is 5 mg twice daily when administered as adjunctive therapy with either lithium or valproate. Depending on the clinical response and tolerability in the individual patient, the dose can be increased to 10 mg twice daily. The safety of doses above 10 mg twice daily as adjunctive therapy with lithium or valproate has not been evaluated in clinical trials.

For patients on asenapine, used as adjunctive therapy with lithium or valproate, it is generally recommended that responding patients continue treatment beyond the acute episode.

3 DOSAGE FORMS AND STRENGTHS

  • Asenapine sublingual tablets, 5 mg, black cherry flavor, are White, Round, FFBE Tablets, debossed “Σ” on one side and “16” on the other side.
  • Asenapine sublingual tablets, 10 mg, black cherry flavor, are White, Round, FFBE Tablets, debossed “Σ” on one side and “17” on the other side.

4 CONTRAINDICATIONS

Asenapine is contraindicated in patients with:

  • Severe hepatic impairment (Child-Pugh C) [see Specific Populations ( 8.7), Clinical Pharmacology ( 12.3)]. Severe hepatic impairment (Child-Pugh C) [see Specific Populations ( 8.7), Clinical Pharmacology ( 12.3)].
  • A history of hypersensitivity reactions to asenapine. Reactions have included anaphylaxis, angioedema, hypotension, tachycardia, swollen tongue, dyspnea, wheezing and rash [see Warnings and Precautions ( 5.6), Adverse Reactions ( 6)]. A history of hypersensitivity reactions to asenapine. Reactions have included anaphylaxis, angioedema, hypotension, tachycardia, swollen tongue, dyspnea, wheezing and rash [see Warnings and Precautions ( 5.6), Adverse Reactions ( 6)].

5 WARNINGS AND PRECAUTIONS

5.1 Increased Mortality in Elderly Patients with Dementia-Related Psychosis

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group.

Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Asenapine is not approved for the treatment of patients with dementia-related psychosis Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Asenapine is not approved for the treatment of patients with dementia-related psychosis [see Boxed Warning and Warnings and Precautions ( 5.2)].

5.2 Cerebrovascular Adverse Events, Including Stroke, In Elderly Patients with Dementia-Related Psychosis

In placebo-controlled trials in elderly subjects with dementia, patients randomized to risperidone, aripiprazole, and olanzapine had a higher incidence of stroke and transient ischemic attacks, including fatal stroke. Asenapine is not approved for the treatment of patients with dementia-related psychosis [see Boxed Warning and Warnings and Precautions ( 5.1)].

5.3 Neuroleptic Malignant Syndrome

A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with administration of antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, delirium and autonomic instability. Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. If NMS is suspected, immediately discontinue asenapine and provide intensive symptomatic treatment and monitoring.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.