Asenapine

ASENAPINE MALEATE

Manufacturer: Breckenridge Pharmaceutical, Inc.

Score: 144.0

Quick Summary

Asenapine is an atypical antipsychotic used for the treatment of schizophrenia and bipolar I disorder. It is available in sublingual tablet form and should be placed under the tongue, where it dissolves within seconds. The recommended dose is 5 mg twice daily for schizophrenia and 5-10 mg twice daily for bipolar I disorder. Asenapine has several important safety considerations, including a boxed warning for increased mortality in elderly patients with dementia-related psychosis, and contraindications for patients with severe hepatic impairment and a history of hypersensitivity reactions. Common adverse reactions include akathisia, oral hypoesthesia, and somnolence.

Key Clinical Findings and Indications

Treatment of schizophrenia in adults
Treatment of bipolar I disorder, including acute manic or mixed episodes and maintenance monotherapy
Adjunctive treatment to lithium or valproate in adults with bipolar I disorder

Important Safety Information

Warning

Increased mortality in elderly patients with dementia-related psychosis

Contraindications

Severe hepatic impairment (Child-Pugh C)
History of hypersensitivity reactions to asenapine

Adverse Reactions

Akathisia
Oral hypoesthesia
Somnolence
Dizziness
Extrapyramidal symptoms
Increased weight

Dosing Recommendations

General Guidance

Dose adjustments may be necessary in patients with hepatic impairment or when co-administered with certain other medications

Schizophrenia

Adult Dose

5 mg twice daily

Pediatric Dose

Not established

Bipolar I disorder

Adult Dose

5-10 mg twice daily

Pediatric Dose

2.5-10 mg twice daily (ages 10-17)

Special Population Considerations

Pregnancy

Pregnancy exposure registry available
Studies have not been conducted in pregnant women
Neonates exposed to antipsychotic drugs during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms

Nursing Mothers

It is not known whether asenapine is excreted in human milk

Pediatric Use

Safety and efficacy in pediatric patients under 10 years of age have not been established
Pediatric patients aged 10-17 years may be more sensitive to dystonia with initial dosing

Geriatric Use

Clinical studies did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients
Elderly patients with dementia-related psychosis are at increased risk of death compared to placebo

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