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Asenapine Maleate

Also known as: Asenapine

Route: Sublingual

2 interactions on record⛔ Black Box Warning

Asenapine Maleate has 2 known drug interactions based on U.S. FDA drug labeling data. Notable interactions include combinations with Fluvoxamine, Paroxetine. Patients taking Asenapine Maleate should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 2
Moderate: 2

Moderate (2)

Asenapine Maleate + Fluvoxamine— Strong CYP1A2 inhibitor that increases asenapine exposure. Full therapeutic dose expected to cause greater increase in a…
Asenapine Maleate + Paroxetine— CYP2D6 substrate and inhibitor that increases paroxetine exposure 2-fold when combined with SAPHRIS. Paroxetine dose sho…

Asenapine Maleate + Fluvoxamine🟡Moderate

Strong CYP1A2 inhibitor that increases asenapine exposure. Full therapeutic dose expected to cause greater increase in asenapine exposure.

Asenapine Maleate + Paroxetine🟡Moderate

CYP2D6 substrate and inhibitor that increases paroxetine exposure 2-fold when combined with SAPHRIS. Paroxetine dose should be reduced by half.

⛔ FDA Black Box Warning

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 sublingual tablets are not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1 , 5.2) ]. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Asenapine sublingual tablets are not approved for the treatment of patients with dementia-related psychosis. ( 5.1 , 5.2 )

Contraindications

4 CONTRAINDICATIONS Asenapine sublingual tablets are contraindicated in patients with: 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) ]. Severe hepatic impairment (Child-Pugh C). ( 8.7 , 12.3 ) Known hypersensitivity to asenapine sublingual tablets, or to any components in the formulation. ( 4 , 5.6 , 17 )

Pregnancy & Breastfeeding

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asenapine sublingual tablets during pregnancy. For more information contact the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. Risk Summary 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 asenapine sublingual tablets in pregnant women. There are no available human data informing the drug-associated risk. The background risk of major birth defects and miscarriage for the indicated populations are unknown. However, the background risk in the U.S. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. No teratogenicity was observed in animal reproduction studies with intravenous administration of asenapine to rats and rabbits during organogenesis at doses 0.7 and 0.4 times, respectively, the maximum recommended human dose (MRHD) of 10 mg sublingually twice daily. In a pre- and post-natal study in rats, intravenous administration of asenapine at doses up to 0.7 times the MRHD produced increases in post-implantation loss and early pup deaths, and decreases in subsequent pup survival and weight gain [see Data ]. Advise pregnant women of the potential risk to a fetus. Clinical Considerations Fetal/Neonatal Adverse Reactions Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs during the third trimester of pregnancy. These symptoms have varied in severity. Some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. Monitor

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine, supplemented with a small number of well-established interactions from curated clinical references. For informational purposes only. Always consult your pharmacist or physician.