Last update June 15, 2022

Asenapine Maleate

Likely Compatibility

Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.

Atypical or second generation antipsychotic used in the treatment of schizophrenia and bipolar disorder. Sublingual administration twice daily.

Since the last update we have not found published data on its excretion in breastmilk.

Its pharmacokinetic data (very high percentage of protein binding and very wide volume of distribution) make it highly unlikely that significant quantities will pass into breast milk.

Its practically zero oral bioavailability makes it difficult for it to pass to the infant plasma from ingested breast milk, except in premature infants and in the immediate neonatal period in which there may be greater intestinal permeability.

Clozapine has little or no significant effect on prolactin levels. (Peuskens 2014, Citrome 2014)

Until more published data is known about this drug in relation to breastfeeding, known safer alternatives are preferable (Klinger 2013), especially during the neonatal period and in the event of prematurity.


See below the information of this related product:

Alternatives

  • Olanzapine (Safe substance and/or breastfeeding is the best option.)
  • Quetiapine Fumarate (Safe substance and/or breastfeeding is the best option.)
  • Risperidone (Safe substance and/or breastfeeding is the best option.)

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

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Other names

Asenapine Maleate in other languages or writings:

Groups

Asenapine Maleate belongs to these groups or families:

Tradenames

Main tradenames from several countries containing Asenapine Maleate in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. subling: 35; oral: <2% %
Molecular weight 402 daltons
Protein Binding 95 %
VD 20 - 25 l/Kg
Tmax 0.5 - 1.5 hours
T½ 24 hours

References

  1. FDA. Asenapine. Org Summary. 2017 Full text (in our servers)
  2. EMA Asenapina Ficha técnica 2015 Full text (in our servers)
  3. Peuskens J, Pani L, Detraux J, De Hert M. The effects of novel and newly approved antipsychotics on serum prolactin levels: a comprehensive review. CNS Drugs. 2014 May;28(5):421-53. Abstract Full text (link to original source)
  4. Citrome L. Asenapine review, part II: clinical efficacy, safety and tolerability. Expert Opin Drug Saf. 2014 Jun;13(6):803-30. Abstract
  5. Klinger G, Stahl B, Fusar-Poli P, Merlob P. Antipsychotic drugs and breastfeeding. Pediatr Endocrinol Rev. 2013 Mar-Apr;10(3):308-17. Review. Abstract
  6. Bartlett JA, van der Voort Maarschalk K. Understanding the oral mucosal absorption and resulting clinical pharmacokinetics of asenapine. AAPS PharmSciTech. 2012 Abstract Full text (in our servers)

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