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Alfaxalone

Pharmacology

Clinical Particulars

Regulatory Class

Alfaxalone (3α-hydroxy-5α-pregnane-11, 20-dione) is a neuroactive steroid with anaesthetic properties and a wide margin of safety. It is a positive allosteric modulator of GABA-A receptors and, at high concentrations, a direct agonist of the GABA-A receptor. Alfaxalone produces significant neuro-depression and muscular relaxation at clinical doses but lacks analgesia (Albertson et al., 1992; Harrison and Simmonds, 1984).

Pharmacodynamics

Pharmacokinetics

Mechanism of Action

The primary mechanism for Alfaxalone's anaesthetic action is the modulation of neuronal cell-membrane chloride-ion transport induced by its binding to GABA cell surface receptors (Albertson et al., 1992; Harrison and Simmonds, 1984).

Summary of Applications

There are a variety of potential applications; Alfaxalone (alfaxalone or alfaxalone) is a neuroactive steroid, general anaesthetic induction agent, injectable anaesthetic, multimodal anaesthesia component, and animal sedative.

  • Authorised Species: Alfaxalone is used in veterinary practice and is licensed for use in rabbits, dogs and cats (SPC data).

  • Unauthorised Species: Alfaxalone is legally marketed as an unapproved agent in specific countries for a range of minor species excluding any food‑producing species including captive reptiles, captive amphibians, ornamental fish, including species used in research such as the zebrafish, pet birds in the orders Psittaciformes, Passeriformes, and Columbiformes, non‑human primates, captive rodents, captive mustelids, captive marsupials non‑human primates and captive minor species ungulates. These are individually referenced withing species-specific dosing recommendations.

Pharmacodynamics

Administration

At the time of writing, alfaxalone is authorised for intravenous use in cats, dogs, and rabbits. However, it has been successfully administered by various routes for both anaesthesia and sedation in various veterinary species.


  • Intravenous (IV): In cats, dogs and rabbits, Alfaxalone is authorised for intravenously IV use as a bolus or via constant-rate infusion CRI) (Chiu et al., 2016; SPC data). IV use is also standard across various unauthorised species, including birds (White and Martinez-Taboada, 2019)

  • Intramuscular (IM): Cats, Dogs and rabbits are commonly sedated using intramuscular alfaxalone (Bradley et al., 2019; Murdock et al., 2020; Tamura et al., 2015). IM use is also standard across various unauthorised species, including lizards (Bertelsen and Sauer, 2011) and chelonians (Scarabelli and Di Girolamo, 2022). Often, IM use is multimodal with additional agents as described in species-specific dosing recommendation monographs.

  • Intraperitoneal (IP): Variable sedation and anaesthesia rates were observed when dosing rats with alfaxalone IP (Lau et al., 2013). However, most IP use was effective.

  • Intracoelomic (ICo):

  • Subcutaneous: Successful sole agent SC is described in bearded dragons (Doss et al., 2017; Webb et al., 2023) and snakes (Rockwell et al., 2021). Successful multimodal subcutaneous use is described in Guinea pigs (Avelino et al., 2024) and mice (Young et al., 2024).

  • Intraosseous (IO):  IO alfaxalone has been used successfully in chelonians (Scarabelli and Di Girolamo, 2022).

  • Transcutaneous: Amphibians have been anaesthetised via dermal administration of alfaxalone in a water bath (Jones, 2012; McMillan and Leece, 2011).

Biotransformation

  • Hepatic: In vitro cat and dog hepatocyte studies show Alfaxalone undergoes Phase I (cytochrome P450 dependent) and Phase II  (conjugation dependent) metabolism. Both cats and dogs form similar Phase I metabolites. Phase II metabolites differ between cats and dogs, with cats producing Alexalone sulphate and Alexalone glucuronide, while Alexalone glucuronide is observed in dogs.

Half-Life

  • Feline: Alfaxalone's mean terminal plasma elimination half-life in cats is approximately 45 minutes for a 5 mg/kg dose. Mean plasma clearance for a 5 mg/kg dose is 25.1 ± 7.6 ml/kg/minute.

  • Canine: Alfaxalone's mean terminal plasma elimination half-life in dogs is approximately 25 minutes for a 2 mg/kg dose. Plasma clearance for a 2 mg/kg dose is 59.4 ± 12.9 ml/kg/minute.

Elimination

  • Mixed Routes: Alfaxalone metabolites are eliminated from rabbits, dogs, and cats by the hepatic, faecal, and renal routes, which are expected to be similar in other species. In dogs and cats, the elimination of Alfaxalone demonstrates non-linear (dose-dependent) pharmacokinetics.

Pharmacokinetics

Precautions

Adverse Effects

  • Anaphylaxis/Hypersensitivity

  • Apnea

  • Cardiorespiratory depression

  • Excitement

  • Hepatopathy

  • Hypotension

  • Hypothermia

  • Neonates

  • Pain

Contraindications

  • Inadequate Facilities and Support: (Intubation, IPPV, O2 supply, thermal support)

Reproductive Safety

  • Pregnancy: Caesarians

  • Lactation: No Data; Only use if potential maternal benefits outweigh potential offspring risks.

  • Fertility: No data located

Potentially Significant Interactions

CNS depressants: These potentiate Alfaxan's CNS depressant effects, necessitating a reduced alfaxalone dose and/or cessation of further administration when the required depth of anaesthesia has been reached. The authorised UK product has been demonstrated to be safe when used in combination with the following premedicant classes:


  • Phenothiazines (Acepromazine)

  • Anticholinergic agents (Atropine)

  • Benzodiazepines (Diazepam, Midazolam)

  • Alpha-2-adrenoceptor agonists (Xylazine, Medetomidine)

  • Opiates (Methadone, Morphine, Butorphanol, Buprenorphine)

  • NSAIDs (Carprofen, Meloxicam)

Overdose

  • Presenting Signs: Hypoventilation Apnoea Hypotension

  • Clinical Response: Extended cardiorespiratory and thermal support.

Precautions

Availability

  • Alfaxalone Injection: 10 mg/mL in 10- and 20-mL multidose vials; approved for use in cats and dogs. 10 mg/mL in 10-mL multidose vials IDX; Marketed for use in various non-food-producing minor species, including reptiles, amphibians, ornamental fish, birds, non-human primates, rodents, mustelids, marsupials, and minor species ungulates.

Availability

Identifiers

  • Systematic Name: 11-oxo-3α,5α-tetrahydroprogesterone, 5α-pregnan-3α-ol-11,20-dione, or 3α-hydroxy-5α-pregnane-11,20-dione; 5alpha-Pregnan-3alpha-ol-11,20-dione;  Alfaxalonum [INN-Latin]

  • Formula: C21-H32-O3

  • Pharmacotherapeutic Group: Anaesthetics - Alphaxolone is a corticosteroid hormone.

  • ATC vet code: QN01AX05

  • ATC code: N01AX05

Identifiers

Evidence Base

Reference Management

Bibliography

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Evidence

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