FLUANXOL

What it is

Fluanxol is a solution for injection containing flupentixol decanoate, available as Fluanxol Depot at 20 mg/mL. Fluanxol Concentrated Depot is also available as a concentrated injection containing 100 mg/mL flupentixol decanoate. Fluanxol Depot injection presents as a clear, colourless to slightly yellowish oil, whilst Fluanxol Concentrated Depot injection presents as a clear, yellowish to yellow oil. Flupentixol is a potent, relatively non-sedating, neuroleptic drug of the thioxanthene class.

Approved indications

— Maintenance treatment of chronic schizophrenia and other related chronic psychoses, in patients intolerant of and/or refractory to other depot preparations.

Dosing overview

Fluanxol is administered by intramuscular injection in the gluteus maximus. Patients not previously treated with long-acting depot neuroleptics should be given an initial test dose of 5 mg to 20 mg, with an initial dose of 20 mg usually well tolerated; however, a 5 mg test dose is recommended in elderly, frail and cachectic patients, and in patients whose individual or family history suggests a predisposition to extrapyramidal reactions. A second dose of 20 mg or 40 mg can be given 4 to 10 days after the initial injection, and the majority of patients can be adequately controlled by 20 to 40 mg of Fluanxol every 2 to 4 weeks. Doses greater than 100 mg/fortnight are usually not deemed necessary although higher doses have been used occasionally in some treatment-resistant patients.

Key safety warnings

Neuroleptic malignant syndrome is a rare but potentially fatal complication of the use of neuroleptic drugs, with core features including hyperthermia, muscle rigidity and fluctuating consciousness along with autonomic dysfunction such as labile blood pressure, tachycardia, and diaphoresis. Neuroleptic malignant syndrome has been reported with Fluanxol. Tardive dyskinesia may develop in some patients on long-term therapy with antipsychotic medications or may occur after therapy has been discontinued, with the risk appearing to be greater in elderly patients on high dose therapy, especially females, and the symptoms potentially irreversible in some patients. The most common adverse reaction reported with flupentixol has been extrapyramidal disorder. Extrapyramidal symptoms include hypo- and hyperkinetic states, tremors, pseudoparkinsonism, dystonia, hypertonia, akathisia, oculogyric crises and tardive dyskinesia. Flupentixol decanoate may cause QT prolongation, and persistently prolonged QT intervals may increase the risk of malignant arrhythmias. Rare cases of QT prolongation, ventricular arrhythmias including ventricular fibrillation, ventricular tachycardia, Torsade de Pointes and sudden unexplained death have been reported for flupentixol decanoate. Leukopenia, neutropenia and agranulocytosis have been reported with antipsychotics, including flupentixol. Blood dyscrasias and liver damage have been reported sporadically with this class of drugs including Fluanxol, and routine blood counts and hepatic function tests are advisable, particularly during the first months of therapy.

Contraindications

Flupentixol is contraindicated in patients with known hypersensitivity to the thioxanthenes. Flupentixol is also contraindicated in patients with known hypersensitivity to the excipient used (fractionated coconut oil) in the injection. Flupentixol is contraindicated in the presence of depressed level of consciousness due to any cause (such as intoxication with alcohol, barbiturates or opiates), circulatory collapse, coma, and suspected or established subcortical brain damage, blood dyscrasias and phaeochromocytoma.

PBS listing

Fluanxol is listed on the PBS in two strengths: oily intramuscular injection 100 mg in 1 mL with unrestricted access at an ex-manufacturer price of A$34.74, and oily intramuscular injection 20 mg in 1 mL with unrestricted access at an ex-manufacturer price of A$11.39.

Regulatory history

Fluanxol Depot (20 mg/1 mL and 40 mg/2 mL injection ampoules) and Fluanxol Concentrated Depot (100 mg/1 mL injection ampoules) were first listed on the ARTG on 10 January 1994.