MODAFIN

What it is

MODAFIN is a wakefulness-promoting agent for oral administration. MODAFIN tablet contains 100 mg of modafinil. MODAFIN tablet is white to off-white colour, capsule shape, biconvex, uncoated tablets with 'L233' debossed on one side and plain on other side.

Approved indications

— To improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy. — To treat excessive sleepiness associated with moderate to severe chronic shift work sleep disorder where nonpharmacological interventions are unsuccessful or inappropriate. — As an adjunct to continuous positive airways pressure (CPAP) in obstructive sleep apnoea/hypopnoea syndrome in order to improve wakefulness.

Dosing overview

In patients with severe hepatic impairment, the dose of modafinil should be reduced to one-half of that recommended for patients with normal hepatic function. In elderly patients, elimination of modafinil and its metabolites may be reduced as a consequence of aging, and consideration should be given to the use of lower doses in this population.

Key safety warnings

Serious rash requiring hospitalisation and discontinuation of treatment has been reported in association with modafinil use, including rare cases of Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, and Drug Rash with Eosinophilia and Systemic Symptoms in adults and children in post-marketing experience. Nearly all cases of serious rash associated with modafinil occurred within 1 to 5 weeks after treatment initiation, although isolated cases have been reported after prolonged treatment. Modafinil should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug-related. Multi-organ hypersensitivity reactions have occurred in close temporal association to the initiation of modafinil and may result in hospitalisation or be life-threatening. Patients typically presented with fever and rash associated with other organ system involvement, with associated manifestations including myocarditis, hepatitis, liver function test abnormalities, and haematological abnormalities. Psychiatric adverse experiences have been reported in patients treated with modafinil, and patients should be monitored for the development of new psychiatric disorders or exacerbation of pre-existing psychiatric disorders at every adjustment of dose and regularly during treatment. The onset or worsening of aggressive or hostile behaviour has been reported in patients treated with modafinil, and patients should be carefully monitored for the appearance or worsening of such behaviour. Suicidal ideation and suicide-related behaviour have been reported in patients treated with modafinil, and patients should be carefully monitored for the appearance or worsening of suicidal thinking and behaviour. In hypertensive patients, blood pressure should be adequately controlled before initiating treatment with modafinil and monitored regularly during treatment, and blood pressure, heart rate and general cardiovascular status should be monitored in all patients during treatment. It is recommended that modafinil not be used in patients with a history of left ventricular hypertrophy or ischaemic ECG changes, chest pain, arrhythmia or other clinically significant manifestations of mitral valve prolapse in association with central nervous system stimulant use. Based on human experience, modafinil is suspected to cause congenital malformations and spontaneous abortion when administered during pregnancy, and females of reproductive potential should have a negative pregnancy test within a week prior to starting treatment and sexually active women of child-bearing potential should be established on a contraceptive program before taking modafinil. The effectiveness of steroidal contraceptives may be reduced when used with modafinil and alternative or concomitant methods of contraception must be used for patients treated with modafinil and for two months after discontinuation of treatment.

Contraindications

Hypersensitivity to modafinil or any other component of the product. Modafinil is contraindicated in pregnancy.

PBS listing

MODAFIN 100 mg tablet is listed on the PBS with one item, authority required restriction, and an ex-manufacturer price of A$48.37.

Regulatory history

MODAFIN modafinil 100 mg tablet was first registered on the Australian Register of Therapeutic Goods on 20 November 2015.