EMA issues warning that Noxafil tablets and oral suspension not interchangeable
June 27 2016
The tablet and oral suspension preparations of Noxafil (posaconazole) are not interchangeable, the European Medicines Agency has warned. Due to the formulations not having the same pharmacokinetics, there are concerns that patients may be receiving an ineffective dose or overdose if there has been a change from the prescribed formulation.
EMA issued the warning on Friday saying that Noxafil is available as 100mg tablets or as a 40mg/ml oral suspension. The drug is indicated for a number of fungal infections where other antifungal agents are ineffective or not suitable for use, and for prophylactic use in certain other circumstances.
“The recommended oral dosage is 300 mg once a day with the tablets (after a loading dose of 300 mg twice daily on day 1) and 200 mg three to four times a day (600 to 800 mg daily) with the oral suspension,” said EMA. “Medication errors have been reported following erroneous switching, resulting in over or under-dosage and consequent dose-related toxicity or lack of efficacy.
“It is important that the dosage form as well as the relevant dose be specified on the prescription, and that pharmacists ensure the correct oral dosage form is dispensed.”
EMA has said that the Summary of Product Characteristics (SmPC) and patient information leaflet (PIL) for Noxafil are being updated to strengthen warnings about the differences between the two formulations. In addition, “the outer cartons will be revised to further differentiate the two and to include a warning statement that they cannot be simply substituted without adjusting the dose.”
It will be writing to health professionals to remind them of the issue.