Direct healthcare professional communication on the non-interchangeability of Noxafil (posaconazole) tablet and oral suspension
24.08.2016
Merck Sharp & Dohme Limited, in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and the European Medicines Agency (EMA), has informed healthcare professionals of the non-interchangeability of Noxafil (posaconazole) tablet and oral suspension.
Summary
- Posaconazole tablets and oral suspension are not interchangeable.
- Substitution of the tablets for the oral suspension, or vice versa, can result in inadvertent overdosing or underdosing, and the risk of serious adverse drug reactions or lack of efficacy.
- Prescribers should specify the dosage form for posaconazole on each prescription and pharmacists should ensure the correct oral form is dispensed to patients.
Further information
Posaconazole is a broad-spectrum triazole antifungal for the treatment of fungal infections and prophylaxis of invasive fungal infections (IFIs).
Posaconazole is available as an oral suspension (40 mg/mL), tablets (100 mg), and concentrate for solution for infusion (300 mg). The labelled oral dosage of posaconazole is:
- Tablet: 300 mg /day (following a loading dose on Day 1 of 600 mg/day)
- Oral suspension: 600-800 mg/day
Medication errors related to substitutions of Noxafil tablets and oral suspension have been reported. Inadvertent switching from oral solution to tablets has resulted in cases of dose-related toxicity, while switching from tablets to oral solution has resulted in under-dosing and lack of efficacy. The posaconazole SmPC and Package Leaflet are being updated to clarify that the oral solution cannot be directly substituted for the oral tablet, or vice versa. The outer cartons of the EU oral forms are also being revised in order to include the specified warning statement.
Here you may view the direct healthcare professional communication.
Healthcare professionals are reminded that they should report any adverse reaction, as well as quality defect to HALMED. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED. HALMED recommends patients to contact their doctor or pharmacist regarding any adverse reaction they notice.
