Bioavailability is one of the key clinical-pharmacology attributes that drove the selection of the dispersible tablet format for deferasirox - and that drives the standard recommendation to take DEFRATAJ on an empty stomach, at the same time each day.
Absolute Bioavailability #
The absolute oral bioavailability of deferasirox in the dispersible tablet formulation is approximately 70% when administered on an empty stomach (in reference adult volunteers). Bioavailability is reproducible and consistent across the clinical dose range.
Effect of Food #
Food increases the bioavailability of deferasirox in a clinically relevant way:
- A standard meal raises AUC by approximately 15-25%
- A high-fat meal can raise AUC by up to ~30%
- Effect on Cmax is generally smaller and delayed (longer Tmax)
To control this variability and maintain reproducible exposure, the prescribing recommendation is administration at least 30 minutes before food, at a consistent time each day.
Effect of Dispersion Vehicle #
Deferasirox can be dispersed in water, orange juice or apple juice without affecting bioavailability in a clinically meaningful way. Approximately 100-200 mL of liquid is recommended; the glass should be rinsed with additional liquid to ensure the full dose is taken.
Dose Linearity #
Bioavailability is dose-proportional across the clinical dose range, supporting straightforward weight-based dose calculations.
Comparative Bioavailability - Dispersible vs Other Forms #
Innovator deferasirox is also available in film-coated tablet and granule forms in some markets, with different bioavailability characteristics and administration instructions (some can be taken with food). The DEFRATAJ dispersible tablet retains the original empty-stomach administration profile and is widely registered as a generic equivalent. Bioequivalence to the reference product is supported by comparative pharmacokinetic studies; full comparative data is available in the CTD dossier on request.
Practical Patient Counselling Points #
- Take DEFRATAJ at the same time every day.
- Take on an empty stomach - at least 30 minutes before any food.
- Disperse fully in 100-200 mL water or juice; drink immediately; rinse and drink again.
- Do not chew or swallow tablets whole - they are designed to disperse.
- If a dose is missed: take it as soon as remembered on the same day; do not double-dose.