FEXERIC Film-coated tablet Ref.[49917] Active ingredients: Ferric citrate

Posology

Starting dose

The recommended starting dose of Fexeric is 3 to 6 g (3 to 6 tablets) per day based on serum phosphorus levels.

CKD patients who are not on dialysis require the lower starting dose, 3 g (3 tablets) per day.

Fexeric must be taken in divided doses with or immediately after meals of the day.

Patients previously on other phosphate binders who are switched to Fexeric should start taking 3 to 6 g (3 to 6 tablets) per day.

Patients receiving this medicine should adhere to their prescribed low phosphate diets.

Dose titration

Serum phosphorus concentrations should be monitored within 2 to 4 weeks of starting or changing the dose of Fexeric, and approximately every 2-3 months when stable. The dose can be increased or decreased by 1 to 2 g (1 to 2 tablets) per day at 2- to 4-week intervals as needed to maintain serum phosphorus at recommended target levels up to a maximum of 12 g (12 tablets) per day.

There are limited data available for doses higher than 9 g (9 tablets) per day in CKD patients not on dialysis; therefore in this population doses higher than 9 g/day should be used with caution.

Temporarily discontinue Fexeric if the serum phosphorus is <3 mg/dl and resume at a lower dose once the serum phosphorus has returned to the target range.

Treatment with Fexeric may lead to elevations in iron stores, particularly in patients receiving concomitant intravenous iron therapy. Fexeric should be temporarily discontinued if serum ferritin exceeds 800 ng/ml (see section 4.4).

Long term safety data are limited in non-dialysis and peritoneal dialysis (PD) patients (see section 5.1).

Paediatric population

The safety and efficacy of Fexeric in children and adolescents aged 0 to 18 years have not yet been established. No data are available.

Elderly population

Fexeric has been administered to over 400 patients ≥ 65 years of age in studies where the dose was titrated to achieve target serum phosphorus levels. The elderly patients were treated according to the recommended dosing regimen without any safety concerns. Experience from clinical studies in patients above the age of 75 years is limited.

Hepatic impairment

Experience from clinical studies in patients with hepatic impairment is limited. No dosage reduction is considered necessary but patients with hepatic impairment should initiate treatment with the lower starting dose, 3 g (3 tablets) per day (see section 5.1).

Method of administration

For oral use. Tablets should be taken whole.

Patients must take Fexeric with or immediately after meals. The total daily dose should be divided across the meals of the day.

No data are available regarding overdose of Fexeric in humans. In patients with CKD, the maximum dose studied was 12 g (12 tablets) of Fexeric per day.

Iron overdose is dangerous, particularly in children, and requires immediate attention. The symptoms of acute iron overdose include vomiting, diarrhoea, abdominal pain, irritability, and drowsiness. If someone is known or suspected to have accidentally or intentionally ingested an overdose of Fexeric, immediate medical attention should be sought.

2 years.

Shelf-life after first opening of the bottle: 60 days.

Do not store above 25°C.

Keep the bottle tightly closed in order to protect from moisture.

HDPE bottles with child-resistant closure with desiccant.

Pack size: 200 film-coated tablets.

No special requirements.