Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: AVEROA SAS, 11 Avenue Paul Verlaine, 38100 Grenoble, France
Xoanacyl is indicated for the treatment of concomitant elevated serum phosphorous and iron deficiency in adult patients with chronic kidney disease (CKD).
Treatment should be initiated under the supervision of a physician experienced in the management of patients with renal disorders.
The recommended starting dose of Xoanacyl is:
Xoanacyl must be taken with or immediately after meals. The total daily dose should be equally divided across the meals of the day where possible, rounded to the nearest whole film-coated tablet; if total daily dose cannot be divided equally, the higher number of film-coated tablets should be taken with the largest meal of the day.
The efficacy of Xoanacyl has not been studied in clinical trials in dialysis dependent patients without permitting concomitant treatment with intravenous iron and/or erythropoiesis-stimulating agent (ESA) as needed.
Other oral iron therapy and phosphate binding therapy should be discontinued on initiation of Xoanacyl. A reduction or discontinuation of intravenous iron may also be required (see section 4.4).
Patients receiving this medicinal product should adhere to their prescribed low phosphate diets.
Iron parameters (e.g. haemoglobin, serum ferritin and transferrin saturation (TSAT)) and serum phosphorus concentrations should be monitored within 2 to 4 weeks of starting or changing the dose of Xoanacyl, and approximately every 2-3 months when stable. The dose can be increased or decreased by 1 to 2 film-coated tablets per day at 2- to 4-week intervals as needed to maintain iron parameters and serum phosphorus at recommended target levels up to a maximum of 12 film-coated tablets per day. Consideration should be given to the dual effect of the product to avoid overtreatment (see section 4.4).
There are limited data available for doses higher than 9 film-coated tablets per day in CKD patients not on dialysis; therefore, in non-dialysis dependent CKD patients doses higher than 9 film-coated tablets per day should not be used unless with intensified monitoring.
Treatment should be temporary discontinued if hypophosphatemia develops or if serum ferritin exceeds 700 ng/mL and/or TSAT exceeds 40%. Once resolved, treatment could be resumed at a lower dose level (see section 4.4).
If an intake is missed during the day, patients should be instructed not to take the forgotten dose at the next meal.
No dose adjustment is necessary in elderly (see section 5.1).
Patients with hepatic impairment should initiate treatment with the lower starting dose, 3 film-coated tablets per day.
The safety and efficacy of Xoanacyl in children and adolescents below 18 years have not yet been established. No data are available.
For oral use.
The film-coated tablets must be swallowed whole; film-coated tablets must not be chewed or crushed because it may cause discoloration of mouth and teeth.
Iron overdose is dangerous 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 Xoanacyl, immediate medical attention should be sought. Supportive and symptomatic measures reflecting best standard medical care should be implemented and the use of an iron chelator such desferrioxamine should be considered.
Xoanacyl overdose can also induce hypophosphataemia that could lead to nausea and headache and should be treated by standard clinical practice.
2 years.
Shelf-life after first opening of the bottle: 2 months.
Do not store above 30°C.
Keep the bottle tightly closed in order to protect from moisture.
High density polyethylene (HDPE) bottles sealed with child-resistant polypropylene screw caps, an aluminium foil heat-sealed with a polyethylene liner and two silica gel sachets.
Each bottle contains 200 film-coated tablets and is packed into a carton box.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.