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  • Fosrenol Oral Powder
    / Shire


    Active Ingredient
    Lanthanum 750 mg, 1000 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Powder

    90 SACHETS X 750 mg

    partial basket chart

    Powder

    90 SACHETS X 1000 mg

    partial basket chart 24742 6560

    Related information


    Dosage

    Fosrenol is for oral administration.
    Fosrenol oral powder is intended to be mixed with a small quantity of soft food (e.g. applesauce or other similar food product) and consumed immediately (within 15 minutes). The sachet must not be opened until ready to use. Once mixed with food, Fosrenol oral powder must not be stored for future use. Fosrenol oral powder is insoluble and must not be dissolved in liquid for administration.
    Adults, including elderly (> 65 years): Fosrenol should be taken with or immediately after food, with the daily dose divided between meals. Patients should adhere to recommended diets in order to control phosphate and fluid intake. Fosrenol is presented as an oral powder intended to be mixed with soft food, therefore avoiding the need to take additional fluid. Serum phosphate levels should be monitored and the dose of Fosrenol titrated every 2-3 weeks until an acceptable serum phosphate level is reached, with regular monitoring thereafter. Dose titration may be performed with the chewable tablet presentation as these are available in a number of strengths allowing for smaller increases in dose.
    Control of serum phosphate level has been demonstrated at doses starting from 750 mg per day. The maximum dose studied in clinical trials, in a limited number of patients, is 3750 mg. Patients who respond to lanthanum therapy, usually achieve acceptable serum phosphate levels at doses of 1500 – 3000 mg lanthanum per day.
    Paediatric population: The safety and efficacy of Fosrenol in children and adolescents below the age of 18 years has not been established.
    Hepatic impairment: The effect of hepatic impairment on Fosrenol pharmacokinetics has not been assessed. Due to its mechanism of action and the lack of liver metabolism doses in hepatic impairment should not be modified, but patients should be monitored carefully.


    Indications

    Fosrenol is indicated as a phosphate binding agent for use in the control of hyperphosphataemia in chronic renal failure patients on haemodialysis or continuous ambulatory peritoneal dialysis (CAPD). Fosrenol is also indicated in adult patients with chronic kidney disease not on dialysis with serum phosphate levels ≥1.78 mmol/L in whom a low phosphate diet alone is insufficient
    to control serum phosphate levels.


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients.
    Hypophosphataemia.


    Special Precautions

    Tissue deposition of lanthanum has been shown with Fosrenol in animal studies. In 105 bone biopsies from patients treated with Fosrenol, some for up to 4.5 years, rising levels of lanthanum were noted over time. Cases of lanthanum deposition in gastrointestinal mucosa, mainly after long term use, have been reported. The clinical significance of this finding is yet unknown.
    The use of Fosrenol in clinical studies beyond 2 years is currently limited. However, treatment of subjects with Fosrenol for up to 6 years has not demonstrated a change in the benefit/risk profile.
    There have been cases of gastrointestinal obstruction, ileus, subileus, and gastrointestinal perforation reported in association with lanthanum, some requiring surgery or hospitalisation.
    Exercise caution in all patients predisposed to gastrointestinal obstruction, ileus, subileus and perforation; for example those with altered gastrointestinal anatomy (e.g., diverticular disease, peritonitis, history of gastrointestinal surgery, gastrointestinal cancer and gastrointestinal ulceration), hypomotility disorders (e.g., constipation, diabetic gastroparesis) and when used with medications known to potentiate these effects.
    During treatment with lanthanum carbonate, physicians and patients should remain alert for signs and symptoms of gastrointestinal disorders, especially constipation and abdominal pain/distension which may indicate bowel obstruction, ileus or subileus.
    Treatment with lanthanum carbonate should be re-evaluated in patients who develop severe constipation or other severe gastrointestinal signs and symptoms.
    Patients with acute peptic ulcer, ulcerative colitis, Crohn’s disease or bowel obstruction were not included in clinical studies with Fosrenol.
    Patients with renal insufficiency may develop hypocalcaemia. Fosrenol does not contain calcium. Serum calcium levels should therefore be monitored at regular time intervals for this patient population and appropriate supplements given.
    Lanthanum is not metabolised by liver enzymes but it is most likely excreted in the bile.
    Conditions resulting in a marked reduction of bile flow may be associated with incrementally slower elimination of lanthanum, which may result in higher plasma levels and increased tissue deposition of lanthanum. As the liver is the principle organ of elimination of absorbed lanthanum monitoring of liver function tests is recommended.
    Paediatric population: Safety and efficacy of Fosrenol have not been established in children and adolescents; use in children and adolescents is not recommended.
    Fosrenol should be discontinued if hypophosphataemia develops.
    Abdominal x-rays of patients taking lanthanum carbonate may have a radio-opaque appearance typical of an imaging agent.
    Patients with rare glucose-galactose malabsorption should not take this medicine.


    Side Effects

    The most commonly reported adverse drug reactions, with the exception of headache and allergic skin reactions, are gastrointestinal in nature; these are minimised by taking Fosrenol with food and generally abated with time with continued dosing.
    Very Common: Headache, abdominal pain, diarrhoea, nausea, vomiting.
    Common: Hypocalcaemia, constipation, dyspepsia, flatulence.
    See prescribing information for full details.


    Drug interactions

    Lanthanum carbonate hydrate may increase gastric pH. It is recommended that compounds, which are known to interact with antacids, should not be taken within 2 hours of dosing with Fosrenol (e.g. chloroquine, hydroxychloroquine and ketoconazole).
    In healthy subjects, the absorption and pharmacokinetics of lanthanum were not affected by coadministration of citrate.
    Serum levels of fat-soluble vitamins A, D, E and K, were not affected by Fosrenol
    administration in clinical studies.
    Human volunteer studies have shown that co-administration of Fosrenol with digoxin, warfarin or metoprolol does not produce clinically-relevant changes in the pharmacokinetic profiles of these drugs.
    In simulated gastric juice, lanthanum carbonate hydrate did not form insoluble complexes with warfarin, digoxin, furosemide, phenytoin, metoprolol or enalapril, suggesting a low potential to affect the absorption of these drugs.
    However, interactions with drugs such as tetracycline and doxycycline are theoretically possible and if these compounds are to be co-administered, it is recommended that they are not to be taken within 2 hours of dosing with Fosrenol.
    The bioavailability of oral ciprofloxacin was decreased by approximately 50% when taken with Fosrenol in a single dose study in healthy volunteers. It is recommended that oral floxacin formulations are taken at least 2 hours before or 4 hours after Fosrenol.
    Phosphate binders (including Fosrenol) have been shown to reduce the absorption of levothyroxine. Consequently, thyroid hormone replacement therapy should not be taken within 2 hours of dosing with Fosrenol and closer monitoring of TSH levels is recommended in patients receiving both medicinal products.
    Lanthanum carbonate hydrate is not a substrate for cytochrome P450 and does not significantly inhibit the activities of the major human cytochrome P450 isoenzymes, CYP1A2, CYP2D6, CYP3A4, CYP2C9 or CYP2C19 in vitro.


    Pregnancy and Lactation

    Pregnancy: There are no adequate data from the use of Fosrenol in pregnant women. Fosrenol is not recommended for use during pregnancy.
    Lactation: It is unknown whether lanthanum is excreted in human breast milk. The excretion of lanthanum in milk has not been studied in animals. Caution should be used in taking a decision whether to continue/discontinue breast feeding or to continue/discontinue therapy with Fosrenol, taking into account the potential benefit of breast feeding to the child and the potential benefit of Fosrenol therapy to the nursing mother.
    See prescribing information for full details.


    Overdose

    No case of overdose has been reported. The highest daily dose of lanthanum administered to healthy volunteers during Phase I studies was 4718 mg given for 3 days. The adverse events seen were mild to moderate and included nausea and headache.


    Manufacturer
    Shire Pharmaceuticals Ltd., UK
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