Sucroferric oxyhydroxide: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the Singapore prescribing information.

Generic Medicine Info

Indications and Dosage

Oral
Hyperphosphataemia in chronic kidney disease

Adult: For patients requiring haemodialysis or peritoneal dialysis: Dose is expressed in terms of Fe content; each chewable tab contains 500 mg of Fe (equivalent to 2,500 mg sucroferric oxyhydroxide). Initially, 1,500 mg (3 tabs) daily in 3 divided doses with meals. Titrate the dose in increments or decrements of 500 mg daily at intervals of at least 1 week or every 2-4 weeks as needed until acceptable serum phosphorus levels are achieved and with regular monitoring thereafter. Usual maintenance dose: 1,500-2,000 mg (3-4 tabs) daily in divided doses. Max: 3,000 mg (6 tabs) daily. Dose titration interval recommendations may vary between countries (refer to detailed local product guidelines).

Administration

Should be taken with food. Chew/crush tab & do not swallow whole.

Contraindications

Haemochromatosis and other Fe accumulation disorders.

Special Precautions

Patient with history of peritonitis (within the last 3 months), significant gastrointestinal disorders, or major gastrointestinal surgery. Hepatic impairment. Pregnancy and lactation.

Adverse Reactions

Significant: Stool discolouration (black) which may visually mask gastrointestinal bleeding; diarrhoea.
Gastrointestinal disorders: Nausea, vomiting, constipation, dyspepsia, flatulence, tooth and tongue discolouration, dysphagia, gastritis, abdominal pain or discomfort, GERD.
General disorders and administration site conditions: Abnormal product taste, fatigue.
Metabolism and nutrition disorders: Hypercalcaemia, hypocalcaemia.
Nervous system disorders: Headache.
Respiratory, thoracic and mediastinal disorders: Dyspnoea.
Skin and subcutaneous tissue disorders: Pruritus, rash.

Pregnancy Category (US FDA)

PO: B

Monitoring Parameters

Monitor serum phosphorus, Ca, and PTH levels.

Drug Interactions

May decrease the serum concentrations of doxycycline, cefalexin, aspirin, and levothyroxine; administer these agents at least 1 hour before giving sucroferric oxyhydroxide (dosing interval of interacting agents may vary between countries).

Action

Description:
Mechanism of Action: Sucroferric oxyhydroxide is a mixture of polynuclear iron (III)-oxyhydroxide (pn-FeOOH), sucrose and starches that acts as a phosphate binder. It binds phosphate in the aqueous environment of the gastrointestinal tract by ligand exchange between hydroxyl groups and/or water of sucroferric oxyhydroxide and dietary phosphate. The reduced absorption of dietary phosphate results in decreased levels of serum phosphorus and Ca-phosphorus product.
Pharmacokinetics:
Absorption: Not systemically absorbed. The pn-FeOOH (active moiety) is practically insoluble and not absorbed. Mononuclear Fe species (degradation product) can be released from the pn-FeOOH surface and be absorbed.
Distribution: Absorbed Fe is distributed to target organs (e.g. liver, spleen, bone marrow) and incorporated into RBCs.
Metabolism: The active moiety, pn-FeOOH, is not metabolised.
Excretion: Via faeces (as bound phosphate).

Storage

Store between 15-30°C. Protect from moisture.

MIMS Class

Antidotes & Detoxifying Agents

ATC Classification

V03AE05 - sucroferric oxyhydroxide ; Belongs to the class of drugs used in the treatment of hyperkalemia and hyperphosphatemia.

References

Anon. Sucroferric Oxyhydroxide. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 21/12/2023.

Anon. Sucroferric Oxyhydroxide. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 06/10/2023.

Buckingham R (ed). Sucroferric Oxyhydroxide. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/10/2023.

Joint Formulary Committee. Sucroferric Oxyhydroxide. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/10/2023.

Velphoro 500 mg Chewable Tablets (Fresenius Kabi Malaysia Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 21/12/2023.

Velphoro 500 mg Chewable Tablets (Vifor Fresenius Medical Care Renal Pharma France). MHRA. https://products.mhra.gov.uk. Accessed 06/10/2023.

Velphoro Tablet, Chewable (Fresenius Medical Care North America). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 21/12/2023.

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