Fresenius Kabi Ketosteril 100 Tablets – Essential Amino Acid & Keto Analogue Supplement for Chronic Kidney Disease

Product Overview

Ketosteril is a nitrogen-free amino-acid analogue product that enables nephrologists to prescribe a very-low-protein diet (VLPD) in pre-dialysis chronic kidney disease (CKD) without inducing protein-energy wasting. The formulation provides ketoanalogues of isoleucine, leucine, phenylalanine, valine and methionine, which are transaminated in vivo using circulating urea-derived nitrogen to regenerate the parent amino acids. This transamination pathway effectively recycles nitrogen that would otherwise accumulate as uraemic toxins, reducing the symptomatic burden of uraemia while preserving nutritional status on a restricted protein intake.

Evidence from the Modification of Diet in Renal Disease (MDRD) study and subsequent meta-analyses (Cochrane Review: Rughooputh et al., 2015; Bellizzi et al., Nephrol Dial Transplant 2018) supports the use of VLPD supplemented with ketoanalogues to slow the decline in glomerular filtration rate, delay dialysis initiation, and attenuate metabolic acidosis and hyperphosphataemia in stage 4-5 CKD. For Singapore nephrologists, renal dietitians, and clinic pharmacies managing the growing pre-dialysis population, Ketosteril is a KDIGO-relevant nutritional intervention where VLPD is clinically appropriate.

Specifications

Clinical Indications

• Adults with stage 4-5 chronic kidney disease (glomerular filtration rate below 25 ml/min per 1.73 sq m) on a very-low-protein diet (0.3-0.4 g/kg/day), to prevent protein-energy wasting
• Reduction of uraemic symptoms (pruritus, nausea, fatigue) attributable to accumulation of nitrogenous waste products
• Delay of dialysis initiation in non-diabetic and selected diabetic CKD patients managed conservatively, per KDIGO 2024 guidance
• Attenuation of secondary hyperparathyroidism and metabolic acidosis where dietary protein restriction is the primary nutritional intervention
• Nutritional management of hyperphosphataemia, as VLPD naturally reduces phosphate intake
• Post-transplant patients with residual graft dysfunction and proteinuria, under nephrologist-dietitian co-management

Frequently Asked Questions

What is the recommended dose and administration?

The Ketosteril SmPC recommends one tablet per 5 kg body weight per day (for a 70 kg adult, approximately 14 tablets daily in three divided doses with meals). Tablets should be swallowed whole with liquid during or immediately after meals to optimise absorption and coadminister with dietary protein. Dose must be individualised by the prescribing nephrologist based on body weight, GFR, and protein intake.

Which patients are not candidates for Ketosteril plus VLPD?

Ketosteril is contraindicated in hypercalcaemia, disturbed amino-acid metabolism, and hereditary phenylketonuria (due to phenylalanine ketoanalogue). Caution is required in patients on dialysis (where protein requirements increase to 1.2 g/kg/day per KDOQI), in those unable to tolerate VLPD due to sarcopenia risk, and in paediatric populations where evidence is limited. The Subjective Global Assessment and serum albumin should be monitored regularly.

How does Ketosteril differ from standard protein-restricted diet alone?

A VLPD without supplementation risks essential amino acid deficiency, sarcopenia and protein-energy wasting. Ketosteril provides the essential amino acids plus keto-analogues that use endogenous urea-derived nitrogen to regenerate non-essential amino acids. This nitrogen-sparing effect is the clinical rationale: the Cochrane Review and European Renal Nutrition Working Group position papers conclude that VLPD plus keto-analogue supplementation is superior to VLPD alone for metabolic endpoints and dialysis-delay outcomes.

How should calcium load be managed?

Each Ketosteril tablet contributes 50 mg elemental calcium (1.25 mmol). At a therapeutic dose of 14 tablets per day this equates to approximately 700 mg calcium, which must be integrated into the patient's total daily calcium balance, particularly in those already on calcium-based phosphate binders. Serum calcium and corrected calcium should be monitored monthly, and the prescribing team should consider switching to non-calcium binders (sevelamer, lanthanum) in hypercalcaemic patients.

What regulatory status does Ketosteril have in Singapore?

Ketosteril is a prescription-only medicine registered with Singapore Health Sciences Authority (HSA). It must be prescribed by a registered medical practitioner, typically a nephrologist, and dispensed by a licensed pharmacy. Fresenius Kabi manufacturing facilities are certified to ISO 9001 and ISO 13485, and the product is supplied under the Singapore marketing authorisation holder's HSA licence. Essential Medical International Supplies Pte Ltd is a Singapore-licensed medical product dealer.