Renesis50 mg

Renesis 50 mg is an oral medicine used for the treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adults, including patients who are on dialysis and those who are not on dialysis, where regionally approved and prescribed by a specialist.

Contains Renesis 50 mg as the active ingredient, available as oral film-coated tablets in a range of strengths (commonly including 20 mg, 50 mg, 70 mg, 100 mg, and 150 mg). Note that some formulations contain soya lecithin as an excipient. Exact strengths available may vary by market; refer to the specific product's label.

Renesis 50 mg is an oral medicine used to treat anaemia caused by chronic kidney disease. It belongs to a newer class of medicines called hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs), which work by mimicking the body's natural response to low oxygen levels, stimulating the body's own production of erythropoietin and improving iron availability, ultimately increasing red blood cell production. It offers an oral alternative to injectable erythropoiesis-stimulating agents for eligible patients with CKD-related anaemia, prescribed and monitored by a specialist.

Therapeutic Class: Anti-anaemic agent for Chronic Kidney Disease

Renesis 50 mg stabilizes hypoxia-inducible factor (HIF), a transcription factor that regulates genes involved in erythropoiesis (red blood cell production) and iron metabolism. This leads to increased endogenous erythropoietin production, improved iron absorption and mobilization, and reduced levels of hepcidin, a protein that otherwise restricts iron availability, particularly in the setting of chronic inflammation associated with kidney disease. Renesis 50 mg is a substrate of certain liver enzymes and can form chelates with multivalent cations such as calcium, iron, magnesium, and aluminium, which affects the timing of administration relative to phosphate binders and similar products.

• Taken by mouth, swallowed whole with water, with or without food, as directed by the prescribing physician
• Renesis 50 mg should be taken at least 1 hour after phosphate binders or other medicines or supplements containing multivalent cations (such as calcium, iron, magnesium, or aluminium), since these can reduce Renesis 50 mg absorption
• Follow the specific dosing days and schedule set by the prescribing specialist, since Renesis 50 mg is generally not taken every day

The following should be assessed by the treating specialist before or during Renesis 50 mg therapy:

• Phosphate binders and other products containing calcium, iron, magnesium, or aluminium, which can reduce Renesis 50 mg absorption if taken too close together; Renesis 50 mg should generally be taken at least 1 hour after these products
• Strong inducers or inhibitors of certain liver metabolizing enzymes, which may alter Renesis 50 mg blood levels
• Statins, since Renesis 50 mg may affect blood levels of some statin medicines
• Other medicines affecting iron metabolism or erythropoiesis, which should be coordinated by the treating nephrology team

Common side effects

• Headache
• Dizziness
• Hypertension (raised blood pressure)
• Musculoskeletal pain
• Nausea

Serious side effects (seek urgent medical attention)

• Signs of a serious cardiovascular or thrombotic event: chest pain, sudden weakness or numbness, difficulty speaking, leg swelling or pain suggestive of deep vein thrombosis, or shortness of breath suggestive of pulmonary embolism
• Signs of seizure
• Signs of serious infection, including sepsis: fever, chills, confusion
• Signs of a severe allergic reaction: swelling of the face or throat, difficulty breathing, especially in patients with a peanut or soya allergy

Pregnancy

Renesis 50 mg is contraindicated in the third trimester of pregnancy. Use earlier in pregnancy should only occur if the treating specialist determines the benefit outweighs the potential risk, since data in human pregnancy are limited.

Breastfeeding

Renesis 50 mg is contraindicated during breastfeeding, as data on its excretion into human milk and potential effects on a nursing infant are not established.

• Cardiovascular and thrombotic risk: Renesis 50 mg carries a risk of serious, including fatal, cardiovascular and thrombotic vascular events, such as stroke, deep vein thrombosis, and pulmonary embolism; patients should be monitored accordingly.
• Seizures: Seizures have been reported with Renesis 50 mg use; use with caution in patients with a history of seizure disorder.
• Serious infections: Increased risk of serious infections, including sepsis, has been observed; monitor for signs of infection.
• Peanut/soya allergy: Some formulations contain soya lecithin and are contraindicated in patients allergic to peanut or soya.
• Regular monitoring of haemoglobin is required throughout treatment to guide dose adjustments and avoid excessive or insufficient correction of anaemia.

Overdose of Renesis 50 mg may increase the risk of excessive erythropoiesis (overproduction of red blood cells) and related cardiovascular or thrombotic complications, or may increase other known adverse effects. Suspected overdose should be evaluated promptly by the treating medical team; management is generally supportive, including closer haemoglobin monitoring and, if necessary, therapeutic phlebotomy or dose interruption, as directed by the treating specialist.

Store at controlled room temperature, protected from moisture, as directed on the specific product's packaging. Keep out of reach of children. Follow the specific product's label for exact storage instructions.

• Dialysis-dependent and non-dialysis-dependent CKD patients: Renesis 50 mg is used in both groups, with dosing individualized according to dialysis status by the treating specialist.
• Hepatic impairment: Use with caution; specific dose guidance should be confirmed with the treating specialist, given hepatic involvement in Renesis 50 mg metabolism.
• Elderly: Used under the same specialist-guided titration approach as other adults, with attention to cardiovascular risk factors.

Renesis 50 mg is generally used as ongoing, long-term therapy for chronic kidney disease-related anaemia, for as long as clinically indicated and tolerated, with regular haemoglobin monitoring and dose adjustment by the treating specialist.

Drug Class: Hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI)

Renesis 50 mg works by blocking enzymes (prolyl hydroxylases) that normally break down hypoxia-inducible factor (HIF) when oxygen levels are adequate. By stabilizing HIF, Renesis 50 mg mimics the body's natural response to reduced oxygen availability, which increases the body's own production of erythropoietin, improves how well the body absorbs and uses iron, and reduces hepcidin, ultimately promoting more coordinated red blood cell production than iron supplementation or erythropoietin therapy alone.

Renesis 50 mg is used in adult patients with chronic kidney disease-related anaemia; established dosing and safety information for use in children is limited, and any pediatric use should only occur under specialist supervision where an alternative treatment is not suitable.