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Oroxat70 mg
Eskayef Bangladesh Ltd.
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Generic medicine
Roxadustat: Brands, Price & Uses in Bangladesh
Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor used in the management of anaemia.
About Roxadustat
Indications of Roxadustat
Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor used in the management of anaemia. Its evidence-based uses are classified below.
Established / Approved Use
- Symptomatic anaemia associated with chronic kidney disease (CKD) in adults, including patients who are dialysis-dependent (haemodialysis or peritoneal dialysis) and those who are non-dialysis-dependent. Roxadustat is approved for this indication in several markets (including China, Japan, and the European Union, where it is marketed as Evrenzo), and is used as an oral alternative to injectable erythropoiesis-stimulating agents (ESAs).
Regulatory Note
Roxadustat has not been approved by the US FDA; a US advisory committee raised safety concerns (thromboembolic and cardiovascular risk) in 2021 and the application was not approved in the United States. Approval status and local availability should always be confirmed with a physician or pharmacist, as regulatory status differs by country.
Not Established
Roxadustat is not indicated for anaemia due to causes other than CKD (e.g. chemotherapy-induced anaemia, myelodysplastic syndromes) and should not be used off-label for these purposes outside of a clinical trial setting.
Dosage & Administration of Roxadustat
General Principles
Roxadustat dosing is individualised, based on body weight and (for patients switching from an ESA) prior ESA dose, then titrated according to haemoglobin (Hb) response. The target Hb range is generally 10-12 g/dL; the treating physician sets and monitors this target and dose adjustments should not be made by the patient.
| Patient Group | Starting Dose | Maximum Dose |
|---|---|---|
| Non-dialysis-dependent CKD, body weight <100 kg | 70 mg three times weekly | 3 mg/kg or 300 mg three times weekly, whichever is lower |
| Non-dialysis-dependent CKD, body weight ≥100 kg | 100 mg three times weekly | 3 mg/kg or 300 mg three times weekly, whichever is lower |
| Dialysis-dependent CKD | 70-200 mg three times weekly (based on prior ESA dose, or 50-100 mg three times weekly if ESA-naive) | 3 mg/kg or 400 mg three times weekly, whichever is lower |
Dose Titration
Doses are typically adjusted no more than once every 4 weeks, based on the change in Hb and current Hb level, using a step-wise titration schedule provided by the prescriber. If Hb rises by more than 2 g/dL within 4 weeks, or exceeds the target range, the dose is reduced or interrupted.
Discontinuation of Ineffective Therapy
If an adequate Hb response is not achieved after an appropriate escalation period (approximately 24 weeks), Roxadustat should generally be discontinued and alternative therapy considered, under physician guidance.
Administration Instructions
- Taken orally, three times weekly, on non-consecutive days, with or without food.
- Swallow the tablet whole.
- Take at least 1 hour before or after phosphate binders and other multivalent cation-containing products (e.g. iron, calcium, magnesium, aluminium preparations), as these reduce absorption of Roxadustat.
- Do not change the dose or frequency without consulting the prescribing physician.
Side Effects of Roxadustat
Common / Very Common
- Hypertension (new-onset or worsening high blood pressure)
- Vascular access thrombosis (in dialysis patients)
- Hyperkalaemia
- Nausea, diarrhoea, vomiting
- Peripheral oedema
- Headache, dizziness
- Metabolic acidosis
- Upper respiratory tract infection
Less Common but Clinically Important
- Seizures
- Deep vein thrombosis, pulmonary embolism, and other thromboembolic events (see Precautions and Warnings)
- Elevated liver enzymes / hepatotoxicity (see Precautions and Warnings)
Patients should seek prompt medical attention for chest pain, shortness of breath, leg swelling/pain, seizure activity, or signs of jaundice while taking Roxadustat.
Contraindications of Roxadustat
- Known hypersensitivity to Roxadustat or to any of the excipients in the formulation (including peanut or soya-derived excipients used in some formulations).
Use in the third trimester of pregnancy and during breast-feeding is also contraindicated on current labelling (see Pregnancy and Lactation for details); other cautions such as thromboembolic risk, hepatic impairment, and hypertension are important precautions but are not absolute contraindications and are addressed under Precautions and Warnings.
Frequently Asked Questions about Roxadustat
What is Roxadustat used for?
Roxadustat is an oral medicine used to treat symptomatic anaemia (low haemoglobin/red blood cell count) in adults with chronic kidney disease, including those on dialysis and those not yet on dialysis. It works by helping the body produce more of its own erythropoietin.
Is Roxadustat the same as erythropoietin injections?
No. Roxadustat is a tablet taken by mouth that stimulates the body's own erythropoietin production, whereas erythropoiesis-stimulating agents (ESAs) are given by injection. Roxadustat should not be taken together with ESA injections unless specifically directed by your physician.
What are the most serious risks with Roxadustat?
The most important risks are blood clots (thromboembolic events, including clots in the dialysis access, legs, lungs, or elsewhere), seizures, liver enzyme elevation, and high blood pressure. Seek immediate medical attention for leg swelling or pain, sudden chest pain, breathlessness, seizure activity, or yellowing of the skin/eyes while taking Roxadustat.
Can I take Roxadustat during pregnancy or while breastfeeding?
Roxadustat is not recommended in the third trimester of pregnancy and is not recommended during breast-feeding, based on limited safety data. If you are pregnant, planning pregnancy, or breastfeeding, discuss this with your physician before starting or continuing Roxadustat, as the benefits and risks need to be weighed carefully for your individual situation.
How should I take Roxadustat?
Roxadustat is usually taken three times a week on non-consecutive days, with or without food, exactly as prescribed. Take it at least 1 hour apart from phosphate binders, iron, calcium, magnesium, or aluminium-containing products, as these can reduce its absorption. Never change your dose without consulting your physician, since your haemoglobin target is set individually.
Is Roxadustat approved and available everywhere?
Roxadustat (brand name Evrenzo in some markets) is approved in a number of countries including China, Japan, and the European Union, but it has not been approved by the US FDA. Its availability and approved use can vary by country, so confirm with your physician or pharmacist whether Roxadustat is appropriate and accessible for you.
Disclaimer
The information provided is accurate to the best of our knowledge, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy, and the absence of specific information about a drug should not be taken as an endorsement. We are not responsible for any consequences arising from this information, so please consult a healthcare professional for any concerns or questions.