Hemadus 100 Tablet

Hemadas Tablet contains Roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor used for the treatment of anemia associated with chronic kidney disease (CKD). It stimulates the body's natural production of erythropoietin (EPO), improves iron utilization, reduces hepcidin levels, and promotes red blood cell production, helping increase hemoglobin levels.

• Roxadustat should be taken orally three times per week. It should not be taken daily.
• The treatment goal is to achieve and maintain a hemoglobin level of 10–12 g/dL.

Patients not receiving erythropoiesis-stimulating agents (ESAs):

• Initial dose: 70 mg three times weekly for patients weighing less than 100 kg.
• Initial dose: 100 mg three times weekly for patients weighing 100 kg or more.

Patients switching from ESA therapy:

• Initial dose is selected based on the previous ESA dose and adjusted according to the patient's response.

Dose adjustment:

• Adjust the dose according to hemoglobin response.
• Maintain the adjusted dose for at least 4 weeks before making further changes.
• Reduce the dose or temporarily discontinue treatment if hemoglobin rises by more than 2 g/dL within 4 weeks.

Administration:

• May be taken with or without food.

Missed dose:

• If the next scheduled dose is more than 24 hours away, take the missed dose as soon as possible.
• If the next dose is due within 24 hours, skip the missed dose.
• Do not take two doses on the same day.

Drug Interactions

Hemadas may interact with other medicines. Patients should inform their healthcare provider about all prescription medicines, over-the-counter drugs, vitamins, and herbal supplements they are taking before starting treatment.

Contraindications

There are no specific absolute contraindications listed, but Hemadas should not be used in patients with known hypersensitivity to Roxadustat or its ingredients.

Side Effects

Common side effects include:

• High blood pressure
• Gastrointestinal discomfort
• Diarrhea
• Nausea
• Swelling (edema)
• Hyperkalemia
• Kidney-related bleeding

Pregnancy & Lactation

• Pregnancy: Not recommended during pregnancy.
• Breastfeeding: Use is not recommended while breastfeeding.

Precautions & Warnings

Use Hemadas with caution in patients who:

• Have a history of thromboembolic events or are at increased risk of thrombosis.
• Have obesity or other risk factors for vascular events.
• Have a history of seizures.
• Have active serious infections.
• Have liver disease, particularly moderate or severe hepatic impairment.

Do not initiate treatment during pregnancy.

Use in Special Populations

• Children: Safety and efficacy have not been established; use is not recommended.
• Hepatic impairment: Not recommended in patients with moderate or severe liver disease.

Overdose

Overdose may lead to excessive increases in hemoglobin levels and, in some cases, increased heart rate. Management includes reducing the dose or discontinuing treatment based on the patient's clinical condition.

Therapeutic Class

Drugs for Hemolytic, Hypoplastic & Renal Anemia

Storage

Store below 30°C in a dry place, protected from light and moisture. Keep out of the reach of children.