Aprodust 4 Tablet 1 Strip

✔️ Dosage & Administration | Evaluation Before and During Treatment

Assessment of Anemia & Iron Status:
Before starting therapy, other causes of anemia, such as vitamin deficiencies, chronic inflammatory diseases, metabolic disorders, or bleeding, should be identified and corrected. Iron status should be monitored regularly. Supplemental iron may be required if:

• Serum ferritin is below 100 mcg/mL, or
• Transferrin saturation is below 20%.

Most CKD patients on dialysis will require iron supplementation during treatment.

Liver Function Monitoring:
Serum ALT, AST, alkaline phosphatase, and bilirubin levels should be evaluated before initiating therapy and repeated if symptoms of liver disease occur during treatment.

✔️ Overdose Effects

Symptoms of overdose may include headache, nausea, and other gastrointestinal disturbances. There is no specific antidote available. Hemodialysis is unlikely to effectively remove the drug because it is highly protein-bound.

✔️ Missed Dose

If a dose is missed, take it as soon as remembered unless it is nearly time for the next dose. Do not take double doses.

✔️ Important Dosing Instructions

• Use the lowest effective dose necessary to minimize the need for blood transfusions.
• Hemoglobin should not be targeted above 11 g/dL.
• Tablets may be taken with or without food and regardless of dialysis timing.
• Swallow tablets whole; do not crush, chew, or split them.

✔️ Aprodust should not be used in patients who:

• Are taking strong CYP2C8 inhibitors such as gemfibrozil
• Have uncontrolled hypertension

✔️ Starting Dose | Aprodust

For adults with CKD-related anemia receiving dialysis for at least 4 months, the initial dose depends on the patient’s current hemoglobin level and prior ESA use. Dose adjustments may be necessary in hepatic impairment or when used with moderate CYP2C8 inhibitors.

Monitoring & Dose Adjustment

• Hemoglobin should be checked every 2 weeks during the first month and every 4 weeks thereafter.
• Dose changes should not occur more often than every 4 weeks.
• Adjust only one dose level at a time.

Dose reduction is recommended if:

• Hemoglobin rises more than 1 g/dL within 2 weeks, or
• More than 2 g/dL within 4 weeks, or
• Hemoglobin exceeds 11 g/dL.

If hemoglobin rises above 12 g/dL, therapy should be temporarily discontinued and restarted later at a lower dose when appropriate.

If no clinically meaningful hemoglobin improvement occurs after 24 weeks, alternative causes of treatment failure should be investigated before restarting therapy.

Hepatic Impairment

• In moderate hepatic impairment (Child-Pugh B), reduce the starting dose by half unless already receiving 1 mg.
• Use is not recommended in severe hepatic impairment (Child-Pugh C).

Concomitant Use with Moderate CYP2C8 Inhibitors

When used with clopidogrel or other moderate CYP2C8 inhibitors, the starting dose should generally be reduced by 50%, unless the patient is already receiving 1 mg.

✔️ Side Effects

Commonly reported adverse effects include:

• Increased risk of hospitalization due to heart failure
• Elevated blood pressure
• Gastrointestinal erosions involving the stomach, esophagus, or intestines

✔️ Pregnancy & Lactation

Daprodustat may cause harm to the fetus and should be avoided during pregnancy unless clearly necessary. Breastfeeding is not recommended during treatment and for at least one week after the last dose.

✔️ Special caution is advised because of the potential risk of:

• Death, myocardial infarction, stroke, venous thromboembolism, and vascular access thrombosis
• Hospitalization due to heart failure
• Hypertension
• Gastrointestinal erosions
• Serious adverse effects in CKD patients not on dialysis
• Possible malignancy-related concerns

✔️ Drug Interactions

CYP2C8 Inhibitors

Strong CYP2C8 inhibitors such as gemfibrozil can significantly increase daprodustat exposure and are contraindicated.

CYP2C8 Inducers

Drugs such as rifampin may reduce daprodustat levels and decrease therapeutic effectiveness.

✔️ Storage:

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