Daprotab 4mg Tablet 1 Strip

✔️ Side Effects

⚠ Serious Risks:

• Heart failure hospitalization.
• High blood pressure.
• Gastrointestinal erosion (damage to stomach, esophagus, and intestines).

Pregnancy & Lactation

🚫 Not recommended during pregnancy—may cause fetal harm.
🚼 Breastfeeding should be avoided until one week after the final dose.

Warnings & Precautions

⚠ Increased Risk of:
✔ Death, myocardial infarction, stroke, venous thromboembolism, & vascular access thrombosis.
✔ Hospitalization due to heart failure.
✔ Hypertension.
✔ Gastrointestinal erosion.
✔ Malignancy risk in CKD patients not on dialysis.

Use in Special Populations

✔ Children: Safety and efficacy not established.
✔ Elderly: Dose adjustments not necessary unless contraindicated.

✔️ Overdose Effects

⚠ Symptoms:

• Headache
• Nausea/GI disturbances

⚠ No specific antidote available. Hemodialysis is not effective due to high protein binding.

✔️ Dosage & Administration

Pre-Treatment & On-Treatment Evaluations

✔ Anemia & Iron Stores

• Correct other causes of anemia (e.g., vitamin deficiencies, inflammation, bleeding) before starting Daprodustat.
• Monitor iron levels before and during treatment.
• Supplemental iron therapy is recommended if serum ferritin <100 mcg/mL or transferrin saturation <20%.

✔ Liver Function Tests

• Assess ALT, AST, alkaline phosphatase, and bilirubin before initiating treatment.
• Repeat liver tests if signs of liver dysfunction appear.

✔️ Important Dosing Information

✅ Individualized dosing—Use the lowest effective dose to minimize red blood cell transfusion dependency.
✅ Do not exceed hemoglobin levels of 11 g/dL.
✅ Can be taken with or without food.
✅ Swallow whole—do not cut, crush, or chew.
✅ Dosing is independent of dialysis timing.

🚨 Missed Dose: Take as soon as possible, unless it is the same day as the next dose. Do not double the dose.

✔️ Recommended Starting Dose

For Adults with CKD on Dialysis (≥4 Months)

✔ Not on ESA Therapy:

• Dosing based on hemoglobin level before treatment.

✔ On ESA Therapy:

• Adjust based on previous ESA dose.

✔️ Monitoring & Dose Adjustments

✔ Monitor hemoglobin every 2 weeks for the first month, then every 4 weeks.
✔ Adjust doses only every 4 weeks, increasing or decreasing one level at a time.
✔ Reduce the dose if:

• Hemoglobin increases >1 g/dL in 2 weeks or >2 g/dL in 4 weeks.
• Hemoglobin exceeds 11 g/dL.
  ✔ Interrupt treatment if hemoglobin exceeds 12 g/dL. Resume at a lower dose when levels normalize.
  ✔ Discontinue use if no meaningful hemoglobin increase within 24 weeks.

✔️ Dose Adjustments for Special Populations

✔ Moderate Hepatic Impairment (Child-Pugh B): Reduce dose by half, except for those already on 1 mg.
✔ Severe Hepatic Impairment (Child-Pugh C): Not recommended.
✔ Patients on Moderate CYP2C8 Inhibitors (e.g., Clopidogrel): Reduce dose by half, except if already on 1 mg.

✔️ Drug Interactions

❌ Strong CYP2C8 Inhibitors (e.g., gemfibrozil) → Contraindicated due to increased drug exposure.
⚠ CYP2C8 Inducers (e.g., rifampin) → May reduce efficacy.

✔️ Do not use if the patient has:

• Uncontrolled hypertension.
• Concomitant use of strong CYP2C8 inhibitors (e.g., gemfibrozil)

✔️ Storage:

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