Drug Guide
Daprodustat
Classification
Therapeutic: Hematologic agent (Anemia in CKD)
Pharmacological: Hematopoietic agent (Hypoxia-inducible factor prolyl hydroxylase inhibitor)
FDA Approved Indications
- Treatment of anemia associated with chronic kidney disease (CKD) in adult patients on dialysis
Mechanism of Action
Daprodustat stimulates erythropoiesis by inhibiting hypoxia-inducible factor prolyl hydroxylase, leading to stabilization of hypoxia-inducible factors (HIFs), which increases endogenous erythropoietin production and enhances red blood cell production.
Dosage and Administration
Adult: The recommended starting dose is 4 mg orally once daily. Dose adjustments are based on hemoglobin response.
Pediatric: Not approved for pediatric use.
Geriatric: No specific dose adjustments recommended solely based on age.
Renal Impairment: Adjustments not specified; monitor hemoglobin levels closely.
Hepatic Impairment: No specific adjustments; clinical data limited.
Pharmacokinetics
Absorption: Rapidly absorbed after oral administration.
Distribution: Appears to be extensively distributed; specific volume not specified.
Metabolism: Metabolized primarily via non-enzymatic pathways; minor contribution from CYP enzymes.
Excretion: Mostly excreted in feces; minimal renal excretion.
Half Life: Approximately 12 hours.
Contraindications
- Hypersensitivity to daprodustat or excipients.
- Uncontrolled hypertension.
Precautions
- Monitor hemoglobin levels regularly.
- Risk of hypertension, thrombosis, and cardiovascular events.
- Avoid in patients with active malignancy or history of malignancy.
- Use with caution in patients with liver disease or edema.
Adverse Reactions - Common
- Headache (Uncommon)
- Nausea (Uncommon)
- Hypertension (Common)
- Diarrhea (Uncommon)
Adverse Reactions - Serious
- Thromboembolic events (Rare)
- Hypertensive crises (Rare)
- Malignancy (Uncertain, ongoing studies)
Drug-Drug Interactions
- Immunosuppressants, other erythropoiesis-stimulating agents, CYP inducers or inhibitors affecting metabolism.
Drug-Food Interactions
N/ADrug-Herb Interactions
N/ANursing Implications
Assessment: Monitor hemoglobin, hematocrit, blood pressure, and signs of thromboembolic events.
Diagnoses:
- Risk for embolism related to erythropoiesis stimulation.
- Ineffective tissue perfusion related to thromboembolic events.
Implementation: Administer orally as prescribed; educate patient on adherence and monitoring.
Evaluation: Assess hemoglobin response; ensure blood pressure remains within target range; monitor for adverse reactions.
Patient/Family Teaching
- Take medication exactly as prescribed.
- Report symptoms of hypertension or blood clots (chest pain, leg swelling, sudden numbness).
- Maintain follow-up appointments for blood tests.
Special Considerations
Black Box Warnings:
- Risk of thrombosis, including thromboembolic events.
- Potential for tumor progression or recurrence in patients with active malignancy.
Genetic Factors: Genetic polymorphisms affecting HIF pathway may influence response.
Lab Test Interference: May affect erythropoietin levels and hematology parameters.
Overdose Management
Signs/Symptoms: Symptoms of excessive erythropoiesis, hypertension, thromboembolic events.
Treatment: Supportive care; monitoring; no specific antidote.
Storage and Handling
Storage: Store at room temperature, 20°C to 25°C (68°F to 77°F).
Stability: Stable under recommended storage conditions.