Daprotab(Daprodustat)
Therapeutic Group: HIF-PH Inhibitor
Presentation
Daprotab™ 1: Each film coated tablet contains Daprodustat INN 1 mg.
Daprotab™ 2: Each film coated tablet contains Daprodustat INN 2 mg.
Daprotab™ 4: Each film coated tablet contains Daprodustat INN 4 mg.
Daprotab™ 6: Each film coated tablet contains Daprodustat INN 6 mg.
Description
Daprotab contains Daprodustat, an inhibitor of hypoxia inducible factor (HIF), prolyl 4- hydroxylases (PH)1, PH2 and PH3
Indications
Daprodustat is indicated for the treatment of anemia due to Chronic Kidney Disease (CKD) in adults who have been receiving dialysis for at least four months.
Dosage & Administration
Correct and exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding) and Irone stores, Liver condition before initiating Daprodustat.
Adults with anemia due to CKD receiving dialysis for at least 4 months
For adults not being treated with an ESA, the starting dose of Daprodustat is based on the hemoglobin level.
| Pre-Treatment Hemoglobin Level (g/dL) | Starting Dose of Daprodustat (Once Daily Dosing) |
|---|---|
| <9 | 4 mg |
| ?9 to ?10 | 2 mg |
| >10 | 1 mg |
For adults being switched from an ESA to Daprodustat, the starting dose of Daprodustat is based on the dose regimen of the ESA at the time of substitution.
| Current Dose of ESA | Dose of Daprodustat | ||
|---|---|---|---|
| Epoetin Alfa Intravenous (IU/week) | Darbepoetin Alfa Subcutaneous /Intravenous (mcg/4 weeks) | Methoxy PEG Epoetin Beta Subcutaneous/Intravenous (mcg/month) | Once Daily Dosing |
| Less than or equal to 2,000 | 20 to 30 | 20 to 30 | 4 mg |
| Greater than 2,000 to less than 10,000 | Greater than 30 to 150 | Greater than 40 to 180 | 6 mg |
| Greater than or equal to 10,000 to less than 20,000 | Greater than 150 to 300 | Greater than 180 to 360 | 8 mg |
| Greater than or equal to 20,000 | Greater than 300 | Greater than 360 | 12 mg |
For patients on subcutaneous epoetin alfa, convert the epoetin alfa subcutaneous dose to intravenous dose equivalent by multiplying the subcutaneous dose received per week by 1.42 to obtain the weekly intravenous dose.
Missed dose
If a dose of Daprodustat is missed, it should be taken as soon as possible, unless it is the same day as the next dose. In this case, the missed dose should be skipped and the next dose taken at the usual time. Double-doses should not be taken to make-up for a missed dose.
Method of administration
Daprodustat can be taken with or without food and without regard to concomitant administration of iron or phosphate binders. Daprodustat should be swallowed whole.
Precautions
Daprodustat tablets should be used in caution. It may increase the risk of hospitalization for Heart Failure patients, may worsen hypertension in patients may cause gastrointestinal erosion. It is not indicated for treatment of anemia of CKD in patients who are not dialysis-dependent and may have unfavorable effects on cancer growth. It is not recommended in case of active malignancy.
Use in Pregnancy & Lactation
Pregnancy: May cause fetal harm; Lactation: Breastfeeding not recommended until one week after the final dose; Hepatic impairment: Reduce the starting dose in patients with moderate hepatic impairment (Child-Pugh Class B). Daprodustat not recommended in severe hepatic impairment (Child-Pugh Class C); Overdosage: Headache and gastrointestinal adverse reactions (e.g., nausea) may be seen with acute overdose with Daprodustat.
Drug Interaction
Reduce starting dose in case of moderate CYP2C8 Inhibitors.
Storage
Do not store above 30 ºC. Keep away from light and out of the reach of children.
Commercial Pack
Daprotab™ 1: Each film coated tablet contains Daprodustat INN 1 mg.
Daprotab™ 2: Each film coated tablet contains Daprodustat INN 2 mg.
Daprotab™ 4: Each film coated tablet contains Daprodustat INN 4 mg.
Daprotab™ 6: Each film coated tablet contains Daprodustat INN 6 mg.