Pharmacokinetics in children
No information is present at this moment.
dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
Available formulations
No information is present at this moment.
Dosages
| Anemia in chronic kidney disease |
- Intravenous
-
3 months
up to
18 years
Children treated with ESA and stable Hb can be converted to methoxypolyethylene glycol-epoetin beta according to the table below.
| Previous weekly dose Darbepoëtine alfa (microgram/week) |
Previous weekly dose epoëtine (IE/week) |
Dose methoxypolyethyleenglycolepoëtine beta (microgram once every 4 weeks) |
| 9-12 |
2000-2700 |
30 |
| 12-15 |
2700-3500 |
50 |
| 15-24 |
3500-5500 |
75 |
| 24-30 |
5500-6500 |
100 |
| 30-35 |
6500-8000 |
120 |
| 35-47 |
8000-10.000 |
150 |
| 47-60 |
10.000-13.000 |
200 |
| 60-90 |
13.000-20.000 |
250 |
| ≥ 90 |
≥ 20.000 |
360 |
Dose adjustments: Based on effect, increase/decrease dose by 25% every 4 weeks as needed.
- ALTERNATIVE: Subcutaneous injection. Do retain the chosen route of administration
- If the hemoglobin level continues to rise after dose reduction, treatment should be interrupted until the hemoglobin level begins to decrease. At that time, treatment should be restarted with a dose 25% lower than the previously administered dose
- Hemoglobin target value between 10 g/dl (6.2 mmol/l) and 12 g/dl (7.5 mmol/l).
|
Renal impaiment in children > 3 months
No information available on dose adjustment in renal impairment.
The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here
Side effects in children
The safety profile in children is generally similar to that in adults.
The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here
Contra-indications
No information available on specific contra indications in children.
The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here
Warnings & precautions in children
In children, especially younger than 1 year of age, evaluate carefully before switching ESA. Stabilize Hb levels before switching to methoxypolyethylene glycol epoetin β. After ESA conversion, check Hb levels every 4 weeks.
Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
OTHER ANTIANEMIC PREPARATIONS
This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.
| Other antianemic preparations |
|
|
|
B03XA02
|
|
|
|
B03XA01
|
|
|
|
B03XA01
|
|
|
|
B03XA01
|
Reference
-
Roche Registration GmbH, SmPC Mircera (EU/1/07/400/008) rev 30, 07 -12-2023, www.emea.europa.eu
Therapeutic Drug Monitoring
Overdose