- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
Paediatric patients: Cmax: approx. 2 hours (after single-dose administration); total apparent clearance: about 3.0 L/h
Adults: Cmax: 3 - 4 hours; total clearance: about 3.3 L/h
(SmPC Eliquis)
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
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Available formulations
No information is present at this moment.
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General Dose Info
- start after at least 5 days of initial parenteral anticoagulant therapy;
- switching from or to a parenteral anticoagulant can be done at the next scheduled dose.
Dosages
| Treatment of venous thrombo-embolic events (VTE) and prevention of recurrent venous thrombo-embolic events (VTE) |
|---|
|
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Renal impaiment in children > 3 months
Based on adult data and limited data in paediatric patients, no dose adjustment is necessary in paediatric patients with mild to moderate renal impairment. Apixaban is not recommended in paediatric patients with severe renal impairment. (SmPC Eliquis)
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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
Overall, the safety profile in paediatric patients 28 days to < 18 years of age was similar to that in adults and was generally consistent across different paediatric age groups.
The following side effects were reported more frequently as compared to adults, but in the same frequency category as the paediatric patients in the standard of care (SOC) arm:
Very common: epistaxis, abnormal vaginal haemorrhage (SOC arm: common)
Common: hypersensitivity, anaphylaxis, pruritus, hypotension, haematochezia, aspartate aminotransferase increased, alopecia, and post procedural haemorrhage;
In all but one case, hepatic transaminase elevations were reported in paediatric patients receiving concomitant chemotherapy for an underlying malignancy.
(SmPC Eliquis)
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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
No information available on specific warnings and precautions in children.
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Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
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| Vitamin K antagonists | ||
|---|---|---|
| B01AA07 | ||
| B01AA04 | ||
| Heparin group | ||
|---|---|---|
| B01AB04 | ||
| B01AB09 | ||
| B01AB05 | ||
| B01AB01 | ||
| B01AB06 | ||
| B01AB10 | ||
| Platelet aggregation inhibitors excl. heparin | ||
|---|---|---|
| B01AC06 | ||
| B01AC04 | ||
| B01AC09 | ||
| Enzymes | ||
|---|---|---|
| B01AD02 | ||
| B01AD01 | ||
| B01AD04 | ||
| Direct thrombin inhibitors | ||
|---|---|---|
| B01AE07 | ||
| Direct factor Xa inhibitors | ||
|---|---|---|
| B01AF01 | ||
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References
- Bristol-Myers Squibb/Pfizer EEIG, SmPC Eliquis Filmtbl 2,5 mg (EU/1/11/691/001-015) Rev. 34, 19-08-2024, www.ema.europa.eu
- Bristol-Myers Squibb/Pfizer EEIG, SmPC Eliquis Filmtbl 2,5 mg (EU/1/11/691/001-015) Rev. 38, 26-11-2025, www.ema.europa.eu
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Changes
Changes
