Apixaban

Generic name
Apixaban
Brand name
ATC Code
B01AF02
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)

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.

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)
  • Oral
    • 1 month up to 18 years and ≥ 35 kg
      • Initial dose: Day 1-7: 20 mg/day in 2 doses.
      • Maintenance dose: From day 8 onwards: 10 mg/day in 2 doses.
    • 1 month up to 18 years and 4 up to 5 kg
      • Initial dose: Day 1-7: 1.2 mg/day in 2 doses.
      • Maintenance dose: From day 8 onwards: 0.6 mg/day in 2 doses.
    • 1 month up to 18 years and 5 up to 6 kg
      • Initial dose: Day 1-7: 2 mg/day in 2 doses.
      • Maintenance dose: From day 8 onwards: 1 mg/day in 2 doses.
    • 1 month up to 18 years and 6 up to 9 kg
      • Initial dose: Day 1-7: 4 mg/day in 2 doses.
      • Maintenance dose: From day 8 onwards: 2 mg/day in 2 doses.
    • 1 month up to 18 years and 9 up to 12 kg
      • Initial dose: Day 1-7: 6 mg/day in 2 doses.
      • Maintenance dose: From day 8 onwards: 3 mg/day in 2 doses.
    • 1 month up to 18 years and 12 up to 18 kg
      • Initial dose: Day 1-7: 8 mg/day in 2 doses.
      • Maintenance dose: From day 8 onwards: 4 mg/day in 2 doses.
    • 1 month up to 18 years and 18 up to 25 kg
      • Initial dose: Day 1-7: 12 mg/day in 2 doses.
      • Maintenance dose: From day 8 onwards: 6 mg/day in 2 doses.
    • 1 month up to 18 years and 25 up to 35 kg
      • Initial dose: Day 1-7: 16 mg/day in 2 doses.
      • Maintenance dose: From day 8 onwards: 8 mg/day in 2 doses.

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)

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)

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.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

ANTITHROMBOTIC AGENTS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

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

References

  1. 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
  2. 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

Changes

Therapeutic Drug Monitoring


Overdose