Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Enoxaparin

Generic name
Enoxaparin
Brand name
ATC Code
B01AB05

Pharmacokinetics in children

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

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Available formulations

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Dosages

Prophylaxis for thromboembolic complications
  • Subcutaneous
    • 0 months up to 2 months
      [3] [12]
      • 1.5 mg/kg/day in 2 doses. (equivalent to 150 IU/kg/day).
        • Titrate the dose based on the concentrations, see warning & precautions section
        • Dissolve the dose in a minimum of 0.2 ml
    • 2 months up to 18 years
      [3] [12]
      • 1 mg/kg/day in 2 doses. (equivalent to 100 IU/kg/day).
        • Titrate the dose based on the concentrations, see warnings & precautions section
        • Dissolve the dose in a minimum of 0.2 ml
Deep vein thrombosis
  • Subcutaneous
    • Premature neonates: Gestational age < 37 weeks
      [3]
      • 4 mg/kg/day in 2 doses. (equivalent to 400 IU/kg/day).
        • Titrate the dose based on the concentrations, see warnings & precautions section
        • The dose may be diluted to a mimumum of 0,2 ml to enable precise administration of small doses. 
    • 0 months up to 2 months
      [3]
      • 3.4 mg/kg/day in 2 doses. (equivalent to 340 IU/kg/day).
        • Titrate the dose based on the concentrations, see warnings & precautions section
        • The dose may be diluted to a mimumum of 0,2 ml to enable precise administration of small doses. 
    • 2 months up to 6 years
      [1] [3]
      • 2.6 mg/kg/day in 2 doses. (equivalent to 260 IU/kg/day).
        • Titrate the dose based on the concentrations, see warnings & precautions section
        • The dose may be diluted to a mimumum of 0,2 ml to enable precise administration of small doses. 
    • 6 years up to 18 years
      [3]
      • 2 mg/kg/day in 2 doses. (equivalent to 200 IU/kg/day).
        • Titrate the dose based on the concentrations, see warnings & precautions section
        • The dose may be diluted to a mimumum of 0,2 ml to enable precise administration of small doses. 

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Renal impaiment in children > 3 months

Therapeutic dose:

  • GFR ≥ 50: adjustment of dose is not necessary.
  • GFR 30-50: 1st dose 100% of normal single dose, then 75% of normal single dose, interval between two doses: 12 hours; if used longer than 3 days, dose according to anti-Xa levels.
  • GFR 10-30: 1st dose 100% of normal single dose, then 50% of normal single dose, interval between doses: 12 hours; if used for more than 3 days, dose according to anti-Xa levels.
  • GFR <10: general advice is not given.

Prophylactic dose:

  • GFR ≥10: adjustment of dose is not necessary.
  • GFR <10: general advice is not given.
Clinical consequences

With impaired kidney function, the half-life of enoxaparin is prolonged. This increases the risk of bleeding.

Clinical implications:
Bleeding

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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

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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 in children

1 mg of protamine sulfate neutralizes 100 IU of anti-Xa-enoxaparin. See further protamine monograph.

Target levels and monitoring:
Anti-FXa level measured 4 hours after gift (3 hours in neonates); first anti-FXa measured after 3 gifts.
Target anti-FXa level:
therapeutic: 0.5 - 1.0 E/mL;
prophylactic: 0.1 - 0.4 E/mL,

>40 kg: generally no monitoring anti-FXa necessary, WELL in sick children, co-medication and/or poor renal function

After any dose adjustment it is not necessary to wait for 3 doses and can be agreed upon with the local laboratory. Upon reaching therapeutic level, only further monitoring is necessary in neonates, critically ill patients, and patients during asparaginase use (due to decreasing antithrombin).

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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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Heparin group
B01AB04
B01AB01
B01AB06
Platelet aggregation inhibitors excl. heparin
B01AC06

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References

  1. NVK, Werkboek kinderhematologie, http://www.hematologienederland.nl/werkboek-kinderhematologie , 2014, Geraadpleegd 20-01-14
  2. M. Cnossen. , Expertopinie profylaxe dosering sectie Benigne Hematologie, 14 jan 2014
  3. Klaassen ILM. et al, Are low-molecular-weight heparins safe and effective in children? A systematic review., Blood Rev, 2018, 10.1016/j.blre.2018.06.003
  4. Sanofi-Aventis Deutschland GmbH, SmPC, Clexane® Injektionslösung in einer Fertigspritze (15854.00.00), 04/18
  5. Techdow Europe AB, SmPC, Inhixa Injektionslösung (EU/1/16/1132/001), 08/17
  6. Sanofi-Aventis Deutschland GmbH, SmPC, Clexane® multidose Injektionslösung (99843.00.00), 04/18
  7. Laboratorios Farmacéuticos ROVI, SmPC, Enoxaparin Becat Injektionslösung in einer Fertigspritze (99912.00.00), 03/18
  8. Chemi S.p.A, SmPC, Hepaxane Injektionslösung in einer Fertigspritze (2201226.00.00), 10/18
  9. Uptodate: UpToDate®, Pediatric Drug information: Enoxaparin Topic 13270 Version 181.0, accessed 03/19
  10. DinH C, et al, A Critical Evaluation of Enoxaparin Dose Adjustment Guidelines in Children, J Pediatr Pharmacol Ther, 2019, 24(2):, 128–133
  11. NKFK Workinggroup Acute Kidney Impairment, Extrapolation of KNMP risk analysis "Impaired renal function" for adults to children, 20 Dec 2021
  12. Monagle P, et al., Antithrombotic therapy in neonates and children: Antithrombotic Therapy and Prevention of Thrombosis. 9th ed: American College of Chest Physicians Evid ence-Based Clinical Practice Guidelines., Chest, 2012, Feb;141(2 Suppl), e737S-e801S

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Changes

Changes