Tinzaparine

Generic name
Tinzaparine
Brand name
ATC Code
B01AB10

Tinzaparine

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

No information.

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

Deep vein thrombosis
  • Subcutaneous
    • 0 months up to 2 months
      • 275 IU/kg/day in 1 dose
      • Titrate the dose based on the concentrations. See warnings and precautions.

        ...read more
    • 2 months up to 1 year
      • 250 IU/kg/day in 1 dose
      • Titrate the dose based on the concentrations. See warnings and precautions section.

    • 1 year up to 5 years
      • 240 IU/kg/day in 1 dose
      • Titrate the dose based on the concentrations. See warnings and precautions section.

    • 5 years up to 10 years
      • 200 IU/kg/day in 1 dose
      • Titrate the dose based on the concentrations. See warnings and precautions section.

    • 10 years up to 18 years
      • 175 IU/kg/day in 1 dose
      • Titrate the dose based on the concentrations. See warnings and precautions section.

    • 0 months up to 2 months
      [1] [3] [5]
      • 275 IU/kg/day in 1 dose
      • Titrate the dose based on the concentrations. See warnings and precautions.

        ...read more
    • 2 months up to 1 year
      [1] [3] [5]
      • 250 IU/kg/day in 1 dose
      • Titrate the dose based on the concentrations. See warnings and precautions section.

    • 1 year up to 5 years
      [1] [3] [5]
      • 240 IU/kg/day in 1 dose
      • Titrate the dose based on the concentrations. See warnings and precautions section.

    • 5 years up to 10 years
      [1] [3] [5]
      • 200 IU/kg/day in 1 dose
      • Titrate the dose based on the concentrations. See warnings and precautions section.

    • 10 years up to 18 years
      [1] [3] [5]
      • 175 IU/kg/day in 1 dose
      • Titrate the dose based on the concentrations. See warnings and precautions section.

Renal impaiment in children > 3 months

Therapeutic use:

  • 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 2 doses: 24 hours; if used longer than 3 days, titrate based on anti-Xa levels.
  • GFR 10-30: 1st dose 100% of normal single dose, then 50% of normal single dose, interval between 2 doses: 24 hours; titrate on the basis of anti-Xa levels if used for more than 3 days.
  • GFR <10: general advice is not given.

Prophylacticuse:

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

With impaired renal function, clearance of low molecular weight heparins may be delayed. This cannot be fully predicted from creatinine clearance.

Clinical effects:
Bleeding. No difference has been shown in the top level of anti-Xa factor in patients with and without impaired renal function. However, patients with ClCr 10-20 ml/min were not included.

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

Side effects

No information is present at this moment.

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 protaminesulfaat neutralises100 IE anti-Xa-tinzaparine

Anti-FXa levels and monitoring:
Anti-FXa level, measured 4 hours after dose, measure first anti-FXa after 3 doses.
Target anti-FXa level
therapeutic: 0.5 - 1.0 U / mL;
prophylactic: 0.1-0.4 E /m L,

> 40 kg: in general no anti-FXa monitoring necessary, except for sick children, co-medication and / or poor kidney function

After possible dose adjustment, it is not necessary to wait for 3 doses. This can be agreed in consultation with the local laboratory. When therapeutic level is reached, further monitoring is only necessary in neonates, severely ill patients, and patients during asparaginase use (due to decreasing antithrombin).

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
Platelet aggregation inhibitors excl. heparin
B01AC06
B01AC04
B01AC09
Enzymes
B01AD02
B01AD01
B01AD04
Direct thrombin inhibitors
B01AE07
Direct factor Xa inhibitors
B01AF02
B01AF01

References

  1. NVK, Werkboek kinderhematologie, http://www.hematologienederland.nl, 30 sept 2012
  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, DOI: 10.1016/j.blre.2018.06.003
  4. Kuhle S, et al, Dose-finding and pharmacokinetics of therapeutic doses of tinzaparin in pediatric patients with thromboembolic events, Thromb Haemost., 2005, 94(6), 1164-71
  5. Nederlandse Vereniging voor Kindergeneeskunde, sectie kinderhematologie, Richtlijn Diagnostiek en behandeling van veneuze trombo-embolische complicaties bij neonaten en kinderen tot 18 jaar, https://hematologienederland.nl/kwaliteit/werkboek-kinderhematologie/, 2020, jan, Revisie 1
  6. NKFK Workinggroup Acute Kidney Impairment, Extrapolation of KNMP risk analysis "Impaired renal function" for adults to children, 20 Dec 2021

Changes

Therapeutic Drug Monitoring


Overdose