- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
No information.
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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
| Deep vein thrombosis |
|---|
|
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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.
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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 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).
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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 | ||
| Platelet aggregation inhibitors excl. heparin | ||
|---|---|---|
| B01AC06 | ||
| B01AC04 | ||
| B01AC09 | ||
| Enzymes | ||
|---|---|---|
| B01AD02 | ||
| B01AD01 | ||
| B01AD04 | ||
| Direct thrombin inhibitors | ||
|---|---|---|
| B01AE07 | ||
| Direct factor Xa inhibitors | ||
|---|---|---|
| B01AF02 | ||
| B01AF01 | ||
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References
- NVK, Werkboek kinderhematologie, http://www.hematologienederland.nl, 30 sept 2012
- M. Cnossen., Expertopinie profylaxe dosering sectie Benigne Hematologie, 14 jan 2014
- 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
- 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
- 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
- NKFK Workinggroup Acute Kidney Impairment, Extrapolation of KNMP risk analysis "Impaired renal function" for adults to children, 20 Dec 2021
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Changes
Changes
