Alteplase (r-tPA)

Generic name
Alteplase (r-tPA)
Brand name
ATC Code
B01AD02
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Alteplase (r-tPA)

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

No information available about the kinetic parameters in children.

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

Thrombolysis
  • Intravenous
    • 0 years up to 18 years
      • Initial dose: 0.01 - 0.1 mg/kg/hour, continuous infusion.
      • Maintenance dose: If the thrombus does not decrease and there is no tendency to bleed: increase every 6- 12 hours to a maximum of 0.5 mg/kg/hour, continuous infusion.
      • Duration of treatment:

        Thrombolysis until the thrombus is smaller and less threatening, Start with therapeutic doses of LMWH or unfractioned heparin 2 hours after discontinuation of alteplase.

        • Administer preferably by central venous cathether.
        • In neonates, due to the physiologically low plasminogen level: Plasma (FFP) 10 ml/kg for initial r-tPA and then once  daily during r-tPA.
        • In the event of bleeding: stop r-tPA, plasma (FFP) 10-20 ml/kg, 50 mg/kg/day IV of tranexamic acid in 4 divided doses if needed.
Thrombolytic treatment of occluded central venous access devices (CVAD)
  • Route of administration not applicable
    • 1 month up to 18 years and < 30 kg

      • Instillation in an occluded central venous access device: infusion fluid 1 mg/ml: Per blockage, slowly infuse a volume equal to 110% of the internal lumen volume of the device (max. 2 mg/dose) into the non-functioning central venous device. Repeat if necessary after 120 minutes

    • 1 month up to 18 years and ≥ 30 kg

      • Instillation in an occluded central venous access device: infusion fluid 1 mg/ml: Slowly infuse up to 2 mg per blockage into the non-functioning central venous device. If necessary, repeat after 120 minutes

Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

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 in children

(Relative) contraindications:

  • Major surgical procedure in the last 10 days
  • Intracranial bleeding in the last 10 days
  • Major surgical procedure due in the next three days
  • Active bleeding
  • Very severe asphyxia
  • Very premature neonates with a high risk of IVH
  • Thrombocytopenia

 

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

Before start of treatment:
- Ultrasound cerebrum in infants
- Lab control: APTT, PT, VBB, d-dimer, fibrinogen
Conditions:
- Trombos> 50-100 x109 / L in sick children
- Trombos> 50 x109 / L in stable patient
- Fibrinogen> 1.0 mg / L
- Normal or minimally extended PT and APTT
Low platelet count: platelet transfusion
Low fibrinogen: plasma transfusion
In infants because of physiologically low plasminogen: Plasma 10 cc / kg before starting r-tPA and then 1 dd during r-tPA.

Checks during treatment
Ultrasound or echocardiography to check the thrombus size at least once daily Daily ultrasound scan of the cerebrum in neonates. Lab 1x daily: VBB, D-dimer, fibrinogen if necessary, plasminogen.

There is no good laboratory measure for the degree of thrombolysis. Evaluation consists mainly of clinical course and ultrasound. Increase in d-dimers indicates degradation of fibrin and can serve as an indicator. Fibrinolysis can also be clearly visible with the ROTEM.

Do not perform invasive procedures such as rectal temperatures, intramuscular injections etc during thrombolysis.


 

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
B01AD01
B01AD04
Direct thrombin inhibitors
B01AE07
Direct factor Xa inhibitors
B01AF02
B01AF01

References

  1. NVK, Werkboek kinderhematologie, www.hematologienederland.nl, 30 sept 2012
  2. 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, Rev1
  3. Boehringer Ingelheim BV, SmPC Actilyse Cathflow (RVG 103374) 03-08-2022, www.geneesmiddeleninformatiebank.nl

Changes

Therapeutic Drug Monitoring


Overdose