Thiotepa

Generic name
Thiotepa
Brand name
ATC Code
L01AC01
Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

No information is present at this moment.

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

Oncological conditions
  • Intravenous
    • 0 years up to 18 years

      • Note:
        the dose and dosing frequency of cytostatic agents depend on the condition and are very much subject to new insights. Cytostatic drugs are mostly used in oncology and haematology in combinations. For this reason, please refer to the detailed treatment protocols.

        The following indicative dosages have been stated by the manufacturer:

        Autologous haematopoietic stem cell transplants
        For solid tumours:
        6-14 mg/kg/day IV in a single dose (equivalent to 150-350 mg/m²/day) for 2-3 successive days before HPCT. The maximum cumulative dose is 42 mg/kg, equivalent to 1050 mg/m².
        For CNS tumours:
        10-14 mg/kg/day in a single IV dose (equivalent to 250-350 mg/m²/day) for 3 successive days before HPCT. Max cumulative dose: 42 mg/kg, equivalent to 1050 mg/m².

        Allogeneic haematopoietic stem cell transplants
        Haematological diseases:
        5-10 mg/kg/day in 1-2 IV doses (equivalent to 125-250 mg/m²/day) for 1-3 successive days before HPCT. Max cumulative dose: 15 mg/kg, equivalent to 375 mg/m².
        Leukaemia: 10 mg/kg/day in two IV doses (equivalent to 250 mg/m²/day) before HPCT, maximum cumulative dose 10 mg/kg (equivalent to 250 mg/m²).
        Thalassaemia: 8-10 mg/kg/day in two IV doses (equivalent to 200-250 mg/m²/day) before HPCT, maximum cumulative dose 10 mg/kg (equivalent to 250 mg/m²).
        Refractory cytopenia: 5 mg/kg/day in a single IV dose (equivalent to 125 mg/m²/day) for 3 successive days before HPCT; maximum cumulative dose 15 mg/kg (equivalent to 375 mg/m²).
        Genetic diseases: 5 mg/kg/day in a single IV dose (equivalent to 125 mg/m²/day) for 2 successive days before HPCT; maximum cumulative dose 10 mg/kg (equivalent to 250 mg/m²).
        Sickle cell anaemia: 10 mg/kg/day in two IV doses (equivalent to 250 mg/m²/day) before HPCT, maximum cumulative dose 10 mg/kg (equivalent to 250 mg/m²).

Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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

Very common (> 10%): hypogonadism, hypothyroidism, memory disorder, paresis. Cardiac arrest, haemorrhage, increased ALAT; desquamation, growth disorder, bladder conditions.

Common (1-10%): thrombocytic purpura, cardiovascular insufficiency, electrolyte disorders, extension of the prothrombin time, pulmonary bleeding, respiratory arrest, intestinal obstruction, liver failure.

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

ALKYLATING 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.

Nitrogen mustard analogues
L01AA05
L01AA01
L01AA06
Alkyl sulfonates
L01AB01

Reference

  1. Adienne S.r.l.SU, SmPC Tepadina (EU/1/10/622/002) 22-12-2015, www.geneesmiddeleninformatiebank.nl

Changes

Therapeutic Drug Monitoring


Overdose