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

Interactions
PK
Renal impairment
References

Bortezomib

Generic name
Bortezomib
Brand name
ATC Code
L01XG01

Pharmacokinetics in children

The following kinetic parameters have been observed for bortezomib in the treatment of ALL (after a dose of 1.3 mg/m², n=3) [Horton 2007]:

Cmax: 63 ng/ml
t½:  725 min
Cl: 38 ml/hour/m²

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

No information is present at this moment.

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Available formulations

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Dosages

Acute alloantibody-mediated kidney rejection (acute AMR)
  • Intravenous
    • 3 years up to 18 years
      • 1.3 mg/m²/dose on days 1, 4, 8 and 11 in a 21 day treatment cycle.. 1 treatment cycle = 21 days.

      • Treatment by or after consultations with a paediatric specialist (nephrology) who has experience using bortezomib for this indication.
Recurrent/refractory ALL
  • Intravenous
    • 6 months up to 18 years

      • The dosage and dosing frequency of oncological agents depend on the condition and are very much subject to new insights. Oncological drugs are often used in combinations. For these reasons, please refer to the detailed treatment protocols (see www.skion.nl); no dose recommendations have been included.

      • Treatment by or after consultations with a paediatric specialist (oncology) who has experience using bortezomib for this indication

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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.

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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

As of yet there is insufficient evidence to include the indication thrombotic thrombocytopenia purpura. Treatment by a paediatric specialist (haematologist) who has experience with using bortezomib for this indication.

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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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Methylhydrazines
L01XB01
MONOKLONALE ANTILICHAMEN
L01XC11
L01XC18
L01XC18
Other antineoplastic agents
L01XX01
L01XX02
L01XX05
L01XX23
L01XX24
L01XX14
Antineoplastic cell and gene therapy
L01XL04

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References

  1. Claes DJ et al., Protective immunity and use of bortezomib for antibody-mediated rejection in a pediatric kidney transplant recipient., Pediatr Transplant., 2014, Jun;18(4), E100-5
  2. Nguyen S et al. 2014, Efficacy of bortezomib for reducing donor-specific antibodies in children and adolescents on a steroid minimization regimen., Pediatr Transplant., 2014, Aug;18(5), 463-8
  3. Twombley K et al., Acute antibody-mediated rejection in pediatric kidney transplants: a single center experience., Pediatr Transplant., 2013, Nov;17(7):, E149-55
  4. Westphal S et al. , Successful treatment of severe ABO antibody-mediated rejection using bortezomib: a case report. , Transplant Proc., 2013, Apr;45(3), 1213-5
  5. Messinger YH et al, Bortezomib with chemotherapy is highly active in advanced B-precursor acute lymphoblastic leukemia: Therapeutic Advances in Childhood Leukemia &amp; Lymphoma (TACL) Study., Blood, 2012, Jul 12;120(2), 285-90
  6. Horton TM et al., A phase 1 study of the proteasome inhibitor bortezomib in pediatric patients with refractory leukemia: a Children's Oncology Group study., Clin Cancer Res., 2007, Mar 1;13(5), 1516-22
  7. Kizilbash S et al., Bortezomib in the treatment of antibody-mediated rejection in pediatric kidney transplant recipients: A multicenter Midwest Pediatric Nephrology Consortium study, Pediatr Transplant., 2017, Jan 16
  8. Westphal S et al., Successful treatment of severe ABO antibody-mediated rejection using bortezomib: a case report., Transplant Proc., 2013, Apr;45(3), 1213-5

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Changes

Changes