Gemcitabine

Generic name
Gemcitabine
Brand name
ATC Code
L01BC05
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Gemcitabine

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

The following kinetic parameters were found in children aged 2-21 years [Reid 2004; Steinherz 2002]: 

Dose (mg/m²)n=Cmax (µg/ml)Vss (l/m²)
1000 6 15.6 24.1
1200 6 17.5 31.8
1500 5 27.2 18.5
1800 5 41.0 14.2
2100 4 57.2 15.8

t½: 13.4-62 min
Cl: 2.2 l/min/m²

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

Recurrent or refractory Hodgkin lymphoma
  • Intravenous
    • 1 year 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 this reason, please refer to the detailed treatment protocols (see www.skion.nl) 

        The following indicative dosages have been stated in the literature:
        - Combined with vinorelbine or with vinorelbine and doxorubicin: 1000 mg/m²/dose on days 1 and 8 of a 21-day cycle.

      • Treatment by or after consultations with a paediatric specialist (oncologist) who has experience using gemcitabine for this indication.

    • 1 year up to 18 years
      [7] [8]

      • 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 this reason, please refer to the detailed treatment protocols (see www.skion.nl) 

        The following indicative dosages have been stated in the literature:
        - Combined with vinorelbine or with vinorelbine and doxorubicin: 1000 mg/m²/dose on days 1 and 8 of a 21-day cycle.

      • Treatment by or after consultations with a paediatric specialist (oncologist) who has experience using gemcitabine for this indication.
Recurrent or refractory sarcomas
  • Intravenous
    • 1 year up to 18 years
      [4] [5] [6]

      • 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 this reason, please refer to the details treatment protocols (see www.skion.nl)

        The following indicative dosages have been stated in the literature:
        - Combined with docetaxel: 675 mg/m²/dose on days 1 and 8 of a 21-day cycle.

      • Treatment by or after consultations with a paediatric specialist (oncologist) who has experience using gemcitabine for this indication.

Renal impaiment in children > 3 months

The dose does not need to be adjusted for renal function disorders.

 

Patients on dialysis

No generalized recommendations are given.

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

Dysuria, hypokalaemia, hypophosphataemia, periods of fainting, seizures.

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

ANTIMETABOLITES

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Purine analogues
L01BB06
L01BB05
L01BB02
L01BB07
L01BB03
Pyrimidine analogues
L01BC01
L01BC52

References

  1. Reid JM et al. , Phase I trial and pharmacokinetics of gemcitabine in children with advanced solid tumors. , J Clin Oncol., 2004 , Jun 15;22(12), 2445-51
  2. Steinherz PG et al., Phase I study of gemcitabine (difluorodeoxycytidine) in children with relapsed or refractory leukemia (CCG-0955): a report from the Children's Cancer Group., Leuk Lymphoma., 2002, Oct;43(10), 1945-50
  3. Geoerger B et al., Phase II study of gemcitabine combined with oxaliplatin in relapsed or refractory paediatric solid malignancies: An innovative therapy for children with Cancer European Consortium Study., Eur J Cancer., 2011, Jan;47(2), 230-8
  4. He A et al., Comparison of pirarubicin-based versus gemcitabine-docetaxel chemotherapy for relapsed and refractory osteosarcoma: a single institution experience., Int J Clin Oncol., 2013, Jun;18(3), 498-505
  5. Navid F et al. , Combination of gemcitabine and docetaxel in the treatment of children and young adults with refractory bone sarcoma. , Cancer. , 2008 , Jul 15;113(2), 419-25
  6. Song BS et al., Gemcitabine and docetaxel for the treatment of children and adolescents with recurrent or refractory osteosarcoma: Korea Cancer Center Hospital experience., Pediatr Blood Cancer., 2014, Aug;61(8):, 1376-81
  7. Cole PD et al., Phase II study of weekly gemcitabine and vinorelbine for children with recurrent or refractory Hodgkin's disease: a children's oncology group report., J Clin Oncol., 2009, Mar 20;27(9), 1456-61
  8. Jaffray M et al., Salvage therapy with gemcitabine, vinorelbine, and pegylated liposomal doxorubicin for relapsed or refractory pediatric Hodgkin lymphoma. Results of a retrospective series of four children., Ann Hematol., 2015, Aug;94(8), 1401-6
  9. Reid JM et al., Phase I trial and pharmacokinetics of gemcitabine in children with advanced solid tumors., J Clin Oncol., 2004, Jun 15;22(12), 2445-51
  10. Navid F et al., Combination of gemcitabine and docetaxel in the treatment of children and young adults with refractory bone sarcoma., Cancer., 2008, Jul 15;113(2), 419-25

Changes

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