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

Interactions
PK
Renal impairment
References

Folinic acid

Generic name
Folinic acid
Brand name
ATC Code
V03AF03

Pharmacokinetics in children

There is no specific information available for children.

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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

Epileptic encephalopathy
  • Oral
    • 1 month up to 18 years
      • 2 - 5 mg/kg/day in 2 doses.

      • The scientific evidence is limited: 3 case reports in which folinic acid was given orally. No studies have been carried out into intravenous application. The Wilhelmina Children’s Hospital formulary of 2008 states that folinic acid can also be given intravenously at the same dosage as orally.

    • 1 month up to 18 years
      [6] [7] [8] [9]
      • 2 - 5 mg/kg/day in 2 doses.

      • The scientific evidence is limited: 3 case reports in which folinic acid was given orally. No studies have been carried out into intravenous application. The Wilhelmina Children’s Hospital formulary of 2008 states that folinic acid can also be given intravenously at the same dosage as orally.

    • 1 month up to 18 years
      • 2 - 5 mg/kg/day in 2 doses.

      • The scientific evidence is limited: 3 case reports in which folinic acid was given orally. No studies have been carried out into intravenous application. The Wilhelmina Children’s Hospital formulary of 2008 states that folinic acid can also be given intravenously at the same dosage as orally.
Toxoplasmosis, congenital
  • Oral
    • Term neonate
      • 10 - 20 mg/dose 3 times a week.
      • Duration of treatment:

        during the first year of life

      • In combination with sulfadiazine and pyrimethamine.
HD-MTX rescue
  • Intravenous
    • 1 month up to 18 years

      • Dosage depends on the MTX treatment; for this reason, please refer to the detailed treatment protocols. Use:
        12-15 mg/m² starting 24-42 hours after starting MTX and then every 6 hours.

        Continue until MTX concentrations are < 0.01-0.25 µmol/l
        MTX level determination according to protocol, usually at t=48 hours after the start of the infusion. At high MTX levels of ≥ 1.0 µmol/l, increase the dosage of folinic acid: dosage = standard daily dosage x (MTX concentration at t=48 hours in µmol/l)

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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

No information is present at this moment.

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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

No information available on specific warnings and precautions in children.

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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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Antidotes
V03AB27
V03AB16
V03AB24
V03AB25
V03AB33
V03AB17
V03AB15
V03AB13
V03AB19
V03AB14
V03AB06
V03AB35
Iron chelating agents
V03AC03
V03AC02
V03AC01
Drugs for treatment of hyperkalemia and hyperphosphatemia
V03AE07
V03AE01
V03AE02
V03AE01
Detoxifying agents for antineoplastic treatment
V03AF01
V03AF07
Drugs for treatment of hypoglycemia
V03AH01
Other therapeutic products
V03AX03
DETOXIFYING AGENTS FOR ANTINEOPLASTIC TREATMENT
V03AF01
V03AF07
OTHER THERAPEUTIC PRODUCTS
V03AX03

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References

  1. Etienne MC, et al, l-folinic acid versus d,l-folinic acid in rescue of high-dose methotrexate therapy in children, J Natl Cancer Inst, 1992, Aug 5;84(15):, 1190-5
  2. Skarby TV, et al, High leucovorin doses during high-dose methotrexate treatment may reduce the cure rate in childhood acute lymphoblastic leukemia, Leukemia, 2006, Nov;20(11), 1955-62
  3. Thyss A, et al, Evidence for CSF accumulation of 5-methyltetrahydrofolate during repeated courses of methotrexate plus folinic acid rescue, Br J Cancer, 1989, Apr;59(4), 627-30
  4. Cohen IJ, Defining the appropriate dosage of folinic acid after high-dose methotrexate for childhood acute lymphatic leukemia that will prevent neurotoxicity without rescuing malignant cells in the central nervous system, J Pediatr Hematol Oncol, 2004, Mar;26(3), 156-63
  5. Borsi JD, et al, How much is too much? Folinic acid rescue dose in children with acute lymphoblastic leukaemia, Eur J Cancer, 1991, 27(8), 1006-9
  6. Gallagher RC, et al, Folinic acid-responsive seizures are identical to pyridoxine-dependent epilepsy, Ann Neurol., 2009, May;65(5), 550-6
  7. Gospe SM, Jr., Neonatal vitamin-responsive epileptic encephalopathies., Chang Gung Med J., 2010, Jan-Feb;33(1), 1-12
  8. Hansen FJ, et al, Cerebral folate deficiency: life-changing supplementation with folinic acid, Mol Genet Metab., 2005, Apr;84(4), 371-3
  9. Torres OA, et al, Folinic acid-responsive neonatal seizures, J Child Neurol, 1999, Aug;14(8), 529-32
  10. Hartwig NG, et al., Vademecum Pediatrische Antimicrobiële Therapie, 2005

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Changes

Changes