Interferon alpha 2b

Generic name
Interferon alpha 2b
Brand name
ATC Code
L03AB05
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Interferon alpha 2b

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

The dose-corrected Cmax, Cmin and AUC values are similar to those of adults

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

Laryngeal papillomatosis (human papilloma virus)
  • Subcutaneous
    • 1 month up to 18 years
      • Initial dose: 2.000.000 IU/m²/day in 1 dose Initial dose for 4 weeks..
      • Maintenance dose: 2.000.000 IU/m²/dose 3x per week.
      • Duration of treatment:

        maintenance dose for 6 months

      • No studies have been performed on the application of interferon alpha 2b in children with laryngeal papillomatosis

    • 1 month up to 18 years
      • Initial dose: 2.000.000 IU/m²/day in 1 dose Initial dose for 4 weeks..
      • Maintenance dose: 2.000.000 IU/m²/dose 3x per week.
      • Duration of treatment:

        maintenance dose for 6 months

      • No studies have been performed on the application of interferon alpha 2b in children with laryngeal papillomatosis
Chronically active hepatitis C
  • Subcutaneous
    • 1 month up to 18 years
      • 3.000.000 - 5.000.000 IU/m²/dose 3-5 times a week. in combination with ribavirin.

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 in children

Weight loss and growth inhibition are common in children. In children and adolescents, the following are reported more often: abnormalities at the injection site, fever, anorexia, vomiting, emotional lability, suicidal thoughts, suicide attempts.

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications in children

Children and adolescent with severe psychiatric impairment, particularly severe depression, suicidal thoughts or suicide attempts in the previous history.

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

Suicidal behaviour was observed more often in children and adolescents than in adults (2.4% versus 1%). In children and adolescents, check for signs of thyroid function disorders every three months. It is recommended that the growth of children receiving ribavirin combined with interferon α-2b should be monitored. In children and adolescents, check for signs of thyroid function disorders every three months.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

IMMUNOSTIMULANTS

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

Colony stimulating factors
L03AA02
L03AA14
Interferons
L03AB11
L03AB10
Other immunostimulants
L03AX13
L03AX15
L03AX16

References

  1. Gonzalez-Peralta RP, et al, Interferon alfa-2b in combination with ribavirin for the treatment of chronic hepatitis C in children: efficacy, safety, and pharmacokinetics, Hepatology, 2005, Nov;42(5), 1010-8
  2. Boxall EH, et al, Long-term follow-up of hepatitis B carrier children treated with interferon and prednisolone, J Med Virol, 2006, Jul;78(7), 888-95
  3. Dikici B, et al, Current therapeutic approaches in childhood chronic hepatitis B infection: a multicenter study, J Gastroenterol Hepatol, 2004, Feb;19(2), 127-33
  4. Gurakan F, et al, Comparison of standard and high dosage recombinant interferon alpha 2b for treatment of children with chronic hepatitis B infection, Pediatr Infect Dis J, 2000, Jan;19(1), 52-6
  5. Helvaci M, et al, Efficacy of hepatitis B vaccination and interferon-alpha-2b combination therapy versus interferon-alpha-2b monotherapy in children with chronic hepatitis B, J Gastroenterol Hepatol, 2004, Jul;19(7), 785-91
  6. Torre D, et al, Interferon-alpha therapy for chronic hepatitis B in children: a meta-analysis, Clin Infect Dis, 1996, Jul;23(1):, 131-7
  7. Wirth S, et al, [Chronic hepatitis B. Treatment in childhood with alpha-interferon], Monatsschr Kinderheilkd., 1992, Oct;140(10), 775-9
  8. Merck Sharp & Dohme Limited, SPC IntronA (EU/1/99/127/011-014), Geraadpleegd 23 dec 2011, http://www.ema.europa.eu/docs/nl_NL/document_library/EPAR_-_Product_Information/human/000281/WC500034679.pdf
  9. CHMP, EPAr IntronA, Doc. Ref.: EMA/10685/2010, http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/000281/WC500034673.pdf

Changes

Therapeutic Drug Monitoring


Overdose