Ribavirin

Generic name
Ribavirin
Brand name
ATC Code
J05AB04
Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

No kinetic studies are known to have been carried out in children.

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

Chronic hepatitis C
  • Oral
    • 3 years up to 18 years
      [1] [2] [3] [4] [5]
      • 15 mg/kg/day in 2 doses.

      • In combination with (PEG) interferon α-2b subcutaneously 3 times a week for 48 weeks (genotypes I and IV) or 24 weeks (genotypes II and III)

Renal impaiment in children > 3 months

Adjustment in renal impairment as specified:

GFR 50-80 ml/min/1.73 m2
No adjustment necessary.
GFR 30-50 ml/min/1.73 m2
25 percentage of single dose and dosing interval : 24 uur
The first 2 doses given are 100% of the normal single dose each time (2 times 7.5 mg/kg with a dosing interval of 12 hours).
GFR 10-30 ml/min/1.73 m2
16 percentage of single dose and dosing interval : 24 uur
The first 2 doses given are 100% of the normal single dose each time (2 times 7.5 mg/kg with a dosing interval of 12 hours).
GFR < 10 ml/min/1.73 m2
16 percentage of single dose and dosing interval : 24 uur
The first 2 doses given are 100% of the normal single dose each time (2 times 7.5 mg/kg with a dosing interval of 12 hours).
Clinical consequences

Dose-related side effects, including anemia (iron independent). Therefore, treatment with ribavirin should be done under close monitoring of the hemoglobin concentration; monitoring of the ribavirin level can be considered.

Patients on dialysis

In case of intermittent hemodialysis, continuous venovenous hemodialysis and hemo (dia) filtration, peritoneal dialysis: avoid use. If this is not possible: loading dose of 15 mg/kg in 2 doses (dosing interval 12 hours), followed by 16.7% of the normal single dose and interval between two doses: 24 hours.

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

Oral: In general, the side effects in children and adolescents are similar. However, growth inhibition is observed in about 21% of the children that can also last years after stopping the therapy (> 5 years); the risk of growth inhibition is the greatest in prepubescent children. In combination with interferon α-2b, the following are also seen relatively often in this age category: fever, anorexia, vomiting, emotional lability, suicidal thoughts or attempts (about 2%), elevation of TSH.

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

Contra-indications in children

Oral: Children and adolescents:
- existing severe psychological conditions, in particular severe depression, suicidal thoughts/attempts or in medical history
- autoimmune hepatitis or autoimmune disease in medical history
- GFR <50 ml/min/1.73m²

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

Monitor the growth and development, thyroid function (elevated TSH), HCV/HIV co-infection and problems with the teeth and gums. Monitor for anaemia in cases of renal impairment. Carefully monitor whether significantly deviating hepatic function abnormalities develop during the therapy.

Interactions

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

DIRECT ACTING ANTIVIRALS

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

Nucleosides and nucleotides excl. reverse transcriptase inhibitors
J05AB01
J05AB11
J05AB14
Protease inhibitors
J05AE10
J05AE03
Nucleoside and nucleotide reverse transcriptase inhibitors
J05AF10
J05AF05
J05AF01
Non-nucleoside reverse transcriptase inhibitors
J05AG01
Neuraminidase inhibitors
J05AH02
Antivirals for treatment of HIV infections, combinations
J05AR02
J05AR10
Other antivirals
J05AX12
J05AX08
ANTIVIRALS FOR TREATMENT OF HIV INFECTIONS, COMBINATIONS
J05AR02
J05AR10
Antivirals for treatment of HCV infections
J05AP57
J05AP08
J05AP55

References

  1. Schwarz KB, et al, The Combination of Ribavirin and Peginterferon Is Superior to Peginterferon and Placebo for Children and Adolescents Chronic Hepatitis C, Gastroenterology, 2010, Oct 28
  2. Wirth S, et al, Peginterferon alfa-2b plus ribavirin treatment in children and adolescents with chronic hepatitis C, Hepatology, 2005, May;41(5), 1013-8
  3. Wirth S, et al, Recombinant alfa-interferon plus ribavirin therapy in children and adolescents with chronic hepatitis C, Hepatology, 2002, Nov;36(5), 1280-4
  4. Fried MW, et al, Hepatitis C in adults and adolescents with hemophilia: a randomized, controlled trial of interferon alfa-2b and ribavirin, Hepatology, 2002, Oct;36(4 Pt 1), 967-72
  5. Hu J, et al, Treatment of hepatitis C in children: a systematic review, PLoS One, 2010, 5(7), e11542
  6. Wheeler JG, et al, Historical cohort evaluation of ribavirin efficacy in respiratory syncytial virus infection, Pediatr Infect Dis J, 1993, Mar;12(3), 209-13
  7. Van Woensel J, et al, Therapy for respiratory tract infections caused by respiratory syncytial virus, Eur J Pediatr, 2000, Jun;159(6), 391-8
  8. Ventre K, et al, Ribavirin for respiratory syncytial virus infection of the lower respiratory tract in infants and young children, Cochrane Database Syst Rev, 2007, (1), CD000181
  9. Long CE, et al, Long term follow-up of children hospitalized with respiratory syncytial virus lower respiratory tract infection and randomly treated with ribavirin or placebo, Pediatr Infect Dis J, 1997, Nov;16(11), 1023-8
  10. MSD SHARP & DOHME GMBH, SmPC Rebetol 200mg Hartkapseln (EU/1/99/107/001), 10/2015
  11. ratiopharm, SmPC Ribavirin 200mg/400mg Filmtabletten (82714.00.00), 11/2016
  12. MSD SHARP & DOHME GMBH, SmPC Rebetol 40mg/ml Lösung zum Einnehmen (EU/1/99/107/004), 10/2015
  13. Roche, SmPC Copegus 200mg/400mg Filmtabletten (54828.00.00), 01/2015
  14. Online GL. Gelbe Liste Online, https://www.gelbe-liste.de/, Accessed May 25, 2018
  15. Aurobindo, SmPC Ribavirin 200mg Hartkapseln (84747.00.00), 02/2016

Changes

Therapeutic Drug Monitoring


Overdose