Peginterferon alfa-2b

Generic name
Peginterferon alfa-2b
Brand name
ATC Code
L03AB10
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Peginterferon alfa-2b

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

The pharmacokinetic properties after repeated dosing of PegIntron and ribavirin (capsules and solution) in children and adolescents with chronic hepatitis C have been evaluated in a clinical trial. For children and adolescents who received a BSA-based dosage of 60 μg/m²/week of PegIntron, it was predicted that the log-transformed estimated ratio of exposure during the dosage interval would be 58% (90% CI: 141-177%) higher than the value observed in adult patients getting 1.5 μg/kg/week.

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, without hepatic decompensation, positive for HCV RNA
  • Subcutaneous
    • 3 years up to 17 years
      • 60 microg./m²/dose once a week. Combined with ribavirin, 15 mg/kg/day in 2 doses.
      • Duration of treatment:

        Genotypes 1 and 4: 1 year
        Genotypes 2 and 3: 24 weeks

      • If serious side effects or deviations from laboratory values occur during treatment with
        PegIntron, the PegIntron dose can be adjusted until the side effects decrease. In children and adolescents, the dose of PegIntron is reduced to 40 mcg/m²/week on the first dose reduction and to 20 mcg/m²/week on the second dose reduction

Renal impaiment in children > 3 months

Adjustment in renal impairment as specified:

GFR 50-80 ml/min/1.73 m2
Adjustment not necessary
GFR 30-50 ml/min/1.73 m2
75% of the initial dose
GFR 10-30 ml/min/1.73 m2
50% of the initial dose
GFR < 10 ml/min/1.73 m2
Do not administer

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

Very common: Anaemia, leukopenia, neutropenia, anorexia, decreased appetite, mental disorders, headaches, dizziness, abdominal pain, upper abdominal pain, vomiting, nausea, alopecia, dry skin, myalgia, arthralgia, erythema at the injection site, fatigue, pyrexia, rigor, influenza-like illness, asthenia, pain, malaise, irritability, growth retardation (height and/or weight low for age).
Common: Fungal infection, influenza, oral herpes, otitis media, streptococcal pharyngitis, nasopharyngitis, sinusitis, thrombocytopenia, lymphadenopathy, hypothyroidism, suicidal thoughts, suicide attempt, depression, aggression, affection lability, anger, agitation, anxiety, mood changes, restlessness, nervousness, insomnia, dysgeusia, syncope, attention disorder, sleepiness, poor quality sleep, eye pain, vertigo, palpitations, tachycardia, flushing, coughing, epistaxis, pharyngolaryngeal pain, diarrhoea, aphthous stomatitis, cheilosis, mouth ulceration, abdominal discomfort, oral pain, pruritus, rash, erythematous rash, eczema, acne, erythema, skeletal muscle pain, pain in the extremities, back pain, reactions or pruritus or rash or dryness or pain at the injection site, feeling cold, thyroid-stimulating hormone concentration in the blood increased, thyroglobulin elevated.
Uncommon:    Pneumonia, ascariasis, enterobiasis, herpes zoster, cellulite, urinary tract infection, gastroenteritis, abnormal behaviour, depressive mood, emotional disorder, fear, nightmares, neuralgia, lethargy, paraesthesia, hypoesthesia, psychomotor hyperactivity, tremor, conjunctival haemorrhage, eye pruritus, keratitis, eyesight blurred, photophobia, hypotension, pallor, wheezing, nasal discomfort, rhinorrhoea, dyspepsia, gingivitis, hepatomegaly, photosensitivity reaction, maculo-papular rash, skin exfoliation, pigmentation disorder, atopical dermatitis, skin discoloration, muscle contracture, muscle twitches, proteinuria, chest pain, chest discomfort, facial pain, antithyroid antibody positive, bruising. Women: dysmenorrhoea.
 

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 adolescents with an existing severe psychiatric condition or a medical history of one.

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

Where possible, the child should be treated after the adolescent growth spurt to reduce the risk of growth inhibition. Children and adolescents should be checked every 3 months for signs of thyroid dysfunction

In renal impairment:

  • Creatinine clearance 30-50 ml/min: reduce the starting dose by 25%.
  • Creatinine clearance 15-29 ml/min: reduce the starting dose by 50%.
  • Creatinine clearance < 15 ml/min: discontinue if renal function drops further

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
L03AB05
L03AB11
Other immunostimulants
L03AX13
L03AX15
L03AX16

Reference

  1. Merck Sharp & Dohme Limited, SPC PegIntron (EU/1/00/131/006-010, 027) 25 mei 2010, www.ema.europa.eu

Changes

Therapeutic Drug Monitoring


Overdose