- 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.
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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
| Chronic hepatitis C, without hepatic decompensation, positive for HCV RNA |
|---|
|
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Renal impaiment in children > 3 months
Adjustment in renal impairment as specified:
GFR 50-80 ml/min/1.73 m2
Adjustment not necessaryGFR 30-50 ml/min/1.73 m2
75% of the initial doseGFR 10-30 ml/min/1.73 m2
50% of the initial doseGFR < 10 ml/min/1.73 m2
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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 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.
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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 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
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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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| Colony stimulating factors | ||
|---|---|---|
| L03AA02 | ||
| L03AA14 | ||
| Interferons | ||
|---|---|---|
| L03AB05 | ||
| L03AB11 | ||
| Other immunostimulants | ||
|---|---|---|
| L03AX13 | ||
| L03AX15 | ||
| L03AX16 | ||
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Reference
- Merck Sharp & Dohme Limited, SPC PegIntron (EU/1/00/131/006-010, 027) 25 mei 2010, www.ema.europa.eu
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Changes
Changes
