Active Ingredient: Nintedanib
Nintedanib is indicated in adults for the treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype.
Nintedanib is indicated in children and adolescents from 6 to 17 years old for the treatment of clinically significant, progressive fibrosing interstitial lung diseases (ILDs).
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 150 milligrams nintedanib, once every 12 hours.
The recommended dose is 150 mg nintedanib twice daily administered approximately 12 hours apart. The 100 mg twice daily dose is only recommended to be used in patients who do not tolerate the 150 mg twice daily dose.
If a dose is missed, administration should resume at the next scheduled time at the recommended dose. If a dose is missed the patient should not take an additional dose. The recommended maximum daily dose of 300 mg should not be exceeded.
No overall differences in safety and efficacy were observed for elderly patients. No a-priori dose adjustment is required in elderly patients. Patients ≥75 years may be more likely to require dose reduction to manage adverse effects.
In addition to symptomatic treatment if applicable, the management of adverse reactions to nintedanib could include dose reduction and temporary interruption until the specific adverse reaction has resolved to levels that allow continuation of therapy. Nintedanib treatment may be resumed at the full dose (150 mg twice daily in adult patients) or a reduced dose (100 mg twice daily in adult patients). If an adult patient does not tolerate 100 mg twice daily, treatment with nintedanib should be discontinued.
If diarrhoea, nausea and/or vomiting persist despite appropriate supportive care (including anti-emetic therapy), dose reduction or treatment interruption may be required. The treatment may be resumed at a reduced dose (100 mg twice daily in adult patients) or at the full dose (150 mg twice daily in adult patients). In case of persisting severe diarrhoea, nausea and/or vomiting despite symptomatic treatment, therapy with nintedanib should be discontinued.
In case of interruptions due to aspartate aminotransferase (AST) or alanine aminotransferase (ALT) elevations >3× upper limit of normal (ULN), once transaminases have returned to baseline values, treatment with nintedanib may be reintroduced at a reduced dose (100 mg twice daily in adult patients) which subsequently may be increased to the full dose (150 mg twice daily in adult patients).
For:
Regimen A, in case that patient age in years is ≥ 6 and patient weight is ≥ 13.5 kg and patient weight is ≤ 22.9 kg
Oral, 50 milligrams nintedanib, once every 12 hours.
Regimen B, in case that patient age in years is ≥ 6 and patient weight is ≥ 23 kg and patient weight is ≤ 33.4 kg
Oral, 75 milligrams nintedanib, once every 12 hours.
Regimen C, in case that patient age in years is ≥ 6 and patient weight is ≥ 33.5 kg and patient weight is ≤ 57.4 kg
Oral, 100 milligrams nintedanib, once every 12 hours.
Regimen D, in case that patient age in years is ≥ 6 and patient weight is ≥ 57.5 kg
Oral, 150 milligrams nintedanib, once every 12 hours.
Growth must be regularly monitored, and evaluation of epiphyseal growth plate alteration via annual bone imaging is recommended in patients with open epiphyses. Treatment interruption should be considered in patients who develop signs of growth impairment or epiphyseal growth plates alterations.
Oral dental examination must regularly be performed at least every 6 months until development of dentition is completed.
The recommended dose of nintedanib for paediatric patients aged 6 to 17 years of age is based on the patient's weight and is administered twice daily, approximately 12 hours apart (see table). The dose should be adjusted according to weight as treatment progresses.
Nintedanib dose and reduced dose recommendation in milligrams (mg) by body weight in kilograms (kg) for paediatric patients aged 6 years to 17 years old:
| Weight range | Nintedanib dose | Nintedanib reduced dose* |
|---|---|---|
| 13.5** - 22.9 kg | 50 mg twice daily | 25 mg twice daily |
| 23.0 - 33.4 kg | 75 mg twice daily | 50 mg twice daily |
| 33.5 - 57.4 kg | 100 mg twice daily | 75 mg twice daily |
| 57.5 kg and above | 150 mg twice daily | 100 mg twice daily |
* Reduced dose is recommended in children and adolescents with mild hepatic impairment (Child Pugh A) and for the management of adverse reactions in the paediatric population.
** Weight below 13.5 kg:
Treatment should be interrupted in case the patient experiences a weight decrease below 13.5 kg.
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