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Nintedanib Accord is a brand name for Nintedanib. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Nintedanib Accord is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF). Nintedanib Accord is also indicated in adults for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype (see section 5.1). Nintedanib Accord is indicated in children and…
Verbatim from this product's EMA label. Tap a section to expand.
Adults:
Treatment should be initiated by physicians experienced in the management of diseases for which Nintedanib Accord is approved. 3 Paediatric patients: Treatment should be initiated only after involvement of a multidisciplinary team (physicians, radiologists, pathologists) experienced in the diagnosis and treatment of fibrosing interstitial lung diseases (ILDs).
Posology Adults Idiopathic pulmonary fibrosis (IPF) Other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype Systemic sclerosis associated interstitial lung disease (SSc-ILD) 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. 8) could include dose reduction and temporary interruption until the specific adverse reaction has resolved to levels that allow continuation of therapy. Nintedanib Accord 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 Accord 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). 4). 8). For specific dose reduction recommendations for the management of adverse reactions in paediatric population, see Table 1.
Children and adolescents from 6 to 17 years old Treatment of clinically significant, progressive fibrosing interstitial lung diseases (ILDs) Treatment of systemic sclerosis associated interstitial lung disease (SSc-ILD) Growth must be regularly monitored, and evaluation of epiphyseal growth plate alteration via annual bone imaging is recommended in patients with open epiphyses.
Summary of the safety profile In clinical trials and during the post-marketing experience, the most frequently reported adverse reactions associated with the use of nintedanib included diarrhoea, nausea and vomiting, abdominal pain, decreased appetite, weight decreased and hepatic enzyme increased.
4. Tabulated list of adverse reactions Table 2 provides a summary of the adverse drug reactions (ADRs) by MedDRA System Organ Class (SOC) and frequency category using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1 000 to <1/100), rare (≥1/10 000 to <1/1 000), very rare (<1/10 000), not known (cannot be estimated from the available data).
1), diarrhoea was the most frequent gastro-intestinal event reported. In most patients, the event was of mild to moderate intensity. More than two thirds of patients experiencing diarrhoea reported its first onset already during the first three months of treatment.
4). 6% of patients treated with nintedanib and placebo, respectively. 7% of patients treated with nintedanib and placebo, respectively. 1% of patients treated with nintedanib and placebo, respectively. Elevations of liver enzymes were reversible and not associated with clinically manifest liver disease.
2, respectively. 3% for SENSCIS). Non-serious epistaxis was the most frequent bleeding event reported. 7% for SENSCIS). 4). 0% for SENSCIS). Nephrotic syndrome has not been reported in clinical trials. Very few cases of nephrotic range proteinuria with or without renal function impairment have been reported post-marketing.
Histological findings in individual cases were consistent with glomerular microangiopathy with or without renal thrombi. Reversal of the symptoms has been observed after nintedanib was […]
8). In most patients, the adverse reaction was of mild to moderate intensity and occurred within the first 3 months of treatment. Serious cases of diarrhoea leading to dehydration and electrolyte disturbances have been reported in the post-marketing.
g. loperamide, and may require dose reduction or treatment interruption. 2). In case of persisting severe diarrhoea despite symptomatic treatment, therapy with nintedanib should be discontinued. 8). In most patients with nausea and vomiting, the event was of mild to moderate intensity.
4% of patients. If symptoms persist despite appropriate supportive care (including anti-emetic therapy), dose reduction or treatment interruption may be required. 2 Dose adjustments). In case of persisting severe symptoms therapy with nintedanib should be discontinued.
Hepatic function The safety and efficacy of nintedanib has not been studied in patients with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment. 2). Based on increased exposure, the risk for adverse reactions may be increased in patients with mild hepatic impairment (Child Pugh A).
2). Cases of drug-induced liver injury have been observed with nintedanib treatment, including severe liver injury with fatal outcome. The majority of hepatic events occur within the first three months of treatment. Therefore, hepatic transaminase and bilirubin levels should be investigated before treatment initiation and during the first month of treatment with nintedanib.
g. at each patient visit or as clinically indicated. 8) and bilirubin were reversible upon dose reduction or interruption in the majority of cases. If transaminase (AST or ALT) elevations > 3× ULN are measured, dose reduction or interruption of the therapy with nintedanib is recommended and the patient should be monitored closely.
2 Dose adjustment). g. jaundice, treatment with nintedanib should be permanently discontinued. Alternative causes of the liver enzyme elevations should be investigated. Adult patients with low body weight (< 65 kg), Asian and female patients have a higher risk of elevations of liver enzymes.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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8). 8). The recommended dose of Nintedanib Accord 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 1). The dose should be adjusted according to weight as treatment progresses.
4 Table 1: 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 # Nintedanib Accord is only available as 100 mg and 150 mg soft capsules.
Thus, it is not possible to administer Nintedanib Accord to paediatric patients that require less than a full 100 mg dose. If an alternative dose is required, other nintedanib products offering such an option should be used. Special populations Elderly patients (≥ 65 years) No overall differences in safety and efficacy were observed for elderly patients.
No a-priori dose adjustment is required in elderly patients. 2). Renal impairment Adjustment of the starting dose in adult and paediatric patients with mild to moderate renal impairment is not required. The safety, efficacy, and pharmacokinetics of nintedanib have not been studied in adult and paediatric patients with severe renal impairment (< 30 mL/min creatinine clearance).
Hepatic impairment In adult patients with mild hepatic impairment (Child Pugh A), the recommended dose of Nintedanib Accord is 100 mg twice daily approximately 12 hours apart. In paediatric patients with mild hepatic impairment (Child Pugh A), a reduced starting dose is recommended (see table 1).
In adult and paediatric patients with mild hepatic impairment (Child Pugh A), treatment interruption or discontinuation for management of adverse reactions should be considered. The safety and efficacy of nintedanib have not been investigated in adult and paediatric patients with hepatic impairment classified as Child Pugh B and C.
2). Paediatric population The safety and efficacy of nintedanib have not been studied in paediatric patients below 6 years old. Therefore, treatment of children below 6 years old with nintedanib is not recommended. 4 kg 100 […]
2). Close monitoring is recommended in patients with these risk factors. 8). Patients should be monitored during nintedanib therapy, with particular attention to those patients exhibiting risk factors for renal impairment/failure. 2 Dose adjustments).
Haemorrhage Vascular endothelial growth factor receptor (VEGFR) inhibition might be associated with an increased risk of bleeding. Patients at known risk for bleeding including patients with inherited predisposition to bleeding or patients receiving a full dose of anticoagulative treatment were not included in the clinical trials.
Nonserious and serious bleeding events, some of which were fatal, have been reported in the postmarketing period (including patients with or without anticoagulant therapy or other medicinal products that could cause bleeding). Therefore, these patients should only be treated with nintedanib if the anticipated benefit outweighs the potential risk.
Arterial thromboembolic events Patients with a recent history of myocardial infarction or stroke were excluded from the clinical trials. 7% for SENSCIS). 5%), while adverse events reflecting ischaemic heart disease were balanced between the nintedanib and placebo groups.
9%. 7%) and not observed in the nintedanib group. Caution should be used when treating patients at higher cardiovascular risk including known coronary artery disease. Treatment interruption should be considered in […]