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Prior to the initiation of nintedanib treatment, conduct liver function tests for all patients and perform pregnancy testing for females of reproductive potential.
The recommended dose of nintedanib is 150 mg, administered orally twice daily, with an interval of approximately 12 hours between doses.
Nintedanib capsules should be taken with meals and swallowed whole with water. Due to their bitter taste, nintedanib capsules should not be chewed.
Do not open or crush nintedanib capsules. If contact with the capsule contents occurs, wash hands thoroughly immediately. The impact of chewing or crushing the capsules on nintedanib pharmacokinetics remains unclear.
If a dose of nintedanib is missed, take the next scheduled dose at its regular time. Advise patients not to take a double dose to make up for the missed one. The maximum daily dose shall not exceed 300 mg.
For patients with mild hepatic impairment (Child-Pugh Class A), the recommended dose of nintedanib is 100 mg, administered orally twice daily at approximately 12-hour intervals, taken with meals.
Treatment with nintedanib is not recommended.
In addition to symptomatic treatment (if applicable), management of nintedanib-related adverse reactions may require dose reduction or temporary treatment interruption until the specific adverse reaction resolves to a level that allows resumption of treatment. Nintedanib therapy may be resumed at the full dose (150 mg twice daily) or the reduced dose (100 mg twice daily), with subsequent escalation back to the full dose if tolerated. Discontinue nintedanib treatment if the patient is unable to tolerate the dose of 100 mg twice daily.
Elevated liver enzymes may necessitate dose adjustment or treatment interruption. Perform liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], and bilirubin) prior to the initiation of nintedanib treatment, periodically during the first three months of treatment, and thereafter at regular intervals or as clinically indicated. For patients reporting symptoms that may indicate liver injury (including fatigue, anorexia, right upper quadrant discomfort, dark urine, or jaundice), measure liver function promptly. Discontinue nintedanib in patients with AST or ALT levels greater than 3 times the upper limit of normal (ULN) accompanied by signs or symptoms of liver injury, as well as in those with AST or ALT elevations greater than 5 times the ULN. For patients with AST or ALT levels greater than 3 times but less than 5 times the ULN without signs of liver injury, interrupt treatment or reduce the nintedanib dose to 100 mg twice daily. Once liver enzymes return to baseline values, nintedanib therapy may be reinitiated at the reduced dose (100 mg twice daily), with subsequent escalation back to the full dose (150 mg twice daily) if tolerated.
For patients with mild hepatic impairment (Child-Pugh Class A), consider treatment interruption or discontinuation for the management of adverse reactions.
FDA，2024.10
