non-small cell lung cancer<\/a> (NSCLC) of adenocarcinoma tumour histology after first-line chemotherapy. Nintedanib is also indicated for the treatment of idiopathic pulmonary fibrosis (IPF).<\/p>\nDOSAGE AND ADMINISTRATION<\/h4>\n
The recommended dose of Nintedanib is 200 mg twice daily administered approximately 12 hours apart, on days 2 to 21 of a standard 21-day Docetaxel treatment cycle. It must not be taken on the same day of Docetaxel chemotherapy administration (= day 1).
\nIf a dose of Nintedanib is missed, administration should resume at the next scheduled time at the recommended dose. The individual daily doses of Nintedanib should not be increased beyond the recommended dose to make up for missed doses. The recommended maximum daily dose of 400 mg should not be exceeded.
\nPatients may continue therapy with Nintedanib after discontinuation of docetaxel for as long as clinical benefit is observed or until unacceptable toxicity occurs.<\/p>\n
WARNING AND PRECAUTIONS<\/h4>\n
Hepatic impairment:<\/strong><\/em> Nindanix 100mg is not recommended for use in patients with moderate or severe hepatic impairment. In patients with mild hepatic impairment (Child Pugh A), the recommended dosage is 100 mg twice daily approximately 12 hours apart taken with food. Consider treatment interruption, or discontinuation for management of adverse reactions in these patients.<\/p>\nElevated liver enzymes and drug-induced liver injury:<\/strong><\/em> ALT, AST, and bilirubin elevations have occurred with Nintedanib, including cases of drug induced liver injury. In the post-marketing period, non-serious and serious cases of drug-induced liver injury, including severe liver injury with fatal outcome, have been reported. The majority of hepatic events occur within the first three months of treatment. Liver enzyme and bilirubin increases were reversible with dose modification or interruption in the majority of cases. Monitor ALT, AST, and bilirubin prior to initiation of treatment, at regular intervals during the first three months of treatment, and periodically thereafter or as clinically indicated. Temporary dosage reductions or discontinuations may be required.<\/p>\nGastrointestinal disorders:<\/em><\/strong> Diarrhea, nausea, and vomiting have occurred with Nintedanib. Treat patients at first signs with adequate hydration and antidiarrheal medicine (e.g., loperamide) or anti-emetics. Discontinue Nintedanib if severe diarrhea, nausea, or vomiting persists despite symptomatic treatment.<\/p>\nEmbryo-Fetal toxicity:<\/em><\/strong> Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. Arterial thromboembolic events have been reported. Use caution when treating patients at higher cardiovascular risk including known coronary artery disease. Bleeding events have been reported. Use Nintedanib in patients with known bleeding risk only if anticipated benefit outweighs the potential risk. Gastrointestinal perforation has been reported. Use Nintedanib with caution when treating patients with recent abdominal surgery, previous history of diverticular disease or receiving concomitant corticosteroids or NSAIDs. Discontinue Nintedanib in patients who develop gastrointestinal perforation. Only use Nintedanib in patients with known risk of gastrointestinal perforation if the anticipated benefit outweighs the potential risk.<\/p>\n <\/p>\n