Ofev

Nintedanib

Idiopathic pulmonary fibrosis (IPF) & chronic fibrosing ILDs w/ progressive phenotype in adults. Slows pulmonary function decline rate in patients w/ systemic sclerosis-associated ILD (SSc-ILD).

Adult 150 mg bd approx 12 hr apart. Max: 300 mg daily. Patient not tolerating 150 mg bd 100 mg bd. Mild hepatic impairment (Child-Pugh A) 100 mg bd approx 12 hr apart.

Should be taken with food: Swallow whole w/ water, do not chew/crush/open.

Hypersensitivity to nintedanib, peanut or soya. Pregnancy.

Soya & peanut protein allergy. Discontinue use if persisting severe diarrhoea, nausea & vomiting occur; GI perforation or ischaemic colitis develops. Patients w/ inherited predisposition to bleeding or receiving full dose anticoagulative treatment; low body wt (<65 kg); recent history of MI or stroke; higher CV risk eg, known CAD, acute myocardial ischemia; thromboembolic events; previous abdominal surgery, history of peptic ulceration, diverticular disease; HTN or history of aneursym; signs or symptoms of nephrotic syndrome; QTc prolongation. May impair wound healing. Asian & female patients. Monitor hepatic transaminase & bilirubin levels prior to, during 1st 3 mth & periodically thereafter. Concomitant use w/ corticosteroids, NSAIDs. Co-administration w/ pirfenidone. May affect ability to drive & use machines. Mild hepatic impairment. Not recommended in patients w/ moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic & severe renal impairment (CrCl <30 mL/min). Women of childbearing potential should use effective contraception during & at least 3 mth after last dose. Not to be used during pregnancy. Lactation. Childn 0-18 yr. Elderly ≥75 yr.

Diarrhoea, nausea, abdominal pain; increased hepatic enzyme. Decreased wt & appetite; bleeding; vomiting; increased ALT, AST & γ-glutamyltransferase; headache. IPF & other ILDs: Rash. SSc-ILD & other ILDs: HTN; increased blood alkaline phosphatase. Other ILDs: Drug-induced liver injury.

Increased exposure by potent P-gp inhibitors eg, ketoconazole, erythromycin or cyclosporine. Decreased exposure by potent P-gp inducers eg, rifampicin, carbamazepine, phenytoin, St. John's wort.

Other Drugs Acting on the Respiratory System

L01EX09 - nintedanib ; Belongs to the class of other protein kinase inhibitors. Used in the treatment of cancer.

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