Ofev

Nintedanib

Idiopathic pulmonary fibrosis (IPF); other chronic fibrosing ILDs w/ a progressive phenotype; systemic sclerosis associated interstitial lung disease (SSc-ILD).

Adult Recommended dose: 150 mg bid approx 12 hr apart. Max daily dose: 300 mg. Dose adjustments: Resume treatment at 150 mg bid or reduce dose to 100 mg bid. Interruptions due to AST or ALT transaminase elevations >3x ULN Reintroduce at reduced dose of 100 mg bid, subsequently increased to 150 mg bid. Mild hepatic impairment (Child Pugh A) 100 mg bid approx 12 hr apart.

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

Hypersensitivity to nintedanib, peanut or soya. Pregnancy.

Discontinue treatment in case of persisting severe diarrhoea; nausea & vomiting; if posterior reversible encephalopathy syndrome (PRES) is suspected. Permanently discontinue treatment if any liver test elevations are associated w/ clinical signs or symptoms of liver injury eg, jaundice; in patients who develop GI perforation. Interrupt treatment in patients who develop signs or symptoms of nephrotic syndrome; acute myocardial ischaemia. Reduce dose, interrupt treatment & monitor patient closely if AST or ALT elevations >3x ULN are measured. Non-serious & serious cases of drug-induced liver injury, including severe liver injury w/ fatal outcome. May impair wound healing. Increased risk of thromboembolic events. Patients at known risk for bleeding including patients w/ inherited predisposition to bleeding or receiving full dose of anticoagulative treatment; w/ recent history of MI or stroke; higher CV risk including known CAD; previous abdominal surgery, recent history of hollow organ perforation, previous history of peptic ulceration, diverticular disease. Adult w/ low body wt (<65 kg), Asian, female & Black patients. Investigate hepatic transaminase & bilirubin levels upon initiation of treatment, at regular intervals during the 1st three mth of treatment & periodically thereafter or as clinically indicated. Concomitant corticosteroids or NSAIDs. Initiate at least 4 wk after major, including abdominal surgery. May affect ability to drive & use machines. Not recommended in patients w/ moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment. Consider interruption, discontinuation or dose reduction in patients w/ mild hepatic impairment (Child Pugh A). Severe renal impairment (CrCl <30 mL/min). Women of childbearing potential should avoid becoming pregnant while receiving treatment & use highly effective contraceptive methods at initiation of, during & at least 3 mth after last dose. Not to be applied during pregnancy & pregnancy testing must be conducted prior to & during treatment. Discontinue breastfeeding during treatment. Ped patients w/ fibrosing ILDs. May require dose reduction in elderly ≥75 yr.

Diarrhoea, vomiting, nausea, abdominal pain, pancreatitis; drug-induced liver injury; increased hepatic enzyme, ALT, AST, blood alkaline phosphatase & γ-glutamyltransferase, hyperbilirubinemia; HTN, bleeding; thrombocytopenia; decreased appetite & wt; rash, pruritus, alopecia; headache, PRES; proteinuria.

Increased exposure w/ potent P-gp inhibitors (eg, ketoconazole, erythromycin). Decreased exposure w/ 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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