Ofev

Nintedanib

Treatment of idiopathic pulmonary fibrosis (IPF); systemic sclerosis associated ILD (SSc-ILD); other chronic fibrosing ILD w/ a progressive phenotype (progressive fibrosing ILD).

Adult Recommended dose: 150 mg bd administered approx 12 hr apart, can be reduced to 100 mg bd. Patient w/ 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.

Hypersensitivity to nintedanib, peanut or soya. Pregnancy.

Reports of GI disorders eg, diarrhoea, nausea & vomiting; arterial thromboembolic events. Treat diarrhea at 1st signs w/ adequate hydration & anti-diarrheal medication; dose reduction or treatment interruption may be required. Caution when treating patients at higher CV risk including known CAD. Consider treatment interruption in case of signs or symptoms of acute myocardial ischemia. In clinical trials, no increased risk of VTE was observed in nintedanib-treated patients. May increase BP; systemic BP should be measured periodically & as clinically indicated. Should not be used in patients w/ severe pulmonary HTN. Closely monitor patients w/ mild to moderate pulmonary HTN. Exercise caution when treating patients w/ previous abdominal surgery, previous history of peptic ulceration, diverticular disease or receiving concomitant corticosteroids or NSAIDs. Ofev should only be initiated at least 4 wk after abdominal surgery. Permanently discontinued in patients who develop GI perforation or ischaemic colitis. Exceptionally, Ofev can be reintroduced after complete resolution of ischaemic colitis & careful assessment of patient's condition & other risk factors. Increased risk of bleeding; use in patients w/ known risk of bleeding only if anticipated benefit outweighs the potential risk. Reports of drug-induced liver injury in both clinical trials & post-marketing surveillance database. Associated w/ elevations of liver enzymes & bilirubin; monitor hepatic transaminase & bilirubin levels before treatment initiation & during the 1st mth of treatment; monitor at regular intervals during the subsequent 2 mth of treatment & periodically thereafter. Patients should be monitored during therapy, w/ particular attention to those patients exhibiting risk factors for renal impairment/failure. Consider treatment interruption in patients who develop signs or symptoms of nephrotic syndrome. Safety, efficacy & pharmacokinetics of nintedanib have not been studies in patients w/ severe renal impairment (<30 mL/min CrCl). No increased frequency of impaired wound healing was observed in the clinical trials. Exercise caution when nintedanib is administered in patients who may develop QTc prolongation. Patients with known allergy to peanut protein carry an enhanced risk for severe reactions to soya prep.

Decreased wt, decreased appetite, bleeding, diarrhea, nausea, abdominal pain, vomiting, increased hepatic enzyme, rash, headache; HTN (common in PF-ILD & SSc-ILD), drug induced liver injury (common in PF-ILD).

Increased exposure w/ potent P-gp & CYP3A4 inhibitor (eg, ketoconazole). Decreased exposure w/ potent P-gp & CYP3A4 inducer.

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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