Ofev

In combination w/ docetaxel for adults w/ locally advanced, metastatic or recurrent NSCLC of adenocarcinoma tumour histology after failure of 1st-line chemotherapy. Idiopathic pulmonary fibrosis (IPF), other chronic fibrosing ILD w/ progressive phenotype & systemic sclerosis associated ILD (SSc-ILD) in adults.

Adult NSCLC 200 mg bid approx 12 hr apart, on days 2-21 of a standard 21-day docetaxel treatment cycle. Must not be taken on the same day of docetaxel chemotherapy administration (day 1). Max: 400 mg daily. IPF, other chronic fibrosing ILD w/ a progressive phenotype & SSc-ILD 150 mg bid approx 12 hr apart. Max: 300 mg daily. 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/crush/open cap. May be taken w/ small amount (tsp) of cold or room temp soft food eg, apple sauce or chocolate pudding & must immediately swallow unchewed.

Hypersensitivity to nintedanib, peanut, soya or to any excipients. Pregnancy.

Diarrhea, nausea, vomiting (dehydration w/ or w/o electrolyte disturbances which may progress to renal function impairment; administration of electrolytes & fluids is required & plasma levels of electrolytes should be monitored. Neutropenia & sepsis. Frequent monitoring of CBC at the beginning of each treatment cycle & around the nadir for patients receiving treatment w/ nintedanib in combination w/ docetaxel. Hemorrhage. Discontinue use if persisting severe diarrhea occur, w/ life-threatening venous thromboembolic reactions & if GI perforation develops. Nephrotic range proteinuria. Discontinue treatment if posterior reversible encephalopathy syndrome is suspected. Wound healing complication. Close monitoring is recommended in patients weighing <50 kg. Do not use if patient is allergic to peanut or soya. Not recommended in patients w/ recent pulmonary bleeding (>2.5 mL of red blood), w/ centrally located tumors w/ radiographic evidence of local invasion of major blood vessels or radiographic evidence of cavitary or necrotic tumors, active brain metastasis. Concomitant anticoagulation eg, warfarin or phenprocoumon should be monitored regularly for changes in prothrombin time, INR, or clinical bleeding episodes. Use caution in patients w/ higher CV risk including known CAD. Treatment interruption should be considered in patients who develop signs or symptoms of acute myocardial ischemia. Increased risk of VTE including DVT. Caution in patients w/ previous abdominal surgery or recent history of hollow organ perforation (only initiated at least 4 wk after major, including abdominal, surgery), previous history of peptic ulceration, diverticular disease or receiving concomitant corticosteroids or NSAIDs. Severe renal impairment (CrCl <30 mL/min). Not recommended in patients w/ moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment. Based on increased exposure, risk for adverse events may be increased in patients w/ mild hepatic impairment (Child Pugh A). Drug-induced liver injury; elevations of liver enzymes (ALT, AST, ALKP, γ-glutamyltransferase (GGT) & bilirubin were reversible upon dose reduction or interruption. Patients w/ low body wt (<65 kg), female & Asian patients. Permanently discontinue treatment if any liver test elevations are associated w/ clinical signs or symptoms of liver injury (eg, jaundice). Caution when driving or using machines during treatment. Women of childbearing potential should avoid becoming pregnant; use adequate contraception at initiation of, during & at least 3 mth after last dose. Discontinue during pregnancy & lactation. Not recommended in childn or adolescents. Elderly ≥65 yr.

Diarrhoea, vomiting, nausea, abdominal pain, pancreatitis; drug-induced liver injury, increased liver enzymes (eg, ALT, AST, alkaline phosphatase, γ-glutamyltransferase), hyperbilirubinemia; HTN, bleeding; thrombocytopenia; decreased appetite, decreased wt; headache, posterior reversible encephalopathy syndrome; rash, pruritus, alopecia; proteinuria. Oncology: Perforation; VTE; neutropenia; sepsis, febrile neutropenia, abscesses; dehydration, electrolyte imbalance; peripheral neuropathy; mucositis including stomatitis.

Increased exposure w/ potent P-gp inhibitor (eg, ketoconazole or erythromycin). Decreased exposure w/ potent P-gp inducers (eg, rifampicin, carbamazepine, phenytoin & St. John's wort).

Other Drugs Acting on the Respiratory System / Targeted Cancer Therapy

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

Rx