Boehringer Ingelheim


Concise Prescribing Info
In combination w/ docetaxel for adults w/ locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after 1st-line chemotherapy. Idiopathic pulmonary fibrosis (IPF). Chronic fibrosing interstitial lung diseases (ILDs) w/ a progressive phenotype. Slow the rate of decline in pulmonary function in patients w/ systemic sclerosis associated interstitial lung disease (SSc-ILD).
Dosage/Direction for Use
NSCLC 200 mg bd (approx 12 hr apart), on days 2-21 of a standard 21-day docetaxel treatment cycle. Max daily dose: 400 mg. IPF/chronic fibrosing ILDs w/ a progressive phenotype/SSc-ILD 150 mg bd (approx 12 hr apart). Max daily dose: 300 mg. 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.
Special Precautions
Discontinue therapy if severe diarrhoea, nausea & vomiting persists. Diarrhoea & vomiting may lead to dehydration w/ or w/o electrolyte disturbances which may progress to renal function impairment; administer electrolytes & fluids in the event of dehydration; monitor electrolyte plasma levels if relevant GI adverse effects occur. Periodically measure systemic BP. May promote formation of aneurysm &/or artery dissection; carefully consider patients w/ risk factors eg, poorly controlled HTN or a history of aneurysm. Perform frequent monitoring of complete blood counts at the beginning of each treatment cycle & around the nadir for patients receiving combination therapy w/ docetaxel, & after administration of last combination cycle. Interrupt treatment or permanently discontinue in case of specific changes in liver values (AST/ALT >3 x ULN in conjunction w/; bilirubin ≥2 x ULN & ALKP <2 x ULN). Closely monitor female & Asian patients, & those w/ low body wt [(<65 kg) in IPF & SSc-ILD treatment only] for higher risk of developing liver enzyme elevations; patients weighing <50 kg (NSCLC treatment only). Monitor patients exhibiting risk factors for renal impairment/failure. May consider discontinuation in patients who experienced grade ¾ bleeding events. Not recommended in patients w/ recent pulmonary bleeding (>2.5 mL of red blood), & centrally-located tumours w/ radiographic evidence of local invasion of major blood vessels or of cavitary or necrotic tumours; active brain metastasis. Closely monitor for signs & symptoms of cerebral bleeding in patients w/ adequately pre-treated brain metastases which were stable for ≥4 wk before start of treatment. Regularly monitor patients taking concomitant anticoagulation eg, warfarin or phenprocoumon, for changes in prothrombin time, INR or clinical bleeding episodes. Patients w/ a higher CV risk including known CAD. Consider treatment interruption in patients who develop signs or symptoms of acute myocardial ischaemia. Discontinue in patients w/ life-threatening VTE reactions. Permanently discontinue in patients who develop GI perforation. May impair wound healing. Patient who may develop QTc prolongation. Enhanced risk for severe reactions to soya prep in patients w/ known allergy to peanut protein. Severe renal impairment (<30 mL/min CrCl). Not recommended in patients w/ moderate (Child-Pugh B) & severe (Child-Pugh C) hepatic impairment. May affect ability to drive & use machines. Black patients. Women of childbearing potential should use highly effective contraception methods during & at least 3 mth after the last dose of treatment & avoid becoming pregnant while receiving treatment. Do not use during pregnancy; discontinue use if patient becomes pregnant during treatment. Discontinue breastfeeding during treatment. Childn 0-18 yr. Elderly ≥75 yr.
Adverse Reactions
NSCLC: Neutropenia (including febrile neutropenia); decreased appetite, electrolyte imbalance; peripheral neuropathy; bleeding; diarrhoea, vomiting, nausea, abdominal pain; increased ALT, AST & blood alkaline phosphatase; mucositis (including stomatitis), rash, alopecia. Febrile neutropenia, abscesses, sepsis; thrombocytopenia; dehydration, decreased wt; headache; venous thromboembolism, HTN; hyperbilirubinaemia, increased γ-glutamyltransferase; pruritus. IPF/chronic fibrosing ILDs w/ a progressive phenotype/SSc-ILD: Diarrhoea, nausea, abdominal pain; increased hepatic enzyme. Vomiting. Decreased appetite; increased ALT. Decreased wt; bleeding; increased AST & γ-glutamyltransferase; headache. HTN; increased blood alkaline phosphatase; rash. Drug-induced liver injury.
Drug Interactions
Exposure may be increased by potent P-gp inhibitors (eg, ketoconazole & erythromycin). Exposure may be decreased by potent P-gp inducers (eg, rifampicin, carbamazepine, phenytoin & St. John's wort).
ATC Classification
L01EX09 - nintedanib ; Belongs to the class of other protein kinase inhibitors. Used in the treatment of cancer.
Ofev softcap 150 mg
Ofev softcap 100 mg
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