Boehringer Ingelheim


Concise Prescribing Info
Idiopathic pulmonary fibrosis (IPF) & chronic fibrosing interstitial lung diseases (ILDs) w/ progressive phenotype in adults. Slows pulmonary function decline rate in patients w/ systemic sclerosis-associated interstitial lung disease (SSc-ILD).
Dosage/Direction for Use
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.
Hypersensitivity to nintedanib, peanut or soya. Pregnancy.
Special Precautions
Soya & peanut protein allergy. Discontinue use if persisting severe diarrhoea, nausea & vomiting occur; GI perforation 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, recent history of hollow organ perforation, history of peptic ulceration, diverticular disease; HTN; 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.
Adverse Reactions
Diarrhoea, nausea, abdominal pain; increased hepatic enzyme. Decreased wt & appetite; bleeding; vomiting; increased ALT, AST & γ-glutamyl transferase; headache. IPF & other ILDs: Rash. SSc-ILD & other ILDs: HTN; increased blood alkaline phosphatase. Other ILDs: Drug-induced hepatic injury.
Drug Interactions
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.
MIMS Class
Other Drugs Acting on the Respiratory System
ATC Classification
L01EX09 - nintedanib ; Belongs to the class of other protein kinase inhibitors. Used in the treatment of cancer.
Ofev softcap 100 mg
Ofev softcap 150 mg
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in