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Ofev

Ofev

nintedanib

Manufacturer:

Boehringer Ingelheim

Distributor:

DKSH
Concise Prescribing Info
Contents
Nintedanib
Indications/Uses
Idiopathic pulmonary fibrosis (IPF) in adult. Slows pulmonary function decline rate in patients w/ systemic sclerosis-associated interstitial lung disease (SSc-ILD).
Dosage/Direction for Use
150 mg bd approx 12 hr apart. Patient not tolerating 150 mg bd 100 mg bd. Max: 300 mg daily. Mild hepatic impairment (Child-Pugh A) 100 mg bd approx 12 hr apart.
Administration
Should be taken with food: Swallow whole w/ water, do not chew/crush.
Contraindications
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: Rash. SSc-ILD: HTN; increased blood alkaline phosphatase.
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.
ATC Classification
L01XE31 - nintedanib ; Belongs to the class of protein kinase inhibitors, other antineoplastic agents. Used in the treatment of cancer and other indications.
Presentation/Packing
Form
Ofev softcap 150 mg
Packing/Price
60's
Form
Ofev softcap 100 mg
Packing/Price
60's
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