Ofev

Ofev

nintedanib

Manufacturer:

Boehringer Ingelheim
Concise Prescribing Info
Contents
Nintedanib
Indications/Uses
Idiopathic pulmonary fibrosis (IPF). Systemic sclerosis-associated interstitial lung disease (SSc-ILD). Other chronic fibrosing ILDs w/ a progressive phenotype (also known as progressive fibrosing ILD).
Dosage/Direction for Use
150 mg twice daily approx 12 hr apart. Patient not tolerating 150 mg twice daily dose 100 mg twice daily for patients w/ mild hepatic impairment. Max: 300 mg daily.
Administration
Should be taken with food: Swallow whole w/ water, do not chew/crush.
Contraindications
Hypersensitivity to nintedanib, peanut or soya. Pregnancy.
Special Precautions
Allergy to soya products & peanut proteins. Discontinue use if persisting severe diarrhea, nausea & vomiting despite symptomatic treatment. Patients w/ inherited predisposition to bleeding or receiving full dose of anticoagulative treatment; higher CV risk including known CAD; thromboembolic events; previous abdominal surgery or recent history of hollow organ perforation; HTN, QT prolongation. Interrupt therapy if acute myocardial ischaemia signs or symptoms develop. Periodically measure systemic BP. Check hepatic transaminase & bilirubin levels before initiation of treatment, at regular intervals during 1st 3 mth & periodically thereafter or clinically indicated; reduce dose or interrupt therapy if transaminase (AST or ALT) elevations >3x ULN are measured. Permanently discontinue if any liver test elevations are associated w/ clinical signs or symptoms of liver injury eg, jaundice & GI perforation. Co-administration w/ pirfenidone. May impair wound healing. May affect ability to drive & use machines. Severe renal impairment (CrCl <30 mL/min). Not recommended in moderate (Child-Pugh B) & severe (Child-Pugh C) hepatic impairment. Reduced dose for mild hepatic (Child Pugh A) hepatic impairment. Renal impairment/failure, therapy adjustment should be considered. May promote the formation of aneurysms &/or artery dissections. Not to be used in patients w/ severe pulmonary HTN. Women of childbearing potential should use adequate contraception during & at least 3 mth after last dose. Discontinue during lactation. Childn.
Adverse Reactions
Diarrhoea, nausea, abdominal pain; increased hepatic enzyme. Decreased appetite & wt; bleeding; vomiting; increased ALT, AST & GGT; rash, pruritus; thrombocytopenia; HTN; pancreatitis; hyperbilirubinaemia, increased alkaline phosphatase; drug-induced liver injury, headache, proteinuria.
Drug Interactions
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).
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.
Presentation/Packing
Form
Ofev softcap 100 mg
Packing/Price
6 × 10's
Form
Ofev softcap 150 mg
Packing/Price
6 × 10's
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