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Ofev抑肺纖

Ofev

nintedanib

Manufacturer:

Boehringer Ingelheim

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Nintedanib
Indications/Uses
Treatment of idiopathic pulmonary fibrosis (IPF). Slows the rate of decline in pulmonary function in patients w/ systemic sclerosis associated interstitial lung disease (SSc-ILD). Treatment of other chronic fibrosing interstitial lung diseases w/ a progressive phenotype (progressive fibrosing ILD).
Dosage/Direction for Use
Adult Recommended dose: 150 mg bd administered approx 12 hr apart, can be reduced to 100 mg bd. Max daily dose: 300 mg. Patient w/ 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
Reports of GI disorders eg, diarrhoea, nausea & vomiting; arterial thromboembolic events; wt loss. Patients at higher CV risk including known CAD. Consider treatment interruption in case of signs or symptoms of acute myocardial ischemia. May increase BP; systemic BP should be measured periodically & as clinically indicated thereafter. Patients w/ clinically significant pulmonary HTN. Patients w/ known risk of GI perforation. Increased risk of bleeding. Associated w/ elevations of liver enzymes & bilirubin; monitor hepatic transaminase & bilirubin levels before treatment initiation, then mthly during the 1st 3 mth of treatment, periodically thereafter or as clinically indicated. Not recommended in patients w/ moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment. Patients w/ severe renal impairment (CrCl <30 mL/min). Lactation.
Adverse Reactions
Diarrhea, nausea, vomiting, constipation, abdominal pain, GERD, flatulence, wt decreased, liver enzyme elevation, decreased appetite, headache, HTN, pneumonia, musculoskeletal pain, fatigue, dizziness, UTI.
Drug Interactions
Increased exposure w/ potent P-gp & CYP3A4 inhibitor (eg, ketoconazole). Decreased exposure w/ potent P-gp & CYP3A4 inducer.
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 cap 150 mg
Packing/Price
60's
Form
Ofev cap 100 mg
Packing/Price
60's
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