inactivity [5:5 times ULN or >3 times ULN with signs or symptoms of severe liver damage. In patients with mild hepatic impairment (Child Pugh A), consider treatment interruption, or discontinuation for management of adverse reactions. 3 DOSAGE FORMS AND STRENGTHS 150 mg capsules: brown, opaque, oblong, soft capsules imprinted in black with the Boehringer Ingelheim company symbol and "150". 100 mg capsules: peach, opaque, oblong, soft capsules imprinted in black with the Boehringer Ingelheim company symbol and "100". 4 CONTRAINDICATIONS None 5 WARNINGS AND PRECAUTIONS Hepatic Impairment Treatment with Ofev is not recommended in patients with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment [see Use in Specific Populations ( 8.6 ) and Clinical Pharmacology ( 12.3 )] . Patients with mild hepatic impairment (Child Pugh A) can be treated with a reduced dose of Ofev [see Dosage and Administration ( 2.2 )] . Elevated Liver Enzymes Cases of drug-induced liver injury have been observed with Ofev treatment [see Adverse Reactions ( 6.2 )] . In clinical trials, administration of Ofev was associated with elevations of liver enzymes (ALT, AST, ALKP, GGT) and bilirubin. Liver enzyme and bilirubin increases were reversible with dose modification or interruption. The majority (94%) of patients with ALT and/or AST elevations had elevations] FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only D Pregnancy Category Positive evidence of risk N/A CSA Schedule Not a controlled drug 3 years Approval History FDA approved 2014 Manufacturer Boehringer Ingelheim Pharmaceuticals, Inc. Drug Class Multikinase inhibitors Related Drugs multikinase inhibitors Imbruvica , Nexavar , Jakafi , Sutent , ibrutinib , Stivarga Idiopathic Pulmonary Fibrosis Esbriet , nintedanib , pirfenidone , Actimmune , interferon gamma-1b , More... Ofev Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! Ofev Images Ofev 100 mg (Logo 100 ) View larger images is normally
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