flesh presser [14:3 times but 5 times the ULN without symptoms or hyperbilirubinemia: May continue therapy at full dosage, temporarily interrupt therapy, or reduce dosage until liver function tests return to normal. 1 May resume therapy and subsequently increase to full dosage as tolerated. 1 Monitor patients carefully; discontinue other medications that could cause liver enzyme elevations; exclude other causes of such elevations. 1 ALT or AST elevations >3 times but 5 times the ULN with symptoms or hyperbilirubinemia, or ALT or AST >5 times the ULN: Permanently discontinue therapy. 1 (See Hepatic Toxicity under Cautions.) Other Adverse Effects If clinically important adverse reactions occur (i.e., GI effects such as nausea, diarrhea, dyspepsia, vomiting; photosensitivity reaction or rash), consider interruption of therapy or temporary dosage reduction until symptoms resolve. 1 (See GI Effects and also see Photosensitivity under Cautions.) Concomitant Use with Drugs Affecting Hepatic Microsomal Enzymes If concomitant use with a potent CYP1A2 inhibitor (e.g., fluvoxamine) cannot be avoided, reduce pirfenidone dosage to 267 mg (1 capsule) 3 times daily. 1 If concomitant use with the moderate CYP1A2 inhibitor ciprofloxacin (at a dosage of 750 mg twice daily) cannot be avoided, reduce pirfenidone dosage to 534 mg (two 267-mg capsules) 3 times daily. 1 (See Drugs Affecting Hepatic Microsomal Enzymes under Interactions.) Prescribing Limits Adults Idiopathic Pulmonary Fibrosis Oral 2403 mg daily (801 mg [3 capsules] 3 times daily). 1 Special Populations Hepatic Impairment No initial dosage adjustment required in patients with mild or moderate hepatic impairment (Child-Pugh class A or B); monitor closely for adverse effects. 1 Not studied in patients with severe hepatic impairment (Child-Pugh class C); use not recommended. 1 Renal Impairment No initial dosage adjustment required in patients with mild, moderate, or severe renal impairment; monitor closely for adverse effects. 1 Not studied in patients with end-stage renal disease requiring dialysis; use not recommended. 1 Geriatric Patients Dosage adjustment not required. 1 (See Geriatric Use under Cautions.) Cautions for Esbriet Contraindications Manufacturer states none known. 1 Warnings/Precautions Hepatic Toxicity Elevations in ALT and AST concentrations reported, including rare cases of hyperbilirubinemia. 1 If abnormal liver function test results occur, temporary interruption, dosage reduction, or discontinuance of therapy may be necessary. 1 (See Dosage Modification under Dosage and Administration.) Perform liver function tests prior to initiation, monthly for the first 6 months, and then every 3 months thereafter. 1 Photosensitivity Photosensitivity reactions manifested as rash or other reactions reported. 1 Most of these reactions occurred during the first 6 months following therapy initiation. 1 Interruption of therapy and/or dosage reduction may be necessary in some patients. 1 (See Dosage Modification under Dosage and Administration and see Advice to Patients.) GI Effects Nausea, diarrhea, dyspepsia, vomiting, GERD, and abdominal pain may occur. 1 Adverse GI effects generally occur within first 3 months of therapy and decrease over time. 1 Interruption of therapy and/or dosage reduction may be necessary in some patients. 1 (See Dosage Modification under Dosage and Administration and see Advice to Patients.) Specific Populations Pregnancy Category C. 1 Lactation Distributed into milk in rats; not known whether distributed into human milk. 1 Discontinue nursing or the drug. 1 Pediatric Use Safety and efficacy not established. 1 Geriatric Use No overall differences in safety and efficacy relative to younger adults. 1 Hepatic Impairment Increased peak plasma concentrations and systemic exposure to pirfenidone occurred in patients with moderate hepatic impairment (Child-Pugh class B); not studied in patients with severe hepatic impairment (Child-Pugh class C). 1 (See Hepatic Impairment under Dosage and Administration.) Renal Impairment Increased systemic exposure in patients with mild to severe renal impairment (Cl cr] 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 C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug 3 years Approval History FDA approved 2014 Manufacturer Genentech, Inc. Drug Class Miscellaneous uncategorized agents Related Drugs Idiopathic Pulmonary Fibrosis Ofev , nintedanib , pirfenidone , Actimmune , interferon gamma-1b , More... Esbriet Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! Esbriet Images Esbriet 267 mg (InterMune 267 mg ) View all images even if
could Esbriet getting older
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