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Esbriet Tablets Generic Name & Formulations
Legal Class
Rx
General Description
Pirfenidone 267mg, 801mg; film-coated tabs.
Pharmacological Class
Pyridone.
See Also
How Supplied
Caps—270; Blister packs—63, 252; Tabs 267mg—270; 801mg—90
Manufacturer
Generic Availability
NO
Esbriet Tablets Indications
Indications
Treatment of idiopathic pulmonary fibrosis (IPF).
Esbriet Tablets Dosage and Administration
Adult
Take with food at same time each day. Days 1–7: 267mg 3 times daily; Days 8–14: 534mg 3 times daily; Days 15 onward: 801mg 3 times daily. Max 2403mg/day. Dose modifications: see full labeling. Concomitant strong CYP1A2 inhibitors (eg, fluvoxamine, enoxacin): 267mg 3 times daily. Concomitant moderate CYP1A2 inhibitors (eg, ciprofloxacin 750mg twice daily): 534mg 3 times daily.
Children
Not established.
Esbriet Tablets Contraindications
Not Applicable
Esbriet Tablets Boxed Warnings
Not Applicable
Esbriet Tablets Warnings/Precautions
Warnings/Precautions
Perform liver function tests prior to initiating treatment, monthly for the first 6 months, and every 3 months thereafter. Permanently discontinue if ALT/AST >3 – ≤5XULN with symptoms or hyperbilirubinemia, or if ALT/AST >5XULN occurs. Severe hepatic impairment or ESRD (including dialysis): not recommended. Renal or mild-to-moderate hepatic impairment; monitor and adjust dose or discontinue as needed. Consider treatment interruption or dose reduction if significant adverse reactions (eg, GI, photosensitivity, rash) occur. Avoid/minimize sun exposure or UV light. Smokers. Pregnancy. Nursing mothers.
Esbriet Tablets Pharmacokinetics
See Literature
Esbriet Tablets Interactions
Interactions
Avoid smoking or concomitant drugs known to cause photosensitivity. Concomitant strong CYP1A2 inhibitors: not recommended; if needed, reduce pirfenidone dose (see Adults). Potentiated by moderate CYP1A inhibitors; if ciprofloxacin at dose 750mg twice daily cannot be avoided, reduce pirfenidone dose (see Adults). Monitor closely with ciprofloxacin at dose 250–500mg once daily. Avoid concomitant strong CYP1A2 inducers.
Esbriet Tablets Adverse Reactions
Adverse Reactions
Nausea, rash, abdominal pain, upper respiratory tract infection, diarrhea, fatigue, headache, dyspepsia, dizziness, vomiting, anorexia, GERD, sinusitis, insomnia, weight decreased, arthralgia; elevated liver enzymes.
Esbriet Tablets Clinical Trials
See Literature
Esbriet Tablets Note
Not Applicable
Esbriet Tablets Patient Counseling
See Literature
