Generic Name and Formulations:
Pirfenidone 267mg; hard gel caps.
Indications for ESBRIET:
Treatment of idiopathic pulmonary fibrosis (IPF).
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.
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.
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.
Nausea, rash, abdominal pain, upper respiratory tract infection, diarrhea, fatigue, headache, dyspepsia, dizziness, vomiting, anorexia, GERD, sinusitis, insomnia, weight decreased, arthralgia; elevated liver enzymes.
Caps—270; Blister packs—63, 252; Tabs 267mg—270; 801mg—90