Miscellaneous respiratory disorders:
Indications for: ESBRIET TABLETS
Treatment of idiopathic pulmonary fibrosis (IPF).
Adult Dosage:
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 Dosage:
Not established.
ESBRIET TABLETS 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.
See Also:
ESBRIET TABLETS Classification:
Pyridone.
ESBRIET TABLETS 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.
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.
Generic Drug Availability:
NO
How Supplied:
Caps—270; Blister packs—63, 252; Tabs 267mg—270; 801mg—90
