Generic Name and Formulations:
Pirfenidone 267mg; hard gel caps.

Company:
InterMune
Indications for ESBRIET:
Treatment of idiopathic pulmonary fibrosis (IPF).

Adult:
Take with food at same time each day. Days 1–7: 1 cap 3 times daily; Days 8–14: 2 caps 3 times daily; Days 15 onward: 3 caps 3 times daily. Max 9 caps/day. Dose modifications due to adverse reactions: see full labeling. Concomitant strong CYP1A2 inhibitors (eg, fluvoxamine, enoxacin): 1 cap 3 times daily. Concomitant moderate CYP1A2 inhibitors (eg, ciprofloxacin 750mg twice daily): 2 caps 3 times daily.

Children:
Not established.

Pharmacological Class:
Pyridone.

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 (Cat.C). Nursing mothers: not recommended.

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.

How Supplied:
Caps—270; Blister packs—63, 252