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Pirfenidone

Class
Antifibrotic agents
Subclass
Pyridone derviatives
Generic name
Pirfenidone
Brand names
Esbriet®
Common formulations
Capsule
Dosage and administration
Adults patients
Treatment of idiopathic pulmonary fibrosis
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Start at: 267 mg PO TID for 7 days, then 534 mg PO TID for another 7 days
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Maintenance: 801 mg PO TID
Taken with food at the same time each day.
Indications for use
Labeled indications
Adults
•
Treatment of idiopathic pulmonary fibrosis
Safety risks
Contraindications
Hypersensitivity to pirfenidone or its components
Warnings and precautions
Drug-induced liver injury
•
Maintain a high level of suspicion, as cases of drug-induced liver injury have occurred with pirfenidone. Obtain LFTs before initiating pirfenidone, monthly for the first 6 months, every 3 months thereafter, and as clinically indicated. Consider reducing the dose or interrupting treatment if liver enzyme elevations occur.
Gastrointestinal adverse events
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Maintain a high level of suspicion, as pirfenidone has been associated with an increased risk of nausea, diarrhea, dyspepsia, vomiting, GERD, and abdominal pain. Consider reducing the dose in some cases of astrointestinal adverse reactions.
Photosensitivity of skin
•
Maintain a high level of suspicion, as pirfenidone has been associated with an increased risk of photosensitivity reactions. Advise patients to avoid or minimize sun exposure, use sunscreen, wear sun-protective clothing, and avoid concomitant medications known to cause photosensitivity.
Severe cutaneous adverse reactions
•
Maintain a high level of suspicion, as pirfenidone has been associated with an increased risk of severe cutaneous adverse reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS syndrome. Consider reducing the dose or interrupting treatment in some cases of photosensitivity reactions or rash.
Specific populations
Renal impairment
eGFR 0-80 mL/min/1.73 m²
•
Use with caution. Monitor for adverse reactions.
Renal replacement therapy
Any modality
•
Do not use.
Hepatic impairment
Child-Pugh A (mild)
•
Use with caution. Monitor for adverse reactions.
Child-Pugh B (moderate)
•
Use with caution. Monitor for adverse reactions.
Child-Pugh C (severe)
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Do not use.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: B3
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Insufficient evidence. Avoid use.
Breastfeeding
Use only if benefits outweigh potential risks.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Very common > 10%
•
Gastroesophageal reflux disease, abdominal pain, diarrhea, fatigue, dizziness, dyspepsia, headache, loss of appetite, nausea, skin rash, vomiting, sinusitis, upper respiratory tract infections
Common 1-10%
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Dysgeusia, photosensitivity of skin, asthenia, chest pain, insomnia, weight loss, arthralgia, itching
Unknown frequency
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Agranulocytosis, angioedema, DRESS syndrome, drug-induced liver injury, ↑ liver enzymes, Stevens-Johnson syndrome, toxic epidermal necrolysis
Interactions
Drug(s)
Check Interactions
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