Pirfenidone (2 brand names, 2 dosage forms, 1 route)
Available dosage forms: TABLET, CAPSULE.
Routes of administration: ORAL.
Brand Names
- ESBRIET
- PIRFENIDONE
Indications and Usage
Pirfenidone capsules are indicated for the treatment of idiopathic pulmonary fibrosis (IPF).
Contraindications
None.
Adverse Reactions
The following adverse reactions are discussed in greater detail in other sections of the labeling: Liver Enzyme Elevations and Drug-Induced Liver Injury [see Warnings and Precautions (5.1)] Photosensitivity Reaction or Rash [see Warnings and Precautions (5.2)] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.3)] Gastrointestinal Disorders [see Warnings and Precautions (5.4)]
Mechanism of Action
The mechanism of action of pirfenidone in the treatment of IPF has not been established.
Overdosage
There is limited clinical experience with overdosage. Multiple dosages of pirfenidone up to a maximum tolerated dose of 4005 mg per day were administered as five 267 mg capsules three times daily to healthy adult volunteers over a 12-day dose escalation. In the event of a suspected overdosage, appropriate supportive medical care should be provided, including monitoring of vital signs and observation of the clinical status of the patient.