Pirfenidone
Pirfenidone Prescribing Information
Pirfenidone tablets are indicated for the treatment of idiopathic pulmonary fibrosis (IPF).
Pirfenidone Tablets USP,
Pirfenidone Tablets USP,
- Hepatic Impairment: Monitor for adverse reactions and consider dosage modification or discontinuation of pirfenidone as needed. Pirfenidone is not recommended for use in patients with severe hepatic impairment. , 12.3)
8.6 Hepatic ImpairmentPirfenidone should be used with caution in patients with mild (Child Pugh Class A) to moderate (Child Pugh Class B) hepatic impairment. Monitor for adverse reactions and consider dosage modification or discontinuation of pirfenidone as needed
[seeDosage and Administration (2.3)].The safety, efficacy, and pharmacokinetics of pirfenidone have not been studied in patients with severe hepatic impairment. Pirfenidone is not recommended for use in patients with severe (Child Pugh Class C) hepatic impairment
[see Clinical Pharmacology (12.3)]. - Renal Impairment: Monitor for adverse reactions and consider dosage modification or discontinuation of pirfenidone as needed. Pirfenidone is not recommended for use in patients with end stage renal disease on dialysis. , 12.3)
8.7 Renal ImpairmentPirfenidone should be used with caution in patients with mild (CLcr50 mL/min to 80 mL/min), moderate (CLcr30 mL/min to 50 mL/min), or severe (CLcrless than 30 mL/min) renal impairment
[see Clinical Pharmacology (12.3)].Monitor for adverse reactions and consider dosage modification or discontinuation of pirfenidone as needed[seeDosage and Administration (2.3)]. The safety, efficacy, and pharmacokinetics of pirfenidone have not been studied in patients with end-stage renal disease requiring dialysis. Use of pirfenidone in patients with end-stage renal diseases requiring dialysis is not recommended. - Smokers: Decreased exposure has been noted in smokers which may alter the efficacy profile of pirfenidone.
8.8 SmokersSmoking causes decreased exposure to pirfenidone
[see Clinical Pharmacology (12.3)],which may alter the efficacy profile of pirfenidone. Instruct patients to stop smoking prior to treatment with pirfenidone and to avoid smoking when using pirfenidone.
None.
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)]
Moderate (e.g., ciprofloxacin) and strong inhibitors of CYP1A2 (e.g., fluvoxamine) increase systemic exposure of pirfenidone and may alter the adverse reaction profile of pirfenidone. Discontinue fluvoxamine prior to administration of pirfenidone or reduce to 267 mg three times a day. Consider dosage reduction with use of ciprofloxacin.
Pirfenidone is metabolized primarily (70% to 80%) via CYP1A2 with minor contributions from other CYP isoenzymes including CYP2C9, 2C19, 2D6 and 2E1.
The concomitant administration of pirfenidone and fluvoxamine or other strong CYP1A2 inhibitors (e.g., enoxacin) is not recommended because it significantly increases exposure to pirfenidone
Concomitant administration of pirfenidone and ciprofloxacin (a moderate inhibitor of CYP1A2) moderately increases exposure to pirfenidone
Agents or combinations of agents that are moderate or strong inhibitors of both CYP1A2 and one or more other CYP isoenzymes involved in the metabolism of pirfenidone (i.e. CYP2C9, 2C19, 2D6, and 2E1) should be discontinued prior to and avoided during pirfenidone treatment.