Pirfenidone

Cytostatic · Pyridone

Indications

Mild to moderate idiopathic pulmonary fibrosis.

Dosage

Adults: Idiopathic pulmonary fibrosis: ORAL: Day 1-7: 267 mg 3 times daily (801 mg/day), day 8-14: 534 mg 3 times daily (1602 mg/day), day 15 and thereafter (maintenance): 801 mg three times daily; not to exceed 2403 mg/day. In patients with persistent GI adverse effects, the dose may be reduced to 267 to 534 mg 2 or 3 times daily and then increased again to the recommended daily dose as tolerated. In case of mild to moderate hypersensitivity reactions or rash, the dose may be reduced to 267 mg 3 times daily. If the rash remains for more than 7 days, stop treatment for 15 days and then increased again to the recommended daily dose. Children: Not recommended.

Adverse Effects

Nausea, vomiting, diarrhoea, dyspepsia, fatigue, rash, dizziness, weight loss.

Risk Factor (Pregnancy/Lactation)

Pregnancy: Risk cannot be ruled out. Lactation: Caution advised or effect undetermined. Contraindications: Severe hepatic impairment, end-stage liver disease. Severe renal impairment, end-stage renal disease requiring dialysis. Precautions: Consider LFT before starting treatment, monthly for 6 mths and then every 3 mths thereafter. GI disorders.

Interactions

Ciprofloxacin, cimetidine, amiodarone, gemfibrozil, fluoxetine, duloxetine, nifedipine, ofloxacin, tranylcypromine. Enoxacin, fluvoxamine, carbamazepine, phenobarbital, primidone, rifampin (avoid).

Advice to Patient

Take with meals. Avoid or minimize exposure to sunlight. Apply sunscreen daily during treatment. Be cautious while driving or operating machinery. Quit smoking before starting treatment. Limit or avoid grapefruit juice consumption during treatment.

Pharmacokinetics

Absorption: Rapidly absorbed. Metabolism: Hepatic. Half-life elimination: Terminal: Single dose: 2.4 hrs. Excretion: Urine (80%).

Compiled by Healify Pharmacy from published drug references. How we compile it →

Always consult a pharmacist or doctor.