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Contraindications
Severe hepatic and renal impairment, ESRD requiring haemodialysis.
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Special Precautions
Smokers. Mild to moderate hepatic and renal impairment. Pregnancy and lactation. Patient taking fluvoxamine and ciprofloxacin. Patient Counselling Avoid smoking. This drug may cause dizziness and fatigue, if affected, do not drive or operate machinery. Avoid excessive exposure to sun and UV light. Monitoring Parameters Perform LFT before initiation of treatment, monthly for the 1st 6 months and quarterly, thereafter. Monitor weight; signs and symptoms of gastrointestinal and photosensitivity reactions.
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Adverse Reactions
Significant: Nausea, vomiting, diarrhoea, dyspepsia, GERD, abdominal pain, photosensitivity, weight loss, dizziness, increased ALT/AST, angioedema. Rarely, hyperbilirubinaemia.
Gastrointestinal disorders: Constipation, flatulence, gastritis.
General disorders and administration site conditions: Fatigue, asthenia, lethargy, non-cardiac chest pain.
Investigations: Increased γ-glutamyl transferase.
Metabolism and nutrition disorders: Anorexia, decreased appetite.
Musculoskeletal and connective tissue disorders: Myalgia, arthralgia.
Nervous system disorders: Headache, dysgeusia.
Psychiatric disorders: Insomnia, somnolence.
Renal and urinary disorders: UTI.
Respiratory, thoracic and mediastinal disorders: Dyspnoea, cough, upper respiratory tract infection.
Skin and subcutaneous tissue disorders: Rash, pruritus, erythema, dry skin, sunburn.
Vascular disorders: Hot flush.
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Drug Interactions
Increased toxicity with strong (e.g. fluvoxamine) and moderate (e.g. ciprofloxacin) CYP1A2 inhibitors. Decreased efficacy with CYP1A2 inducers (e.g. omeprazole).
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CIMS Class
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ATC Classification
L04AX05 - pirfenidone ; Belongs to the class of other immunosuppressants.
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