Indications

Prutis is approved for

• Idiopathic Pulmonary Fibrosis (IPF)
• Chronic Fibrosing ILDs with progressive phenotype
• Systemic Sclerosis-Associated ILD (SSc-ILD)

Mechanism of Action

Nintedanib is a tyrosine kinase inhibitor that blocks pathways driving lung fibrosis, slowing disease progression.

Dosage and Administration

• Standard: 150 mg twice daily (~12 hours apart, with food)
• Mild Hepatic Impairment: 100 mg twice daily (monitor LFTs)
• Not recommended in moderate/severe hepatic impairment
• Temporary reduction/interruption may be needed for GI intolerance or elevated liver enzymes

Contraindications & Precautions

• Pregnancy and breastfeeding
• Severe liver disease
• Hypersensitivity to nintedanib

Side Effects

• Very common: diarrhoea, nausea, abdominal pain, vomiting, appetite loss, abnormal liver function tests
• Common: weight loss, headache, rash, hypertension, bleeding

Monitoring & Safety Guidance

• LFTs at baseline, first 3 months, and periodically
• Manage diarrhoea and nausea early
• Caution in patients with bleeding risk or GI perforation history

Drug Interactions

• CYP3A4 inhibitors ↑ exposure (ketoconazole, ritonavir, clarithromycin)
• CYP3A4 inducers ↓ exposure (rifampicin, carbamazepine, St. John's Wort)
• Anticoagulants: monitor for bleeding
• NSAIDs/steroids: caution due to GI perforation risk

Storage

Store below 20°C, in original packaging

Clinical Evidence

• INPULSIS/TOMORROW (IPF): Reduced annual FVC decline by ~115 mL vs placebo
• INBUILD (PF-ILD): Significantly slowed progression over 52 weeks
• INJOURNEY (Advanced): Combination with pirfenidone stabilised lung function