Nintedanib

Nintedanib – Patient Guide for Australia

Basic Product Information

Mechanism of Action

For everyone: Nintedanib is a type of medicine known as a "tyrosine kinase inhibitor." It helps slow down the process of scarring or fibrosis in your lungs, which is a key issue in diseases such as idiopathic pulmonary fibrosis (IPF) and some forms of lung cancer.

For healthcare professionals: Nintedanib blocks multiple receptor tyrosine kinases (PDGFR α/β, FGFR 1-3, and VEGFR 1-3). This inhibition reduces fibroblast proliferation, migration, and transformation, which are central to fibrotic lung disease, and also impacts tumour angiogenesis in non-small cell lung cancer (NSCLC).

Pharmacokinetics

• Absorption: After oral administration, bioavailability is about 4.7%. Peak plasma concentrations are reached within 2–4 hours.
• Metabolism: Nintedanib is mainly metabolised in the liver by esterases to metabolites, then eliminated via biliary-faecal excretion. CYP pathways play a minimal role (mainly CYP3A4, minor).
• Elimination: Most of the drug leaves the body via faeces (~93%), with the remainder (<1%) in urine. The mean terminal half-life is about 10–15 hours.
• Duration of action: Requires regular daily dosing to maintain effect.

Use in Everyday Life and Best Practices (Australia Context)

• Typical initial dose (adults): 150 mg orally twice daily, roughly 12 hours apart (morning and evening).
• How to take: Swallow capsules whole, with water. Do not open, crush, or chew.
• Routine: Ideally, take at the same times each day for best results. Set reminders if needed. Missed doses should be skipped if the next dose is within 12 hours.
• General guidelines: Only use under specialist supervision, usually a respiratory, oncology, or interstitial lung disease physician. Regular liver function and blood tests will be needed, and your practitioner will review for side effects or drug interactions.

Dosing in the Morning vs Evening

• Morning: May reduce the risk of forgetting the dose if part of a breakfast routine. Some stomach upset may be minimised by taking with a meal.
• Evening: Taking at dinner may spread potential side effects (such as diarrhoea) over the day and night. Avoid taking just before bedtime if it causes nausea.
• Best advice: Try to stick to the same time morning and evening each day. Use phone alarms or a medication diary for consistency.

Taking with Food or on an Empty Stomach

• With food: Recommended. Taking nintedanib with food significantly reduces stomach irritation, which is one of the most common side effects. In Australia, incorporate your medicine into standard mealtimes—breakfast and dinner—using what works with your regular diet, such as cereal or toast in the morning and meat/vegetarian dishes at night.
• On an empty stomach: Not recommended due to higher risk of gastrointestinal upset. Always follow your doctor's or pharmacist's advice regarding meals.

Interaction Warnings

Indications

Dosing According to Clinical Indication

Safety Profile and Side Effects

• Very common (≥10%): Diarrhoea, nausea, vomiting, abdominal pain, reduced appetite, weight loss, elevated liver enzymes, headache
• Common (1–10%): Bleeding (mainly nosebleeds), hypertension, rash, pruritus (itching)
• Uncommon/Rare (<1%): Serious liver damage, pancreatitis, allergic reactions, clotting disorders

• Women who are pregnant or could become pregnant must use effective contraception during treatment and for at least 3 months after.
• Report any signs of liver trouble (yellowing of skin/eyes, dark urine).
• Watch for severe diarrhoea or bleeding and contact your doctor immediately if these occur.

Guidelines for Proper Use in Australia

• Supply: Nintedanib is supplied on prescription by Australian pharmacies after specialist initiation. PBS subsidy is available for eligible patients with certain lung conditions.
• Monitoring: Regular bloods for liver function, complete blood count, and kidney tests are essential before and during treatment—these can be arranged through your local GP or hospital respiratory clinic.
• Storage: Store at room temperature (below 25°C), in a cool, dry place away from direct sunlight.
• Travel: Carry a letter from your doctor and medication in original packaging when travelling within Australia or abroad.
• General advice: If unsure about your tablets or experience new symptoms, contact your dispensing pharmacy or prescriber.

Alternative Treatment Options

• Pirfenidone (Esbriet®): Also approved via PBS for idiopathic pulmonary fibrosis. Works differently and has its own side effect profile. May suit some patients better, especially if nintedanib is not tolerated.
• Supportive care: Includes oxygen therapy, pulmonary rehabilitation, and symptom management.
• Other disease-modifying agents: Choices may include immunosuppressants (e.g., mycophenolate, azathioprine for specific subtypes based on clinical guidance), although these are less common for IPF and not specifically reimbursed by PBS for this indication.
• Comparative overview:
  • Nintedanib and pirfenidone both slow IPF progression; choice depends on tolerance, comorbidities, and specialist advice.
  • Both are PBS reimbursed for specific patients in Australia.

Legal, Registration, and Reimbursement Status in Australia

• TGA Registration: Registered as a prescription medicine by the Therapeutic Goods Administration (TGA).
• PBS (Pharmaceutical Benefits Scheme): PBS subsidy available for IPF and selected fibrosing interstitial lung diseases where PBS criteria are met—substantial out-of-pocket cost reduction.
• Prescribing: Can only be prescribed by medical practitioners (usually a respiratory, oncology, or rheumatology specialist) under regulation 24 (prescriber’s instructions for repeats and quantities).
• Legal status: Schedule 4 (S4) – prescription only. Not available as over-the-counter medicine in Australia.

Latest Research and Clinical Guidance (2022–2025)

• Australian guidelines (Thoracic Society of Australia and New Zealand, 2023): Nintedanib remains recommended as a first-line agent for IPF, and for patients with non-IPF progressive fibrosing ILD who meet severity criteria.
• Pooled data (Lancet Respir Med, 2022–2024): Show continued reduction in forced vital capacity (FVC) decline across various subtypes, including scleroderma-related and other progressive fibrotic ILDs.
• Efficacy and safety meta-analyses (European Respiratory Journal, 2023): Emphasise the importance of regular liver monitoring, and confirm a generally manageable safety profile.
• Ongoing studies are exploring new indications and optimal treatment durations, including potential combination with new anti-fibrotic therapies.
• Always follow up with your specialist for the latest treatment advice tailored to your situation.

Availability and Delivery in Australia

Frequently Asked Questions (FAQ)

• 1. What happens if I accidentally miss a dose?
  If you are within 12 hours of your next scheduled dose, just skip the missed capsule. Do not take double doses. Resume your regular schedule.
• 2. Will nintedanib cure my lung condition?
  No, nintedanib does not cure lung fibrosis or cancer, but it helps slow disease progression and may improve quality of life and breathing over time.
• 3. Can I take nintedanib with other regular medicines?
  Many medicines can be safely used with nintedanib, but some—such as certain antibiotics, anti-epileptics or herbal products (like St John’s wort)—require monitoring or should be avoided. Always inform your doctor or pharmacist about all your medicines.
• 4. What lifestyle changes should I make while on nintedanib?
  Eat regular meals, drink plenty of water, limit alcohol, get regular blood tests, and keep your vaccination status up to date (including influenza and COVID-19 vaccines per Australian recommendations).
• 5. Can I drive or operate machinery while using nintedanib?
  Most people can, but be aware of possible dizziness or tiredness. Avoid driving if experiencing severe side effects.

For further information or support in Australia, consult your specialist, local hospital pharmacy, or call the Medicines Line on 1300 633 424.