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Generic Nintedanib Information
Introduction
Nintedanib is a tyrosine‑kinase inhibitor that has become a cornerstone of chronic fibrotic lung disease management in the United Kingdom. The active compound, Nintedanib, is classified under the General health medication group and is authorised for adult patients with idiopathic pulmonary fibrosis (IPF) and systemic‑sclerosis‑associated interstitial lung disease (SSc‑ILD). It is supplied by the original developer — Boehringer Ingelheim — and is listed on the UK Medicines and Healthcare products Regulatory Agency (MHRA) database. The drug also shows activity in other fibrotic conditions, which are under clinical investigation.
What is Nintedanib?
Nintedanib is a small‑molecule inhibitor that blocks multiple receptor tyrosine kinases (RTKs) involved in angiogenesis and fibroblast proliferation. It is marketed as a film‑coated capsule, and the only authorised brand name in the EU is Ofev.
Nintedanib is the generic version of Ofev, containing the same active compound Nintedanib. Our online pharmacy provides this generic alternative as a cost‑effective treatment option.
The medication is manufactured to pharmaceutical‑grade standards, complying with European Union Good Manufacturing Practice (GMP) and the MHRA’s quality‑assurance requirements.
How Nintedanib Works
Fibrotic lung diseases are driven by an imbalance between tissue‑repair signalling and chronic inflammation. Nintedanib competitively binds to the intracellular ATP‑binding sites of three RTK families:
- Vascular endothelial growth factor receptors (VEGFR‑1, 2, 3)
- Platelet‑derived growth factor receptors (PDGFR‑α, β)
- Fibroblast growth factor receptors (FGFR‑1, 2, 3)
Inhibition of these pathways reduces endothelial‑and fibroblast‑mediated proliferation, migration and extracellular‑matrix deposition. Clinically, this translates into a slower decline in forced vital capacity (FVC) and a reduction in the frequency of acute exacerbations. Pharmacokinetic studies show peak plasma concentrations 2–4 hours after oral intake, a terminal half‑life of ≈ 10 hours, and primarily hepatic metabolism via CYP3A4. Steady‑state is achieved after 7–10 days of twice‑daily dosing.
Conditions Treated with Nintedanib
Indication | UK epidemiology | Rationale for use |
---|---|---|
Idiopathic Pulmonary Fibrosis (IPF) | ≈ 5 000–8 000 confirmed cases (estimated prevalence ≈ 7 / 100 000) | Progressive loss of lung tissue is driven by VEGF/PDGF/FGF signalling; Nintedanib attenuates that pathway, preserving FVC and quality of life. |
Systemic‑Sclerosis‑Associated Interstitial Lung Disease (SSc‑ILD) | Systemic sclerosis prevalence ≈ 7 / 10 000; 30 % develop clinically significant ILD | Fibrotic activity in systemic sclerosis overlaps with IPF mechanisms; trials demonstrated reduced FVC decline and fewer severe respiratory events. |
Other fibrotic disorders (off‑label) – e.g., progressive fibrosing non‑IPF lung diseases, chronic liver fibrosis (research stage) | Limited data in the UK; ongoing phase III trials | The same RTK inhibition strategy applies, but formal approval is pending. |
Nintedanib is prescribed when pulmonary function is deteriorating despite optimal supportive care, and when the disease is unlikely to respond to anti‑inflammatory agents alone.
Suitable Candidates for Nintedanib Treatment
- Adults with a confirmed diagnosis of IPF based on a multidisciplinary discussion, HRCT pattern of usual interstitial pneumonia, and exclusion of alternative causes.
- Adults with SSc‑ILD demonstrating ≥ 10 % predicted forced vital capacity and evidence of progressive fibrotic change on serial imaging or pulmonary‑function testing.
- Patients whose disease trajectory is characterised by ≥ 5 % annual FVC loss despite standard care, indicating high‑risk progression.
Contraindications include severe hepatic impairment (Child‑Pugh C), uncontrolled cardiovascular disease, and pregnancy. Nintedanib is not recommended for patients with active gastrointestinal ulceration, or for those taking strong CYP3A4 inhibitors (e.g., ketoconazole) without dose adjustment.
Risks, Side Effects, and Interactions
Common adverse events
- Diarrhoea – usually mild to moderate, may result in dehydration; manage with fluid replacement and antihydration.
- Nausea and vomiting – can be mitigated by taking the capsule with food.
- Decreased appetite – may lead to unintentional weight loss; regular nutritional assessment is advised.
Rare adverse events
- Elevated liver enzymes (ALT/AST) – asymptomatic laboratory abnormality; monitor monthly for the first 3 months, then quarterly.
- Bleeding events – particularly when combined with anticoagulants; caution is required in patients with chronic anticoagulation.
- Hypertension exacerbation – patients with pre‑existing hypertension should have blood pressure checked regularly.
Serious adverse events
- Severe liver injury – rare but potentially fatal; discontinue immediately if bilirubin rises > 2 × ULN with concurrent ALT/AST elevation.
- Cardiovascular events (e.g., myocardial infarction, arrhythmia) – more likely in patients with uncontrolled cardiac disease.
- Intestinal perforation – requires prompt surgical assessment; early recognition of severe abdominal pain is critical.
Clinically relevant drug–drug interactions
- CYP3A4 inhibitors (e.g., clarithromycin, itraconazole) may increase Nintedanib exposure – dose reduction to 100 mg twice daily is recommended.
- CYP3A4 inducers (e.g., rifampicin, carbamazepine) can lower exposure – may reduce efficacy; consider alternative agents.
- P‑glycoprotein inhibitors (e.g., elacridar) have limited clinical data but could augment systemic levels.
- Concurrent anticoagulation (warfarin, direct oral anticoagulants) – assess bleeding risk; monitor INR or anti‑Xa levels more closely.
Practical Use: Dosing, Missed Dose, Overdose
- Standard dosing – 150 mg (one capsule) taken twice daily, spaced approximately 12 hours apart. The regimen is identical for IPF and SSc‑ILD.
- Dose adjustments – For moderate hepatic impairment (Child‑Pugh B) or severe gastrointestinal toxicity, the dose may be reduced to 100 mg twice daily; for severe hepatic impairment, Nintedanib is contraindicated.
- Missed dose – If a dose is forgotten and the next scheduled intake is ≥ 6 hours away, the missed dose should be taken immediately. If the next dose is due sooner, skip the missed dose and resume the regular schedule; doubling up is not advised.
- Overdose – Acute over‑intake (≥ 300 mg) may produce intensified diarrhoea, hepatic enzyme rise, and hypotension. Patients should seek urgent medical attention; management is supportive, consisting of intravenous fluids, electrolyte replacement, and liver‑function monitoring.
- Food and alcohol – Capsules can be swallowed with or without food; high‑fat meals may marginally delay absorption but do not affect efficacy. Moderate alcohol consumption does not contraindicate therapy, but excessive alcohol can compound hepatic risk and should be avoided.
- Comorbidities – Renal insufficiency does not require dose modification, yet severe hepatic disease does. Regular assessment of lung function, liver enzymes, and blood pressure is essential.
Buying Nintedanib from Our Online Pharmacy
Nintedanib can be purchased directly from our online pharmacy in UK. Our service delivers several advantages:
- Affordable pricing – Generic capsules are sourced at near‑manufacturer cost, offering significant savings compared with brand‑name retail prices.
- Verified quality – All stock originates from overseas licensed pharmacies that hold EU and MHRA certifications; authenticity and potency are guaranteed by third‑party quality‑control testing.
- Guaranteed delivery – Discreet, trackable shipping is provided; express parcels arrive within 7 working days, while routine airmail typically takes up to 3 weeks.
- Pharmacy‑broker model – We act as a bridge between UK patients and verified international suppliers, ensuring privacy‑preserving packaging that respects patient confidentiality.
For individuals with limited access to conventional pharmacies, high co‑payments, or those residing in regions where Nintedanib is not routinely stocked, our online platform offers a safe, cost‑effective alternative.
FAQ
-
**Is Nintedanib available in both brand‑name and generic forms in the UK?
Yes. The original branded product is marketed as Ofev, while generic capsules containing the same active ingredient are supplied by licensed overseas manufacturers. The generic version is typically less expensive and is distributed through our online pharmacy. -
**How should Nintedanib be stored to maintain stability?
Store the capsules at controlled room temperature (15 °C–30 °C). Keep them away from direct sunlight, moisture, and heat sources such as radiators or bathroom sinks. Do not refrigerate unless specifically instructed by the supplier. -
**Can I travel internationally with Nintedanib, and are there customs considerations?
Yes, you may travel with the medication in its original packaging, accompanied by a copy of the prescription or a doctor’s letter. When entering the UK, personal import of a 30‑day supply is permitted for a licensed medication; larger quantities may require a prescription import licence. -
**What is the appearance of the Nintedanib capsule, and does it differ between regions?
The capsule is a film‑coated, orange‑coloured hard gelatin capsule containing white to off‑white powder. Minor variations in colour shade can occur between batches produced for different markets, but the active content remains identical. -
**Are there specific warnings for patients with Asian ancestry?
Clinical data suggest a higher incidence of hepatic enzyme elevation among East‑Asian patients receiving standard doses. Consequently, Asian patients may require closer liver‑function monitoring during the first two months of therapy. -
**Does Nintedanib affect the results of a drug‑screening test?
Nintedanib is not listed in standard occupational or forensic drug‑testing panels, as it is not a substance of abuse. However, if a laboratory uses a broad‑spectrum mass‑spectrometry assay, the medication could be detected; it does not produce a positive result for controlled substances. -
**Is it safe to use Nintedanib together with a COVID‑19 vaccination?
Current guidance indicates that Nintedanib does not impair the immunogenicity of mRNA or adenoviral COVID‑19 vaccines. Patients can receive routine vaccinations but should be observed for any unexpected gastrointestinal upset post‑vaccination. -
**Can I split or crush Nintedanib capsules for easier swallowing?
The formulation is designed for intact oral ingestion; splitting or crushing can alter the release characteristics and may increase systemic exposure, raising the risk of adverse reactions. Do not modify the dosage form without a pharmacist’s advice. -
**What is the shelf‑life of Nintedanib capsules supplied by our pharmacy?
The product carries a shelf‑life of 24 months from the date of manufacture, provided it remains in its original, unopened container and is stored under the recommended conditions. -
**How should I dispose of unused Nintedanib capsules?
Unused capsules should be returned to a pharmacy or placed in a approved medication‑return bin. Do not discard in household waste streams, as this may contaminate water sources. -
**Is Nintedanib classified as a controlled substance in the UK?
No. Nintedanib is not scheduled under the Misuse of Drugs Regulations and can be imported for personal use under the MHRA’s “unlicensed medicines” provisions, provided a valid prescription and supporting documentation are supplied.
Glossary
- Tyrosine‑kinase inhibitor (TKI)
- A class of drugs that blocks the activity of enzymes (tyrosine kinases) responsible for signalling pathways that promote cell growth, angiogenesis, and fibrosis.
- Forced vital capacity (FVC)
- The maximal volume of air that can be expelled from the lungs after a full inhalation; a key functional measurement in interstitial lung disease.
- Child‑Pugh score
- A system used to assess the severity of chronic liver disease, categorising patients into class A (mild), B (moderate), or C (severe) based on clinical and laboratory parameters.
- Pharmacokinetic half‑life
- The time required for the plasma concentration of a drug to decrease by 50 % after a single dose; determines dosing intervals and accumulation.
⚠️ Disclaimer
The information provided about Nintedanib is for general knowledge only. It does not replace professional medical consultation. All treatment decisions should be made under the supervision of a qualified healthcare provider. We assume all readers are responsible adults capable of making informed decisions about their health. Our online pharmacy offers access to Nintedanib for individuals who may have limited availability through traditional pharmacies, prescription‑based insurance schemes, or who are seeking affordable generic alternatives. Always consult your doctor before starting, changing, or discontinuing any medication.