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Nintedanib

3.71
Nintedanib is a tyrosine kinase inhibitor used to treat idiopathic pulmonary fibrosis and certain types of chronic lung diseases. It helps adults by blocking the pathways that lead to lung tissue scarring, thereby slowing the progression of respiratory dysfunction and preserving lung function.


Ingredient
Availability
In Stock
Delivery Time
Airmail (14-21 days) | EMS trackable (5-9 days)
Product is shipped in a fully discreet envelope with no content disclosure, including all required documentation inside

Product Sheet

Active Ingredient(s)
Nintedanib
Reference Brand
Ofev
Product Form
Capsule
Regulatory Classification
Rx
Primary Category
Lung Health
Product Category
Antineoplastic agents, Protein kinase inhibitors
Pharmacological Class
Tyrosine kinase inhibitor
Manufacturer Description
A specialized medicine used to slow down the scarring of the lungs in chronic lung diseases.
Mechanism of Action
Nintedanib blocks several pathways involved in the scarring (fibrosis) of lung tissue. By inhibiting these signals, it slows the progression of lung stiffening.
Route of Administration
Oral
Onset Time
Slows progression over months
Duration
12 hours
Contraindications
Severe liver impairment, Hypersensitivity to peanut or soya
Severe Adverse Events
Liver enzyme elevation, Bleeding events, Gastrointestinal perforation, Heart attack
Common Side Effects
Nausea, Weight loss, Reduced appetite
Uncommon Side Effects
Diarrhea, Vomiting, Abdominal pain, High blood pressure
Drug Interactions
Ketoconazole, Rifampicin, Anticoagulants
Pregnancy Safety Warnings
Contraindicated; effective contraception required during treatment.
Age Restrictions
Adults only
Storage Guidelines
Store at room temperature below 25°C in the original package.
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Nintedanib FAQ

What is the primary purpose of nintedanib in lung disease?

Nintedanib slows the progression of lung scarring by inhibiting enzymes that drive tissue fibrosis, thereby preserving lung capacity and delaying functional decline.

Can nintedanib be used to treat asthma?

No. Nintedanib is not approved for asthma and works on different biological pathways than those involved in reversible airway constriction.

How often should liver function be checked while taking nintedanib?

Initial monitoring is recommended every 4 weeks for the first three months, then at intervals determined by the prescriber based on clinical response.

Is it safe to take nintedanib with a common antihistamine for allergy relief?

Most antihistamines do not interact with nintedanib. However, always inform your clinician of all medicines you are taking, including over-the-counter products.

What should I do if I experience persistent diarrhoea?

Contact your healthcare provider promptly; they may adjust the dose, recommend supportive therapy, or suggest dietary modifications to manage the symptom.

Does nintedanib affect blood clotting?

The medication can increase bleeding risk, especially when combined with anticoagulants or antiplatelet drugs. Regular monitoring of bleeding signs is advisable.

Can I take nintedanib on an empty stomach?

It is best taken with food to reduce gastrointestinal upset; taking it on an empty stomach may worsen nausea or diarrhoea.

Are there any special considerations for travel with nintedanib?

Carry the medication in its original labelled container, keep it at room temperature, and bring a copy of the prescription for customs if needed.

What imprint or colour identifies a 100 mg nintedanib capsule?

In the UK, the 100 mg capsule is typically a white, hard gel capsule imprinted with “NIN-100”. Variations may exist depending on the manufacturer.

How does nintedanib differ from other antifibrotic drugs like pirfenidone?

Both target fibrotic pathways, but nintedanib inhibits multiple tyrosine-kinase receptors, whereas pirfenidone’s exact mechanism is less defined and involves modulation of cytokine production.

Nintedanib: Generic Medication Overview

Nintedanib is the active ingredient in a capsule formulation that is marketed in a 100 mg strength. It belongs to the therapeutic class of tyrosine-kinase inhibitors (TKIs) and is used primarily for certain chronic lung conditions that affect breathing. In the United Kingdom, nintedanib is a prescription-only medicine (POM) regulated by the Medicines and Healthcare products Regulatory Agency (MHRA).

How Nintedanib Works in the Body

Nintedanib blocks several intracellular enzymes called tyrosine kinases. These enzymes normally help control cell growth, division, and the formation of new blood vessels. By inhibiting the vascular endothelial growth factor (VEGF) receptor, fibroblast growth factor (FGF) receptor, and platelet-derived growth factor (PDGF) receptor pathways, nintedanib reduces abnormal tissue remodeling and fibrosis (thickening and scarring) in the lungs. The result is a slower decline in lung function for conditions in which excessive scarring is the main problem.

Key pharmacologic points:

  • Onset: Clinical effects on lung function are generally observed after several weeks of regular dosing.
  • Peak plasma concentration: Reached approximately 2-4 hours after swallowing the capsule.
  • Metabolism: Primarily processed by the liver enzyme CYP3A4 and by the drug transporter P-glycoprotein (P-gp).
  • Excretion: Mainly via feces; a smaller portion is eliminated in urine.

Conditions Treated by Nintedanib

Approved Medical Uses

In the UK, nintedanib is authorised for the following indications:

  • Idiopathic Pulmonary Fibrosis (IPF): A chronic, progressive scarring of the lung tissue with no known cause.
  • Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs): Including systemic sclerosis-associated interstitial lung disease and other non-IPF conditions where lung scarring continues despite standard therapy.

These uses are based on robust clinical trial data demonstrating a reduction in the rate of forced vital capacity (FVC) decline, a key measure of lung function.

Not Indicated for Asthma

Although the broader therapeutic category relates to breathing, nintedanib is not approved for the treatment of asthma or other reversible airway diseases. Patients with asthma should continue to use inhaled therapies and other guideline-directed treatments.

Patient Suitability and Contra-indications

Who Should Not Use Nintedanib?

  • Known hypersensitivity to nintedanib or any capsule excipients.
  • Severe hepatic impairment (Child-Pugh class C) because the drug is metabolised in the liver.
  • Active bleeding or high-risk anticoagulation (e.g., uncontrolled haemorrhage, recent major surgery) due to an increased risk of bleeding events.

Relative Contra-indications

  • Mild to moderate liver disease - dose may need adjustment and liver enzymes must be monitored.
  • Renal impairment - caution is advised; no specific dose reduction is required, but regular renal function checks are prudent.
  • Pregnancy and lactation - nintedanib can cause fetal harm; it is contraindicated in pregnancy and should not be used while breastfeeding.

Special Populations

  • Women of child-bearing potential: Effective contraception is required during treatment and for at least 3 months after the last dose.
  • Elderly patients: No separate dose is recommended, but clinicians often monitor for increased gastrointestinal side effects.

Safety Profile: Side Effects and Interactions

Common Side Effects

  • Diarrhoea - reported in the majority of patients; often mild to moderate and manageable with diet and hydration.
  • Nausea and vomiting - may improve with taking the capsule with food.
  • Abdominal pain - occasional; usually transient.

Serious Adverse Events

  • Liver enzyme elevation (ALT, AST) - may indicate liver injury; regular blood-test monitoring is essential.
  • Bleeding complications - gastrointestinal bleeding or epistaxis can occur, especially when combined with anticoagulants or antiplatelet agents.
  • Cardiovascular events - rare cases of myocardial infarction have been reported; patients with existing heart disease should be assessed carefully.

Drug Interactions

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): can increase nintedanib exposure → dose reduction or avoidance is recommended.
  • Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine): may lower drug levels → may reduce efficacy.
  • P-gp inhibitors (e.g., verapamil, itraconazole): may increase systemic exposure.
  • Anticoagulants/antiplatelet agents (e.g., warfarin, clopidogrel): heightened bleeding risk; close monitoring is advised.

Food and Lifestyle Interactions

  • Take with food to lessen gastrointestinal upset.
  • Alcohol should be limited as it can exacerbate liver enzyme elevations.
  • Driving and machinery: No restrictive effects have been identified, but patients experiencing severe diarrhoea or dizziness should exercise caution.

How to Take Nintedanib

  • Formulation: 100 mg hard capsule (cap).
  • Administration: Swallow the capsule whole with a glass of water; do not crush or chew.
  • Timing: Typically taken twice daily, with meals, unless the prescriber advises otherwise.
  • Missed Dose: Take the missed dose as soon as remembered provided it is not within 12 hours of the next scheduled dose. Do not double up.
  • Overdose: Symptoms may include severe diarrhoea, abdominal pain, and elevated liver enzymes. Seek urgent medical care; supportive treatment is the mainstay.
  • Discontinuation: Nintedanib should be tapered under medical supervision if long-term therapy is stopped, to monitor for any rebound of symptoms.

Because dosing regimens are individualized, the exact number of capsules per day will be determined by the prescribing clinician.

Monitoring and Follow-Up

  • Liver function tests (ALT, AST, bilirubin): Baseline and then every 4 weeks for the first 3 months, followed by periodic checks.
  • Pulmonary function (FVC): Every 3-6 months to assess disease progression.
  • Complete blood count: Periodically, especially if combined with anticoagulants.
  • Clinical review: Any new or worsening symptoms (e.g., persistent diarrhoea, abdominal pain, unusual bleeding) should prompt an earlier appointment.

Storage and Handling

  • Temperature: Store at 20-25 °C (room temperature); excursions between 15-30 °C are acceptable.
  • Moisture: Keep the capsule bottle tightly closed to protect from humidity.
  • Light: Store in a light-protected container.
  • Expiration: Do not use after the expiry date printed on the package.
  • Disposal: Follow local pharmacy guidelines for safe disposal of unused medication; do not flush.

Medication-Specific Glossary

Tyrosine-Kinase Inhibitor (TKI)
A class of drugs that block enzymes (tyrosine kinases) involved in cell signalling pathways that promote tissue growth and fibrosis.
Forced Vital Capacity (FVC)
The total amount of air a person can forcibly exhale after a full inhalation; a key measure of lung function in fibrotic lung disease.
CYP3A4
A major liver enzyme responsible for metabolising many drugs; inhibition can raise levels of medications that rely on this pathway.
P-glycoprotein (P-gp)
A cellular transporter that pumps drugs out of cells; inhibitors can increase the intracellular concentration of substrates like nintedanib.

Medical Disclaimer

This article provides educational information about nintedanib and is not a substitute for professional medical advice. Treatment decisions, including use for unapproved indications, must be made under the guidance of a qualified healthcare provider. The content is intended for informational purposes and does not constitute medical recommendations. Always consult a physician before starting, stopping, or changing any medication regimen.

Information for Nintedanib is sourced from established medical standards and updated frequently. It is provided for general guidance and should be confirmed with a healthcare professional before use.
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