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Nintedanib

3.71
A specialized medicine used to slow down the scarring of the lungs in chronic lung diseases.


Ingredient
Availability
In Stock
Delivery
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

Alternative/Local Brand
Ofev
Active Ingredient(s)
Nintedanib
Primary Category
Lung Health
Therapeutic Class
Antineoplastic agents, Protein kinase inhibitors
Pharmacological Class
Tyrosine kinase inhibitor
Indications
Idiopathic pulmonary fibrosis, Systemic sclerosis-associated interstitial lung disease
Contraindications
Severe liver impairment, Hypersensitivity to peanut or soya
Minor Side Effects
Nausea, Weight loss, Reduced appetite
Moderate Side Effects
Diarrhea, Vomiting, Abdominal pain, High blood pressure
Serious Side Effects
Liver enzyme elevation, Bleeding events, Gastrointestinal perforation, Heart attack
Dosage Forms
Capsule
Administration Route
Oral
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.
Prescription Status
Rx
Patient Summary
A specialized medicine used to slow down the scarring of the lungs in chronic lung diseases.
Onset Time
Slows progression over months
Duration
12 hours
Storage Instructions
Store at room temperature below 25°C in the original package.
Drug Interactions
Ketoconazole, Rifampicin, Anticoagulants
Age Restrictions
Adults only
Pregnancy Use
Contraindicated; effective contraception required during treatment.
Alternative Drugs
Pirfenidone

Nintedanib: Generic Medication Overview

Nintedanib is a prescription medication classified under respiratory health. It is available as a 100 mg capsule (cap) and is approved for the treatment of certain fibrotic lung conditions. In Hong Kong, the Drug Office of the Department of Health evaluates and authorizes its use based on safety and efficacy data submitted by the manufacturer. Nintedanib is marketed internationally under brand names such as Ofev, but the active ingredient itself is widely prescribed in its generic form.

How Nintedanib Works in the Body

Nintedanib is a tyrosine kinase inhibitor that blocks several growth factor receptors involved in tissue scarring, including vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF), and fibroblast growth factor (FGF) receptors. By inhibiting these pathways, the drug reduces the activation, proliferation, and migration of fibroblasts-the cells responsible for producing excess collagen and extracellular matrix in the lungs. This action helps slow the progression of pulmonary fibrosis, leading to a slower decline in lung function. The medication is taken orally, with peak plasma concentrations reached within a few hours after ingestion. Its metabolism is primarily hepatic, involving the enzyme CYP3A4, and it is excreted mainly via feces.

Conditions Treated by Nintedanib

  • Idiopathic Pulmonary Fibrosis (IPF) - a chronic, progressive scarring of lung tissue with no known cause. Nintedanib is approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Hong Kong Department of Health for this indication.
  • Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) - a condition where connective-tissue disease leads to lung fibrosis. Regulatory agencies in the EU and Hong Kong have extended approval to include this indication.

These approvals are based on randomized controlled trials that demonstrated a reduction in the rate of decline of forced vital capacity (FVC), a key measure of lung function.

Investigational Uses Under Study

Researchers are evaluating nintedanib in other fibrotic disorders such as:

  • Progressive fibrosing interstitial lung diseases (PF-ILDs) beyond IPF and SSc-ILD. Early trial data suggest potential benefit, but these uses are not yet authorized by regulatory bodies.
  • Fibrotic liver disease and certain cancer subtypes where similar signaling pathways drive disease progression.

Disclaimer: Off-label use of nintedanib requires medical supervision and individualized risk assessment. Patients should discuss potential benefits and risks with a qualified healthcare provider before initiating therapy for unapproved conditions.

Who Should (and Should Not) Use Nintedanib?

Absolute Contraindications

  • Known hypersensitivity to nintedanib or any of its excipients.
  • Severe hepatic impairment (Child-Pugh Class C).
  • Pregnancy or breastfeeding (risk of fetal toxicity).

Relative Contraindications

  • Moderate hepatic impairment (Child-Pugh Class B) - dose adjustment may be needed.
  • Concurrent use of strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) - may increase drug exposure.
  • Elderly patients with multiple comorbidities - close monitoring is advised.

Special Populations

  • Pregnancy/Lactation: Nintedanib is contraindicated; effective contraception is required during treatment and for at least three months after the last dose.
  • Renal Impairment: No specific dose adjustment is recommended for mild to moderate renal dysfunction, but severe renal failure warrants caution.
  • Geriatric Patients: Start at the recommended dose and monitor for gastrointestinal side effects and liver enzyme changes.

Safety Profile: Side Effects and Interactions

Common Side Effects

  • Diarrhea - reported frequently; managing with hydration and antidiarrheal agents is recommended.
  • Nausea and abdominal pain - may improve when the capsule is taken with food.
  • Elevated liver enzymes (ALT, AST) - routine laboratory monitoring is required.

Serious Adverse Events

  • Severe hepatotoxicity - indicated by marked ALT/AST elevations; discontinue if liver enzymes exceed three times the upper limit of normal with symptoms.
  • Bleeding complications - rare but may occur, especially in patients on anticoagulants.
  • Cardiovascular events - monitor patients with pre-existing heart disease.

Drug Interactions

  • Major: Strong CYP3A4 inhibitors (e.g., azole antifungals, some macrolide antibiotics) can raise nintedanib plasma levels; dose reduction or alternative therapy should be considered.
  • Moderate: P-glycoprotein (P-gp) inhibitors (e.g., verapamil) may modestly increase exposure.
  • Inducers: CYP3A4 inducers such as rifampicin can lower drug concentrations, potentially reducing efficacy.

Food and Lifestyle Interactions

  • Food: Taking nintedanib with a main meal reduces gastrointestinal upset.
  • Alcohol: Excessive alcohol may exacerbate liver toxicity; limit intake.
  • Driving: No direct impairment, but severe diarrhea or fatigue could affect concentration.

Patients should inform their healthcare provider of all prescription medicines, over-the-counter drugs, supplements, and herbal products before starting nintedanib.

How to Take Nintedanib

  • Standard dosing: The medication is supplied as a 100 mg capsule. The exact dosing schedule (e.g., once daily or twice daily) must follow the prescribing information provided by the treating physician.
  • Administration: Swallow the capsule whole with a glass of water. It may be taken with food to lessen stomach irritation.
  • Missed dose: If a dose is omitted, take it as soon as remembered unless it is close to the time of the next scheduled dose. Do not double the dose.
  • Overdose: Symptoms may include severe gastrointestinal distress, nausea, vomiting, and elevated liver enzymes. Seek emergency medical attention; supportive care is the mainstay of treatment.
  • Discontinuation: Abrupt cessation is generally safe, but physicians may choose a tapering strategy in patients who have experienced significant side effects.

Note: Dosing must be individualized. Typical regimens for tyrosine-kinase inhibitors in this class start at 100 mg once or twice daily and are adjusted based on tolerability and liver function tests.

Monitoring and Follow-Up

  • Liver function tests (ALT, AST, bilirubin): Baseline before initiation, then at 2-4 weeks, and periodically thereafter.
  • Pulmonary function (FVC): Every 3-6 months to assess disease progression.
  • Complete blood count: Periodic monitoring to detect rare hematologic effects.
  • Clinical assessment: Patients should report persistent diarrhea, abdominal pain, or signs of liver injury promptly.

Regular follow-up with a pulmonologist or respiratory specialist is essential for optimal disease management.

Storage and Handling

  • Store the 100 mg capsules at room temperature (15-30 °C), protected from moisture and light.
  • Keep the medication out of reach of children and pets.
  • Do not use the product after the expiration date printed on the packaging.
  • Dispose of unused capsules according to local pharmacy or waste-disposal guidelines.

Medication-Specific Glossary

Tyrosine Kinase Inhibitor
A class of drugs that block enzymes (tyrosine kinases) involved in signaling pathways that promote cell growth and fibrosis.
Fibroblast
A type of cell that produces collagen and extracellular matrix; overactivity contributes to lung scarring in fibrotic diseases.
Interstitial Lung Disease (ILD)
A broad term for disorders causing inflammation and fibrosis of the lung interstitium, leading to impaired gas exchange.
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 fibrosis.
Child-Pugh Classification
A scoring system used to assess the severity of chronic liver disease, guiding dose adjustments for hepatically cleared drugs.

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.

Nintedanib FAQ

What should I do if I experience persistent diarrhea while taking nintedanib?

Persistent diarrhea should be reported to your healthcare provider promptly. Management may include dietary adjustments, hydration, and possibly anti-diarrheal medication. In some cases, dose reduction or temporary interruption of therapy may be recommended.

Can nintedanib be taken with other medications for pulmonary hypertension?

Yes, nintedanib can be co-prescribed with pulmonary hypertension drugs, but potential interactions-especially with agents metabolized by CYP3A4-should be reviewed by a clinician to avoid altered drug levels.

Is it safe to travel internationally with nintedanib capsules?

Nintedanib capsules are permitted for personal medical use when carried in original packaging with a prescription label. Keep them in your carry-on luggage to avoid temperature extremes and ensure you have a copy of the prescription for customs authorities.

Do the capsules have any distinctive imprint or color that helps identify them?

The generic 100 mg nintedanib capsule is typically white to off-white and may bear the imprint “NIN 100” or a similar manufacturer-specific code. Verify the imprint with the dispensing pharmacy if you have any doubts.

How does nintedanib differ from pirfenidone, another antifibrotic agent?

Nintedanib inhibits multiple tyrosine kinases, while pirfenidone’s mechanism involves modulation of cytokines and growth factors. Both slow lung function decline, but they have distinct side-effect profiles and dosing schedules, making individual patient factors important in drug selection.

Can I take nintedanib if I have mild liver enzyme elevation before starting therapy?

Mild elevations should be evaluated by a healthcare professional. If liver enzymes are within safe limits, treatment may commence with close monitoring; significant elevations usually contraindicate initiation.

Are there any dietary restrictions while on nintedanib?

No specific food is prohibited, but taking the capsule with food reduces gastrointestinal irritation. Avoid excessive alcohol to minimize additional liver stress.

Store the capsules in a cool, dry place away from direct sunlight. If ambient temperatures exceed the recommended range, keep the medication in a temperature-controlled cabinet or insulated container.

Do I need to inform my employer if I am taking nintedanib for a job that requires regular health screenings?

Informing a health professional conducting the screening is advisable, as certain laboratory tests (e.g., liver function) may be required. Disclosure to an employer is not mandatory unless workplace policies specifically address medication use.

Is a dose reduction ever necessary for elderly patients?

Elderly individuals may experience increased sensitivity to side effects, particularly gastrointestinal upset and liver enzyme changes. A lower starting dose or slower titration may be considered based on clinical judgment.

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