NINTEDONE 100 is an advanced formulation containing Nintedanib 100 mg, developed and marketed by Steris Healthcare Pvt Ltd. This breakthrough medication is approved for the treatment of Idiopathic Pulmonary Fibrosis (IPF), Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD), and certain forms of Non-Small Cell Lung Cancer (NSCLC). With its potent anti-fibrotic and anti-angiogenic actions, Nintedanib plays a pivotal role in slowing the progression of life-altering lung conditions and offering hope to thousands of patients worldwide.
Composition and Formulation
Each film-coated tablet of NINTEDONE 100 contains Nintedanib Esylate, equivalent to Nintedanib 100 mg. The formulation is designed for oral use, ensuring high bioavailability and therapeutic consistency. The tablets are easy to swallow and come in tamper-evident packaging to ensure quality and safety from manufacturing to consumption.
Mechanism of Action
Nintedanib is a tyrosine kinase inhibitor (TKI) that blocks multiple growth factor receptors involved in fibrosis and cancer progression, such as:
Vascular Endothelial Growth Factor Receptors (VEGFR)
Fibroblast Growth Factor Receptors (FGFR)
Platelet-Derived Growth Factor Receptors (PDGFR)
By inhibiting these pathways, Nintedanib 100 mg reduces the excessive cell proliferation and tissue scarring seen in fibrotic lung diseases and impedes tumor angiogenesis in certain cancers.
Uses and Indications
Nintedanib 100 mg uses include several FDA and globally approved indications:
Idiopathic Pulmonary Fibrosis (IPF)
Systemic Sclerosis–Associated Interstitial Lung Disease (SSc-ILD)
Other chronic fibrosing Interstitial Lung Diseases (ILDs) with a progressive phenotype
Advanced or metastatic Non-Small Cell Lung Cancer (NSCLC), particularly adenocarcinoma, in combination with Docetaxel
This wide spectrum of indications showcases its utility in both respiratory and oncology settings.
Dosage and Administration
The standard dose of Nintedanib 100 mg is twice daily, administered approximately 12 hours apart. Tablets should be taken with food to minimize gastrointestinal discomfort. Swallow the tablets whole with water—do not crush, chew, or split them.
In NSCLC treatment, Nintedanib is used alongside Docetaxel, and dosing may be adjusted based on patient response or tolerability. Physicians may initiate dose modifications based on liver enzyme levels or the presence of adverse reactions.
Efficacy and Clinical Evidence
The efficacy of Nintedanib 100 mg has been well established through major global clinical trials:
The INPULSIS 1 & 2 trials confirmed a significant reduction in the annual rate of FVC (Forced Vital Capacity) decline in IPF patients.
The SENSCIS trial demonstrated its ability to preserve lung function in SSc-ILD patients.
The LUME-Lung 1 trial supported its use in NSCLC, showing improved progression-free survival when combined with Docetaxel.
These studies collectively highlight the long-term benefit of Nintedanib in managing complex and progressive conditions.
Side Effects and Safety Profile
Understanding nintedanib side effects is crucial for both patients and healthcare providers to ensure safe and effective treatment.
Nintedanib 100 mg is generally well tolerated, but like all medications, it may cause side effects in some individuals. The most commonly reported nintedanib side effects include:
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Diarrhea
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Nausea and vomiting
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Abdominal discomfort
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Loss of appetite
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Elevated liver enzymes (AST, ALT)
In rare instances, nintedanib side effects may also include:
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Gastrointestinal bleeding
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Thromboembolic events (such as stroke or deep vein thrombosis)
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Liver impairment requiring dose modification or discontinuation
Contraindications and Precautions
Nintedanib is contraindicated in individuals with known hypersensitivity to the drug or its components. It is also not recommended for use during pregnancy due to potential fetal harm.
Caution is advised in patients with:
Pre-existing liver disease
High bleeding risk
Gastrointestinal ulcers or perforations
Cardiovascular history
Liver function monitoring is essential during treatment, especially in patients with hepatic impairment.
Drug Interactions
Nintedanib may interact with several drugs:
Co-administration with P-glycoprotein inhibitors (like ketoconazole) can increase its blood levels.
Drugs like rifampicin may reduce its effectiveness.
Combining it with NSAIDs or anticoagulants increases the risk of bleeding.
Patients should always inform their healthcare provider about all ongoing medications before starting Nintedanib 100 mg.
Warnings and Regulatory Status
Nintedanib carries specific warnings regarding liver toxicity and gastrointestinal effects. It has been approved by the US FDA, EMA, and CDSCO for multiple indications and is included in major respiratory and oncology guidelines.
Proper patient selection and monitoring are essential to optimize therapy and minimize adverse effects.
Patient Advice and Tips
To ensure safe and effective use of Nintedanib 100 mg, patients should:
Always take the tablet with food
Stay well hydrated
Report symptoms such as jaundice, bleeding, or persistent diarrhea
Avoid alcohol and grapefruit juice
Not double doses if a tablet is missed
Attend regular follow-up appointments and liver function tests
Patient education can significantly improve treatment compliance and outcome.
Availability
NINTEDONE 100 is readily available across India and through authorized pharmacy and hospital networks. It is manufactured in Steris Healthcare’s WHO-GMP certified facilities, ensuring consistent quality, affordability, and timely supply. The product is also eligible for global exports and institutional supply under regulatory compliance.
Frequently Asked Questions:
Q1: What is Nintedanib 100 mg used for?
A: Nintedanib 100 mg is used to treat IPF, SSc-ILD, and NSCLC to slow disease progression and improve quality of life.
Q2: What are the side effects of Nintedanib 100 mg?
A: Common side effects include diarrhea, nausea, vomiting, and liver enzyme elevation.
Q3: How should Nintedanib 100 mg be taken?
A: It should be taken with food, twice daily, at 12-hour intervals or as prescribed by a physician.
Q4: Can Nintedanib 100 mg be used in cancer?
A: Yes, it is used with Docetaxel in treating NSCLC, especially adenocarcinoma subtype.
Q5: Is Nintedone 100 available in India?
A: Yes, it is widely available under the brand name NINTEDONE 100 by Steris Healthcare Pvt Ltd.
Why Choose Steris Healthcare Pvt Ltd
Steris Healthcare Pvt Ltd is a name synonymous with trust, innovation, and pharmaceutical excellence. By offering Nintedanib 100 mg under the brand name NINTEDONE 100, the company ensures:
WHO-GMP certified manufacturing
Strict quality control and pharmacovigilance
Competitive pricing for better accessibility
End-to-end technical and logistic support
Ethical practices and timely supply
Whether you are a healthcare professional or a patient, Steris Healthcare provides unmatched value and reliability for long-term therapies like Nintedanib.
Conclusion
Nintedanib 100 mg, available as NINTEDONE 100, is a clinically proven treatment that offers meaningful benefits in progressive fibrotic lung diseases and NSCLC. With robust research backing its use, a favorable safety profile, and global endorsements, Nintedanib has become a vital tool in respiratory and oncology care.
Choosing Steris Healthcare Pvt Ltd as your trusted source ensures quality, safety, and continuous therapeutic support. When it comes to effective and affordable Nintedanib 100 mg, NINTEDONE 100 is a name you can rely on.
