Product image of Nintedanib Stada (Nintedanib) supplied by GNH India

Nintedanib Stada

Active Ingredient:
Nintedanib
Origin:
EU

Nintedanib Stada (Nintedanib)

Nintedanib, the active ingredient in Nintedanib Stada, is a tyrosine kinase inhibitor presented as an oral dosage form for oral use. It is indicated for the treatment of idiopathic pulmonary fibrosis and certain forms of lung cancer in adult patients.

GNH India supplies Nintedanib Stada as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.

Manufacturer / TM Owner

Stada Arzneimittel Ag

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Indications & Clinical Uses

Nintedanib acts on pathways involved in fibroblast activity and tumor angiogenesis, making it useful for fibrotic lung disease and certain cancers.

  • Idiopathic pulmonary fibrosis: slows decline in lung function and disease progression.
  • Non‑small cell lung cancer: used in combination regimens to inhibit tumor growth.
  • Systemic sclerosis‑associated interstitial lung disease: reduces rate of forced vital capacity loss.

How It Works

  • Nintedanib inhibits multiple receptor tyrosine kinases—including VEGFR, FGFR and PDGFR—by binding to their ATP‑binding sites. This blocks downstream signaling that drives fibroblast proliferation, migration and transformation, as well as tumor angiogenesis, thereby limiting fibrotic tissue formation and neoplastic vascular supply.

Side Effects

Nintedanib may cause a range of adverse reactions, from mild to serious.

Common Side Effects

  • Nausea: mild to moderate gastrointestinal upset.
  • Diarrhea: frequent loose stools, often requiring supportive care.
  • Vomiting: occasional episodes, usually early in therapy.
  • Abdominal pain: crampy discomfort in the upper abdomen.
  • Decreased appetite: reduced food intake leading to weight loss.
  • Headache: transient mild to moderate head pain.

Serious or Rare Side Effects

  • Elevated liver enzymes: may indicate hepatic injury.
  • Bleeding events: increased risk of gastrointestinal or other hemorrhage.
  • Cardiovascular events: rare cases of myocardial infarction or stroke.
  • Severe infections: opportunistic infections in immunocompromised patients.
  • Gastrointestinal perforation: rare but life‑threatening condition.
  • Severe skin reactions: such as Stevens‑Johnson syndrome.

Precautions & Warnings

Before initiating therapy, clinicians should evaluate several safety aspects.

  • Liver function monitoring: check ALT/AST levels regularly.
  • Bleeding risk assessment: avoid in patients with active ulcers or anticoagulant therapy.
  • Cardiovascular evaluation: caution in patients with recent cardiac events.
  • Gastrointestinal history: monitor for severe diarrhea or abdominal pain.
  • Hepatic impairment: avoid or adjust dose in severe liver disease.
  • Store at ambient temperature: keep in the original container, protect from moisture and light.

Avoid Interactions

Nintedanib can interact with other medicines, requiring careful management.

Major Interactions (Avoid)

  • Strong P‑gp inhibitors (e.g., ketoconazole): may increase nintedanib exposure.
  • Anticoagulants (e.g., warfarin): heightened bleeding risk.
  • High‑dose aspirin or NSAIDs: additive bleeding potential.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inhibitors (e.g., erythromycin): may modestly raise levels.
  • CYP3A4 inducers (e.g., rifampicin): may reduce efficacy.
  • Diuretics: monitor electrolytes and renal function.
  • Antacids containing aluminum or magnesium: may affect absorption if taken simultaneously.

Frequently Asked Questions

Nintedanib Stada is prescribed for adults with idiopathic pulmonary fibrosis, non‑small cell lung cancer (usually in combination with other anticancer agents), and systemic sclerosis‑associated interstitial lung disease. In each case, the drug targets pathways that drive fibrosis or tumor angiogenesis, helping to slow disease progression.

Nintedanib blocks several receptor tyrosine kinases—VEGFR, FGFR and PDGFR—by occupying their ATP‑binding pockets. This inhibition stops downstream signaling that promotes fibroblast growth, migration and transformation, as well as new blood‑vessel formation in tumors, thereby reducing fibrotic tissue and tumor vascular supply.

The specific dose and dosing schedule of Nintedanib Stada are determined by the prescribing clinician based on the patient’s indication, disease severity, renal and hepatic function, and concomitant medications. Patients should follow the exact regimen provided by their healthcare professional.

Safety data for Nintedanib Stada in pregnancy and lactation are limited, and the product is generally not recommended for use in pregnant or nursing women unless the potential benefit justifies the potential risk. Women of childbearing potential should use effective contraception during treatment.

To place an order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain needs) and required import documentation.

Nintedanib differs from other antifibrotics such as pirfenidone by targeting a broader range of tyrosine kinases, which may provide additional anti‑angiogenic effects in cancer. Clinical trials have shown comparable efficacy in slowing lung‑function decline in idiopathic pulmonary fibrosis, but safety profiles and tolerability can vary between agents.

Nintedanib Stada should be stored at ambient temperature, below 25 °C, in its original packaging to protect it from moisture and light. Do not store in areas with high humidity or direct sunlight, and keep the product out of reach of children.

Nintedanib Stada is taken orally, usually with food to reduce gastrointestinal discomfort. The tablets should be swallowed whole with a full glass of water and not crushed, chewed, or split unless specifically instructed by a healthcare professional.

The most serious risks include significant liver enzyme elevations indicating possible hepatic injury, severe bleeding events especially when combined with anticoagulants, and rare but life‑threatening gastrointestinal perforations. Patients should be monitored regularly for signs of these complications.

Nintedanib Stada is contraindicated in patients with known hypersensitivity to nintedanib or any excipients, those with severe hepatic impairment, and individuals with active, clinically significant bleeding disorders. Caution is also advised for patients with uncontrolled cardiovascular disease or severe gastrointestinal conditions.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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