Ofev (nintedanib) (Nintedanib CAPSULE) 100 mg/1

Ofev (nintedanib) is an oral tyrosine kinase inhibitor approved by the FDA as an orphan drug for treating progressive fibrosing interstitial lung diseases. Manufactured by Boehringer Ingelheim, it represents a significant therapeutic advance in pulmonology for patients with idiopathic pulmonary fibrosis (IPF), chronic fibrosing interstitial lung diseases (ILDs), and systemic sclerosis-associated ILD (SSc-ILD).

Strength

100 mg/1

Pack Size

1 BOTTLE in 1 CARTON (0597-0143-60) / 60 CAPSULE in 1 BOTTLE

Manufacturer / TM Owner

Boehringer Ingelheim

Select Quantity

Pack/s

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Indications & Clinical Uses

Ofev is indicated for slowing the rate of decline in pulmonary function in patients with idiopathic pulmonary fibrosis (IPF), a progressive and often fatal lung disease characterized by progressive fibrosis and loss of lung function. It is also used to treat chronic fibrosing interstitial lung diseases (ILDs) with progressive phenotype and systemic sclerosis-associated interstitial lung disease (SSc-ILD). The drug targets multiple pathways involved in lung fibrosis by inhibiting tyrosine kinases including FGFR, VEGFR, and PDGFR. Nintedanib works by reducing fibroblast proliferation and differentiation, key mechanisms in the pathogenesis of pulmonary fibrosis. The patient population includes adults with confirmed diagnosis of IPF or fibrosing ILDs, typically presenting with progressive dyspnea, reduced exercise tolerance, and declining forced vital capacity (FVC). Ofev is particularly valuable for patients with progressive disease who require disease-modifying therapy to delay disease progression and preserve lung function.

Side Effects

Common adverse effects of Ofev include gastrointestinal disturbances such as diarrhea (most frequent), nausea, vomiting, and abdominal pain, which may necessitate dose adjustment or management with antidiarrheal agents. Hepatotoxicity is a serious concern requiring baseline and periodic liver function monitoring. Other notable adverse events include elevated liver enzymes, bleeding risk, and thromboembolic events. Patients require regular monitoring of liver function tests, complete blood counts, and renal function. Gastrointestinal tolerability should be assessed at follow-up visits, and dose modifications may be necessary. Serious adverse events warrant immediate medical attention and possible discontinuation.

Precautions & Warnings

Ofev is contraindicated in patients with severe hepatic impairment and requires dose adjustment in moderate hepatic impairment. It is not recommended during pregnancy due to potential teratogenic effects and is contraindicated in nursing mothers. Pediatric use has not been established. Patients with baseline liver disease, renal impairment, or bleeding disorders require careful monitoring and dose consideration. Caution is advised in patients receiving anticoagulants or antiplatelet agents due to increased bleeding risk. Regular assessment of hepatic and renal function is essential throughout treatment. Patients should be counseled regarding gastrointestinal side effects and advised to report signs of hepatotoxicity or unusual bleeding.

Avoid Interactions

Nintedanib is metabolized via CYP3A4 and glucuronidation; concurrent use of strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) may increase nintedanib exposure. Strong CYP3A4 inducers (e.g., rifampicin, phenytoin) may decrease drug levels. Concurrent anticoagulants or antiplatelet agents increase bleeding risk. NSAIDs should be used cautiously due to gastrointestinal and renal effects. Grapefruit juice should be avoided as it inhibits CYP3A4. Patients should inform healthcare providers of all concurrent medications to assess potential interactions.

Frequently Asked Questions

Ofev (nintedanib) is used to slow the rate of decline in pulmonary function in patients with idiopathic pulmonary fibrosis (IPF), chronic fibrosing interstitial lung diseases (ILDs), and systemic sclerosis-associated ILD (SSc-ILD). It works by inhibiting tyrosine kinases involved in lung fibrosis pathways, reducing fibroblast proliferation and helping preserve lung function in progressive fibrosing lung diseases.

Ofev is administered orally as a capsule, typically at a dose of 150 mg twice daily with food. The medication should be taken consistently with meals to optimize absorption and reduce gastrointestinal side effects. Dose adjustments may be necessary based on tolerability and liver function monitoring.

The most common side effects include diarrhea, nausea, vomiting, and abdominal pain. Elevated liver enzymes may occur, requiring periodic monitoring of liver function. Most gastrointestinal side effects are manageable with dose adjustment, dietary modifications, or supportive care with antidiarrheal agents.

Ofev is manufactured by Boehringer Ingelheim, a global pharmaceutical company specializing in respiratory, cardiovascular, and metabolic diseases.

Yes, Ofev received FDA orphan drug designation for the treatment of idiopathic pulmonary fibrosis and other fibrosing interstitial lung diseases. This designation recognizes its importance in treating rare, life-threatening conditions affecting a limited patient population and provides regulatory incentives for development.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated: 17 Jun 2026

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