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Nintedanib

Generic name: nintedanib
Brand name: Ofev
Dosage form: capsule
Drug class: Multikinase inhibitors

Medically reviewed by Melisa Puckey, BPharm. Last updated on Aug 4, 2023.

What is nintedanib?

Nintedanib is a drug that has been approved by the FDA for some types of Interstitial lung disease (ILD) which have symptoms of shortness of breath, a dry cough, feeling tired and chest discomfort.  It is used for types of ILD that cause scarring in the lungs such as idiopathic pulmonary fibrosis (IPF), certain chronic fibrosing interstitial lung diseases (ILDs) and nintedanib helps lung function in people with systemic sclerosis-associated interstitial lung disease.

Nintedanib is a tyrosine kinase inhibitor (TKI), which blocks enzymes in cells in the lungs called tyrosine kinases. Blocking these enzymes helps decrease fibrous tissue forming in the lungs and so stops the symptoms of lung disease getting worse. This medicine is a capsule that is usually taken twice a day with food.

What is nintedanib used for?

Nintedanib is a prescription medicine used:

It is not known if this medicine is safe and effective in children.

Important information

What should I tell my doctor before taking nintedanib?

Before you take this medicine, tell your doctor about all of your medical conditions, including if you:

How should I take nintedanib?

Dosing information

The usual recommended dosage of nintedanib is a 150 mg capsule swallowed whole with liquid, taken twice daily approximately 12 hours apart.
Your dose may be decreased or treatment paused if you have side effects or changes in your liver tests.

What are the side effects of nintedanib?

Nintedanib may cause serious side effects, including:

The most common side effects of nintedanib are:

These are not all the possible side effects of nintedanib. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Interactions

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may affect nintedanib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or planning a pregnancy:

Breastfeeding

If you are breastfeeding or are planning to breastfeed:

Storage

How should I store nintedanib?

What are the ingredients in nintedanib?

Active ingredient: nintedanib

Ofev Inactive ingredients:
Fill Material: triglycerides, hard fat, lecithin.
Capsule Shell: gelatin, glycerol, titanium dioxide, red ferric oxide, yellow ferric oxide, black ink

Ofev
Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA
Licensed from: Boehringer Ingelheim International GmbH

 

Popular FAQ

Nintedanib inhibits a variety of receptor and nonreceptor tyrosine kinases – these are signaling proteins that work as an ON/OFF switch in many cell-to-cell communications. Tyrosine kinases play an important role in cell growth, differentiation, and metabolism and there is substantial evidence that certain tyrosine kinases, notably platelet-derived growth factor receptor (PDGFR), vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptor (FGFR), as well as non-receptor tyrosine kinases, are associated with scar tissue and the progression of pulmonary fibrosis and other interstitial lung diseases. Nintedanib inhibits the following RTKs:

  • PDGFR α and β
  • FGFR 1-3
  • VEGFR 1-3
  • colony-stimulating factor 1 receptor (CSF1R)
  • Fms-like tyrosine kinase-3 (FLT-3)
  • Non-receptor tyrosine kinases: Lck, Lyn, and Src kinases.

Research has shown that nintedanib starts to improve FVC within 6 weeks of starting the medication. FVC (forced vital capacity) is a lung function test that measures the total amount of air exhaled during the forced expiratory volume (FEV) test. This tells your doctor the effect your lung disease has on your ability to inhale and exhale, and this measurement, alongside others such as worsening symptoms or worsening imaging, determine how effective nintedanib is for you at slowing disease progression. Generally, nintedanib is well tolerated and effectively slows disease progression for up to 3 years.

Nintedanib can be taken long-term, and research has shown it is safe for up to 51 months, possibly longer. As long as you are tolerating nintedanib, and it is still slowing your condition's progression, you can keep taking it.

There has been one phase 4 trial that has investigated the combination of Ofev (nintedanib) and Esbriet (pirfenidone) for idiopathic pulmonary fibrosis (IPF) that showed a slightly increased risk of side effects with combination treatment, but the trial was not large enough to make a solid conclusion about increased/decreased effectiveness. Both Ofev and Esbriet slow IPF’s worsening but do not stop its progression, and neither medication is recommended over the other. Because they work on different aspects of the fibrotic cascade, there has been some suggestion that there may be some benefit in combining them. Continue reading

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.