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Ofev

Generic name: nintedanib [ nin-TED-a-nib ]
Drug class: Multikinase inhibitors

Medically reviewed by Judith Stewart, BPharm. Last updated on Sep 20, 2023.

What is Ofev?

Ofev is used in people with diseases that cause scar tissue (fibrosis) to form deep within the lungs. The scar tissue thickens and becomes stiff over time, which can make it harder for your lungs to work. Decreased lung function can make it hard for you to breathe. Other medical problems can occur when your brain, heart, and other organs do not get enough oxygen.

Ofev is used to treat a lung disease called idiopathic pulmonary fibrosis (IPF).

Ofev is also used to treat chronic (long lasting) interstitial lung disease in which the scar tissue keeps getting worse.

Ofev is also used to slow the decline in lung function in people with a disorder called systemic sclerosis-associated interstitial lung disease (sometimes called scleroderma-associated ILD).

Ofev is not a cure for IPF or ILD, but this medicine can slow the effects of these diseases on your lungs.

Warnings

Ofev can cause birth defects or death in an unborn baby. Avoid getting pregnant while you are using this medicine and for at least 3 months after your last dose. Use effective birth control, with an extra barrier method (condom, diaphragm, cervical cap, contraceptive sponge).

Before taking this medicine

To make sure Ofev is safe for you, tell your doctor if you have ever had:

You may need to have a negative pregnancy test before starting this treatment.

Nintedanib can cause birth defects or death in an unborn a baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 3 months after your last dose. Tell your doctor if you become pregnant.

If you use hormonal birth control (birth control pills, injections, implants, skin patches, or vaginal rings), also use a barrier form of birth control to prevent pregnancy while taking Ofev. Barrier forms include a condom, diaphragm, cervical cap, or contraceptive sponge).

Ofev may affect fertility (your ability to have children) in women. However, it is important to use birth control to prevent pregnancy because this medicine can harm an unborn baby.

You should not breastfeed while using this medicine.

Ofev is not approved for use by anyone younger than 18 years old.

Ofev pregnancy and breastfeeding warnings (more detail)

How should I take Ofev?

Ofev is usually taken 2 times per day, every 12 hours. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using Ofev.

Take with food and a full glass of water.

Swallow the capsule whole and do not crush, chew, break, or open it.

Take your doses at regular intervals, usually every 12 hours.

Ofev can cause severe diarrhea, which can be life-threatening if it leads to dehydration. You may need to take medication to prevent or quickly treat diarrhea.

Your doctor may recommend you have an anti-diarrhea medicine such as loperamide (Imodium) available at all times while you are taking Ofev. Take the anti-diarrhea medicine as directed on the label, or as prescribed by your doctor.

Drink plenty of liquids and call your doctor at once if you have diarrhea while taking Ofev.

You will need frequent medical tests to be sure nintedanib is not causing harmful effects on your liver. Your next few doses may be delayed based on the results.

Store this medicine in the original container at room temperature, away from moisture and heat.

Dosing information

Usual Adult Dose for Idiopathic Pulmonary Fibrosis:

150 mg orally every 12 hours
Maximum dose: 300 mg/day

Comments:
-Conduct liver function tests prior to initiating therapy.
-Conduct a pregnancy test in females of reproductive potential prior to initiating therapy.

Uses:
-For the treatment of idiopathic pulmonary fibrosis (IPF)
-To slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD)

Usual Adult Dose for Chronic Lung Disease:

150 mg orally every 12 hours
Maximum dose: 300 mg/day

Comments:
-Conduct liver function tests prior to initiating therapy.
-Conduct a pregnancy test in females of reproductive potential prior to initiating therapy.

Uses:
-For the treatment of idiopathic pulmonary fibrosis (IPF)
-To slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD)

Detailed Ofev dosage information

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not take more than 300 milligrams of nintedanib in one day.

What to avoid

Smoking can make Ofev less effective. Avoid smoking while taking this medicine, or try to quit before you start this treatment.

Avoid taking an herbal supplement containing St. John's wort.

Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), diclofenac, indomethacin, meloxicam, and others. Using an NSAID with nintedanib may cause you to bruise or bleed easily.

Ofev side effects

Get emergency medical help if you have signs of an allergic reaction to Ofev: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

Liver problems may be more likely in women, in people who weigh less than 143 pounds (65 kilograms), and in people of Asian descent.

Your doses may be delayed if you have certain side effects.

Common Ofev side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ofev side effects (more detail)

What other drugs will affect Ofev?

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 interact with 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.

Ofev drug interactions (more detail)

Popular FAQ

If you experience side effects from Ofev such as diarrhea, nausea, and vomiting it may help to avoid the following foods and drinks:

  • Alcohol or caffeine
  • Brassicas, such as broccoli, cauliflower, brussels sprouts, cabbage, collards, or Bok choy
  • Fried or greasy foods, such as French fries, burgers, and fried chicken
  • High-fiber foods, such as beans, lentils, or whole grains
  • Milk or milk products
  • Spicy foods, such as chili
  • Sugar-free candy made with alcohols such as xylitol.
Continue reading

It takes 6 to 12 weeks for Ofev to start working, which has been measured in clinical trials of people with interstitial lung disease as less of a change in lung capacity (as measured by an FVC or Forced Vital Capacity) after at least 6 weeks in those prescribed Ofev. Continue reading

Experts are not sure exactly why Ofev causes diarrhea but research has suggested that it may be due to receptor inhibition (Ofev is a triple receptor [PDGFR, VEGFR, or FGFR] tyrosine kinase inhibitor) or via a direct inflammatory action on intestinal mucosa by Ofev or its breakdown products. Continue reading

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

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.

View more FAQ

References

  1. Ofev Product Label

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Ofev only for the indication prescribed.

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

Medical Disclaimer

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